# Patent

## Title
Collapsible/expandable prosthetic heart valves with native calcified leaflet retention features

## Abstract

A prosthetic heart valve includes an annular frame that is adapted for (1) delivery into a patient's native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential re-expansion when in the annulus, the frame, in an expanded condition. The frame having a longitudinal axis, an inflow end and an outflow end, a first portion of the frame adjacent the inflow end inclining radially outwardly in a direction toward the inflow end, and a second portion of the frame between the first portion and the outflow end bulging radially outwardly, the second portion of the frame being positioned between a first axial distance from the inflow end and a second axial distance from the inflow end. The frame also includes a plurality of commissure members. The heart valve further includes a flexible leaflet structure disposed in the frame.

## Background
This application is a continuation application of U.S. application Ser. No. 14/824,209, filed Aug. 12, 2015, which is a continuation application of U.S. application Ser. No. 14/280,868, filed May 19, 2014 which is a continuation application of U.S. application Ser. No. 12/733,763, filed Mar. 18, 2010, which is a national phase entry under 35 U.S.C. §371 of International Application No. PCT/US2008/11181, filed Sep. 26, 2008, published in English, which claims the benefit of U.S. Provisional Patent Application No. 60/995,845, filed Sep. 28, 2007, the disclosures of all of which are hereby incorporated herein by reference.


