# Patent

## Title
Circulatory valve, system and method

## Abstract

Apparatuses, systems, and methods for use in a vascular system. The apparatus include a circulatory valve having a valve frame in which frame members define frame cells. Frame cells include joints in opposing relationship, where the joints transition from a first stable equilibrium state through an unstable equilibrium state to a second stable equilibrium state as the joints are drawn towards each other.

## Background
TECHNICAL FIELD
The present disclosure relates generally to apparatuses, systems, and methods for use in the vascular system; and more particularly to apparatuses, systems, and methods for native valve replacement and/or augmentation.
BACKGROUND
Valves of the vascular system can become damaged and/or diseased for a variety of reasons. For example, damaged and/or diseased cardiac valves are grouped according to which valve or valves are involved, and the amount of blood flow that is disrupted by the damaged and/or diseased valve. The most common cardiac valve diseases occur in the mitral and aortic valves. Diseases of the tricuspid and pulmonary valves are fairly rare.
The aortic valve regulates the blood flow from the heart's left ventricle into the aorta. The aorta is the main artery that supplies oxygenated blood to the body. As a result, diseases of the aortic valve can have a significant impact on an individual's health. Examples of such diseases include aortic regurgitation and aortic stenosis.
Aortic regurgitation is also called aortic insufficiency or aortic incompetence. It is a condition in which blood flows backward from a widened or weakened aortic valve into the left ventricle of the heart. In its most serious form, aortic regurgitation is caused by an infection that leaves holes in the valve leaflets. Symptoms of aortic regurgitation may not appear for years. When symptoms do appear, it is because the left ventricle must work harder relative to an uncompromised aortic valve to make up for the backflow of blood. The ventricle eventually gets larger and fluid backs up.
Aortic stenosis is a narrowing or blockage of the aortic valve. Aortic stenosis occurs when the valve leaflets of the aorta become coated with deposits. The deposits change the shape of the leaflets and reduce blood flow through the valve. Again, the left ventricle has to work harder relative to an uncompromised aortic valve to make up for the reduced blood flow. Over time, the extra work can weaken the heart muscle.



BRIEF DESCRIPTION OF THE DRAWINGS
The features of the drawing are not to scale.
FIG. 1 illustrates an example of a cardiac valve according to the present disclosure.
FIG. 2 illustrates an example of a frame cell according to the present disclosure.
FIG. 3 illustrates an example of a joint and compliant section of a frame cell according to the present disclosure.
FIG. 4A illustrates an example of a cardiac valve in an undeployed state according to the present disclosure.
FIG. 4B illustrates an example of the cardiac valve of FIG. 4A in a deployed state according to the present disclosure.
FIG. 5 illustrates an example of a cardiac valve according to the present disclosure.
FIG. 6 illustrates an example of a frame cell and a locking mechanism according to the present disclosure.
FIG. 7 illustrates an example of a frame cell and a deployment mechanism according to the present disclosure.
FIGS. 8A and 8B illustrate a cross-sectional view of an embodiment of a system that includes a cardiac valve according to the present disclosure.
FIG. 8C illustrates a balloon catheter used with an embodiment of the system that includes a cardiac valve according to the present disclosure.



DETAILED DESCRIPTION
Embodiments of the present invention are directed to apparatuses, systems, and methods for native valve replacement and/or augmentation. For example, the apparatus can include a circulatory valve that can be used to replace an incompetent native valve (e.g., an aortic valve, a mitral valve, a tricuspid valve, a pulmonary valve, and/or a venous valve) in a body lumen. Embodiments of the valve include a valve frame having frame members defining frame cells with joints that transition from a first stable equilibrium state through an unstable equilibrium state to a second stable equilibrium state as the joints are drawn towards each other. In one example, embodiments of the present disclosure may help to augment or replace the function of a native valve of individuals having heart and/or venous valve disease.
The figures herein follow a numbering convention in which the first digit or digits correspond to the drawing figure number and the remaining digits identify an element or component in the drawing. Similar elements or components between different figures may be identified by the use of similar digits. For example, 110 may reference element “10” in FIG. 1, and a similar element may be referenced as 210 in FIG. 2. As will be appreciated, elements shown in the various embodiments herein can be added, exchanged, and/or eliminated so as to provide any number of additional embodiments of a valve and/or a system. In addition, as will be appreciated the proportion and the relative scale of the elements provided in the figures are intended to illustrate the embodiments of the present invention, and should not be taken in a limiting sense.
Various embodiments of the present disclosure are illustrated in the figures. Generally, the circulatory valve can be implanted within the fluid passageway of a body lumen, such as for replacement or augmentation of a native cardiac valve structure within the body lumen (e.g., an aortic valve), to regulate the flow of a bodily fluid through the body lumen in a single direction.
