JP2018023825A - Modular percutaneous valve structure and delivery method - Google Patents

Abstract

A modular prosthetic valve device is delivered in a disassembled state and can be assembled in the body. Module 10 of valve device 30 is delivered sequentially to or near an implantation site in a body cavity. In order to do so, they are connected by a pull wire 40 and assembled remotely using a pull wire. Various locking mechanisms are provided for bringing together device modules. Because it can be delivered as a module, the delivery diameter can be smaller than a pre-assembled percutaneous valve, allowing the use of a delivery device with a smaller diameter. [Selection] Figure 1

Description

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

The present invention relates to a prosthetic valve device for implantation in the body and a method for deploying the device. In particular, the present invention relates to a multi-component or modular percutaneous prosthetic valve device, ie a transdermal valve device that is delivered in a disassembled state and can be assembled in the body, and thus fully assembled. It is related with the artificial valve which can make a delivery diameter smaller than this. The present invention also utilizes a system comprising such a modular valve device and a delivery device having a smaller diameter compared to a delivery device for a fully assembled percutaneous valve device, as well as this small diameter delivery device system. And a method for delivering and deploying such a modular valve device. Furthermore, the present invention relates to a method for assembling a modular valve device, which includes locking device modules together using a locking mechanism.

There are various natural valves in the human body, such as heart valves, esophageal valves, gastric valves, intestinal valves, and valves in the lymphatic system. Natural valves can be altered for a variety of reasons, such as disease and age. A malfunctioning valve cannot maintain fluid flow in a single direction with minimal pressure loss. An example of a dysfunctional valve is a heart valve that may be stenotic (ie, the valve leaflets do not open completely) or closed (ie, the valve leaflets do not close properly). In order to restore the proper functioning of the organ with which the valve is concerned, it is desirable to restore the valve function. For example, with proper valve function in the heart, blood flow is maintained in a single direction through the valve with minimal pressure loss, thereby allowing blood circulation and blood pressure to be maintained. Similarly, with proper esophageal valve function, acid gastric secretion does not cause inflammation or permanent damage to the lining of the esophagus.

Several percutaneous prosthetic valve systems have been described. An example described in Andersen et al. (US Pat. No. 5,411,552) comprises an expandable stent and a folding valve that is placed on the stent prior to deployment. This folding valve may be a biological valve or may be made from a synthetic material. The Anderson prosthetic valve is delivered and deployed using a balloon catheter with a balloon that is used to expand the valve-stent prosthesis to its final size. Further, US Pat. No. 6,168,614 (Andersen et al.) Entitled “Valve Prosthesis for Implantation in the Body” and US Pat. No. 5, entitled “System and Method for Implanting Cardiac Valves”. See 840,081 (Andersen et al.).

Spenser et al. (US Pat. No. 6,893,460) describe 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 composed of a conduit having an inlet and an outlet, and configured to provide a foldable wall at the outlet. is there. The valve assembly is attached to the support stent prior to deployment. The completed valve device is deployed at a target location within the body duct using deployment means such as a balloon catheter or similar device.

Prosthetic valve percutaneous implantation is safer and less expensive than standard surgical procedures and can reduce patient recovery time. However, current artificial percutaneous prosthetic valves have the disadvantage of being extremely bulky even when compressed for delivery. The problem with this bulk is that a delivery catheter with a larger diameter is required. Large catheters are generally not suitable for percutaneous procedures and require phlebotomy procedures and surgeons and / or complex and difficult perforation suture techniques. Furthermore, the current valve devices and delivery systems are bulky and large in diameter, coupled with the anatomy that needs to deliver these devices through, leading to a success rate of delivery into the body cavity. , Deployment accuracy, and complication risk. Specifically, the complexity of delivery can be caused by the shape of the body cavity, for example, the large natural curve of the aortic arch and / or the serpentine iliac / femoral artery into which the catheter is introduced. In addition, such diameter catheters tend to be less flexible than smaller diameter catheters, especially when loaded with bulky inflexible devices, and such loaded catheters tend to be narrow vessels and especially Manipulating it through a curved blood vessel greatly increases the possibility of damage to the vessel wall.

Accurate placement of current percutaneous valve devices relative to existing innate anatomy is often a problem, especially in the case of aortic valve replacement. A prosthetic valve that is placed in an excessively distal direction (ie, in the direction of the aorta) may block or prevent flow into the coronary artery hole. For example, depending on the location of the coronary ostium, a prosthetic valve or large natural leaflet skirt pressed against the aortic wall may physically or functionally block the hole and impede 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 CARDIOVASCULAR INTERVENTIONS, 1: 74-81 (2008); Webb, JG, et al. , "Percutaneous aortic valve implantation retrograde from the femoral artery," CIRCULATION, 113: 842-850 (2006). This occlusion may be physical or functional. In other words, even if the coronary artery hole is physically open, the flow into the coronary artery is partially impaired by the change in the flow pattern caused by the artificial valve. A prosthetic valve placed too proximally (ie, in the direction of the left ventricular outflow tract) may interfere with the mitral posterior leaflet, atrioventricular node, or his bundle (conducting tissue) . Approximately 30% of patients who have a prosthetic valve placed percutaneously need a pacemaker. The reason is that this valve is placed at the end of the ventricle, either too close to the left leg or on the left leg, and exerts pressure on the electrical conduction device. For example, Piazza, N., et al., "Early and persistent intraventricular conduction abnormalities and requirements for pacemaking following percutaneous replacement of the aortic valve," JACC CARDIOVASCULAR INTERVENTIONS, 1: 310-316 (2008); 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).

US Pat. No. 5,411,552 US Pat. No. 6,168,614 US Pat. No. 5,840,081 US Pat. 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 pacemaking following percutaneous replacement of the aortic valve," JACC Cardiovascular Interventions, 1: 310-316 (2008)

Accordingly, 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 multi-component or modular percutaneous valve devices and systems and methods of delivering a prosthetic valve device in a disassembled state and assembling a 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 percutaneous valve delivery.

A 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 a valve device assembled in the body. The valve module is the part of the valve device that has a leaflet and, when assembled, forms a conduit having an inlet end and an outlet end. The valve module itself may include a plurality of device modules. Further, in one embodiment, the valve module may further include a plurality of valve sections that can be assembled in vivo to form a valve assembly. The valve assembly can then be combined with a support structure into an assembled valve device. In another embodiment, a plurality of device modules may include a plurality of valve sections that can be deployed, assembled into a valve assembly, and implanted without a support structure. Alternatively, individual valve sections may be implanted, for example when the natural leaflet is 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. Further, the system may include a configuration 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 for delivering a modular valve device to a body cavity requiring a valve and a method for assembling a modular valve device within a body cavity. Various methods can be used to deliver the device module to a desired location for assembly in the body. The method includes transcutaneously introducing the valve (in a module) in a disassembled state rather than as a whole by a delivery device such as a catheter. These parts may include a support structure and a valve module. The valve module may be a single piece valve component or a valve assembly including multiple parts. The device modules may be assembled sequentially at the implantation site, or may be sequentially assembled (and then implanted) at a site different from the implantation site. Device modules may be assembled and implanted in any order suitable for a particular valve replacement procedure. Thus, for example, sections of the valve assembly may be assembled at a remote site, such as in the ascending or descending aorta, and then delivered to the target site, where the valve assembly is then coupled to the support structure. . Alternatively, the valve assembly may be combined with the support structure at a 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 merged by a locking mechanism. The locking mechanism of the present invention may be part of the device module, i.e., the locking mechanism is integral with the structure of the device module as a whole, or 1 or prior to delivery and deployment into the body cavity. Attached to two or more device modules. Alternatively, the locking mechanism of the present invention may not be integral with the device module, i.e., at least a portion of the locking mechanism is a separate structure from the modular valve device, i.e., the device module (or multiple modules). Applied to one or more device modules after delivery and deployment into the body, or removed from the valve device during or after the locking process.

For example, in one embodiment, the valve module includes a set of lockable tabs that, when engaged, apply sufficient radial force to the support structure to couple the support structure to the valve module. But you can. In another embodiment, the support structure engages a portion of the valve module that is designed to exert an outward radial force on the support structure, such as a geometrical engagement such as a ring in a groove. A set of composite structures may be included. In yet another embodiment, the valve module and the support structure may each have a female component, and a locking tab having a male component is inserted into the assembled valve device and the assembled valve It may be arranged to mate with both the valve module and the support structure of the device to hold the two components together. In yet another embodiment, a set of pins or rivets may join the valve module to the support structure. In another embodiment, the edges of the unassembled valve module may include an interlocking geometry that allows the edges to be locked together by a ziplock type fastener. Several other embodiments of the locking mechanism are included within the scope of the present invention, as described herein or as will be readily recognized by those skilled in the art. The integral locking mechanism may allow the portions of the device module that are to be locked together to automatically engage when properly positioned.

