Devices, systems and methods for repairing lumenal systems

Abstract
The disclosure provides valve prostheses and methods of installation. One embodiment of the prosthesis has a generally tubular body adapted for placement proximate a mitral annulus. The tubular body has a generally tubular upper portion adapted to substantially reside in the left atrium above the mitral annulus. The generally tubular upper portion has a first circumferential wall that is outwardly biased to urge against cardiac tissue of the left atrium. The tubular body also includes a lower portion extending downwardly from the generally tubular upper portion, the lower portion being configured to substantially reside in the left ventricle below the mitral annulus. The lower portion of this embodiment can be defined by an generally circumferential wall that extends downwardly from the generally tubular upper portion. The generally circumferential wall has a first circumferential end and a second circumferential end, and defines a circumferential extent therebetween.
Description
BACKGROUND

Heart valves permit unidirectional flow of blood through the cardiac chambers to permit the heart to function as a pump. Valvular stenosis is one form of valvular heart disease that prevents blood from flowing through a heart valve, ultimately causing clinically significant heart failure in humans. Another form of valvular disease results from heart valves becoming incompetent. Failure of adequate heart valve closure permits blood to leak through the valve in the opposite direction to normal flow. Such reversal of flow through incompetent heart valves can cause heart failure in humans.


The human mitral valve is a complicated structure affected by a number of pathological processes that ultimately result in valvular incompetence and heart failure in humans. Components of the mitral valve include the left ventricle, left atrium, anterior and posterior papillary muscles, mitral annulus, anterior mitral leaflet, posterior mitral leaflet and numerous chordae tendonae. The anterior leaflet occupies roughly ⅔ of the mitral valve area whereas the smaller posterior leaflet occupies ⅓ of the area. The anterior mitral leaflet, however, hangs from the anterior ⅓ of the perimeter of the mitral annulus whereas the posterior mitral leaflet occupies ⅔ of the annulus circumference. Furthermore, the posterior mitral leaflet is often anatomically composed of three separate segments. In diastole, the anterior leaflet and the three posterior leaflets are pushed into the left ventricle opening the mitral orifice for blood to flow into the left ventricle. In systole, the leaflets are pushed toward the plane of the mitral annulus where the posterior leaflets and larger anterior leaflet come into coaptation to prevent blood flow from the left ventricle to the left atrium. The leaflets are held in this closed position by the chordae tendonae. Dysfunction or failure of one or more of these mitral components may cause significant mitral valvular regurgitation and clinical disease in humans.


Surgical treatment has been the gold standard since its introduction in the 1950s. Currently, there are two surgical options offered for treatment. The first, mitral valve replacement, requires complex surgery using cardiopulmonary bypass to replace the mitral valve using a mechanical or bioprosthetic valvular prosthesis. Although a time-tested and proven strategy for treatment, bioprostheic valves suffer from poor long-term durability and mechanical valves require anticoagulation. As an alternative, surgical mitral valve repair has emerged as a superior procedure to achieve mitral valve competence and normal function. This operation is really a collection of surgical techniques and prostheses that collectively are referred to a mitral valve repair. Each component of the mitral valve can be altered, replaced, repositioned, resected or reinforced to achieve mitral valve competence.


Mitral annuloplasty has become a standard component of surgical mitral valve repair. In performing this procedure, the circumference of the mitral valve annulus is reduced and/or reshaped by sewing or fixing a prosthetic ring or partial ring to the native mitral valve annulus. As a consequence of mitral annuloplasty, the posterior mitral leaflet often becomes fixed in a closed position, pinned against the posterior left ventricular endocardium. The opening and closure of the mitral valve is subsequently based almost entirely on the opening and closing of the anterior mitral valve leaflet.


SUMMARY

In accordance with one exemplary embodiment, a valve prosthesis is provided. The valve prosthesis may include a tubular member configured for deployment in a heart valve annulus, a first set of fastening mechanisms radially and outwardly disposed from the tubular member and configured to attach the valve prosthesis to cardiac tissue above the mitral valve annulus, a second set of fastening mechanisms radially and outwardly disposed from the tubular member and configured to attach the valve prosthesis to an incomplete circumference of left ventricular endocardium below the mitral annulus without impairing the opening or closing of the anterior mitral leaflet. The valve prosthesis may also include a partial covering of the internal area of the tubular member to simulate a fixed or mobile posterior mitral valve leaflet. The partial covering may be dynamically adjustable before, during or following implantation to correct mitral valve incompetence. The valve prosthesis may also include elements that traverse the diameter or a chord of the internal aspect of the tubular member to prevent prolapse of the anterior leaflet during systole.


Thus, in accordance with one embodiment, a valve prosthesis is provided. The prosthesis has a generally tubular body adapted for placement proximate a mitral annulus. The tubular body has a generally tubular upper portion adapted to substantially reside in the left atrium above the mitral annulus. The generally tubular upper portion has a first circumferential wall that is outwardly biased to urge against cardiac tissue of the left atrium. The tubular body also includes a lower portion extending downwardly from the generally tubular upper portion, the lower portion being configured to substantially reside in the left ventricle below the mitral annulus. The lower portion of this embodiment can be defined by an generally circumferential wall that extends downwardly from the generally tubular upper portion. The generally circumferential wall has a first circumferential end and a second circumferential end, and defines a circumferential extent therebetween. The generally circumferential wall extends along a posterior portion of the left ventricle. The first and second circumferential ends of the generally circumferential wall define a circumferential gap therebetween. The circumferential gap is preferably of sufficient circumferential extent to substantially prevent the prosthesis from interfering with the opening and closing of a native anterior mitral valve leaflet. The prosthesis further includes at least one prosthetic valve leaflet disposed within the tubular body, the at least one prosthetic valve leaflet being configured to occupy at least a portion of an opening defined by the generally tubular upper portion and the lower portion.


In accordance with further aspects, the at least one prosthetic valve leaflet can include at least one posterior prosthetic valve leaflet disposed proximate a posterior region of the prosthesis. The at least one posterior prosthetic valve leaflet can be configured to coapt with the native anterior mitral valve leaflet to close the mitral valve opening. The at least one posterior prosthetic valve leaflet can include a plurality of prosthetic leaflets. The plurality of prosthetic leaflets can be joined to each other to form a row of leaflets along a posterior portion of the valve prosthesis. If desired, the at least one posterior prosthetic valve leaflet can be substantially fixed. In other implementations, the at least one posterior prosthetic valve leaflet can be substantially movable.


In further implementations, the at least one prosthetic valve leaflet can include biological cells residing on the prosthetic material. If desired, the at least one prosthetic valve leaflet can include fabric. The fabric can include at least one of expanded PTFE, Dacron® polyester, and pericardium tissue. In some implementations, the at least one prosthetic valve leaflet can be substantially or fully formed from living tissue.