BACKGROUND OF THE INVENTION
This invention relates to collapsible/expandable prosthetic heart valves (especially prosthetic aortic valves) for use with non-resected calcified native valves. The prosthetic heart valve design incorporates features that hold open the native calcified leaflets away from the new valve.
BRIEF SUMMARY OF THE INVENTION
In accordance with certain possible aspects of the invention, a prosthetic heart valve may utilize expansion of fork-like fingers to push calcified native leaflets out of the way. This eliminates interference with the newly deployed prosthetic valve and maximizes hemodynamic performance. It also enhances prosthetic valve frame anchoring in the patient as a result of the fingers engaging the calcified leaflets.
A prosthetic heart valve in accordance with the invention may be circumferentially collapsible and re-expandable, and may include an annular frame structure and a flexible leaflet structure disposed in the frame structure. The frame structure is preferably adapted for delivery into a patient's native heart valve annulus in a circumferentially collapsed condition. The frame structure is preferably further adapted for circumferential re-expansion when in the above-mentioned annulus. The frame structure preferably includes a leaflet restraining structure for pushing radially outwardly on a patient's native heart valve leaflet (or leaflets) when the frame structure is re-expanded. The leaflet restraining structure is preferably cantilevered from an annulus portion of the frame structure. (The annulus portion is the portion of the frame structure that re-expands in the native valve annulus.) More particularly, the leaflet restraining structure is preferably cantilevered from the annulus portion to a free end of the leaflet restraining structure that is downstream from the annulus portion in the direction of blood flow through the prosthetic valve when the prosthetic valve is in use in the patient.
The above-mentioned leaflet restraining structure may be resiliently biased to incline radially outwardly from the annulus portion as one proceeds along the restraining structure from the annulus portion toward the free end of the restraining structure.
The leaflet restraining structure may include a plurality of fingers that are spaced from one another in a direction that is circumferential around the annulus portion. Each of these fingers may be cantilevered from the annulus portion and may extend from the annulus portion in the direction of blood flow through the implanted prosthetic valve.
Each of the above-mentioned fingers may have a free end that is remote from the annulus portion. All of the fingers may extend to approximately the same distance downstream from the annulus portion in the direction of blood flow. Alternatively, a first of the fingers may extend a greater distance downstream from the annulus portion in the direction of blood flow than a second of the fingers.
The annulus portion may include two (or more) circumferentially spaced commissure regions. In such a case, and in the case of the alternative mentioned in the immediately preceding paragraph, the fingers may also be circumferentially spaced from one another between two of the commissure regions, and the above-mentioned first finger may be circumferentially closer to one of the above-mentioned two commissure regions than the above-mentioned second finger is to either of those two commissure regions.
In a case in which the leaflet restraining structure includes a plurality of fingers, the leaflet restraining structure may further include a linking structure between two circumferentially adjacent ones of the fingers. This linking structure may be downstream from the annulus portion in the direction of blood flow through the implanted prosthetic valve.
The immediately above-mentioned linking structure may be collapsible and re-expandable in a direction that is circumferential around the annulus portion.
The location of the above-mentioned linking structure may be at the ends of the linked fingers that are remote from the annulus portion.
The annulus portion may include a plurality of circumferentially spaced commissure regions, and the leaflet restraining structure may be circumferentially spaced between two circumferentially adjacent ones of those commissure regions. Especially in such a case, the leaflet restraining structure may be one of a plurality of similar leaflet restraining structures. Each of these leaflet restraining structures may be circumferentially spaced between a respective one of a plurality of pairs of circumferentially adjacent ones of the commissure regions.
The prosthetic heart valve may be an aortic valve, which may further comprise a further frame structure that includes an annular aortic portion and a plurality of struts or links between the aortic portion and the annulus portion. The aortic portion may be adapted for delivery into a patient's aorta in a circumferentially collapsed condition. The aortic portion may be further adapted to circumferentially re-expand when in the aorta. The aortic portion is preferably downstream from the free end of the leaflet restraining structure in the direction of blood flow. The above-mentioned struts or links are preferably circumferentially spaced from the leaflet restraining structure.
In cases like those mentioned in the immediately preceding paragraph, the annulus portion may include a plurality of circumferentially spaced commissure regions. The above-mentioned struts or links may then connect to the annulus portion adjacent the commissure regions. For example, the leaflet restraining structure may be circumferentially spaced between first and second circumferentially adjacent ones of the links, and the first and second links may be respectively connected to the annulus portion adjacent respective first and second circumferentially adjacent ones of the commissure regions.
Further features of the invention, its nature and various advantages, will be more apparent from the accompanying drawings and the following detailed description.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1a is a simplified isometric or perspective view of an illustrative embodiment of a prosthetic heart valve in accordance with the invention.
FIG. 1b shows the FIG. 1a structure from another angle.
FIG. 1c shows the FIG. 1b structure from yet another angle.
FIG. 1d shows the FIG. 1c structure from still another angle.
FIG. 2a is a view similar to FIG. 1a for another illustrative embodiment of a prosthetic heart valve in accordance with the invention.
FIG. 2b shows the FIG. 2a structure from another angle.
FIG. 2c is similar to FIG. 2b, but FIG. 2c shows only some of the structure that is shown in FIG. 2b. 
FIG. 2d shows the FIG. 2c structure from another angle.
FIG. 3a is a simplified view of an illustrative embodiment of a prosthetic heart valve component in accordance with the invention. FIG. 3a shows the depicted component as though cut along a vertical axis and then laid out flat.
FIG. 3b is similar to FIG. 3a for another illustrative embodiment of the invention.
FIG. 3c is similar to FIG. 3b for yet another illustrative embodiment of the invention.
FIG. 3d is similar to FIG. 3c for still another illustrative embodiment of the invention.