Furthermore, the device module may be fixed in place by frictional forces or other positive placement forces such as magnetic force, interference fit, or static fit. A pull wire or push rod may be used to position the valve sections relative to each other during assembly of the valve sections to form a valve assembly, and the device modules may be combined to form an assembled valve device. If so, the positioning of the valve module (eg, valve assembly) within the support structure may be assisted. Further, the pull wire may serve to connect the device modules during delivery so that the modules can be delivered and deployed in tandem.

Additionally, a transdermal modular valve is provided by providing a system for valve delivery and a temporary valve that allows the modular valve device to maintain valve function while being assembled and deployed at the implantation site. A method for maintaining valve function during correct assembly and implantation of a device is provided. 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 placed on the support structure of the permanent valve device, such as a valve module of the permanent valve (eg, leaflet substructure, valve assembly, or individual valve section). By implantation, the temporary leaflets may be crushed or flattened. 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 present invention is not necessary for the method of delivering a modular valve device, but is intended to improve the safety and outcome of percutaneous valve replacement procedures.

Advantages that can be realized by the present invention include that the percutaneous prosthetic valve system according to the present invention reduces the bulk of the valve for delivery and increases the flexibility of the delivery device. In addition, the prosthetic valve device is minimally invasive, and the transdermal delivery method reduces traumatic damage and minimizes the complexity of the procedure, thereby increasing the safety of the procedure, The number of medical facilities for installing percutaneous valve replacement procedures will increase. One advantage of installing 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 eased by preventing unrestricted backflow during the replacement procedure. It is. The use of a temporary valve allows the operator to assemble a modular percutaneous valve device, carefully and accurately position the prosthetic valve device, and adjust the position of the valve without adversely affecting the outcome of the valve replacement procedure. 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 module is 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), wherein the valve module further includes a plurality of valve sections.
(4) The valve device according to (1), wherein the plurality of device modules include a plurality of valve sections.
(5) The valve device according to (2), wherein the valve module is a leaflet substructure.
(6) The valve device according to (2), wherein the valve module is a 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 integrated 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 a body in need of the artificial valve device, including a delivery device and the valve device according to any one of (1) to (6) above.
(13) The system according to (12), further including a temporary valve.
(14) The system according to (12), further including a first tube.
(15) The system according to (12), wherein the delivery device is a catheter.
(16) providing a delivery device containing 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 includes a support structure and a plurality of valve sections, and the deploying step includes deploying the support structure and then deploying the valve section. The method described.
(18) the device module comprising a support structure and a plurality of valve sections and assembling;
Assembling the valve sections to form a valve assembly;
Assembling the valve assembly and the support structure to form a valve device.
(19) The device module includes a locking mechanism, and the method includes:
The method according to (16), further comprising the step of uniting the modules with the locking mechanism.
(20) The delivery device further accommodates a plurality of pull wires, wherein the pull wires each connect and assemble two or more device modules further comprising assembling the device module using the pull wires. The method according to (16) above.
(21) the device module comprising a support structure and a plurality of valve sections, and assembling;
Assembling the valve sections to form a valve assembly;
Assembling the valve assembly and the support structure to form a valve device.
(22) The device module includes a first locking mechanism and a second locking mechanism, and the method includes:
The method of (21) above, further comprising the steps of uniting valve sections with the first locking mechanism and attaching a valve assembly to a support structure with the second locking mechanism.
(23) the delivery device further includes a plurality of pull wires, the plurality of pull wires including a first pull wire and a second pull wire, and assembling the valve section using the first pull wire; Forming the valve assembly; and assembling the valve assembly and support structure using the second pull wire to form a valve device.
(24) A method of delivering a prosthetic valve device to a body cavity in need of the prosthetic valve device,
Introducing a modular valve system including a delivery device and a valve device into a body cavity, wherein the valve device includes a plurality of device modules;
Deploying the device module from the delivery device;
Assembling the device module.
(25) The above (24), wherein the device module includes a support structure and a plurality of valve sections, and the deploying step includes deploying the support structure and then deploying the valve section. The method described.
(26) the device module comprising a support structure and a plurality of valve sections and assembling;
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 assembling,
The method of (24) above, comprising forming a valve device assembled using the pull wire.
(30) The device module includes a locking mechanism, and the method includes:
The method according to (24), further comprising the step of uniting the device modules with the locking mechanism.
(31) The system further includes a temporary valve, and the method includes:
The method according to (24), further comprising deploying the temporary valve.

In this embodiment, it is a figure which shows one Embodiment which assembles a modular artificial valve device (lower part) by combining a valve module (illustrated in the upper part) and a support structure (center) by using a pull wire. . FIG. 3 illustrates one embodiment of a valve module that includes a plurality of valve sections. In this example, three valve sections are assembled to form a valve assembly. 4 shows a valve device comprising four device modules, ie three valve sections (constituting the valve module) and one support structure that can be successively loaded onto 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 a desired site in the body. FIG. 6 illustrates one embodiment of a method in which a pull wire may be used to assemble one embodiment of a valve device that includes four device modules. FIG. 4A illustrates a pull wire threaded through an unassembled module of a valve device such as the embodiment illustrated in FIG. FIG. 4B illustrates the use of a pull wire and push rod to assemble the valve section into a valve assembly. FIG. 4C illustrates the use of a pull wire and push rod to assemble the valve assembly and support structure into a valve device. FIG. 6 shows a valve module including a leaflet substructure in an unassembled configuration (FIG. 5A), a delivery configuration (FIG. 5B), and assembled into a valve component (FIG. 5C). FIG. 7 shows a valve module including a leaflet-ring in an unassembled configuration (FIG. 6A), a delivery configuration (FIG. 6B), and assembled into a valve component (FIG. 6C). FIG. 3 illustrates one embodiment of a locking mechanism for combining the leaflets of FIG. 2 to form a valve assembly. FIG. 6 shows an embodiment of a locking mechanism for mounting a valve module on a support structure. FIG. 6 is a view showing an embodiment of a locking tab as an integrated locking mechanism for attaching a valve module to a support structure. FIG. 6 shows an embodiment of a stud-harbor lock as an integral locking mechanism for attaching a valve module to a support structure. FIG. 10A shows a stud located on the ring of the valve module and a harbor located on the post of the support structure. FIG. 10B shows the stud docked in the harbor located on the post of the support structure. FIGS. 10C and 10C 'show the vertical channel on the stud as part of the ridge / channel base lock between the stud and the harbor in front and top views, respectively. 10D and 10D 'show the vertical ridge on the harbor as part of the ridge / channel base lock between the stud and the harbor in side and front views, respectively. FIG. 6 shows an embodiment of a quick release locking mechanism for attaching a valve module to a support structure. It is a figure which shows one Embodiment of the snap-fit lock as an integrated locking mechanism and a non-integrated locking mechanism. FIG. 12A shows a non-integral snap-fit lock for attaching a valve module to a support structure. FIG. 12A 'shows a snap-fit prong. FIG. 12B shows another embodiment of a non-integral snap-fit lock with the valve module attached to the support structure by a snap-fit receptacle. FIG. 5 shows an interlocking geometry as a non-integrated locking mechanism for attaching a valve module to a support structure. FIG. 13A shows the pin. FIG. 13B shows the pins in use. FIG. 13C shows a peg. FIG. 13D shows the rivet. FIG. 13E shows a stud-tube connector. It is a figure which shows the some aspect of one Embodiment of an interlocking curve groove | channel mechanism. FIG. 14A shows in side view how a string can be used to attach the side of an unassembled valve module to an interlocking curved groove mechanism. FIG. 14B shows a cross-sectional view of one embodiment of an interlocking curved groove mechanism. 14C and 14C 'show cross-sectional views of another embodiment of an interlocking curved groove mechanism in an unlocked state (FIG. 14C) and a locked state (FIG. 14C'). It is a figure which shows the post attached to the support structure. FIG. 2 shows an embodiment of a temporary valve as part of a delivery system according to the present invention. FIG. 5 shows an embodiment of a temporary valve attached to a support structure and delivered together.

The present invention relates to implantable modular percutaneous prosthetic valve devices, systems, and transdermal delivery of implantable percutaneous modular heart valve devices and other implantable percutaneous modular valve devices into body cavities. And 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 artificial valve device of the present invention includes a plurality of device modules for delivery and in vivo assembly. These device modules can be delivered to desired locations in the body, such as near the valve implantation site, the valve implantation site, or a position slightly away from the implantation site, and assembled by assembling at those locations. Valve devices can be formed. 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, houses the valve module, and holds the valve module in place within the body cavity. The valve module includes the leaflets of the valve device and, when assembled into an operating configuration, forms a conduit having an inlet end and an outlet end. The valve module may include a plurality of device modules or may be a single device module.

As used herein, the term “device module” is delivered in an unassembled state, such as a support structure, leaflet substructure, or valve section (eg, part of a valve assembly), and then the valve Refers to the components 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 a part of a permanent valve device comprising one or more 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 a temporary function, as distinguished from a modular valve device that is a valve that is “permanently” installed. The terms multi-component and modular are used interchangeably herein. The terms “transplant site”, “transplant 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 leaflet) that can be assembled into a valve assembly. The multiple valve sections are shaped so that they can be attached together to form a valve assembly that opens and closes to allow unidirectional fluid flow. The valve section or leaflet functions to closely match the physiological function of the normally functioning native valve. The support structure and valve section can be delivered sequentially into the body cavity. The valve sections can be combined into the valve assembly within the support structure, or can be combined within the support structure after being combined into the valve assembly. Alternatively, the valve sections may be assembled one by one to the support structure to form an assembled valve device.