The embodiments of the circulatory valve of the present disclosure include a valve frame that self-expands to a first stable equilibrium state. The first stable equilibrium state of the valve frame is a partially deployed state relative the deployed state of the circulatory valve. In this partially deployed state, the position of the circulatory valve relative the desired implant location can be adjusted to correct any foreshortening and/or stent jump that can occur in self-expanding stents as they expand from the small compressed undeployed state. In addition, having the circulatory valve in the partially deployed state prior to completing the deployment allows for adjustments due to movement caused by the flow output from the ventricle pushing on the deployment system, which can be the case when implanting an aortic valve.
As used herein, a partially deployed state of the valve frame lies between an undeployed state (i.e., the state of the valve frame at the time the valve is outside the body) and a deployed state (i.e., the state of the valve frame at the time the valve is to be left in the body). Structures on the circulatory valve can then be transitioned from the first stable equilibrium state through an unstable equilibrium state to a second stable equilibrium state to deploy the circulatory valve.
In the various embodiments, holding the valve frame in the partially deployed state allows the circulatory valve to be better positioned in a desired location prior to its final deployment. This staged deployment of the circulatory valve of the present disclosure is in contrast to circulatory valves that are deployed without the advantage of temporarily pausing at an intermediate deployment stage (i.e., the partial deployment state) to allow for adjustments in the placement of circulatory valve prior to full deployment.
FIG. 1 provides an embodiment of a circulatory valve 100 of the present disclosure. The circulatory valve 100 includes a valve frame 102 and a valve leaflet 104 coupled to the valve frame 102. The valve frame 102 also includes frame members 106 that define a frame cell 108. The frame cell 108 can include joints 110 that transition from a first stable equilibrium state through an unstable equilibrium state to a second stable equilibrium state. In one embodiment, this transition can occur as one or more of the joints 110 are drawn towards each other, as will be discussed herein.
The valve frame 102 has an elongate tubular structure with a proximal end 112 and a distal end 114. In one embodiment, the frame cell 108 of the present disclosure can be positioned so as to provide both the proximal and distal ends 112, 114 of the valve frame 102. In other words, portions of the frame cell 108 define the proximal and distal ends 112, 114 of the valve frame 102. In an additional embodiment, the frame cell 108 of the present disclosure can be located between proximal and distal ends 112, 114 of the valve frame 102 (i.e., portions of the frame cell 108 does not define the proximal end 112 and/or the distal end 114 of the frame 102). In an alternative embodiment, the frame cell 108 of the present disclosure can be located at one of either the proximal end 112 or the distal end 114 of the valve frame 102. Different combinations are also possible.
For the various embodiments, the joints 110 can be located at a number of different positions on the frame member 106. For example, the joints 110 can be located at the same relative position along the frame member 106. So, when a frame cell 108 includes two joints 110, they can be set opposite each other in a mirror image relationship. This aspect of the disclosure is illustrated in FIG. 1, which shows the circulatory valve 100 in the first stable equilibrium state. Alternatively, the joints 110 can be at different relative locations along the frame member 106, as will be discussed herein.
In an additional embodiment, the joints 110 can be located on the frame member 106 such that as the joint 110 transitions from the first stable equilibrium state to the second stable equilibrium state the size (e.g., length) of the perimeter of the valve frame 102 increases. In other words, the joints 110 are located on the frame member 106 in such a way as to cause the valve frame 102 to radially increase in size as the joints 110 move toward the second stable equilibrium state. In one embodiment, the valve frame 102 increases its perimeter size as the frame cell 108 change shape during the joint 110 transition. As will be appreciated, some change to the longitudinal dimension of the valve frame 102 may occur as the perimeter dimension changes.
As discussed, FIG. 1 provides an illustration where the joints 110 of the valve frame 102 are in the first stable equilibrium state. In the various embodiments, this first stable equilibrium state places the valve frame 102 in a partially deployed state. As used herein, a partially deployed state of the valve frame lies between an undeployed state (i.e., the state of the valve frame at the time the valve is outside the body) and a deployed state (i.e., the state of the valve frame at the time the valve is to be left in the body). The valve frame 102 remains in partially deployed state until the joints 110 are moved to the second stable equilibrium state, as discussed herein. In one embodiment, the valve frame 102 in the first stable equilibrium state is eighty (80) to ninety-five (95) percent of the deployed state. Other percentages of the deployed state are possible (e.g., ninety (90) percent of the deployed state).