DETAILED DESCRIPTION
A collapsible and re-expandable prosthetic aortic valve that can self-anchor around the native commissures in the valsalva sinus is shown in Alkhatib PCT patent application No. PCT/US08/09950, filed Aug. 21, 2008, which is hereby incorporated by reference herein in its entirety. The illustrations that form part of the present disclosure are embodiments of valves like those shown in the above-mentioned reference, with the addition of leaflet retention or restraining features in accordance with this invention. It will be understood that the particular structures shown and described herein are only illustrative, and that the invention can be applied to many other prosthetic valve constructions. Some of these possible variations will be mentioned later in this specification.
FIGS. 1a-d are several views of an illustrative embodiment of the invention, including fork-like fingers 10 for pushing a patient's native leaflet tissue (which may be calcified) out of the way of the leaflet structure 20 of prosthetic heart valve 30. The upper free ends of fingers 10 are cantilevered from annular stent structure 40 of the valve. When the valve is implanted in a patient, stent structure 40 resides in or near the patient's native valve annulus. Hence this portion 40 of the frame structure of valve 30 may sometimes be referred to as the annulus portion of the frame structure. Valve 30 is configured for use as an aortic valve replacement. In such use, an annular aortic portion 50 of the valve resides in the patient's aorta downstream (in the direction of blood flow through the implanted valve) from the patient's native valve annulus. Portions 40 and 50 are connected to one another by a plurality of links or struts 60 that pass through the patient's native valsalva sinus and that bulge out into the outwardly bulging lobes of the valsalva sinus. Other details of the construction of valve 30 will more apparent from the above-mentioned Alkhatib reference.
Note that all of the valves shown herein may be elastically collapsible in the annular or circumferential direction to a reduced annular or circumferential size that is suitable for delivery into a patient in a less invasive way (e.g., through tube-like delivery apparatus such as a catheter, a trocar, a laparoscopic instrument, or the like). When the valve reaches the intended site for implantation, the valve may elastically re-expand to normal operating size (e.g., the size shown in FIGS. 1a-d). In all cases herein, the valve frame structure like 10/40/50/60 may be made of a highly elastic metal such as nitinol, while leaflet structure 20 may be made of a synthetic material such as polymer, a natural material such as tissue, or another suitable flexible material. In addition to the structural elements shown herein, valves in accordance with this invention may also include other elements such as other layers of tissue and/or fabric (e.g., an outer fabric cover).
FIGS. 2a-d are several views of another illustrative embodiment of the invention. Reference numbers are repeated from FIGS. 1a-d for features in FIGS. 2a-d that are similar to features in FIGS. 1a-d. FIGS. 2c and d omit depiction of the actual leaflet structure 20 to better reveal certain other features. The principal difference from FIGS. 1a-d is the inclusion in FIGS. 2a-d of collapsible/expandable interconnections 12 between the upper (cantilevered) ends of certain ones of fork-like fingers 10.
FIGS. 3a-d show several further alternative embodiments of the metal frame structure 10/40/50/60/etc. of valves in accordance with the invention. Again, reference numbers are repeated from earlier FIGS. for generally similar components. FIGS. 3a-d show each metal frame structure as though it has been cut along a longitudinal (vertical) axis and then laid out flat. In addition, FIGS. 3a-d show each metal structure in the approximate condition (especially from left to right as viewed in these FIGS.) that it has when annularly collapsed for delivery into a patient in reduced annular or circumferential size. Thus the serpentine or cellular structures (e.g., 40, 50, 12) that extend in the annular direction around the valve are somewhat collapsed or compressed in the left-right direction as viewed in FIGS. 3a-d. Annular portions 40 and 50 shown in FIGS. 3a-d are of a closed-cell design. This is an alternative embodiment to the undulating strut design shown in the earlier FIGS. (Again, it is emphasized that the structures shown in FIGS. 3a-d are not actually flat at any time during their use. They are always closed, annular structures. The flat depictions shown in FIGS. 3a-d are only employed for convenience herein.)
In FIG. 3a the upper ends of cantilevered fork-like fingers 10 are free (e.g., as in FIGS. 1a-d), but these fingers differ in length. In particular, fingers 10 are longer near (in the circumferential direction) each of the three circumferentially spaced commissure posts 42 of the valve, and shorter where farther (in the circumferential direction) from the commissure posts. Another way to state this is by saying that the fingers 10 that are circumferentially closer to commissure posts 42 extend farther in the distal or downstream direction than the fingers 10 that are circumferentially farther from the commissure posts. FIG. 3b shows fingers 10 all of the same length and with their upper ends free.
FIG. 3c shows an embodiment like FIG. 3a, but with the upper ends of the fingers 10 of different lengths linked by serpentine structures 12. Note that each serpentine structure 12 links only the fingers 10 in a set of such fingers that are located between two circumferentially adjacent ones of commissure posts 42. Thus the fingers 10 in such a set and the serpentine structure 12 linking those fingers collectively comprise a leaflet restraining structure that is cantilevered upwardly from annulus portion 40 of the prosthetic valve frame. This structure as a whole (i.e., the set of fingers 10 and the link 12) has a free end (i.e., its upper end, which in this case is defined by link 12).