In accordance with further aspects of the disclosure, the circumferential extent of the generally circumferential wall of the lower portion, or downwardly depending posterior skirt, can be between about 90 degrees and about 270 degrees, about 120 degrees and about 240 degrees, about 150 degrees and about 210 degrees, or about 180 degrees, or any desired extent between about 90 and about 270 degrees in one degree increments. In accordance with a further aspect, the circumferential extent of the generally circumferential wall of the lower portion, also referred to herein and shown in the figures as a downwardly depending posterior skirt, can be configured to reside substantially between the commissures of the mitral valve along a posterior extent of the left ventricle.


In accordance with a further aspect, the prosthesis can form an open channel in the mitral annulus, and the at least one prosthetic valve leaflet can be provided in a separate mechanism, for example, that is attached to the prosthesis body before or after delivering the prosthesis to the mitral valve.


In accordance with yet a further aspect, the prosthesis can further include at least one transverse support extending from a first lateral portion of the prosthesis to an opposing, second lateral portion of the prosthesis to prevent prolapse of an anterior native leaflet during systole. The at least transverse support can include at least one of Dacron® polyester material, expanded PTFE and pericardium tissue.


In some implementations, the prosthesis can further include at least one circumferential inflatable bladder disposed along a portion of the generally circumferential wall of the lower portion, the bladder being configured to inflate outwardly from the generally circumferential wall of the lower portion and against a surface of the left ventricle to prevent flow around the outside of the valve prosthesis. If desired, the prosthesis can further include at least one circumferential inflatable bladder disposed within a portion of the generally circumferential wall of the lower portion, the inflatable bladder being configured to inflate outwardly to cause the generally circumferential wall of the lower portion to urge against an inner surface of the left ventricle to prevent flow around an outer portion of the valve prosthesis. The at least one circumferential bladder can include a plurality of adjacent chambers that can be inflated individually. The plurality of adjacent cells can be arranged circumferentially about the periphery of the generally circumferential wall of the lower portion.


In accordance with further aspects, the prosthesis can further include a plurality of radially distributed fasteners disposed proximate the generally tubular upper portion for helping to maintain the position of the valve prosthesis within the mitral annulus. The fasteners can be within and at least partially define the shape of the generally tubular upper portion. The fasteners can cooperate to cause the generally tubular upper portion to form a funnel shape. The fasteners can be adapted to urge against the walls of the left atrium. If desired, the fasteners can be configured to cause the generally tubular upper portion to form a bell shape. If desired, the fasteners can urge against the atrial side of the mitral annulus. In further implementations, the prosthesis can further include at least one lower fastener disposed proximate the generally circumferential wall of the lower portion, the at least one lower fastener being configured to hold the valve prosthesis in place. The at least one lower fastener can include a plurality of fasteners formed into the generally circumferential wall of the lower portion. If desired, the at least one lower fastener can include at least one fastener disposed radially outwardly from the generally circumferential wall of the lower portion. The at least one lower fastener can be adapted to urge upwardly against the ventricular side of the mitral annulus.


In accordance with further aspects, the valve prosthesis can further include at least one guiding conduit for receiving a delivery rail. The at least one guiding conduit can be configured to permit the valve prosthesis to be guided along the rail to facilitate installation of the valve prosthesis. In some implementations, the generally tubular upper portion can have a “D” shaped cross section formed by a substantially flat wall configured to engage the atrial anterior wall above the native anterior mitral valve leaflet, and a substantially curved wall configured to engage the posterior left atrial wall. The at least one posterior prosthetic valve leaflet can have a curved lateral profile in an anterior-posterior plane within the prosthesis, such that the at least one posterior valve leaflet curves downwardly along a posterior-anterior direction. In further implementations, the valve prosthesis can define a saddle-shaped engagement surface for engaging with a posterior portion of the mitral annulus and an anterior portion of the left atrium above the native anterior mitral valve leaflet, the engagement surface having a “D” shaped projection in a plane substantially parallel to the mitral annulus.


The disclosure also provides a valve prosthesis having a curved body adapted for placement proximate a mitral annulus. The curved body has a generally curved planar upper portion adapted to substantially reside in a posterior region of the left atrium above the mitral annulus, the generally curved planar upper portion having a first circumferential wall that is outwardly biased to urge against cardiac tissue of the posterior of the left atrium, and a lower portion extending downwardly from the generally curved planar upper portion, the lower portion being configured to substantially reside in the left ventricle below the mitral annulus. The lower portion is defined by an generally circumferential wall that extends downwardly from the generally curved planar upper portion. The generally circumferential wall has a first circumferential end and a second circumferential end defining a circumferential extent therebetween. The generally circumferential wall extends along a posterior portion of the left ventricle. The first and second circumferential ends of the generally circumferential wall define a circumferential gap therebetween, the circumferential gap being of sufficient circumferential extent to substantially prevent the prosthesis from interfering with the opening and closing of a native anterior mitral valve leaflet. The prosthesis further includes at least one prosthetic valve leaflet disposed within the curved body. The at least one prosthetic valve leaflet is configured to occupy at least a portion of an opening defined by the generally curved planar upper portion and the lower portion.


In accordance with further aspects, the at least one prosthetic valve leaflet can include at least one posterior prosthetic valve leaflet disposed proximate a posterior region of the prosthesis. The at least one posterior prosthetic valve leaflet is preferably configured to coapt with the native anterior mitral valve leaflet to close the mitral valve opening. The at least one posterior prosthetic valve leaflet can include a plurality of prosthetic leaflets. The plurality of prosthetic leaflets can be joined to each other to form a row of leaflets along a posterior portion of the valve prosthesis. The at least one posterior prosthetic valve leaflet can be substantially fixed or movable. If desired, the at least one prosthetic valve leaflet includes biological cells residing on the prosthetic material. The at least one prosthetic valve leaflet can include fabric. The fabric can include at least one of expanded PTFE, Dacron® polyester, and pericardium tissue. If desired, the at least one prosthetic valve leaflet can be substantially or entirely formed from living tissue.


In some implementations, the circumferential extent of the generally circumferential wall of the lower portion (and/or of the generally curved planar upper portion) can be, for example, between about 90 degrees and about 270 degrees, between about 120 degrees and about 240 degrees, between about 150 degrees and about 210 degrees, or about 180 degrees, or any desired extent between about 90 and about 270 degrees in one degree increments. The circumferential extent of the generally circumferential wall of the lower portion can be configured to reside substantially between the commissures of the mitral valve along a posterior extent of the left ventricle. The prosthesis can form an open channel in the mitral annulus, and the at least one prosthetic valve leaflet can be provided in a separate mechanism.