In the various embodiments, the frame cell 108 can include one or more of the joints 110. As illustrated in FIG. 1, the frame cells 108 include two of the joints 110. In an additional embodiment, each frame cell 108 of the valve frame 102 need not have a joint 110. In other words, a frame cell 108 without a joint 110. So, in one embodiment a valve frame 102 could be configured in such a way that not every frame cell 108 includes a joint 110.
Frame cells 108 not having a joint 110 could be integrated into the valve frame 102 to provide structural characteristics to the frame 102 that are advantageous to the operation of the valve 100. For example, the frame cell 108 without the joint 110 may be more flexible in the radial direction to better accommodate physiological changes at the implant site. Examples of such design properties include, but are not limited to, providing an elastic radial force where the frame members 106 can have serpentine bends that provide for, at least in part, the elastic radial force. Other shapes and configurations for the frame cell 108 (with or without the joint 110) are also possible.
For the various embodiments, the valve frame 102 can be self-expanding. Examples of self-expanding frames include those formed from temperature-sensitive memory alloy which changes shape at a designated temperature or temperature range. Alternatively, the self-expanding frames can include those having a spring-bias. Examples of suitable materials include, but are not limited to, medical grade stainless steel (e.g., 316L), titanium, tantalum, platinum alloys, niobium alloys, cobalt alloys, alginate, or combinations thereof. Examples of shape-memory materials include shape memory plastics, polymers, and thermoplastic materials which are inert in the body. Shaped memory alloys having superelastic properties generally made from ratios of nickel and titanium, commonly known as Nitinol, are also possible materials. Other materials are also possible.
For the various embodiments, the frame member 106 can have similar and/or different cross-sectional geometries along its length. The similarity and/or the differences in the cross-sectional geometries can be based on one or more desired functions to be elicited from each portion of the valve frame 102 and/or the frame cell 108. Examples of cross-sectional geometries include rectangular, non-planar configuration, round (e.g., circular, oval, and/or elliptical), polygonal, arced, and tubular. Other cross-sectional geometries are possible.
The circulatory valve 100 can further include one or more radiopaque markers (e.g., tabs, sleeves, welds). For example, one or more portions of the valve frame 102 can be formed from a radiopaque material. Radiopaque markers can be attached to and/or coated onto one or more locations along the valve frame 102. Examples of radiopaque material include, but are not limited to, gold, tantalum, and platinum. The position of the one or more radiopaque markers can be selected so as to provide information on the position, location and orientation of the valve 100 during its implantation.
The circulatory valve 100 further includes the leaflets 104 having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve 100. For example, the leaflets 104 can be coupled to the valve frame 102 so as to span and control fluid flow through the lumen of the valve 100. For the present embodiment, the valve 100 includes two of the valve leaflet 104 for a bi-leaflet configuration. As appreciated, mono-leaflet, tri-leaflet and/or multi-leaflet configurations are also possible. The each of the valve leaflet 104 are coupled to the valve frame 102, where the leaflets 104 can repeatedly move between an open state and a closed state for unidirectional flow of a liquid through a lumen of the circulatory valve 100.
In one embodiment, the leaflets 104 can be derived from autologous, allogeneic or xenograft material. As will be appreciated, sources for xenograft material (e.g., cardiac valves) include, but are not limited to, mammalian sources such as porcine, equine, and sheep. Additional biologic materials from which to form the valve leaflets 104 include, but are not limited to, explanted veins, pericardium, facia lata, harvested cardiac valves, bladder, vein wall, various collagen types, elastin, intestinal submucosa, and decellularized basement membrane materials, such as small intestine submucosa (SIS), amniotic tissue, or umbilical vein.
Alternatively, the leaflets 104 could be formed from a synthetic material. Possible synthetic materials include, but are not limited to, expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polystyrene-polyisobutylene-polystyrene (SIBS), polyurethane, segmented poly(carbonate-urethane), polyester, polyethlylene (PE), polyethylene terephthalate (PET), silk, urethane, Rayon, Silicone, or the like. In an additional embodiment, the synthetic material can also include metals, such as stainless steel (e.g., 316L) and nitinol. These synthetic materials can be in a woven, a knit, a cast or other known physical fluid-impermeable or permeable configurations. In addition, plated metals (e.g., gold, platinum, rhodium) can be embedded in the leaflet 104 material (e.g., a sandwich configuration) to allow for visualization of the leaflets 104 post placement.
As will be appreciated, the valve 100 can be treated and/or coated with any number of surface or material treatments. Examples of such treatments include, but are not limited to, bioactive agents, including those that modulate thrombosis, those that encourage cellular in growth, through growth, and endothelialization, those that resist infection, and those that reduce calcification.