In another embodiment, the modular valve device may include a plurality of valve sections that are delivered, assembled and implanted without a support structure.

A valve assembly that 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 may re-adjust the position of the support structure relative to the vessel wall or re-adjust the position of 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, a support structure, and a valve module that is a single valve component. The two device modules can be delivered sequentially to the body cavity and assembled in the body. The single 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 operating configuration with a conduit.

In one embodiment, the one-piece valve component has a leaflet substructure, i.e., a first end, a second end, and a base-tip axis in an unassembled configuration. It may be a substantially flat single layer structure. Unassembled leaflet substructures are rolled into a delivery configuration, such as by rolling along a single axis, and delivered away from (or fixedly coupled to) the support structure. Can be unfolded and attached to the valve component (actuating configuration), and the first end and the second end can be locked together. The leaflet sub-structure comprises a plastically deformable member that can be formed into a ring that is wrapped with the valve leaflet sub-structure and helps to deform the leaflet sub-structure into its assembled operating configuration. . In another embodiment, the one-piece valve component has a leaflet-ring, i.e., a first end, a second end, and a base-tip axis, in an unassembled configuration. A substantially flat two-layer structure may be used. This unassembled leaflet-ring can be wound into a delivery configuration, such as by winding along a single axis. The folded, unassembled leaflet ring can be delivered and then opened and attached to the valve component (actuated configuration). The leaflet-ring includes a plastically deformable ring member that is in an unassembled configuration that can maintain the leaflet-ring in an unassembled configuration, and that the member is expanded to remove the leaflet-ring. Having an assembled configuration that can be maintained in an assembled operational configuration.

In any embodiment, after transforming the unassembled shape into an assembled actuation 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 that includes a self-assembling member and a method that can be used to fold and assemble this one-piece valve component was filed on January 12, 2010. Figures 2a-4b and paragraphs 43 and 48 of co-pending US patent application Ser. No. 12 / 686,338 (Self-Assembly) entitled “Self-Assembling Modular Percutaneous Valve and Methods of Folding, Assembly and Delivery”. ˜57. This 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 divided along a circumferential axis to include, for example, two expandable tubular structures that are aligned longitudinally and can be assembled by linking together. In one such embodiment, each part of the multi-part support structure is delivered as two or more compressed tubes while having a higher radial stiffness than a one-piece support structure. It is possible to maintain longitudinal flexibility during delivery. Alternatively, the support structure may be delivered as a bisected tube that can be split along the longitudinal axis and each half compressed into a smaller diameter than the overall support structure.

As used herein, “assembled” means that the valve assembly, valve component, or valve device is substantially in an operating configuration (eg, not a flat, rolled or separated device module). Means that the modules are not necessarily locked together. Furthermore, the assembled configuration can also be referred to as an actuating configuration where the valve module is substantially tubular and forms a conduit having a leaflet in place. An “unassembled” valve module may be folded for delivery (delivery configuration) or may be open and ready for assembly. A “non-assembled” single piece valve component may comprise a leaflet substructure having a first end and a second end, the leaflet substructure being at their ends. Can be configured into a ring as described above so that the assembled valve components are formed (actuated configuration). Similarly, as described above, an “unassembled” valve assembly includes a plurality of valve sections that are configured, for example, in a ring shape, to optimize the folding of the module for delivery. Instead, they can be combined in a vertical state, such as being arranged in a row. 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 particular advantages with regard to 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 cannot be realized in current percutaneous valve devices.

The present invention provides a locking mechanism for bringing together the modules of an implantable modular percutaneous valve device or the ends of one piece of unassembled valve components. The locking mechanism of the present invention can be an integral locking mechanism or a non-integral locking mechanism. “Integrated” is 1 or 2 in that the component (or components) of the locking mechanism is attached to the device module during delivery or is structurally part of the device module. It means that it is continuous with the above device modules. The integral locking mechanism generally provides locking of the device module during or after assembly. “Non-integrated” means that the locking mechanism is delivered in one or more structures that are separate and spaced apart from the device module, preferably in the same delivery device as the device module, after the valve device is assembled. Applied to device modules, meant to include device modules that are locked together or removed from the valve device during or after the locking process. For example, a non-integral locking mechanism may be delivered separately and applied to the device module after the valve device is assembled to lock the device modules together. Alternatively, the non-integral mechanism may be a member that prevents locking, such as a blocking tab, that can be removed to allow the modules to be locked together. Non-integral locking mechanisms may partially utilize integral features of the device module, such as holes, grooves, or other structural parts that interact with the non-integral parts. The integrated locking mechanism of the present invention may also be applicable to lock together parts of a pre-assembled percutaneous valve device.

For example, the valve section (or the side of the valve leaflet substructure) is an integral locking mechanism such as a fitting joint type component, slotted hook mechanism, interlocking curved groove (ziplock) mechanism, interference fit, friction locking , Snap-fit prongs and integral snap-fit mechanisms with snap-fit receptacles, and anchoring components, fishing hooks, interconnecting or interlocking geometries (eg, dovetails or pins, pegs, rivets, or stud-tube connectors) May be attached. Alternatively, the side of the valve section or leaflet substructure includes a non-integrated snap-fit mechanism with snap-fit prongs and snap-fit receptacles, pressure locking connectors, and pins, pegs, rivets, stud-tube connectors, etc. May be combined using separate (non-integral) locking components, such as non-integral interlocking geometries.

Similarly, the present invention provides a locking mechanism for combining the valve module and the support structure. For example, the valve module and support structure may include a hook-groove component, a slotted hook mechanism, a locking tab, a stud-harbor lock, a snap-fit joint component, an integral snap-fit mechanism, a tacking component, a fishing hook, and a pin, It may be attached by an integral locking mechanism, such as integral interlocking geometries such as pegs, rivets, and stud-tube connectors. Alternatively, the valve module and 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). A locking component (non-integral) may be used to merge.

These locking mechanisms may be manufactured from the same material as the support structure, such as, for example, a stainless steel, a shape memory alloy such as Nitinol, or an amorphous metal of a suitable atomic composition such as cobalt chrome, or It may be made from 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 pre-loaded in a delivery device such as a catheter or other similar device known in the art, or the delivery device is in a body cavity. It may be loaded into the delivery device after it has been inserted. The support structure and valve module (or valve section) may be loaded into the catheter in tandem. Alternatively, the support structure may be initially loaded and delivered into the catheter, and then the valve module or valve section is loaded into the catheter in tandem and delivered into the support structure where the finished device is assembled. May be.

Furthermore, 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 can be delivered sequentially within a suitable delivery device, such as a catheter, such as an intravascular catheter or an intraluminal catheter. The device module may be provided preloaded in the delivery device, or 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, such as a body cavity or an implantation site, to form a fully assembled valve device and uses the locking mechanism of the present invention. Can be combined. Device modules may be assembled, for example, using pull wires to position modules or module parts relative to each other. For example, multiple valve sections may be coupled via a pull wire for sequential delivery, and further, after being delivered in tandem and positioned at a target site, a device can be used during assembly of the valve section using the pull wire. Modules may be positioned relative to each other. The pull wire may also facilitate coupling of the valve section to the support structure via a locking mechanism and may assist in positioning the valve assembly within the support structure to form an assembled valve device. In other embodiments, the push rod may be used to assemble the device module alone or with other members, such as in combination with a pull wire. The push rod may be, for example, a stiff wire or a tubular structure. The remote operation of the device module facilitates the assembly of parts in the body. Alternatively, the device module may be provided in paragraphs 38-38, 45-46, 51-69, and FIGS. 2a-c of co-pending US Patent Application No.
10 may be assembled by utilizing, at least in part, a self-assembling member, such as a shape memory wire or shape memory band. This application is incorporated herein by reference. For example, a 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. It may be delivered attached to the self-assembling member, and a locking mechanism according to the present invention may lock the edges of the leaflet substructure together. The second self-assembling member may assist in the assembly of the valve component and support structure, and the valve component and support structure may then be attached using the locking mechanism of the present invention. The valve module may be adjustably coupled to the support structure to allow 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 by the methods described herein, a diameter smaller than that currently required for percutaneous artificial valves of the art. The artificial valve can be delivered percutaneously through the body cavity. For example, the holes required for insertion of the prosthetic valve into the body by reassembling the modules of the valve device one by one at the final implantation location, such as the ascending aorta, or in the body cavity before repositioning the location to the final target site The size of the device, and the ease and flexibility of delivering the device to the desired location within the vessel. The reduced profile of the unassembled valve device of the present invention allows the delivery device of the present invention to have a significantly smaller diameter than the typical diameter of a delivery device required in the art. Thus, for example, a 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 valving 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 the assembly of a percutaneous modular valve that takes approximately 30 seconds or more can proceed. May be. Since this temporary valve is only used temporarily, the temporary valve need not function repeatedly, as expected, in an optimal condition over a long period of time, as required for a permanent valve. Absent. Also, the temporary valve need not be fully opened or fully closed. Temporary valves do not need to have the same functional accuracy and duration, do not need to be made of the same material, or need to have the same long-term persistence in the body, so temporary valves are more efficient It is possible to have a simple design. The temporary valve can be made from a thin material, and the leaflets need only be partially attached to perform a sufficient temporary function during the replacement procedure, and therefore the temporary valve Can be configured to occupy less space, for example during delivery.