FIG. 3d shows an embodiment like FIG. 3b, but with the upper ends of equal-length fingers 10 linked by serpentine structures 12. Once again, in FIG. 3d, each set of fingers 10 (between two circumferentially adjacent commissure posts) and the associated link 12 collectively constitute a leaflet restraining structure that is cantilevered up from annulus portion 40 to a free end (i.e., link 12). In embodiments without links 12, the fingers 10 themselves constitute the leaflet restraining structure of this invention.
Recapitulating and extending the above, the following are some of the important aspects of the invention.
Features 10 (possibly with links 12) are incorporated onto a collapsible valve frame and are designed specifically to hold the native calcified leaflet back (e.g., radially outwardly) and away from the replacement valve.
Features 10 (possibly with links 12) are preferably not tall enough such that they would obstruct the coronary artery ostia.
The cantilevered leaflet retention feature typically includes several elongated, curved, fork-like fingers 10 that can be free-standing or interconnected (e.g., as shown at 12) at the distal (downstream) end.
The fingers 10 are connected to the main stent frame at their proximal (upstream) end.
The fork-like fingers 10 may be curved radially outward, away from the replacement valve.
The fork-like fingers 10 (possibly with links 12) have adequate stiffness in the radial direction to hold the calcified native valve in an open (radially outward) position.
The fork-like fingers 10 (possibly with links 12) can be scalloped (e.g., FIG. 3a or 3c) or straight (e.g., FIG. 3b or 3d) at their distal end.
The fork-like fingers 10 (possibly with links 12) enhance anchoring of the prosthetic valve as a result of engaging the calcified leaflets.
While curved (radially) outward fork-like members 10 will do a good job keeping calcified leaflets out of the way, alternate designs can also be used, ranging from straight up fingers 10 to straight fingers inclined at an angle so that they are radially farther out at their free ends than where joined to annulus portion 40. Preferably, the prosthetic valve frame's geometry is designed to oppose the native leaflet once implanted and is capable of holding open, pushing outwards, engaging, and displacing the native leaflets in desired patterns to clear coronaries, and anchoring in the native leaflets. Many suitable geometries are capable of achieving these goals. The geometries can vary significantly and only some of the possible geometries are described herein.
Although the presently preferred stent structures (like 10/40/50/60) are self-expanding (i.e., elastically deformed), the present invention is equally applicable to balloon-expandable (i.e., plastically deformed) stents or a combination of self-expanding and balloon expandable (e.g., where arms like 10 are resiliently self-expanding, but the rest of the cage like 40/50/60 may be balloon-expanded). The balloon-expandable stents, which can be made of stainless steel, can be used with specifically designed balloons that have, for example, a bulbous midsection. The balloon-expendable stents can also be enlarged in two or more steps. A straight conventional balloon can be used first to anchor one or more stent structures of the valves. A second spherical balloon can then be used to specifically expand the other structure or structures such as fingers 10.
The structures like fingers 10 of this invention can also be designed to provide the following benefits. These structures preferably move the native calcified leaflets radially outwardly away from the new valve structure to avoid potential abrasion of the new valve tissue 20 against the calcified, diseased tissue. Use of this invention can provide more space for a bigger prosthetic valve and better hemodynamics. The structures like 10/12 of this invention can deform the diseased leaflets in such a way as to avoid potential coronary blockage (i.e. occlusion of the ostium of a coronary artery). The structures like 10/12 can be designed to also help with stability and anchoring of the prosthetic valve in the patient. Prior known collapsible prosthetic valves may include cages that are intended to push diseased leaflets out of the way. But these previously known structures do not attempt to control or preferentially displace the diseased leaflets in a specific configuration to provide the benefits described above for the present invention.
The attachment point of fingers 10 to the stent is described as being preferably at or near the proximal end of the prosthetic valve frame structure using the proximal end of the fingers. In another embodiment of the invention, the fingers can extend down from the distal end of stent (outflow side). Other combinations of attachment are also possible (e.g., stent inflow side and members 60 or stent outflow side and members 60).
The foregoing features can be incorporated on minimally invasive surgically implanted valves where resection of the native calcified leaflets has not been performed or is not possible.
An advantage of providing leaflet restraining structures 10/12 as structures that are cantilevered from other structure of the valve frame is that this facilitates giving the leaflet restraining structures various properties that can be relatively independent of the properties of other parts of the frame. For example, the extent to which leaflet restraining structures 10/12 incline or extend radially outwardly can be made to depend solely (or at least largely) on the design of those structures per se, and can be independent of the shape, location, etc., of other adjacent frame components such as links 60, commissure posts 42, aortic portion 50, etc. Similarly, those other portions of the valve can be designed to have properties that are independent of the properties of leaflet restraining structures 10/12. Examples of properties that can thus be designed independently for structures 10/12, on the one hand, and other portions of the frame, on the other hand, include (1) collapsed location (i.e., location during delivery), (2) re-expanded location (i.e., location when deployed and implanted in the patient), (3) size, (4) shape, (5) stiffness, (6) strength, (7) resilience, etc.
It will be understood that the foregoing is only illustrative of the principles of the invention, and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the invention. For example, the number of leaflet restraining structures that are provided can be more or less than the number shown herein.