For the various embodiments, the frame cell 108 also includes a compliant segment 116 that extend between a corner portion 118 and the joint 110 of the frame cell 108. The compliant segment 116 can elastically flex, or deflect, from the corner portion 118 as the joint 110 transitions from the first stable state through the unstable state to the second stable state. The compliant segment 116 in its deflected state can then assist in holding the joint 110 in the second stable equilibrium state.
In one embodiment, the combination of the joint 110 and the compliant segment 116 provide for a bistable compliant mechanism. The bistable compliant mechanism used in frame cell 108 includes two stable equilibrium states within its range of motion. In the present embodiments, these are the first stable equilibrium state and the second stable equilibrium state, with an unstable equilibrium state positioned there between. The bistable mechanism used in the present disclosure does not require power input for the joint 110 of the cell 108 to remain stable at each equilibrium state. The states of stable equilibrium are essentially positions of relative potential energy minimums to which the joints 110 and the compliant segment 116 of the frame cells 108 return when the unstable equilibrium state is not achieved.
FIG. 2 provides an illustration of joint 210 and compliant segment 216 transitioning from the first stable equilibrium state 222 through the unstable equilibrium state 224 to the second stable equilibrium state 226. In one embodiment, this transition occurs as the joint 210 are drawn towards each other. Embodiments illustrating how this force can be applied to the joint 210 and the compliant segment 216 will be described herein.
In addition to illustrating the transition ofjoint 210 and the compliant segment 216, FIG. 2 also provides a graph 230 that illustrates the relative position of the equilibrium states 222 and 226 of the joint 210 and compliant segment 216 as a function of potential energy 232. As illustrated in graph 230, the first and second stable equilibrium states 222 and 226 of the joint 210 and the compliant segment 216 are located at local potential energy minimums (either equal or unequal) with the unstable equilibrium state 224 positioned between the two states 222 and 226. The graph 230 also illustrates that due to the elastic nature of the joint 210 and compliant segment 216 changes to their shape away from the first stable equilibrium state 222 will not result in transition to the second stable equilibrium state 226 unless enough force is supplied to overcome the unstable equilibrium state 224.
FIG. 2 also illustrates how the longitudinal length 228 of the frame cell 208 is greater in the second stable equilibrium state 226 as compared to the first stable equilibrium state 222. This change in longitudinal length 228 of the frame cell 208 helps to increase the peripheral length of the valve in which the frame cell 208 is used, as discussed herein.
As will be appreciated, the configuration and design of the joint 210 and the compliant segment 216 for the cell 208 can change the relative values for the first and second stable equilibrium states 222, 226. For example, such design aspects as a radius of curvature and arc length, among others, for the corner portions 218 and/or the compliant segment 216 can affect relative values for the first and second stable equilibrium states 222, 226. In addition, the number, the position and the configuration of the joint 210 on each frame cell 208 can also affect relative values for the first and second stable equilibrium states 222, 226. Changes to the cross-sectional shape and/or relative dimensions of the member 206 of the different components (e.g., the joint 210 and the compliant segment 216) can also affect relative values for the first and second stable equilibrium states 222, 226.
For the various embodiments, the joint of the present disclosure can have a number of different configurations. For example, the joint 210 illustrated in FIG. 2 has a looped configuration, where the frame member 206 curves over on itself to form a closed curve. In one embodiment, the frame member 206 can be curved over on itself more than once.
In an alternative embodiment, the frame member forming the joint can have a partially open configuration. FIG. 3 provides an illustration of such a partially open configuration for the joint 310. As illustrated, the frame member 306 includes a curve 334 that extends for less than a complete loop.
FIGS. 4A and 4B provide an additional embodiment of the valve 400 according to the present disclosure. The valve 400 includes the valve frame 402 and valve leaflet 404 coupled to the valve frame 402. The valve frame 402 also includes frame members 406 that define a frame cell 408 having joints 410, as discussed herein. FIG. 4A provides an illustration of the valve 400 in an undeployed state, where as FIG. 4B provides an illustration of the valve 400 in a deployed state (e.g., where the joints 410 are in their second stable equilibrium state 426). As illustrated, the joints 410 have a partially open configuration with a curve 434.
The joints 410 illustrated in FIGS. 4A and 4B also include an opening 435 defined by the valve frame 402. In one embodiment, the openings 435 defined by the valve frame 402 can be used to advance the joints 410 of the valve frame 402 from the first stable equilibrium state through the unstable equilibrium state to the second stable equilibrium state. In one embodiment, this transition can occur as one or more of the joints 410 are drawn towards each other, as will be discussed herein.
The valve frame 402 has an elongate tubular structure with a proximal end 412 and a distal end 414. In one embodiment, the frame cell 408 of the present disclosure can be positioned so as to provide both the proximal and distal ends 412, 414 of the valve frame 402. Other configurations are possible, as discussed herein.