In one embodiment, the temporary valve is placed on the delivery device and deployed quickly without the need for precise placement, so that 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 or moved from the permanent valve implantation site. In another embodiment, the temporary valve may be attached to the support structure such that a valve function is 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 to a precise position within the support structure without much concern that proper blood flow is impeded. Bring. The valve module (or multiple valve modules) may be placed over the temporary valve and combined with the support structure. Preferably, the temporary valve is a single piece, such as a membrane with a simple design that is easy to fold for transdermal delivery, easy to install, and easy to pop open for operation. It is a structure. Alternatively, the temporary valve may include more than one piece, but is preferably still easy to fold for delivery, easy to install and easy to pop open for operation It is.

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

The devices, systems, and methods of the present invention are specifically configured for use in percutaneous aortic valve replacement, but include other heart valves such as pulmonary valves, mitral valves, and tricuspid valves, and peripheral It can also be used as a replacement for valves in other body cavities in the vasculature or in the digestive tract, lymphatics, collecting bile ducts, and any other body cavity with valves that require replacement or need valve implantation it can. If the modular valve device is designed to replace an aortic valve, the device may be in the ascending aorta, in the descending aorta, in the ventricle, the implantation site, or part in the implantation site and part in the aorta. May be assembled. Although these devices, systems, and methods are specifically configured for use within a body cavity of a human body, application in animals is also possible.

The valve component and valve assembly of the modular valve device can be manufactured from suitable materials such as polymers, metals, or biological materials. The choice of material, structure, and manufacturing method is preferably made to optimize valve function, durability, and biocompatibility.

The support structure is preferably expandable so that it can be delivered in a compressed (unexpanded) state and then expanded for implantation and assembly of the valve device. The support structure may be manufactured from a biocompatible material that is sufficiently durable that the structure can support the valve component while maintaining the position of the device within the body cavity. The support structure material is also compatible with delivery of the support structure in a compressed state and expansion of the compressed support structure upon deployment within a body cavity. In one embodiment of the invention, the support structure is made from stainless steel or a shape memory alloy such as Nitinol. In another embodiment, the support structure may be made from an amorphous metal alloy of appropriate atomic composition as known in the art. Other embodiments may be made 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 will be implanted. One non-limiting example of a suitable support structure is a stent. The stent, or any other support structure, can be self-expanding or balloon expandable. Other similar support structures are known in the art and can be substituted for the stents according to the present invention.

Upon deployment, the support structure is secured within the body cavity wall so that the valve assembly does not move within the body cavity and is not displaced from the desired position, for example, due to fluid flow pressure in the valve or its impact on a closed valve. As such, it should engage the body cavity wall. The support structure may include a locking mechanism, such as those described herein, for securing the valve assembly (or valve component) therein. In addition, 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 place.

The devices and methods of the present invention are specifically configured for use in percutaneous aortic valve replacement, but include other heart valves such as pulmonary valves, mitral valves, and tricuspid valves, and in the peripheral vasculature It can also be used as a replacement for valves in other body cavities, such as or any other body cavity having a gastrointestinal tract, lymphatic duct, collecting bile duct, and valves that require replacement or need valve implantation. If a modular valve device is designed to replace an aortic valve, the device may be in the ascending aorta, in the descending aorta, in the left ventricle, at the implantation site, or part at the implantation site and part at the aorta. May be assembled. Although these devices, systems, and methods are specifically configured for use within a body cavity of a human body, application in animals is 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 an illustrative understanding of the invention and to schematically illustrate certain embodiments of the invention. Similarly, other similar examples will be readily recognized by those skilled in the art within the scope of the present invention. The drawings are not intended to limit the scope of the invention as defined in the appended claims.

FIG. 1 illustrates one embodiment of a method by which the valve module 10 and support structure 20 of a modular artificial valve device can be assembled. In order to show how to combine a valve module and a support structure 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 support structure 20 can be assembled with 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 retracted into the support structure 20 using a pull wire 40 that may be coupled to both modules, and then the valve module 10 may be attached to the support structure 20. This assembly step may be performed, for example, in the body cavity of the aortic outflow tract or in the ascending aorta. 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. in a non-tandem state (not shown). For example, the support structure 20 is delivered and deployed in the 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. Also good.

FIG. 2 shows one embodiment of a modular valve device having four device modules, namely a support structure (not shown) and three valve sections 50a-50c. The valve sections 50 a-50 c are designed to merge to form the valve assembly 15. In use, the valve section operates in a manner similar to a tissue fold in a natural valve. The valve sections 50a-50c may be pre-attached to the pull wire 40 or string and connected by the pull wire 40 or string.

The pull wire 40 or string can have two purposes. First, the pull wire 40 can tether the valve sections 50a-50c together for delivery so that the valve sections 50a-50c can be delivered through the body cavity in tandem. Secondly, a 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. An example of how pull wires may be used to assemble the modular valve device of FIG. 2 is that the pull wires are tightened one at a time, pulling the valve sections together, thereby forming a valve assembly within the support structure. Alternatively, or alternatively, the valve sections can be pulled together outside the support structure, thereby forming a completed valve assembly and further guiding the valve assembly into the support structure. Other means for positioning and attaching 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 pulling the pull wire 40 and assembling the valve assembly 15 and the support structure 20 in the same manner as illustrated in FIG. Valve sections 50a-50c may be coupled to support structure 20 (see FIG. 3) such that a valve device (not shown) is made. The exact number of valve sections may vary from embodiment to embodiment, but in particular, the valve assembly may comprise, for example, 2-6 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 that form an assembled valve assembly. The valve assembly is secured within the body cavity by a support structure. An assembled valve device designed to replace a mitral valve has, for example, three device modules, i.e. two valve sections that form an assembled valve assembly that is secured in a body cavity by a support structure. May be.

FIG. 3 schematically illustrates how the four modules of the embodiment illustrated in FIG. 2 may be packaged for delivery into a body cavity. The four device modules are connected by a pull wire and may be delivered in tandem with a 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 tied to the valve section. As illustrated in FIG. 3, the support structure 20 and the three valve sections 50a-50c are loosely connected by a pull wire 40 to allow continuous delivery and assembly. As illustrated on the right side of the drawing, the module is folded into a delivery configuration for loading into a delivery device, in this case a catheter 60. Support structure 20 may be self-expanding and / or may be crimped onto a balloon for delivery and deployment, or by other means known in the art. It may be expanded from a compressed configuration. A series (four in FIG. 3) of modules is then introduced into the catheter 60 so that the loaded catheter can be used to deliver the modules to a deployment site within 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 requirements of the particular procedure. In one embodiment where the catheter 60 is an intravascular catheter, the valve device module may be one that can be placed on a guide wire.

The method of delivering and assembling an 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 the support structure 20 and the plurality of valve sections 50a-50c, is placed via a suitable blood vessel at the final location where the valve device will be implanted. May be sent. The support structure may be initially deployed so that it can receive the valve section. When the support structure is in place, the valve sections 50a-50c may be deployed sequentially, and in the embodiment illustrated in FIG. 3, the valve sections are connected together and deployed in tandem. . Valve sections 50a-50c can be combined as described above, for example, using pull wire 40, to create valve assembly 15. The module 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 may be assembled as shown in FIG. It may be positioned in the body 20. Once the valve sections 50a-50c are assembled to form the valve assembly 15 within the support structure 20, each valve section 50a-50c may be sequentially attached to the support structure 20 and then merged. The valve sections 50a-50c may be merged and the valve assembly may then be secured to the support structure by any of several 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 securing mechanisms may be configured and used to guide and / or secure the fully assembled valve device to the body cavity wall or the remaining tissue of the natural vessel wall.

The pull wire can be used to loosely link the valve assembly and support structure for delivery, but also to allow the modules of the device to be combined or assembled when the pull wire is pulled by the operator. And may be threaded 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 to remove the pull wire after the device is implanted and secured to 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 is passed. 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 support structure. For example, an activator, mechanical mechanism, or current in the delivery system may be used to assemble the device module by pulling the pull wire.