If desired, the valve prosthesis can further include at least one transverse support extending from a first lateral portion of the prosthesis to an opposing, second lateral portion of the prosthesis to prevent prolapse of an anterior native leaflet during systole. The at least transverse support can include at least one of Dacron® polyester material, expanded PTFE and pericardium tissue, among others. If desired, the valve prosthesis can further includes at least one circumferential inflatable bladder disposed along a portion of the generally circumferential wall of the lower portion, or downwardly depending posterior skirt. The bladder can be configured to inflate outwardly from the generally circumferential wall of the lower portion, or downwardly depending posterior skirt, and against a surface of the left ventricle to prevent flow around the outside of the valve prosthesis. If desired, the inflatable bladder can be configured to inflate outwardly to cause the generally circumferential wall of the lower portion to urge against an inner surface of the left ventricle to prevent flow around an outer portion of the valve prosthesis. If desired, the at least one circumferential bladder can include a plurality of adjacent chambers that can be inflated individually. The plurality of adjacent cells can be arranged circumferentially about the periphery of the generally circumferential wall of the lower portion.


In some implementations, the valve prosthesis can further include a plurality of radially distributed fasteners disposed proximate the generally curved planar upper portion to help maintain the position of the valve prosthesis within the mitral annulus. The plurality of radially distributed fasteners can be disposed within and at least partially define the shape of the generally curved planar upper portion. The fasteners can cooperate to cause the generally curved planar upper portion to form a funnel shape. The fasteners can be adapted to urge against the posterior wall of the left atrium. The fasteners can cooperate to cause the generally curved planar upper portion to form a bell shape. The fasteners can urge against the atrial side of the mitral annulus.


In some implementations, the prosthesis can further include at least one lower fastener disposed proximate the generally circumferential wall of the lower portion. The at least one lower fastener can be configured to hold the valve prosthesis in place. The at least one lower fastener can include a plurality of fasteners formed into the generally circumferential wall of the lower portion. The at least one lower fastener can include at least one fastener disposed radially outwardly from the generally circumferential wall of the lower portion. The at least one lower fastener can be adapted to urge upwardly against the ventricular side of the mitral annulus.


In some implementations, the valve prosthesis can further include at least one guiding conduit for receiving a delivery rail. The at least one guiding conduit can be configured to permit the valve prosthesis to be guided along the rail to facilitate installation of the valve prosthesis. The at least one posterior prosthetic valve leaflet can have a curved lateral profile in an anterior-posterior plane within the prosthesis, such that the at least one posterior valve leaflet curves downwardly along a posterior-anterior direction. If desired, the valve prosthesis can define a partial saddle-shaped engagement surface for engaging with a posterior portion of the mitral annulus.





BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, aspects, features, and advantages of exemplary embodiments will become more apparent and may be better understood by referring to the following description taken in conjunction with the accompanying drawings, in which:



FIG. 1 illustrates a cross-sectional view taken through a mitral valve in which an exemplary valve prosthesis is deployed at the annulus of the mitral valve. As illustrated, the prosthesis includes a framework formed from a combination of structural loops that may also act as fasteners that can help hold the prosthesis in place. As illustrated, the prosthesis includes a proximal section in the ventricle, a mid section including a valve, and a distal section in the atrium. The posterior aspects of the anatomy are illustrated, but the anterior aspects of how the prosthesis interacts with the anatomy are discussed below.



FIG. 2 illustrates a cross-sectional view through the mitral valve, illustrating the native anterior mitral leaflet with an exemplary valve prosthesis deployed at the annulus (dotted lines) with the native anterior mitral leaflet free to coapt against the prosthetic posterior mitral leaflet as described herein. Also illustrated are fasteners located on an upper generally tubular portion of the prosthesis, and fasteners located on a downwardly extending ventricular skirt of the prosthesis.



FIG. 3 illustrates a longitudinal cross-sectional view of an exemplary prosthesis mounted within an exemplary catheter delivery device.



FIGS. 4A-E—illustrate exemplary aspects of delivering the valve prosthesis from either a left atrial or ventricular approach with or without guided fixation to the mitral annulus. For example, with respect to FIG. 4C, a mitral valve prosthesis is provided having a lower circumferential edge and an upper circumferential edge defining a generally cylindrical body therebetween defined by a plurality of loops connected to a membrane. The body may be tapered along its length and/or have flared ends, as desired, as described herein. The prosthesis, as illustrated, further includes one or more tethers. Prosthesis is installed by advancing it along rails to its final location. FIG. 4C further depicts the access direction in dotted lines in the case of atrial percutaneous delivery.



FIG. 5A-G illustrates various aspects of the designs of different valve prostheses.



FIG. 6 illustrates an exemplary frame of the valve prosthesis with an exemplary prosthetic posterior mitral leaflet equivalent positioned within the frame.



FIG. 7 illustrates a top-down view of an exemplary valve prosthesis with an exemplary prosthetic posterior leaflet in position covering a subtotal area of the tubular member of the prosthesis.



FIG. 8 illustrates how an exemplary valve prosthesis would allow the native anterior mitral valve leaflet to coapt with the prosthetic posterior mitral leaflet during valve closure in systole and open away from an exemplary prosthetic posterior mitral leaflet in diastole.



FIG. 9 illustrates a cross-sectional view of an exemplary prosthesis with an exemplary fixation of the prosthetic posterior mitral leaflet fixed along the mitral plane posteriorly, and more anteriorly down into the ventricular section of the device to its margin.



FIG. 10 illustrates a cross-sectional view of an exemplary prosthesis with an exemplary fixation of the prosthetic posterior mitral leaflet fixed entirely in the plane of the mitral annulus.



FIGS. 11 and 12 illustrate cross-sectional views of an exemplary prosthesis with an exemplary design of the prosthetic posterior mitral leaflet in two sections with the ability to move into (FIG. 12) and out of (FIG. 11) the position of coaptation with the native anterior mitral leaflet to facilitate left ventricular filling during diastole. In an exemplary state, the prosthetic posterior leaflets could be fixed by a tethering mechanism to the ventricular fastening mechanisms to prevent prolapse of the prosthetic posterior leaflet or leaflets during systole.



FIGS. 13 and 14 illustrate cross-sectional views of an exemplary prosthesis with an exemplary design of the prosthetic posterior mitral leaflet in three sections with the ability to move into (FIG. 14) and out of (FIG. 13) the position of coaptation with the native anterior mitral leaflet to facilitate left ventricular filling during diastole.



FIG. 15 illustrates an exemplary design of the valve prosthesis to include two structural barriers at or above the plane of the mitral annulus within the valvular prosthesis attached at two points along the inner circumference of the valvular device to prevent prolapse of the native anterior mitral leaflet during systole as that structure coapts against the prosthetic posterior mitral leaflet or leaflets.