As illustrated, the joints 410 are located on the frame member 406 such that as the joints 410 transition to the second stable equilibrium state the size (e.g., length) of the perimeter of the valve frame 402 increases. In other words, the joints 410 are located on the frame member 406 in such a way as to cause the valve frame 402 to radially increase in size as the joints 410 move toward the second stable equilibrium state. In one embodiment, the valve frame 402 increases its perimeter size as the frame cell 408 change shape during the joint 410 transition. As will be appreciated, some change to the longitudinal dimension of the valve frame 402 may occur as the perimeter dimension changes.
For the various embodiments, the valve frame 402 can be self-expanding, as discussed herein. For the various embodiments, the frame member 406 can also have similar and/or different cross-sectional geometries along its length, as discussed herein. The circulatory valve 400 can further include one or more radiopaque markers (e.g., tabs, sleeves, welds), as discussed herein.
FIG. 5 provides an additional embodiment of the valve 500 according to the present disclosure. The valve 500 includes the valve frame 502 and valve leaflet 504 coupled to the valve frame 502. The valve frame 502 also includes frame members 506 that define a frame cell 508 having joints 510, as discussed herein. As illustrated, while the frame cells 508 are located at the proximal end 512 and distal end 514 of the valve frame 502 not every frame cell 508 includes a joint 510. In addition, joints 510 in the frame cells 508 have different relative locations along the frame member 506.
FIG. 5 also illustrates that the valve frame 502 has frame members 506 that define a predefined frame design 540 that extends between the frame cells 508. As illustrated, the predefined frame design 540 and the frame cells 508 have a different configuration. Selection of the predefined frame design 540 can be based on a number of factors. Such factors include, but are not limited to, the location where the valve 500 is to be implanted, the size of the valve 500, the material(s) used to form the valve frame 502 of the valve 500, among others. Examples of other useful frame designs include those illustrated in co-pending U.S. patent application Ser. No. 60/899,444 entitled “Percutaneous Valve, System and Method”.
FIG. 6 provides an additional embodiment of the present disclosure in which the frame cell 608 includes a lock mechanism 644. In the various embodiments, the lock mechanism 644 can engage to prevent the frame cell 608 from transitioning from the second stable equilibrium state. As illustrated, the lock mechanism 644 of the present embodiment can include a first engagement member 646 and a second engagement member 648 that can engage so as to lock together.
In one embodiment, the first and second engagement members 646, 648 on the frame cell 608 engage to lock together as the frame cell 608 moves from the unstable equilibrium state 624 to the second stable equilibrium state 626. As illustrated, the first engagement member 646 extends from one of the joints 610 (e.g., a first joint), while the second engagement member 648 extends from another of the joint 610 (e.g., a second joint) of the frame cell 608. Alternatively, the engagement members can extend from portions of the compliant segments 616 of the frame cell 608. For the various embodiments, the locking mechanism 644 can allow the second state 626 to be something other than a local potential energy minimum, as it better ensures the frame cell 608 does not return to its first stable equilibrium state 622.
The lock mechanism 644 used with the frame cell 608 can take a number of different forms and configurations. For example, first engagement member 646 of the lock mechanism 644 can include a shaft having a ball tip. The second engagement member 648 can have a socket to receive and lock the ball tip of the shaft. Alternatively, the first engagement member 646 of the lock mechanism 644 can include a shaft having a hook. The second engagement member 648 can have a loop or member segment to receive and engage the hook to lock the frame cell 608. In one embodiment, the loop of the second engagement member 648 could be either the loop of the joint 610 or a portion of the frame member 606, which are opposite to and functionally aligned with the hook.
FIG. 7 provides an illustration of a deployment mechanism 750 used to transition the joint 710 the first stable equilibrium state 722 through the unstable equilibrium state 724 to the second stable equilibrium state 726. As illustrated, the deployment mechanism 750 can be used to apply a force to draw the joints 710 towards each other. Upon reaching the second stable equilibrium state 726, the deployment mechanism 750 can be removed from the joints 710 of the frame cell 708.
For the present embodiment, the deployment mechanism 750 includes a push tube 752 having a lumen 754, and a deployment thread 756 that extends through the lumen 754. The push tube 752 includes a distal end 758 that can abut a first of the joints 710. The deployment thread 756 extends from the lumen 754 and loops through a second of the joints 710 positioned across from the first of the joints 710. A pulling force 760 can be applied through the deployment thread 756 and/or a pushing force 762 can be applied through the push tube 752 to apply force to draw the joints 710 towards each other.