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

In particular, FIGS. 4A-4C illustrate a push rod having a one-way pull wire and a tubular structure that can be used to assemble one embodiment of a modular valve device that includes four modules, such as the embodiment illustrated in FIG. Is illustrated. FIG. 4A illustrates a first pull wire 41 that is disposed within a body cavity, such as the aorta 81, through the valve sections 50a-50c and including the first loop 41a, and 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. The first loop 41a may be threaded 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. Further, the first pull wire may be threaded 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 a later stage 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 the 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, within the aorta 81. It may be advanced to the nearest valve section (eg, 50c in FIG. 4A). Then, both end portions 41b of the first pull wire 41 are pulled with respect to the first tube 63 so that the valve sections are assembled together to form the valve assembly 15 as shown in FIG. 4B. It can assist in locking the valve sections together. The first tube 63 may then be removed. FIG. 4B shows that in this embodiment, the first loop 41a terminates around the valve assembly 15, but the first pull wire 41 and the first loop 41a are to the valve assembly of the valve section. It can be passed through the valve section in any way that facilitates assembly. 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 threaded through the independent support structure 20, and the second pull wire 42 is threaded through the valve assembly 15.

The support structure 20 may then be positioned and expanded at the implantation target location 70 of the valve device. As shown 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 valve assembly 15 and the support structure 20 can then be assembled into an assembled valve device by pulling both ends 42b of the second pull wire 42 against the second tube 64. 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 pulling the second pull wire 42 stepwise and then locked to the support structure 20. The second tube 64 may then be removed. FIG. 4C illustrates that in this embodiment, the second loop 42a terminates around the support structure 20, while the second loop 42a is within the valve device assembly and support structure 20. FIG. The support structure 20 may be threaded in any manner that facilitates positioning of the valve assembly 15. Further, FIG. 4C shows the support structure 20 deployed and expanded to press the natural leaflet 76 against the aortic wall 82, but if this procedure requires it, The cusps 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 one end. Alternatively, the second pull wire 42 may be tied and cut.

The first pull wire and the second pull wire may include biodegradable materials that remain in place and can be degraded. In the embodiment illustrated in FIGS. 4A-4C, the support structure 20 is positioned and expanded after assembly of the valve sections 50a-50c to minimize the period of inactivity of the valve 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 is left in place and 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 that include more or less than four modules illustrated in FIGS. 4A-4C, including modular valve devices that include only a valve section as a device module. Such methods are possible and are suitably included within the scope of the present invention. For example, a modular valve device that includes two modules, a valve component and a support structure, may be similarly assembled using a pull wire and tube, which is considered in the art in view of the foregoing. Appropriately included in 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-organizing), if desired. Is possible.

5A-5C illustrate one embodiment of a one-piece valve module that may include a leaflet substructure 150 in an unassembled state. This one-piece valve module can be folded in a manner 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, assembled) between the base and the tip, as illustrated in FIG. 5A. Unfolded, unassembled, substantially flat and generally in the form of a rectangle or trapezoid having a height axis (along the longitudinal axis of the valve device) and a circumferential axis 101 May be. In the embodiment illustrated in FIGS. 5A-5C, the leaflet substructure 150 has three leaflets 150a-150c, but in other embodiments, the leaflet substructure has two or more. You may have a 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). The plastically deformable member 100 may be mounted along the circumferential axis 101 of the leaflet substructure, so that, for example, in an unassembled state, the plastically deformable member 100 is illustrated in FIG. 5A. May be attached along the base line 102, along the bond line 103 (not shown), or along other perimeter lines along the base-tip axis. Prior to loading into the delivery device, the leaflet substructure 150 is a cylinder of the leaflet substructure 155 in which the first end 151 and the second end 152 of the leaflet substructure 150 are folded. It may be wound along its circumferential axis from base to tip or from tip to base as illustrated in FIG. 5B to form the end of the shape 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 valve components as illustrated in FIG. 5C. The operation of opening the leaflet substructure 155 from the delivery configuration may be assisted (not shown) by, for example, a balloon catheter, by a pull wire and / or by a push rod, or a combination thereof. In one embodiment, pull wires and / or push rods are used to unravel the structure, the first end 151 and second end 152 of the leaflet substructure 150 and the end of the plastically deformable member 100. Can be ring-shaped, for example circular, elliptical, D-shaped, or any other shape suitable for a valve module. In one such embodiment, the plastically deformable member 100 may be attached to the baseline 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 wrapped in a folded leaflet substructure 155, as illustrated in FIG. 5B. In this embodiment, one or more pull wires (not shown) may be wrapped by the folded leaflet substructure 155 through the base of the leaflet substructure 150. The pull wire, like that illustrated in FIGS. 4B-C, pulls the leaflet substructure 155 from the delivery configuration to an unassembled configuration 150 by being pulled, such as in combination with a tubular push rod. Can help spread. As will be appreciated by those skilled in the art, as an alternative, 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 connected to the valve leaflet. It may be attached to one or more tip portions of the leaflets 150a to 150c of the structure 150 and wrapped in a folded leaflet substructure 155.

In order to form the three-dimensional valve component 110, for example, in one embodiment, the first end 151 and the second end 152 of the leaflet substructure 150 are, for example, a pull wire and / or a push rod (see FIG. (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 is passed (see FIG. (Not shown). The leaflet substructure first end 151 and second end 152 may similarly have a pull wire attached and threaded therein. For example, a push rod, such as a tubular push rod similar to that described above in FIGS. 4B-C, is used in combination with one or more pull wires to allow plastically deformable member 100 and leaflet substructure 150. The ends of each may be pulled together to form a tubular structure (not shown). A balloon catheter is then inserted through the tubular structure and inflated to expand the plastically deformable member 100 and leaflet substructure 150 into a ring-like shape, as illustrated in FIG. 5C. An assembled valve component 110, i.e., an actuation configuration having a conduit, can be formed. The “ring-like shape” may be a circular shape, an oval shape, a multi-leaflet shape, a D shape, or a shape suitable for any other valve device. In order to lock the first end 151 together with respect to the second end 152, as further described below, before expanding into the assembled configuration, or after expanding into the assembled configuration, 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 leaflet ring (leaflet-ring) 250. In this embodiment, the leaflet-ring 250 may have an unassembled configuration, ie, a substantially flat bilayer structure, as illustrated in FIG. 6A. The leaflet-ring 250 may include a plastically deformable ring member 200 that is attached to or incorporated into, for example, the base of a valve module (see FIG. 6C). The leaflet-ring 250 has an unassembled configuration with a two-layer substantially flat shape, as illustrated in FIG. 6A. When crushed to 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. Thus, the leaflet-ring 250 can be held in a substantially flat unassembled configuration. From this unassembled configuration, the leaflet-ring 250 can be moved from its tip to the base or from the base to the tip, for example, as shown by the arrows in FIG. 6A and as shown in FIG. 6B. It may be folded into the delivery configuration 255 by winding along a circumferential axis in the height direction.

A pull wire and / or push rod (not shown) may be used to unassemble the unassembled 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 pull wires, which may be used for delivery. It may be wound together with the pointed ring 250. The rolled leaflet-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, such as when the leaflet-ring is wound from the base to the tip. To assist in opening the leaflet-ring 255 wound from the delivery configuration.

To form the three-dimensional valve component 210, the unassembled plastically deformable ring members 200a, 200b are expanded by using push rods and / or pull wires, or combinations thereof, such as by balloon expansion. Thus, as illustrated in FIG. 6C, the leaflet-ring 250 is transformed into an actuated configuration having an assembled valve component 210 or conduit. In one embodiment, for example, a balloon catheter (not shown) is inserted and inflated through an unassembled leaflet-ring 250 and expanded, thereby forming the plastically deformable ring member 200 in a ring-like shape. Can be expanded. A “ring-like shape” may be circular, elliptical, D-shaped, or any other shape suitable for a valve device. In one aspect (not shown) of this embodiment, the valve leaflet is such that the string or pull wire is connected at one end to the balloon catheter to assist in pulling the balloon catheter into the leaflet-ring 250. -May be pre-threaded through the ring 250; When the leaflet-ring 250 is assembled into a three-dimensional valve component 210, the valve component 210 is combined with a support structure (not shown) using a locking mechanism to provide a support structure (not shown). ) To form an assembled valve device. In an alternative embodiment, the leaflet-ring 250 may be assembled into a three-dimensional valve component 210 within the support structure.

FIGS. 7-15 illustrate examples of locking mechanisms that can be used to secure or attach the device modules together after the device modules are assembled 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 connected to 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 a plurality of attachment points with, for example, a locking mechanism including a male component 16 and a female component 17. The male component 16 and the female component 17 are positioned so that the male component 16 from one valve section matches the female component 17 of another valve section.