FIG. 16 illustrates a top-down view of an exemplary design of the valve prosthesis including an exemplary set of structural barriers to prevent anterior leaflet prolapse during systole. The two arrows represent how the structural barriers would move into position as the valve prosthesis was deployed from a catheter or other delivery device.



FIG. 17 illustrates an exemplary design of a single structural barrier to prevent anterior mitral leaflet prolapse during systole fixed transversely in the valve device. The arrow represents how the structural barriers would move into position as the valve prosthesis was deployed from a catheter or other delivery device.



FIG. 18 illustrates a longitudinal cross-sectional view of en exemplary prosthesis deployed in the mitral annulus in a heart with a non-dilated (A) and a dilated (B) mitral annulus. These figures together illustrate a feature of an exemplary prosthesis whereby the first and second sets of atrial and ventricular radially and outwardly disposed fixation elements may act entirely to provide compression fixation of the tubular element of the prosthesis in the mitral annulus through force on the endocardium of the atrium and ventricle, respectively (A). Alternatively, the first and second sets of atrial and ventricular radially and outwardly disposed fixation elements may contact each other in the plane of the mitral annulus for a portion of the circumference of the mitral annulus as well as providing compression fixation of the tubular element of the prosthesis in the mitral annulus through force on the endocardium of the atrium and ventricle laterally, respectively (B).



FIG. 19 illustrates a cross-section through a non-dilated (A) mitral annulus and a dilated (B) mitral annulus with the exemplary prosthesis of FIG. 18 in place. FIG. 19(A) reveals that the lateral wall of the tubular element of the exemplary prosthesis abuts the mitral annulus for a circumference of the mitral annulus except where the anterior mitral leaflet emanates from the anterior mitral annulus between the right and left commissures. FIG. 19(B) reveals that the first and second sets of atrial and ventricular radially and outwardly disposed fixation elements may contact each other in the plane of the mitral annulus between the mitral annulus and the tubular element of the device for less than the entire circumference of the mitral orifice (2), leaving the circumference of the mitral annulus subtending the anterior mitral valve leaflet free (1).





DETAILED DESCRIPTION

Exemplary embodiments provide systems, devices and methods for repairing or replacing elements of the mitral valve. Exemplary elements of the valve prosthesis include the device frame, prosthetic posterior mitral leaflet equivalent and elements to prevent or reduce abnormal prolapse of the native anterior mitral leaflet during systole. Exemplary methods of implanting the valve prosthesis include direct open surgical placement, minimally invasive surgical placement either with or without the use of cardiopulmonary bypass, and totally catheter based implantation. Exemplary methods for maintaining the valve prosthesis in the preferred mitral annular location include external compression, compression following rail or suture guided implantation and seating with subsequent active or passive fixation of the valve prosthesis based upon the rail or suture guides.


Valve Device Frame


Exemplary embodiments on the frame of the valve prosthesis depicted in the Figures include a central element that can be inserted within the mitral valve annulus with elements (e.g., struts, loops and the like) above and below the central element to provide for fixation of the central element in the annulus. In one embodiment of the central element of the valve device (FIGS. 5C, 5F), the prosthesis can be tubular or “D” shaped with the flat portion subtending the atrial side of the anterior annulus between the right and left fibrous trigones with the curved portion of the “D” to subtend the posterior annulus between the trigones. Either the anterior portion of the “D” shaped device, or the posterior portion of the “D” shaped device, or both sections can be distensible and therefore capable of shortening or lengthening to adjust variably to different size mitral annulae. This describes a prosthesis design that is form fitting and/or size adjustable to the shape of the mitral annulus of individual hearts by virtue of design.


The tubular element may be planar or may be shaped planar for a section of the tubular element but with an elevation of one section of the circumference of the tubular element that corresponds to the anterior (atrial) portion of the tubular element of the device. The advantage of such an asymmetrical shape can be that it simulates the natural “saddle” shape of the mitral valve orifice. This shape can allow for radial compression and seating of the valve prosthesis above the mitral annulus subjacent to the anterior mitral leaflet on the atrial side of the device. This exemplary shape can provide for unimpaired excursion of the anterior mitral leaflet to allow adequate opening and closure of the mitral valve orifice based on the movement of the anterior leaflet.


In an alternative embodiment of the tubular or D-shaped member, the anterior circumference of the device can be flat or semicircular, while the remainder of the circumference can remain circular. The anterior section of the device may expand to match the distance between the right and left fibrous trigones of the native mitral annulus. Such a feature can allow one device to fit into differing size mitral annulae.


In a further alternative embodiment (e.g., FIG. 18), the first set of radially and outwardly disposed fixation elements can abut the atrial endocardium above the mitral annulus, holding the tubular element of the device at or above the plane of the mitral annulus. Along the anterior mitral annulus, where the anterior mitral valve attaches to the annulus between the anterior and posterior mitral commissures, the tubular element can be above the annulus. The second set of radially and outwardly disposed fixation elements can be configured to abut the ventricular endocardium along the posterior mitral annulus between the anterior and posterior mitral commissures to provide compression and hold the tubular element at or near the plane of the mitral annulus posteriorly. It is a feature of this embodiment that the first set of fixation elements and second set of fixation elements can abut each other in the plane of the mitral annulus between the anterior and posterior mitral commissures along the posterior mitral annulus. This embodiment can provide a mechanism to utilize the prosthesis to reduce the orifice size of the mitral valve to that of the tubular element of the device. This feature can be used, for example, to treat patients with mitral regurgitation exclusively or partially related to native mitral annular dilatation in conjunction with other prosthesis elements described herein.


An exemplary embodiment of the ventricular portion of the device can include an incomplete circumference designed to provide for compression against the left ventricular endocardium and fixation of the tubular element of the valve device at or above the mitral annulus. This shape and positioning of the valve device can permit unobstructed opening and closing motion of the anterior mitral leaflet. The ventricular posterior of the valve device would theoretically compress the posterior mitral leaflet against posterior left ventricular endocardium when fully deployed.


An exemplary embodiment of the atrial section of the device can expand to coapt with the endocardium of the left atrium to provide for fixation of the tubular section of the valve device at or above the mitral annulus. When the atrial and ventricular sections of the device are fully deployed, the tubular or D-shaped element of the device can occupy the mitral annular plane, or can occupy the mitral annulus and extend into the left atrium and left ventricle for a desired distance.


An exemplary method of fixation of the valve device can include compression or the radial force exerted on the left atrial endocardium, mitral annulus and left ventricular endocardium by the expanded and fully deployed valve device. The atrial section of the device adjacent to the anterior mitral annulus would be held in position by radial force and/or by two points of fixation at the fibrous trigones and/or other points along the circumference of the annulus.