Upon reaching the second stable equilibrium state 726, the deployment thread 756 can be removed from the joint 710 by pulling on a first end of thread 756 to allow the second end of the thread 756 to pass through the joint 710. The thread 756 and the push tube 752 can then be removed from the frame cell 708. Other ways of removing the thread 756 from the frame joint 710 are also possible.
For the various embodiments, the deployment thread 756 can have a number of different configurations. For example, the deployment thread 756 can be a monofilament (i.e., a single strand of material). Alternatively, the deployment thread 756 can have a multistrand configuration. For example, the deployment thread 756 having multiple strands can have a woven, a braided, and/or a twisted configuration. Combinations of these configurations are also possible.
The deployment thread 756 can also have a multilayer construction, where the deployment thread 756 includes a core that is surrounded by one or more layers. The core and layers of the deployment thread 756 can be formed of different materials and/or the same materials having different desired properties. In addition, the deployment thread 756 can further include a coating that does not necessarily constitute a “layer” (i.e., a material that imbeds or integrates into the layer on which it is applied). Such layers and/or coatings can impart properties to the deployment thread 756 such as hardness and/or lubricity, among others.
The deployment thread 756 can be formed of a number of materials. Such materials can have a sufficient tensile strength and yield point to resist stretching so as to allow the frame cells of the present disclosure to be deployed as discussed herein. Examples of such materials include, but are not limited to, polymers such as nylon(s), acetal, Pebax, PEEK, PTFE, polyamide, polypyrol, and Kevlar. Alternatively, the deployment thread 756 can be formed of metal and/or metal alloys, such as stainless steel, elgioly, nitinol, and titanium. Other polymers, metals and/or metal alloys are also possible. The thread 756 could also be coated with a lubricious material, such as a hydrophilic coating. The materials of the deployment thread 756 also include combinations of these materials in one or more of the configurations as discussed herein.
The push tube 752 can formed from a number of different materials. Materials include metal(s), metal alloys, and polymers, such as PVC, PE, POC, PET, polyamide, mixtures, and block co-polymers thereof. In addition, the push tube 752 can have a wall thickness and a lumen diameter sufficient to allow the deployment thread 756 to slide longitudinally through the lumen 754 and to have sufficient column strength to apply the pushing force 762, as discussed herein.
FIGS. 8A and 8B illustrate a cross-sectional view of an embodiment of a system 866 according to the present disclosure. System 866 includes circulatory valve 800, as described herein, releasably joined to an elongate delivery catheter 868. The system 866 also includes a retractable sheath 870, where the circulatory valve 800 is releasably positioned between the sheath 870 and the delivery catheter 868. For example, FIG. 8A illustrates an embodiment in which the retractable sheath 870 is positioned around at least a portion of the delivery catheter 868 to releasably hold the valve 800 in an undeployed state. FIG. 8B illustrates an embodiment in which the sheath 870 has been retracted relative the delivery catheter 868 to allow the valve 800 to expand to its partially deployed state.
In the example, the delivery catheter 868 includes an elongate body 872 having a proximal end 874 and a distal end 876. A lumen 878 extends through the proximal and distal ends 874, 876. In one embodiment, the lumen 878 receives a guidewire for guiding the placement of the circulatory valve 800 in the vasculature.
For the various embodiments, the elongate delivery catheter 868 also includes a distal tip 880. For the various embodiments, the distal tip 880 has a conical configuration, where the tip 880 has a smaller diameter portion near the distal end 876 of the of the delivery catheter 868 as compared to the proximal portion of the tip 880. The distal tip 880 can also include a recessed lip 882 in which a distal portion of the retractable sheath 870 can releasably seat. In one embodiment, seating the distal portion of the retractable sheath 870 in the recessed lip 882 helps to hold the valve 800 in its undeployed state.
The retractable sheath 870 can move longitudinally (e.g., slide) relative the delivery catheter 868 to allow the circulatory valve 800 to expand from its undeployed state towards the first stable equilibrium state. In one embodiment, moving the retractable sheath 870 relative the delivery catheter 868 can be accomplished by pulling, a proximal portion 884 of the sheath 870 relative a proximal portion 886 of the delivery catheter 868.
The system 866 also includes push tubes 852 and deployment thread 856 for a deployment mechanism, as discussed herein. As illustrated, the push tubes 852 are positioned between the sheath 870 and the delivery catheter 868. The push tubes 852 also include a proximal portion 888 from which the tubes 852 can be moved longitudinally relative the sheath 870 and the delivery catheter 868. In one embodiment, the proximal portion 888 allows a user to apply a pushing force through the tubes 852 to the joints 810, as discussed herein. For the various embodiments, the deployment thread 856 extends from the lumen 854 of the push tubes 852, where both the deployment thread 856 and at least the distal end 859 of the push tubes 852 releasably engage the joints 810 of the frame cell 808.