## Claims

1. A prosthetic heart valve comprising:
an annular frame that is adapted for (1) delivery into a patient's native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential re-expansion when in the annulus, the frame, in an expanded condition, having a longitudinal axis, an inflow end and an outflow end, a first portion of the frame adjacent the inflow end inclining radially outwardly in a direction toward the inflow end, and a second portion of the frame between the first portion and the outflow end bulging radially outwardly, the second portion of the frame being positioned between a first axial distance from the inflow end and a second axial distance from the inflow end, the frame further having a first radius at an intersection of the first portion and the second portion, the second portion having a plurality of radii greater than the first radius, the frame also including a plurality of commissure members positioned between the first axial distance from the inflow end and the second axial distance from the inflow end; and
a flexible leaflet structure disposed in the frame.

2. The prosthetic valve as claimed in claim 1, wherein the flexible leaflet structure includes three leaflets.

3. The prosthetic valve as claimed in claim 2, wherein the leaflets are formed from a biological tissue.

4. The prosthetic valve as claimed in claim 1, wherein the flexible leaflet structure further includes an outer fabric cover.

5. The prosthetic valve as claimed in claim 1, wherein the flexible leaflet structure is at least partially disposed within the first portion of the frame.

6. The prosthetic valve as claimed in claim 1, wherein the flexible leaflet structure is at least partially disposed within the second portion of the frame.

7. The prosthetic valve as claimed in claim 1, wherein the flexible leaflet structure is coupled to the frame at the plurality of commissure members.

8. The prosthetic valve as claimed in claim 1, wherein the frame includes a plurality of struts forming cells.

9. The prosthetic valve as claimed in claim 1, wherein the frame is self-expanding.

10. A prosthetic valve, comprising:
a frame having an expanded configuration and a collapsed configuration, the frame in the expanded configuration having a longitudinal axis, an inflow end and an outflow end, the frame having a first portion adjacent the inflow end inclining radially outward in a direction toward the inflow end, a second portion adjacent the outflow end, and a middle portion between the first and second portions, an intersection of the first portion with the middle portion defining a first radius from the longitudinal axis, and an intersection of the second portion with the middle portion defining a second radius from the longitudinal axis, all of a plurality of points on a surface of the middle portion having a radius from the longitudinal axis that is greater than the first radius and the second radius, the frame further including a plurality of commissure members at least partially disposed adjacent the middle portion; and
a valve assembly supported by the frame and coupled to the plurality of commissure members.

11. The prosthetic valve as claimed in claim 10, wherein the first portion inclines radially outwardly in a direction toward the inflow end.

12. The prosthetic valve as claimed in claim 10, wherein the valve assembly further includes an outer fabric cover.

13. The prosthetic valve as claimed in claim 10, wherein the valve assembly includes three leaflets.

14. The prosthetic valve as claimed in claim 13, wherein the leaflets are formed from a biological tissue.

15. The prosthetic valve as claimed in claim 10, wherein the frame includes a plurality of struts forming cells.

16. The prosthetic valve as claimed in claim 10, wherein the frame is self-expanding.

17. The prosthetic valve as claimed in claim 10, wherein the frame is balloon-expandable.

18. The prosthetic valve as claimed in claim 10, wherein the valve assembly is at least partially disposed within the middle portion.

19. The prosthetic valve as claimed in claim 10, wherein the valve assembly is at least partially disposed within the first portion.