An alternate exemplary embodiment of fixation of the valve device at the mitral annular level can be performed by active fixation. Here, barbed arrows or other fasteners can extend radially and outwardly from the tubular element of the valve device to project into the anterior annulus or trigones once the device is deployed. Alternately, hooks or other fasteners can extend radially from the ventricular side of the tubular element to directly engage the anterior annulus at the anterior and posterior commissures posterior to the trigones. Alternatively, barbed spears or hooks or other fasteners can extend radially and outwardly from either the ventricular or atrial fastening members during or after implantation.


One embodiment of the device can include one or more inflatable chambers located on the outer circumference of the central tubular element of the device. The chambers can be filled with liquid or gas or semisolid material remotely or through directly connected tube(s) to cause the inflatable chambers to expand and occupy space between the external central (annular) plane of the device and the native mitral annulus. Such a device can help prevent periprosthetic leak, for example, in the setting of a calcified, irregularly shaped mitral annulus.


In another embodiment of the device, some or all of the frame of the device can be composed of biological tissue and/or tissue permitting tissue ingrowth (e.g., ePTFE). This composition of the device can allow for fixation of the device into the mitral annulus initially through compression with or without active fixation. Over time, the biological tissue would permit growth into the native annulus, left atrium and/or left ventricle where fixation based on compression would no longer be necessary.


Prosthetic Posterior Leaflet Equivalent


An exemplary embodiment of a valve device can include a covering of the central tubular element of the device to create an artificial posterior mitral leaflet connected by a variety of fixation techniques to the posterior circumference of the device. The covering can be of a variety of Artificial or biological tissue compatible types as disclosed elsewhere herein, for example. The covering, or prosthetic posterior mitral leaflet, can either be attached in a fixed or stationary position, or loosely to provide for both an opening and a closing position. The covering can be composed of either a single or multiple covering pieces. The single or multiple covering pieces can be connected to the inside of the device in an annular plane along the posterior circumference of the device not occupied by the anterior mitral leaflet when the anterior mitral leaflet would be in a closed position. The single covering version of the device can have the covering connected to the ventricular fixation portion of the device at the incomplete margin, along the internal aspect of the ventricular fixation element toward the tubular element and then along the annular plane within the tubular element posteriorly. In the double or multiple covering versions, the coverings can be connected to the inner annular portion of the device as above, with sectional coverings held by connecting cords to the ventricular fixation element posteriorly along the base to prevent prolapse above the plane of the tubular element.


In one embodiment, the length and/or height of the artificial posterior covering of the device can be controlled before, during or after device implantation. In a particular embodiment, two ends of one string can run under the posterior mitral covering along the edge to alter the tension and therefore the area of the mitral orifice covered by the posterior covering. Similar mechanisms can provide for altering the shape and circumference covered by the prosthetic posterior mitral leaflet.


In one embodiment of the prosthetic posterior mitral leaflet, the single covering version can include a highly redundant posterior leaflet to treat a restrictive defect in the native anterior mitral leaflet. Also, this version can be used to treat anterior mitral leaflet prolapse by creating a large zone of coaptation in the left atrium.


Another embodiment of the device can include one or more inflatable chambers (see adjacent rectangular chambers in lower portion of prosthesis in FIG. 15) located within the circumference of the device below the tubular element of the device between the ventricular skirt of the device and the one or more prosthetic posterior leaflet equivalents. These inflatable chambers can be filled with liquid or gas or semisolid material at the time of implantation or remotely or through directly connected tubes to advance or retract the prosthetic posterior leaflet. This permits improvement of coaptation between the native anterior mitral leaflet and the prosthetic posterior leaflet(s).


Guided Valve Fixation


In order to steer the valve device and to fix the device in position, one exemplary embodiment can include techniques such as those described in the PCT application incorporated by reference herein, which in some embodiments provides two or more suture guides affixed to the outer circumference of the tubular element of the device to allow for directed placement and/or proper positioning of the device, orientation and fixation, such as illustrated in FIGS. 4A-E. These guides can be located, for example on the external circumference of the tubular element of the device. These suture guides can also be formed as holes or openings defined in the prosthesis frame or body, external rings, tubes or similar shapes. In one embodiment, two guides can be positioned anteriorly to approximate the distance between the right and left fibrous trigones. In another embodiment, the suture guides can be movable to dynamically fit the delivery and seating of the device to different anatomical sizes of mitral annulae. In another embodiment, the device can include one or more such guides on the posterior external circumference of the device with or without such guides on the anterior aspect of the device. These too can be fixed in position or be adjustable to approximate the distance between sutures placed in the native mitral annulus by a variety of techniques and imaged by a variety of techniques.


These guides can, if desired, be used in conjunction with a single suture, a loop of suture, and/or a rail of any material that could be fixed at an annular or periannular location to guide the device into location and possibly to fix the device in place. The suture guides can be used to drive the device into position in a beating heart. Once the device is delivered through the annulus, the ventricular portion of the device can be deployed to bring the ventricular skirt into coaptation with the endocardium of the left ventricle. This action can also incompletely deploy the atrial skirt of the device such that blood can immediately flow through the open central portion of the device, but without the user ever losing control of or being able to fully retrieve the device. The device can then be rotated to identify the best position of the prosthetic posterior mitral leaflet using a dynamic imaging study such as three-dimensional or two-dimensional echocardiography. The sutures or rails passed through the guides can then be tied and/or crimped and subsequently cut to fix the device in permanent position following full deployment.


Anterior Leaflet Prolapse Prevention Element


Prolapse of the anterior leaflet of the mitral valve above the plane of the mitral annulus can result in mitral regurgitation as it fails to achieve coaptation with the posterior mitral leaflet. In some embodiments of the valve device, the device can include anterior-posterior and/or septal-lateral transversely directed “bars” or cords of biological or tissue compatible material such as PTFE or covered tantalum (e.g., see FIGS. 16-17) that spring into place upon deployment of the device at or above the annular plane to prevent anterior leaflet prolapse. These may also be flat straps of tissue compatible material or biological tissue that can rotate at their ends. These straps can rotate parallel to the direction of flow during diastole to avoid obstructing blood flow and then rotate flat during systole to increase the area of coverage of the potentially prolapsing anterior mitral leaflet.


Implantation Method


The valve device(s) described herein may be implanted surgically (on or off cardiopulmonary bypass) or as a minimally invasive surgical procedure. The device can also be implanted in one exemplary design as a fully catheter mounted device. As a fully catheter mounted device, the access to the mitral annulus can be, for example, through the left ventricular apex, through the free wall of the left atrium or through the left atrial septum.


The implant method for such device(s) can allow for rotation under imaging to properly position the partially deployed device and prosthetic posterior leaflet equivalent in conjunction with transesophageal (2D or 3D) or fluoroscopically.