As illustrated in FIG. 8B, the circulatory valve 800 expands to its first stable equilibrium state, as discussed herein, after the retractable sheath 870 has been retracted relative the valve 800. The push tubes 852 are illustrated as bending with the valve 800 in its first stable equilibrium state. The push tubes 852 are also illustrated as abutting the first of the joint 810 while the deployment thread 856 loops through the second of the joint 810 for the frame cell 808. Force applied through the deployment threads 856 and/or the push tubes 852 can then be used to transition the valve 800 from the first stable equilibrium state to the second stable equilibrium state, as discussed herein.
Embodiments of the system 866 can further include an expandable filter that forms a portion of the retractable sheath. Examples of such an embodiment can be found in co-pending U.S. patent application Ser. No. 12/012,911 entitled “Percutaneous Valve, System and Method”, which is hereby incorporated by reference in its entirety.
Each of the delivery catheter 868, the retractable sheath 870 can be formed of a number of materials. Materials include polymers, such as PVC, PE, POC, PET, polyamide, mixtures, and block co-polymers thereof. In addition, each of the delivery catheter 868 and the retractable sheath 870 can have a wall thickness and an inner diameter sufficient to allow the structures to slide longitudinally relative each other, as described herein, and to maintain the circulatory valve 800 in a compressed state, as discussed herein.
As discussed herein, applying force between the push tubes 852 and the deployment thread 856 allows the frame cells 808 to transition to the second stable equilibrium state (e.g., the deployed state). Additional approaches to transitioning frame cells 808 to the second stable equilibrium state (e.g., the deployed state) are also possible. For example, two or more deployment threads could be used for each frame cell to draw the joints into the second stable equilibrium state. Alternatively, the frame cells could abut the retractable sheath at a proximal end of the stent, while deployment threads are used to draw the joints into the second stable equilibrium state. Other configurations are also possible.
In an additional embodiment, seating of the valve 800 in its deployed state within the vasculature can be assisted by radially expanding the valve 800 with a balloon catheter. For example, FIG. 8C provides an illustration of the valve 800 after the push tubes and the deployment thread have been removed from the valve frame 802. A balloon catheter 892 having an inflatable balloon 894 can be positioned in the lumen of the valve 800. The balloon 894 can be inflated with fluid supplied by an inflation device 896 through catheter lumen 898 in fluid communication with the balloon 892. In one embodiment, the balloon 894 can have a “dog bone” shape, where the bulbous ends of the balloon are aligned with the frame cells 808 of the valve 800. The balloon 892 can then contact and radially expand the valve frame 802 to better ensure that the valve 800 is deployed.
In an additional embodiment, the circulatory valve 800 can further include a sealing material 801 positioned on the periphery of the valve frame 802. In one embodiment, once implanted the tissue the sealing material 801 can swell due the presence of liquid to occupy volume between the valve frame 802 and the tissue on which the valve 800 has been implanted so as to prevent leakage of the liquid around the outside of the circulatory valve 800.
A variety of suitable materials for the sealing material 801 are possible. For example, the sealing material 801 can be selected from the general class of materials that include polysaccharides, proteins, and biocompatible gels. Specific examples of these polymeric materials can include, but are not limited to, those derived from poly(ethylene oxide) (PEO), polyethylene terephthalate (PET), poly(ethylene glycol) (PEG), poly(vinyl alcohol) (PVA), poly(vinylpyrrolidone) (PVP), poly(ethyloxazoline) (PEOX) polyaminoacids, pseudopolyamino acids, and polyethyloxazoline, as well as copolymers of these with each other or other water soluble polymers or water insoluble polymers. Examples of the polysaccharide include those derived from alginate, hyaluronic acid, chondroitin sulfate, dextran, dextran sulfate, heparin, heparin sulfate, heparan sulfate, chitosan, gellan gum, xanthan gum, guar gum, water soluble cellulose derivatives, and carrageenan. Examples of proteins include those derived from gelatin, collagen, elastin, zein, and albumin, whether produced from natural or recombinant sources.
The embodiments of the valve described herein may be used to replace, supplement, or augment valve structures within one or more lumens of the body. For example, embodiments of the present invention may be used to replace an incompetent cardiac valve of the heart, such as the aortic, pulmonary and/or mitral valves of the heart. In one embodiment, the native cardiac valve can either remain in place (e.g., via a valvuloplasty procedure) or be removed prior to implanting the circulatory valve of the present disclosure.