As specifically shown in FIG. 7A, for example, a first side in which the first valve section 50a mates with a plurality of female components 17 on the second side 52b of the second valve section 50b. You may provide the several male component 16 on the part 51a. 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 are connected to the third valve section ( The first side 51b of the second valve section 50b matches the plurality of male components 16 on the first side (not shown) of the second valve section 50b. These male components 16 match a plurality of female components 17 on a second side (not shown) of a third valve section (not shown). Similar configurations are possible for valve assemblies that include two, four, five, or more valve sections. 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 support structure. In particular, as illustrated in FIGS. 8A and 8B, the support structure 20 includes a plurality of attachment points including hooks 21. The valve module 10 includes a groove 22 along its proximal edge 12, as defined by fluid flow in the body cavity, ie, the proximal edge 12, which is the "upstream" edge. The hook 21 of the support structure 20 is mounted in the groove 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 throughout the proximal edge 12 of the valve module 10, thereby allowing the hook 21 to capture the groove 22 regardless 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 so as 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 hooks 21 spaced apart along the longitudinal axis to provide more than one attachment position in the proximal-distal direction. It may be. Such a design gives the clinician a degree of 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 tab 392 locks the device module together by an interference fit. The valve module 310 includes or is attached to the ring 300, and the locking tab 392 is attached to the ring 300. As shown in FIG. 9, the locking tab 392 is coupled to the valve module 310 at its base. After the valve module 310 and the support structure are 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 an interference fit lock that uses components that are integral with a valve module that is rotatable about a pivot 395 between an unlocked position 392a and a locked position 392b. Mechanism. Preferably, the valve module 310 has two or more locking tabs 392.

As shown in FIG. 9, the locking tab 392 has a pivot end 397 and a swing end 399, the unlocking position 392a in which the swing end 399 is oriented toward the middle of the valve module; The swinging end 399 operates by rotating between a locked position 392b that is axially oriented, ie, parallel to the longitudinal axis of the valve device. The pivot end 397 has a substantially circular shape and a pivot axis 395, about which the pivot end 397 of the locking tab 392 rotates. As shown in FIG. 9, the pivot shaft 395 is not centered within the substantially circular shape of the pivot end 397 and is in the unlocked position 392a, the pivot end 397. The side edge 394a of the pivot module 397 is substantially flush with the outer periphery of the valve module 310, and at the locked position 392b, the side edge 394b of the pivot end 397 extends beyond the outer periphery of the valve module 310. Sufficient radial force is applied to the support structure to extend and lock the modules together by an interference fit.

10A-D illustrate another embodiment of a stud-harbor lock that is an integral locking mechanism. Stud-harbor locks 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 shown in FIG. 10A, the ring 400 includes a plurality of studs 404 positioned on its outer surface at predetermined intervals around the outer periphery of the ring 400. The stud 404 protrudes from the outer surface of the ring 400 while being fixed outward. A support structure (not shown) comprises a plurality of posts 426 attached thereto on its inner surface and oriented axially. A plurality of posts 426 are attached to the support structure at predetermined intervals around an inner perimeter that matches the stud 404 on the ring 400. Each post 426 includes a plurality of “harbors” 425 (eg, notch grooves, etc.) on the inner surface. Harbor 425 is operable to receive stud 404 in an alignment relationship. Thus, the stud-harbor lock comprises a stud 404 that is positioned on the ring 400 to which the valve module 410 is attached and docked in the harbor 425 that is positioned on the post 426 attached to the support structure, thereby providing Lock the valve module and support structure together.

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

As illustrated in FIGS. 10C and 10C ′, the stud 404 may have a vertical channel 408 and as illustrated in FIGS. 10D and 10D ′, the harbor 425 includes a vertical ridge 4328. You may have. FIG. 10C illustrates the channel 408 in the stud 404 on the ring 400 in a front view and FIG. 10C ′ illustrates the channel 408 in the 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 ratchet mechanism (not shown), the stud 404 and the harbor 425 are angled at a complementary angle relative to each other (eg, in a sawtooth pattern) so that the valve module rotates in one direction, eg, clockwise. May be. The reason is that the front side of the stud 404 is smaller than the rear side. In this embodiment of a ratchet type mechanism for the stud 404 and the harbor 425, the valve module 410 holds the stud 404 in place with the harbor 425 being configured to be in alignment with the stud 404. Up to and including the post 426 may be locked by rotating the valve module 410 in one direction, such as clockwise. At this point, due to the geometry of the stud and harbor, the stud and harbor can be unlocked as needed by rotating the valve module 410 in the same direction, eg, clockwise, relative to the post. For example, counter-clockwise rotation, such as counterclockwise rotation, is prevented by the diameter discontinuity between the ring 400 and the rear side of the stud 404.

FIGS. 11A and 11B illustrate a quick release button locking mechanism comprising a plurality of “buttons” 505 that lock into complementary “harbors” 525. As illustrated in FIG. 11A, the valve module 510 may be attached to the ring 500 or may comprise the ring 500. Ring 500 includes a plurality of buttons 505 positioned on the outer surface thereof at predetermined intervals around the outer periphery of ring 500. The support structure (not shown for clarity) includes a plurality of posts 526 mounted on its inner surface relative to it and axially oriented, as illustrated in FIG. 11B. A plurality of posts 526 are attached to the support structure at predetermined intervals around an inner perimeter that matches the button 505 on the ring 500. Each post 526 includes a harbor 525 (eg, a notch groove) on the inner surface. As illustrated in FIG. 11B, the ring 500, and thus the valve module 510, may be locked to a support structure (not shown) by a button-harbor pair, and a button 505 including a quick release mechanism is provided. Locked in a harbor 525 on a plurality of posts 526 attached to the support structure. 11A and 11B illustrate one 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 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 groove ring on the inner surface of the support structure.

The quick release mechanism of button 505 may comprise a spring, or a push or pull release mechanism, or any other suitable configuration that will be apparent to those 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 activated, the button 505 may be activated to lock into the harbor 525 of the post 526 by protruding outwardly from the outer surface of the ring 500. Similarly, when the safety device is deactivated, the button 505 unlocks the valve member from the device frame by pulling back from the harbor 525 so that it appears substantially flush with the outer surface of the ring 500. The operation is stopped. In an alternative aspect of this embodiment, the button 505 is spring loaded and can be activated and deactivated depending on whether the spring is engaged or disengaged. Activated and deactivated buttons are illustrated in FIG. 11B. Thus, referring to the spring-based system, the button 505a facing the post 526 is restricted from projecting by the post 526 so that the ring 500a moves axially along the post 526 until it faces the harbor 525. It becomes possible. A button 505 facing the harbor 525 protrudes outward from the ring 500 and can be engaged with the harbor 525. If sufficient force is applied, the button 505a can be disengaged from the harbor 525, restricted by the post 526, and the ring 500 can be moved axially along the post 525 again. The option of a post 526 having multiple harbors 525 is further illustrated in FIG. 11B, and this configuration is a simultaneous title entitled “Method and Apparatus for Fine Adjustment of a Percutaneous Valve Structure” filed on the same day as this application. FIG. 1a to Pending US Patent Application No. (Adjustment)
Useful for fine adjustment of the valve module 510 relative to the support structure, as described in detail in Ib and paragraphs 28-29. This application is incorporated herein by reference.

Further, the valve device module may be attached using components that are independent of the device module (ie, not integral with the device module). Non-integrated locking mechanisms can be applied to merge valve sections together or to attach a valve module to a support structure. Thus, independent components can be used as a locking mechanism to join device modules together, as shown by way of example to join a valve module to a support structure as illustrated in FIGS. May be. The locking mechanism of the present invention that is not integral with the device module is preferably of a type that is easily engaged from a remote location, but further provides a fixed fixture that does not disengage in use. Alternatively, the non-integral locking mechanism comprises a member attached to the valve module and / or support structure that prevents engagement until removed, such as a tab that prevents the two components from engaging. Also good.

After the valve module (or plurality of valve modules) and the support structure are assembled and positioned, one or more components are percutaneously placed in 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. FIG. 12A illustrates one embodiment of an independent (non-integrated) snap-fit locking mechanism that uses a single-piece snap-fit prong 692 that includes a leading edge end 692a and a base end 692b. Details of the snap-fit prong 692 are illustrated in FIG. 12A ′. In the embodiment of FIG. 12A, the valve module 610 is attached to, for example, the ring 600 at or near its base, at a predetermined interval around its outer periphery that extends axially from the valve module 610. In addition, a plurality of axial tabs 613 may be provided. Each axial tab 613 includes a hole (not shown), and each hole is 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). The support structure (not shown for clarity) comprises a plurality of posts 626 attached thereto on its inner surface and oriented axially. A plurality of posts 626 are attached to the support structure at predetermined intervals around an inner perimeter that matches (ie, is in alignment with) the valve module axial tab 613. Each post 5626 includes a post hole (not shown), which is further configured to receive a snap-in prong 592 at the same axial level, thereby assembling the valve module 510 and the support structure. And each post hole in the post 626 can be aligned with a hole in the axial tab 613 of the valve module 610.

In another embodiment, as illustrated in FIG. 12B, the snap-fit mechanism is a two-piece mechanism. The snap-fit prong 692 may be received by a snap-fit receptacle 693 opposite the second hole to interlock an interventional device component having an integral hole in which the snap-fit prong can 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, as well as the leading edge 692a of the snap-fit prong 692 How it extends through integral hole 611 in module 610 and integral hole 627 in support structure 620 to engage snap-fit receptacle 693, thereby securing the valve module and support structure. , Schematically. In another aspect of the two-piece snap-fit mechanism (not shown), the snap-fit prong 692 and the snap-fit receptacle 693 may also be used with axial tabs 613 and posts 626.