In one embodiment, the external circumference of the annular level of the device can be coated with a fixed or expandable coating or element that can serve to prevent periprosthetic leak by occupying space between the external annular level of the device and the native mitral annulus. The annulus can be rendered irregularly shaped and firm by virtue of calcification. This element of the prosthesis can occupy such spaces between the irregularly shaped native mitral annulus and the uniformly circumferential external wall of the device.


Thus, in some embodiments the disclosure provides heart valve prosthesis that includes a tubular or “D”-shaped member configured for deployment in a heart valve annulus, first set of fastening mechanisms radially and outwardly disposed from the tubular or “D”-shaped member and configured to attach the valve prosthesis to cardiac tissue above the heart valve annulus, a second set of fastening mechanisms radially and outwardly disposed from the tubular or “D”-shaped member for less than the entire circumference of the tubular or “D”-shaped member and configured to attach the valve prosthesis to cardiac tissue below the heart valve annulus, and an incomplete covering/closure of the interior of the tubular or “D”-shaped member attached by any of various connectors to the inner circumference of the radially and outwardly disposed fastening mechanisms above, at or below the heart valve annulus. The first set of fastening mechanisms radially and outwardly disposed from the tubular or “D”-shaped member can be configured to attach the valve prosthesis to cardiac tissue above the heart valve annulus and can be interrupted for a section of the circumference where hooks, tines (and other connectors) can be disposed to attach the tubular or “D”-shaped member above the heart valve annulus. In some embodiments, two hooks can extend radially outward from the exterior of the tubular of “D”-shaped member for attachment to the myocardium below the annulus to secure the tubular of “D”-shaped member above the annulus. The incomplete covering/closure of the interior of the tubular or “D”-shaped member can be a unitary panel or can be interrupted in one or more sections with attachments to the second set of fastening mechanisms radially and outwardly disposed from the tubular or “D”-shaped member to prevent displacement of the incomplete covering or closure above the highest point of the tubular or “D”-shaped member above the annulus. The incomplete covering/closure of the interior of the tubular or “D”-shaped member may be composed of biological tissue. If desired, the device can be completely or partially constructed of biological material. The incomplete covering/closure of the interior of the tubular or “D”-shaped member may be fixed or mobile. The position of the incomplete covering/closure of the interior of the tubular or “D”-shaped member can be variably controlled by sutures or one or more remotely inflatable chambers. In some implementations, two or more rings can be laterally disposed from the external circumference of the tubular or “D”-shaped member. The rings can freely move in the plane along the external circumference of the tubular or “D”-shaped member until the device is fully deployed. One or more fixed or mobile bars or straps of tissue compatible material may cross the internal area of the tubular or “D”-shaped member or the first set of fastening mechanisms radially and outwardly disposed from the tubular or “D”-shaped member. The external circumference of the tubular or “D”-shaped member can include an expandable material or covering and/or remotely inflatable chambers to adhere to an irregularly shaped valve annulus and can either automatically or controllably oppose and seal the space between the annulus and the device. The device can contain a remote monitor to measure blood flow, blood pressure, heart rate or heart rhythm and transmit the data to a user terminal that can be viewed by a surgeon, physician or operating room assistant.


All statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure.


The methods and systems of the present disclosure, as described above and shown in the drawings, provide for improved techniques for treating mitral valves of patients. It will be apparent to those skilled in the art that various modifications and variations can be made in the devices, methods and systems of the present disclosure without departing from the spirit or scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the subject disclosure and equivalents.

Claims
  • 1. A method of implanting a mitral valve prosthesis having an tubular upper portion to reside in an atrium and an downwardly depending posterior skirt to reside in the left ventricle, comprising: providing a mitral valve prosthesis having a funnel shaped tubular upper portion to reside in and urge against the walls of a patient's atrium above and radially outwardly from the patient's mitral annulus and a downwardly depending posterior skirt disposed in a delivery catheter, wherein the mitral valve prosthesis is configured to not extend below the mitral annulus in the region of an anterior native mitral valve leaflet of the patient;delivering the mitral valve prosthesis into the patient's heart using a delivery catheter;deploying the funnel shaped tubular upper portion of the mitral valve prosthesis from the delivery catheter within the patient's left atrium, the funnel shaped tubular upper portion having a funnel shaped circumferential wall, wherein deploying the funnel shaped tubular upper portion within the patient's left atrium causes the funnel shaped circumferential wall to urge against cardiac tissue of the left atrium;deploying the downwardly depending posterior skirt of the mitral valve prosthesis through the mitral annulus into the left ventricle, wherein the downwardly depending posterior skirt does not interfere with the opening and closing of the native anterior mitral valve leaflet and further wherein the mitral valve includes at least one posterior leaflet coupled to the downwardly depending posterior skirt that coapts with the native anterior mitral valve leaflet to permit the mitral valve to open and close.
  • 2. The method of claim 1, further comprising causing the downwardly depending posterior skirt to urge against an inner surface of the left ventricle to prevent flow around an outer portion of the valve prosthesis.
  • 3. The method of claim 1, wherein the mitral valve prosthesis further includes at least one lower fastener disposed proximate the downwardly depending posterior skirt, and further wherein the method further comprising deploying said at least one lower fastener to hold the mitral valve prosthesis in place.
  • 4. The method of claim 3, wherein the at least one lower fastener includes a plurality of fasteners formed into the downwardly depending posterior skirt.
  • 5. The method of claim 4, wherein the at least one lower fastener includes at least one fastener disposed radially outwardly from the downwardly depending posterior skirt that urges upwardly against the ventricular side of the mitral annulus.
  • 6. The method of claim 1, further comprising outwardly inflating at least one inflatable bladder coupled to the prosthesis against a surface of the left ventricle to prevent flow around an outside of the prosthesis.
  • 7. The method of claim 6, wherein the at least one inflatable bladder is disposed along a portion of the downwardly depending posterior skirt.
  • 8. The method of claim 1, further comprising outwardly inflating at least one inflatable bladder coupled to the prosthesis cause the downwardly depending posterior skirt to urge against an inner surface of the left ventricle to prevent flow around an outer portion of the valve prosthesis.
  • 9. The method of claim 8, wherein the at least one inflatable bladder includes a plurality of adjacent chambers.
  • 10. The method of claim 9, wherein the plurality of adjacent chambers are arranged circumferentially about the downwardly depending posterior skirt.
  • 11. The method of claim 9, wherein each chamber in the plurality of adjacent chambers can be inflated individually.
  • 12. The method of claim 1, further comprising fastening the downwardly depending posterior skirt against a posterior wall of the patient's left ventricle.
  • 13. The method of claim 1, wherein the funnel shaped tubular upper portion includes a plurality of distributed fasteners that urge against the walls of the left atrium to help to maintain the position of the mitral valve prosthesis within the mitral annulus.
  • 14. The method of claim 13, wherein the plurality of distributed fasteners at least partially define the shape of the funnel shaped tubular upper portion.
  • 15. The method of claim 1, wherein the mitral valve prosthesis exerts an outward radial force on the left atrial endocardium, mitral annulus and left ventricular endocardium after it is deployed.
  • 16. The method of claim 1, further comprising fixating the mitral valve prosthesis proximate the fibrous trigones of the mitral valve annulus.
  • 17. The method of claim 1, further comprising rotating the mitral valve prosthesis within the mitral annulus under imaging when the mitral valve prosthesis is in a partially deployed state to align the mitral valve prosthesis with respect to native anatomy.
  • 18. The method of claim 1, wherein an external circumference of the mitral valve prosthesis is coated with a material to prevent a periprosthetic leak by occupying space between an external annular level of the device and the native mitral annulus.
  • 19. The method of claim 1, wherein the mitral valve prosthesis includes at least one guiding conduit to guide the mitral valve prosthesis to the mitral annulus over a guide rail, wherein the guide rail is anchored into tissue proximate the mitral annulus, and further wherein the guide rail is externalized from the patient to permit the prosthesis to be introduced into the patient over the guide rail while it is still inside the delivery catheter.
  • 20. The method of claim 1, wherein, once the mitral valve prosthesis is positioned through the mitral annulus, the method further comprises deploying the downwardly depending posterior skirt to bring the downwardly depending posterior skirt into coaptation with the endocardium of the left ventricle and incompletely deploying the funnel shaped tubular upper portion such that blood can immediately flow through an open central portion of the mitral valve prosthesis, wherein the physician delivering the mitral valve prosthesis is still able to rotate and fully retrieve the mitral valve prosthesis.
CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of U.S. patent application Ser. No. 16/400,020, filed Apr. 30, 2019, which in turn is a continuation of and claims the benefit of priority to U.S. patent application Ser. No. 14/453,478, filed Aug. 4, 2014, which in turn claims the benefit of priority to International Application No. PCT/US2014/49629, filed Aug. 4, 2014, which claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 61/862,041, filed Aug. 4, 2013, U.S. Provisional Patent Application Ser. No. 61/878,264, filed Sep. 16, 2013 and U.S. Provisional Patent Application Ser. No. 62/007,369, filed Jun. 3, 2014. This application is also related to U.S. patent application Ser. No. 14/074,517 filed Nov. 7, 2013 which in turn claims the benefit of U.S. Provisional patent Application Ser. No. 61/723,734, filed Nov. 7, 2012, U.S. patent application Ser. No. 13/240,793, filed Sep. 22, 2011, International Application No. PCT/US2013/28774, filed Mar. 2, 2013, International Application No. PCT/US2011/59586, filed Nov. 7, 2011. The entire contents of each of the above referenced patent applications is incorporated herein by reference for any purpose whatsoever.