In addition, positioning the system having the valve as discussed herein includes introducing the system into the cardiovascular system of the patient using minimally invasive percutaneous, transluminal techniques. For example, a guidewire can be positioned within the cardiovascular system of a patient that includes the predetermined location. The system of the present disclosure, including the valve as described herein, can be positioned over the guidewire and the system advanced so as to position the valve at or adjacent the predetermined location. In one embodiment, radiopaque markers on the catheter and/or the valve, as described herein, can be used to help locate and position the valve.
The valve can be deployed from the system at the predetermined location in any number of ways, as described herein. In one embodiment, valve of the present disclosure can be deployed and placed in any number of cardiovascular locations. For example, valve can be deployed and placed within a major artery of a patient. In one embodiment, major arteries include, but are not limited to, the aorta. In addition, valves of the present invention can be deployed and placed within other major arteries of the heart and/or within the heart itself, such as in the pulmonary artery for replacement and/or augmentation of the pulmonary valve and between the left atrium and the left ventricle for replacement and/or augmentation of the mitral valve. The circulatory valve can also be implanted in the leg veins (e.g., iliac, femoral, great saphenous, popliteal, and superficial saphenous). Other locations are also possible.
As discussed herein, the circulatory valve can be deployed in a staged fashion. In the first stage, the valve is held in its undeployed state (e.g., compressed state) by the retractable sheath. The retractable sheath can then be moved (e.g., retracting the sheath) to allow the valve to radially expand from the undeployed state to the first stable equilibrium state. The joints of the valve frame can then be transitioned from the first stable equilibrium state through the unstable equilibrium state to the second stable equilibrium state to deploy the circulatory valve, as discussed herein. In an additional embodiment, the circulatory valve can also be radially expanded with an inflatable balloon to set the circulatory valve in the deployed state.
Once implanted, the valve can provide sufficient contact with the body lumen wall to prevent retrograde flow between the valve and the body lumen wall, and to securely locate the valve and prevent migration of the valve. The valve described herein also display sufficient flexibility and resilience so as to accommodate changes in the body lumen diameter, while maintaining the proper placement of valve. As described herein, the valve can engage the lumen so as to reduce the volume of retrograde flow through and around valve. It is, however, understood that some leaking or fluid flow may occur between the valve and the body lumen and/or through valve leaflets.
While the present invention has been shown and described in detail above, it will be clear to the person skilled in the art that changes and modifications may be made without departing from the spirit and scope of the invention. For example, the pulling mechanism illustrated herein could be used to mechanically expand a valve frame of other types of self-expanding stents and/or valve frames to enlarge the cross-sectional size (e.g., the diameter) to its fullest dimension. As such, that which is set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined by the following claims, along with the full range of equivalents to which such claims are entitled. In addition, one of ordinary skill in the art will appreciate upon reading and understanding this disclosure that other variations for the invention described herein can be included within the scope of the present invention.
In the foregoing Detailed Description, various features are grouped together in several embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the embodiments of the invention require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment.

## Claims

1. A circulatory valve, comprising:
a valve frame having frame members defining a number of frame cells with joints in opposing relationship and a number of frame cells without joints, where the valve frame self-expands to a first stable equilibrium state at a first relative potential energy minimum, and where the joints are capable of reversibly transitioning from the first stable equilibrium state through an unstable equilibrium state at a relative potential energy maximum to a second stable equilibrium state at a second relative potential energy minimum as the joints are drawn towards each other via an application of force external to the valve frame, wherein the frame cells with joints have a different configuration in the first stable equilibrium state than a configuration in the second stable equilibrium state;
where the frame cells with joints are positioned only at a distal end and a proximal end of the valve frame;
where the frame members of the number of frame cells without joints have serpentine bends providing an elastic radial force; and
a valve leaflet coupled to the valve frame.

2. The circulatory valve of claim 1, where the first stable equilibrium state and the second stable equilibrium state are positions that the joints of the frame cells occupy when the unstable equilibrium state is not achieved.

3. The circulatory valve of claim 1, where the frame cells with joints includes a compliant segment that assists in holding the joints in the second stable equilibrium state.

4. The circulatory valve of claim 1, where the frame members of the frame cells without joints define a predefined frame design that extends between the frame cells with joints, where the predefined frame design and the frame cells with joints having a different configuration.

5. The circulatory valve of claim 1, where each frame cell with joints includes a lock mechanism that engages to prevent each frame cell with joints from transitioning from the second stable equilibrium state.

6. The circulatory valve of claim 5, where each lock mechanism includes a first engagement member that extends from a first joint to engage a second engagement member that extends from a second joint of each frame cell as the joints transition from the unstable equilibrium state to the second stable equilibrium state.

7. The circulatory valve of claim 1, where the valve frame in the first stable equilibrium state has a diameter that is eighty (80) to ninety-five (95) percent of a deployed state diameter of the second stable equilibrium state.