The snap-fit prong 692 may be disposed from within the assembled valve device to the outside of the valve device, as shown 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 central phrase from the outside of the valve device, as illustrated in FIG. 12A, and first pass through the holes in the post 626 and then through the valve module holes 611. You may pass. In the latter case, snap-fit prongs 692 may be disposed through the valve module and support structure before the support structure is fully expanded and implanted in the implantation 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 FIG. 12B, eg, the first valve section relative to the second side of the second valve section. The side portions of the valve section (not shown) may be attached together, such as attaching the first side portions of the valve leaflets, or combining the side portions of the leaflet substructure. Further, the snap-fit locking mechanism may be an integrated locking mechanism (not shown). For example, the snap-fit prongs may be integral with the post of the support structure, in which case the base end is continuous with the support structure. In this embodiment, the valve module may be provided with a receiving space in alignment with each post, spaced around its outer periphery, which is a hole or a structural equivalent of a snap-fit receptacle, The lumen end of the integral snap-fit prong can 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 two device modules. Alternatively, the snap-fit prongs may be integral with the base of the valve module or a ring attached to the valve module and engage a hole or post attached to the support structure, or The post may comprise a receiving space, for example a 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 mechanism 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 edge 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 front edge end 792a is straight when the front edge end 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 end 792b. It comprises two prongs 795a, 795b adapted to bend flat against the outer surface of the device module sandwich on the opposite side of the device module. As illustrated in FIG. 13B, the pin 792 includes a hole integral with a pin tab 713 extending away from the base of the valve module 710, and a post 726 in a support structure (not shown for clarity). You may arrange | position through the post hole 727 which is integral. 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-assembled member, a plastically deformable ring, or a similar structure. . In the embodiment illustrated in FIG. 13B, the pin 792 is oriented to secure the device module in the direction from the blood vessel side to the lumen side of the valve device, so that the pin 792 initially has a post hole 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 fold the pin prongs 795a, 795b to abut the luminal surface of the pin tab 713. Alternatively, the pin prongs 795a, 795b may be manufactured from a shape memory material having a preset folding configuration. Suitable devices can include inflatable balloon catheters. Alternatively, the pins may be disposed in the reverse 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 and 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 present invention that can be used with a post hole or valve module hole, FIG. 13D shows a rivet 992 according to the present invention that can be used with a post hole or valve module hole, and FIG. Figure 8 shows a stud-tube connector 1092 according to the present invention that may be used with a post hole or valve module hole. The device module has 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 to 13E, or a structure similar to the pin illustrated in FIGS. 13A and 13B. May be manufactured so that it is integral with the device component, thereby eliminating the need to apply an interlocking geometry to the device component, thereby simplifying the locking procedure. Other variations of interlocking geometry that can result in an integral locking mechanism included within the scope of the present invention include dovetail, rivet-type and rivet-type. For example, the stud-harbor mechanism may be designed with a dovetail geometry.

In each of the above embodiments, the ring is, for example, a foldable but rigid portion of the valve module that can be positioned at the base of the valve module, or a plastic deformable member as described herein. May be. As an alternative, the ring can be used, for example, in paragraphs 36-38, 45-46, 51-69 of co-pending US patent application Ser. And may be a self-assembled member, as illustrated in FIGS. This application is incorporated herein by reference.

Another example of an integral interlocking geometry mechanism is an interlocking curved groove mechanism, also referred to in the art as a ziplock mechanism, as illustrated in FIGS. This is particularly useful for coalescing the edges of the valve section or the leaflet substructure. In one aspect of this embodiment, the interlocking curve groove mechanism may be a sliding interlocking curve 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 geometric shape that can be interlocked with the second side 1152 in an alignment relationship. As illustrated in FIG. 14A, the first side 1151 and the second side 1152 of the valve module use strings 1145 or wires that are passed 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. The first side 1151 may have an edge having a bulbous cross-section 1153, and the bulbous edge 1153 has a round shape such as a substantially circular shape as shown in FIG. 14B. However, it may be a rectangle (including a regular square), a triangle, or any other suitable geometric shape, as shown, for example, in FIGS. 14C and 14C ′. The second side 1152 of the valve module has a complementary receiving 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 circular as illustrated in FIG. 14B, the receiving edge of the second side 1152 1154 has a complementary circular cross section in which the bulbous edge 1153 of the first side 1151 is engaged or mated therein by an interlock fit and an interference fit. This locking mechanism preferably has a bulbous edge 1153 and a receiving channel edge 1154 along the entire contact portion of the first side 1151 and second side 1152 of the valve module, respectively, as shown in FIG. 14A. Is called an interlocking curved groove mechanism. Thus, the bulbous edge 1153 may be substantially cylindrical, such as in embodiments having a substantially circular cross section, and the receiving channel edge 1154 is a substantially cylindrical groove. There may be.

As illustrated in FIG. 14C, in another aspect of the interlocking curved groove mechanism, 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, which is a static fit or interference, as illustrated in FIG. 14C ′. It is possible to interlock and hold by fitting.

A valve module in an unassembled configuration may have a single leaflet substructure as described, for example, with respect to FIGS. 5A-C, as well as co-pending US patent application Ser. No. 12 / 686,338 (self In one aspect of this interlocking curvilinear groove mechanism or ziplock embodiment, which is a leaflet substructure comprising a self-assembling member as described in (Organization) paragraphs 52-53 and FIGS. 2a-2c. The first side 1151 and the second side 1152 shown above having an interlocking edge geometry may be the first side and the second side of the leaflet substructure. In this aspect of the ziplock embodiment, a push rod and / or pull wire or guide string is used to complement the bulbous first edge and the second edge of the leaflet substructure, The process of placing the in an alignment relationship may be initiated.

The valve module may include a plurality of valve sections, eg, as described above in connection with FIGS. 2-4C, as well as paragraphs 48-51 of the co-pending US patent application Ser. In another aspect of an interlocking curvilinear groove mechanism or ziplock embodiment comprising a valve section that includes a self-assembling member as described in 1a-1d, the first shown above having an interlocking edge geometry. One side 1151 and second side 1152 may be a first side of a first valve section and a second side of an adjacent second valve section. Thus, as an example of a valve module that includes three valve sections, a linear interference fit mechanism may operate as follows. The first side of the first valve section is mounted in a second side receptacle of the second valve section in an alignment relationship, thereby receiving the second side of the second valve section. You may have a bulbous edge to mate with. The edges of each valve section may be pulled together, such as by a wire 1145 such as a pull wire or string passed through the edge as illustrated in FIG. 14A, or by actuation of a self-assembling member. A push rod may be used in combination with a pull wire or string. A straight 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 a receiving passage on the second side of the third valve section, The first side of the valve section may have a bulbous edge that mates with a receiving channel on the second side of the second edge of the first valve section. In view of the description herein, similar configurations for a valve module 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 fit locking mechanism comprises the 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 includes, for example, the inner surface of the first side 1151 and the first surface. Between the facing surfaces of the first side 1151 and the second side 1152, such as between the outer surfaces of the two side portions 1152, and these facing surfaces are Positioned near the edges of the side 1151 and the second side 1152. The interlocking geometries are shown in FIGS. 6, 7, and 3rd row, lines 31-37 of US Pat. No. 5,540,366 and US Pat. No. 2,039,887. 2, FIG. 3, and in the same manner as shown in the first stage, lines 31 to 36, etc., can be attached by an interference fit. This 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 or first hook edge 1157 of the first side 1151 and the second The side edge 1152 of the receiving edge 1154 or the second hook edge 1158 or the interlocking facing surfaces slid along their edges in a complementary manner, such as a slider ziplock configuration. Such geometric structures may be engaged or mated by a device that places the geometric structures in 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-assembling member having a preset ring configuration, was filed on January 12, 2010. This is described in detail in FIG. 7 and paragraph 60 of co-pending US patent application Ser. No. 12 / 686,338 (self-organizing). This application is incorporated herein by reference. For example, the valve module may be attached to a self-assembling member, such as a ring or band, capable of returning from a delivery configuration to a preset ring configuration, or with such a self-assembling member in the middle. May be passed through. The support structure may have a groove or similar structure that is capable of receiving a ring or band when pushed outward into its preset configuration, thereby allowing the support structure to have an interference fit. Lock the valve module against it.

FIG. 15 shows the post 1226 attached to the 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 expandability of the structure. Preferably, the post is sufficiently flexible so as not to unduly hinder the axial flexibility of the support structure, but is sufficiently radiused to function as needed in the particular embodiment used. It is rigid in the direction. The post may be manufactured from the same material as the valve frame or an equivalent material that does not chemically interact with the valve frame material. In any of the embodiments of FIGS. 9-13, the “post” may be replaced with a groove, such as a notch in the ring on the support structure. Harbors and post holes as described with respect to the embodiment of FIGS. 10-13 may be indentations or holes in the grooves.