US Referenced Citations (159)
Number Name Date Kind
4106129 Carpentier et al. Aug 1978 A
4218783 Reul Aug 1980 A
4259753 Liotta et al. Apr 1981 A
4666442 Arru et al. May 1987 A
4692164 Dzemeshkevich et al. Sep 1987 A
5411552 Andersen et al. May 1995 A
5449384 Johnson Sep 1995 A
5606928 Religa et al. Mar 1997 A
5788715 Watson, Jr. et al. Aug 1998 A
5843167 Dwyer Dec 1998 A
5861028 Angell Jan 1999 A
5895410 Forber et al. Apr 1999 A
5928281 Huynh et al. Jul 1999 A
6059769 Lunn et al. May 2000 A
6106510 Lunn et al. Aug 2000 A
6375774 Lunn et al. Apr 2002 B1
6419695 Gabbay Jul 2002 B1
6599303 Peterson Jul 2003 B1
6602271 Adams et al. Aug 2003 B2
6716231 Rafiee et al. Apr 2004 B1
6733525 Yang et al. May 2004 B2
6790229 Berreklouw Sep 2004 B1
6797000 Simpson et al. Sep 2004 B2
6800081 Parodi Oct 2004 B2
6866677 Douk et al. Mar 2005 B2
6869444 Gabbay Mar 2005 B2
6893459 Macoviak May 2005 B1
6911036 Douk et al. Jun 2005 B2
6953476 Shalev Oct 2005 B1
6960217 Bolduc Nov 2005 B2
7044958 Douk et al. May 2006 B2
7066946 Douk et al. Jun 2006 B2
7189259 Simionescu et al. Mar 2007 B2
7195641 Palmaz et al. Mar 2007 B2
7201772 Schwammenthal et al. Apr 2007 B2
7294135 Stephens et al. Nov 2007 B2
7316706 Bloom et al. Jan 2008 B2
7399315 Iobbi Jul 2008 B2
7425219 Quadri Sep 2008 B2
7442204 Schwammenthal et al. Oct 2008 B2
7442207 Rafiee Oct 2008 B2
7445631 Salahieh et al. Nov 2008 B2
7481838 Carpentier et al. Jan 2009 B2
7491232 Bolduc et al. Feb 2009 B2
7524330 Berreklouw Apr 2009 B2
7655040 Douk et al. Feb 2010 B2
7682352 Rafiee et al. Mar 2010 B2
7699892 Rafiee et al. Apr 2010 B2
7716801 Douk et al. May 2010 B2
7753840 Simionescu et al. Jul 2010 B2
7753949 Lamphere et al. Jul 2010 B2
7780726 Seguin Aug 2010 B2
7799069 Bailey et al. Sep 2010 B2
7806917 Xiao Oct 2010 B2
7806919 Bloom et al. Oct 2010 B2
7815673 Bloom et al. Oct 2010 B2
7947072 Yang et al. May 2011 B2
7955384 Rafiee et al. Jun 2011 B2
7972370 Douk et al. Jul 2011 B2
7998188 Zilla et al. Aug 2011 B2
8002825 Letac et al. Aug 2011 B2
8052750 Tuval et al. Nov 2011 B2
8062355 Figulla et al. Nov 2011 B2
8070802 Lamphere et al. Dec 2011 B2
8092518 Schreck Jan 2012 B2
8092520 Quadri Jan 2012 B2
8092524 Nugent et al. Jan 2012 B2
8226710 Nguyen et al. Jul 2012 B2
8252051 Chau et al. Aug 2012 B2
8308798 Pintor et al. Nov 2012 B2
8337541 Quadri et al. Dec 2012 B2
8348995 Tuval et al. Jan 2013 B2
8348996 Tuval et al. Jan 2013 B2
8353954 Cai et al. Jan 2013 B2
8353955 Styrc et al. Jan 2013 B2
20010021872 Bailey et al. Sep 2001 A1
20020032481 Gabbay Mar 2002 A1
20020138138 Yang Sep 2002 A1
20030055495 Pease et al. Mar 2003 A1
20030065386 Weadock Apr 2003 A1
20030097172 Shalev et al. May 2003 A1
20030199975 Gabbay Oct 2003 A1
20040087998 Lee et al. May 2004 A1
20040127916 Bolduc et al. Jul 2004 A1
20040260317 Bloom et al. Dec 2004 A1
20050038508 Gabbay Feb 2005 A1
20050038509 Ashe Feb 2005 A1
20050043790 Seguin Feb 2005 A1
20050055082 Ben-Muvhar et al. Mar 2005 A1
20050137769 Salahieh et al. Jun 2005 A1
20050143809 Salahieh et al. Jun 2005 A1
20050177180 Kaganov et al. Aug 2005 A1
20050288706 Widomski et al. Dec 2005 A1
20060085012 Dolan Apr 2006 A1
20060106449 Ben-Muvhar May 2006 A1
20060106450 Ben-Muvhar May 2006 A1
20060173537 Yang et al. Aug 2006 A1
20060259135 Navia et al. Nov 2006 A1
20070016288 Gurskis Jan 2007 A1
20070043435 Seguin et al. Feb 2007 A1
20070067029 Gabbay Mar 2007 A1
20070250160 Rafiee Oct 2007 A1
20070255398 Yang et al. Nov 2007 A1
20070260305 Drews et al. Nov 2007 A1
20070288089 Gurkis et al. Dec 2007 A1
20070293942 Mizraee Dec 2007 A1
20080021537 Ben-Muvhar et al. Jan 2008 A1
20080065191 Bolduc et al. Mar 2008 A1
20080071369 Tuval Mar 2008 A1
20080077234 Styrc Mar 2008 A1
20080125860 Webler et al. May 2008 A1
20080208328 Antocci et al. Aug 2008 A1
20080221672 Lamphere et al. Sep 2008 A1
20080281411 Berreklouw Nov 2008 A1
20090005863 Goetz et al. Jan 2009 A1
20090062841 Amplatz et al. Mar 2009 A1
20090149949 Quinn Jun 2009 A1
20090270966 Douk et al. Oct 2009 A1
20090270976 Douk et al. Oct 2009 A1
20090306768 Quadri Dec 2009 A1
20090319038 Gurskis et al. Dec 2009 A1
20100036479 Hill et al. Feb 2010 A1
20100082094 Quadri et al. Apr 2010 A1
20100100167 Bortlein et al. Apr 2010 A1
20100174363 Castro Jul 2010 A1
20100179648 Richter et al. Jul 2010 A1
20100179649 Richter et al. Jul 2010 A1
20100185275 Richter et al. Jul 2010 A1
20100249923 Alkhatib et al. Sep 2010 A1
20100262232 Annest Oct 2010 A1
20100280606 Naor Nov 2010 A1
20100298931 Quadri et al. Nov 2010 A1
20110112632 Chau et al. May 2011 A1
20110137409 Yang et al. Jun 2011 A1
20110172784 Richter et al. Jul 2011 A1
20110282438 Drews et al. Nov 2011 A1
20110313515 Quadri et al. Dec 2011 A1
20110319988 Schankereli et al. Dec 2011 A1
20110319989 Lane Dec 2011 A1
20110319990 Macoviak Dec 2011 A1
20120022639 Hacohen Jan 2012 A1
20120059450 Chiang et al. Mar 2012 A1
20120078353 Quadri et al. Mar 2012 A1
20120078360 Rafiee Mar 2012 A1
20120150290 Gabbay Jun 2012 A1
20120179086 Shank Jul 2012 A1
20120179244 Schankereli et al. Jul 2012 A1
20120215303 Quadri et al. Aug 2012 A1
20120316642 Yu et al. Dec 2012 A1
20120323316 Chau et al. Dec 2012 A1
20140018906 Rafiee Jan 2014 A1
20140039083 Rafiee Feb 2014 A1
20140067054 Chau et al. Mar 2014 A1
20140128965 Rafiee May 2014 A1
20140163668 Rafiee Jun 2014 A1
20140324164 Gross Oct 2014 A1
20140343669 Lane et al. Nov 2014 A1
20140358223 Rafiee et al. Dec 2014 A1
20140379074 Spence Dec 2014 A1
Foreign Referenced Citations (7)
Number Date Country
2412397 Feb 2012 EP
100 718 Dec 2010 RU
WO2007121314 Oct 2007 WO
2012061809 May 2012 WO
WO2013131069 Sep 2013 WO
WO2015069947 May 2015 WO
WO2015148821 Oct 2015 WO
Non-Patent Literature Citations (12)
Entry
Final Office Action dated Jul. 19, 2022, in related U.S. Appl. No. 16/400,020, 13 pages.
International Search Report for co-pending international application No. PCT/US2013/028774, dated Jun. 14, 2013.
International Preliminary Report on Patentability and Written Opinion, on related application No. PCT/US2014/064431 dated Mar. 26, 2015.
International Search Report, for related application No. PCT/US2015/022782, dated Jun. 18, 2015.
Patent Examination Report issued in related Australian patent application No. 2013205892, dated Oct. 13, 2015.
USPTO's Non-Final Office Action in related U.S. Appl. No. 13/886,983, dated Dec. 24, 2015.
International Search Report, for related application No. PCT/US2011/059586, dated May 25, 2012.
International Preliminary Report on Patentability and Written Opinion, or related application No. PCT/US2011/059586, dated May 25, 2012.
BioIntegral Surgical, Mitral Valve Restoration System, 2009.
Amendment filed Nov. 11, 2016 in U.S. Appl. No. 14/461,732.
Non-Final Office Action dated Jun. 6, 2016 in U.S. Appl. No. 14/461,732.
Final Office Action dated Dec. 14, 2016 in U.S. Appl. No. 14/461,732.
Related Publications (1)
Number Date Country
20210228354 A1 Jul 2021 US
Provisional Applications (1)
Number Date Country
61723734 Nov 2012 US
Continuations (3)
Number Date Country
Parent 15413017 Jan 2017 US
Child 16557171 US
Parent 14453478 Aug 2014 US
Child 16400020 US
Parent PCT/US2014/049629 Aug 2014 WO
Child 14453478 US
Continuation in Parts (3)
Number Date Country
Parent 16557171 Aug 2019 US
Child 17086106 US
Parent 16400020 Apr 2019 US
Child 17086106 US
Parent 14074517 Nov 2013 US
Child 15413017 US