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

In any of these embodiments, it may be possible and desirable to adjustably connect 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. A mechanism for adjusting the position of the valve module relative to the support structure was filed on Jan. 12, 2010, co-pending US patent application entitled “Method and Apparatus for Fine Adjustment of a Percutaneous Valve Structure”. 12 / 686,340, paragraphs 21-24, 28-39, and FIGS. 1a-7. This application is incorporated herein by reference. The support structure may also be adjustably connected to the vessel wall.

In embodiments where a temporary valve is used, the temporary valve may be located at the permanent valve implantation site or at a location remote from the permanent valve implantation site. As illustrated by way of example in FIG. 16, in aortic valve replacement, 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 useful in procedures where a modular valve is delivered by a tip approach (ie introducing the device from the ventricular side of the coronary venous 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 be equally preferable to place a temporary valve proximal to the implantation location when a retrograde approach (ie, introducing the device from the arterial side of the coronary venous 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 structure, and in this case has the same width as the delivery system that is the catheter 1360, but the temporary valve may be composed of two or more pieces. Good. One advantage of having the temporary valve co-extensive 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 may be advanced to a position where the modular valve device will be implanted, which in this embodiment is the distal position of the coronary ostia 1386, 1387 in the aorta 1381. Well, the temporary valve 1395 may be actuated to automatically expand, such as an inverted umbrella using, for example, a shape memory wire. In an alternative embodiment (not shown), the temporary valve may include two pieces and be designed so that the device module can be passed through the temporary valve to the implantation site. In an alternative embodiment, the temporary valve can be removed from the delivery device, but can be connected by a pull wire that can be used to withdraw the temporary valve from the aorta when 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 withdrawn after installing the temporary valve for deployment of the permanent valve device module. May be. If the temporary valve is installed at the target site, the support structure can be (1) by 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 before the temporary valve by previously deploying the support structure from the delivery device.

In another embodiment illustrated in FIG. 17, the temporary valve can be attached to a support structure and delivered, deployed and expanded by the support structure. The temporary valve 1495 may be attached to the support structure 1420 by similar means known in the art for sewing, glued, or pre-assembled percutaneous valves, or by removable means. Thus, for example, the temporary valve 1495 is attached to the support structure 1420 in this embodiment, shown as a two-piece structure, before the support structure 1420 is compressed and placed in a delivery device (not shown). . As illustrated in FIG. 17, when the support structure 1420 is expanded, the temporary valve 1495 is deployed until the valve portion of a modular valve device (not shown) is combined with the support structure 1420; Control 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 multiple valve modules) are combined with the support structure 1420. In an alternative embodiment, such a temporary valve 1495 may be removed just 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 accurately placed within the blood vessel (or body cavity) to ensure proper valve function and patient safety. Accordingly, the device and system of the present invention and the method of delivering the device are filed on paragraphs 67-82 and FIGS. 7a-8 of US priority application 61 / 144,007 and January 12, 2010. A System
The modular device described in paragraphs 1a-2 and FIGS. 24-42 of co-pending US patent application Ser. No. 12 / 686,337 entitled “Method and Placing a Percutaneous Valve Device”. It can be used in combination with a placement system and placement method for placement. This application is incorporated herein by reference. Placing a prosthetic valve device in a body cavity with improved accuracy, as described in US priority application 61 / 144,007 and co-pending US patent application 12 / 686,337 (placement) The method includes, for example, attaching an anchor in a body cavity at a permanent valve implantation location and using the anchor to guide the prosthetic valve device to the implantation location. The deployment system includes a valve device, a delivery device, and an anchor. Anchors may include buttons or rivet type devices, hooks, percutaneously inserted lead sutures, interconnecting geometries, or any other type of docking device device. In addition, the system may include a placement wire coupled to the anchor. In an embodiment in which an anchor is coupled to a deployment wire, the method includes passing the deployment wire through the valve device and the free end of the deployment wire exits the proximal end of the delivery device. Loading the valve device in a delivery device and guiding the device in the direction of the anchor along the placement wire may further be included. 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 within a delivery device. Methods for placing a valve device within a body cavity include the use of other types of anchors.

It will be apparent to those skilled in the art that many 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 invention. It will be understood. Accordingly, the scope of the invention is intended to encompass any and all possible variations, additions, modifications, or applications as defined by the following claims.

Claims (35)

A modular transcutaneous prosthetic valve device comprising a plurality of device modules, wherein the device module comprises a valve module, wherein the valve module has a flat unassembled configuration and a folded unassembled delivery configuration. The substantially flat unassembled valve module is either crushed or wound along one 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, wherein at least one of the device modules comprises a locking mechanism and locks the deployed configuration via the locking mechanism; Said valve device. The valve device of claim 1, wherein the valve module includes a leaflet substructure having first and second locking members that interlock in a deployed configuration. The first locking member is formed on a first edge of the leaflet substructure, and the second locking member is formed on a second edge of the leaflet substructure. The valve device described. 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 substructure. The valve device of claim 2, wherein the leaflet substructure partially overlaps in a deployed configuration. The valve module includes a plurality of valve sections, each valve section having first and second locking members, the first one of the plurality of valve sections. The first locking member of claim 1, wherein the first locking member interlocks with a second locking member of the adjacent one of the plurality of valve sections in the deployed configuration. Valve device. The first locking member is formed on a first edge of each of the valve sections and a second locking member is formed on a second edge of each of the valve sections. Valve device. The first locking member is formed on an inner surface of a first end of each valve section, 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 curved groove mechanism or a ziplock mechanism. 6. The valve device according to claim 2 or 5, further comprising a pull wire. 6. A valve device according to claim 2 or 5, further comprising a push rod. The valve device of claim 1, further comprising a self-assembling member. 12. A system for assembling a prosthetic valve device in a body in need comprising the transdermal delivery device and the valve device according to any of claims 1-11 contained within the delivery device. The system of claim 12, further comprising a temporary valve, wherein the temporary valve has one of a one-piece structure and a multi-piece structure. 14. The system of claim 13, wherein the temporary valve is the same area 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 of claim 1, wherein the locking mechanism is integral with the valve module. The valve device of claim 1, wherein the locking mechanism is not integral with the valve module. A method for assembling a modular percutaneous valve device, comprising:
Providing a system comprising a transdermal delivery device comprising a plurality of device modules, the device module comprising a valve module, wherein the valve module is in a flat unassembled configuration and folded unassembled Having a delivery configuration, wherein the substantially flat, unassembled valve module is either crushed or rolled along one axis to form the folded unassembled delivery configuration And at least one of the device modules comprises a locking mechanism;
Deploying the valve module from the delivery device;
Assembling the valve module into a valve device in a deployed configuration; and locking the valve module to the deployed configuration via the locking mechanism. A modular percutaneous prosthetic valve device comprising a plurality of device modules, wherein the device module comprises a valve module, the valve module not being assembled for attachment to a delivery device, and a folded assembled Has a delivery configuration that is not
The unassembled valve module is either (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. 21. The valve device of claim 20, wherein the valve module includes a deformable member having a straight delivery configuration, the deformable member being adapted to assist in transforming the valve module into an assembled operating configuration. . The valve device of claim 21, wherein the deformable member is a linear element. The valve device of claim 21, wherein the deformable member is a ring-shaped element, the ring-shaped element having a bent end that holds the valve module in a flat configuration. 21. The valve device of claim 20, further comprising one or more pull wires, push rods, and a balloon catheter to assist in transforming the valve module into an assembled operational configuration. 21. The valve device of claim 20, wherein the device module includes an expandable support structure, the support structure having a compressed, unexpanded delivery configuration that is spatially separated from the valve module. The valve module has a tip-to-base aspect, a circumferential axis, and a height axis to form a folded unassembled delivery configuration from tip to base and from base to tip 21. The valve device of claim 20, wherein the valve device is wound in a manner selected from the group consisting of: A modular percutaneous prosthetic valve device comprising a plurality of device modules, the device module comprising a valve module, the valve module being unassembled and not assembled for attachment to a delivery device Having a delivery configuration;
To form the unassembled delivery configuration from the unassembled configuration, the valve module is either (a) rolled along one axis or (b) crushed 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. 28. The valve of claim 27, wherein the valve module includes 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. 28. The valve device of claim 27, wherein the deformable member is a linear element. 28. The valve device of claim 27, wherein the deformable member is a ring-shaped element, the ring-shaped element having a bent end that holds the valve module in an unassembled delivery configuration. 28. The valve device of claim 27, further comprising one or more pull wires, push rods, and a balloon catheter to assist in transforming the valve module into an assembled operational configuration. 28. The valve device of claim 27, wherein the device module includes an expandable support structure, the support structure having a compressed, unexpanded delivery configuration that is spatially separated from the valve module. The valve module has a tip-to-base aspect, a circumferential axis, and a height axis to form an unassembled delivery configuration from the tip to the base and from the base to the tip. 28. The valve device of claim 27, wound in a more selected manner. 28. The valve device of claim 27, wherein the valve module includes a leaflet structure. 28. The valve device of claim 27, wherein the transdermal delivery device is a catheter.

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