The present disclosure relates to heart valve replacement and, in particular, to collapsible prosthetic heart valves. More particularly, the present disclosure relates to collapsible prosthetic transcatheter heart valves that are easier to load into a delivery device and that minimize or reduce paravalvular leaks.
Prosthetic heart valves that are collapsible to a relatively small circumferential size can be delivered into a patient less invasively than valves that are not collapsible. For example, a collapsible valve may be delivered into a patient via a tube-like delivery apparatus such as a catheter, a trocar, a laparoscopic instrument, or the like. This collapsibility can avoid the need for a more invasive procedure such as full open-chest, open-heart surgery.
Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent. There are two common types of stents on which the valve structures are ordinarily mounted: a self-expanding stent and a balloon-expandable stent. To load such valves into a delivery apparatus and deliver them into a patient, the valve is first collapsed or crimped to reduce its circumferential size.
When a collapsed prosthetic valve has reached the desired implant site in the patient (e.g., at or near the annulus of the patient's heart valve that is to be replaced by the prosthetic valve), the prosthetic valve can be deployed or released from the delivery apparatus and re-expanded to full operating size. For balloon-expandable valves, this generally involves releasing the valve, assuring its proper location, and then expanding a balloon positioned within the valve stent. For self-expanding valves, on the other hand, the stent automatically expands as a sheath covering the valve is withdrawn.
After implantation, imperfect sealing between the prosthetic valve and the native tissue at the site of implantation may cause complications such as paravalvular leakage (“PV leak”) in which retrograde blood flows through one or more gaps formed between the structure of the implanted valve and cardiac tissue as a result of the imperfect sealing.
According to one embodiment of the disclosure, a prosthetic heart valve for replacing a native valve includes a stent having an inflow end, an outflow end, a plurality of cells formed by cell struts, a collapsed condition and an expanded condition. A valve assembly is disposed within the stent. A first cuff is annularly disposed adjacent the stent. A second cuff has a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. A plurality of fingers each has a first end coupled to a corresponding cell of the stent and a free end remote from the first end, the distal edge of the second cuff being coupled to the free ends of the fingers at spaced locations around a circumference of the stent, the free ends of the fingers being spaced radially outward of the corresponding cell in the expanded condition of the stent to position the distal edge of the second cuff radially outward of the corresponding cells of the stent at the spaced locations.
According to another embodiment of the disclosure, a prosthetic heart valve for replacing a native valve includes a stent having an inflow end, an outflow end, a plurality of cells formed by cell struts, a collapsed condition and an expanded condition. A valve assembly is disposed within the stent. A first cuff is annularly disposed adjacent the stent. A second cuff has a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent and positioned radially outward of the first cuff and radially outward of the stent. A third cuff has a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the third cuff being annularly disposed about the stent and positioned radially outward of the second cuff. The distal edge of the second cuff is coupled to the stent at first attachment points spaced around a circumference of the stent, and the distal edge of the third cuff is coupled to the distal edge of the second cuff at second attachment points spaced around a circumference of the second cuff.
According to a further aspect of the disclosure, a prosthetic heart valve for replacing a native valve includes a stent extending in an axial direction from an inflow end to an outflow end, the stent having a plurality of cells formed by cell struts, a collapsed condition and an expanded condition. A valve assembly is disposed within the stent. A first cuff is annularly disposed adjacent the stent. A second cuff has a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The second cuff includes a pleat formed by at least two folds in the second cuff.
According to yet another aspect of the disclosure, a prosthetic heart valve for replacing a native valve includes a stent, a valve assembly, a first cuff, and a second cuff. The stent has an inflow end, an outflow end, a plurality of cells formed by cell stratus, a collapsed condition, and an expanded condition. The valve assembly is disposed within the stent. The first cuff is annularly disposed adjacent the stent. The second cuff has a proximal edge facing toward the inflow end of the stent and a distal edge facing outward the outflow end of the stent. The second cuff is annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The distal edge includes a plurality of peaks and a plurality of troughs, each trough connecting a pair of adjacent peaks. A distalmost portion of each peak is directly coupled to at least one of the first cuff and the stent.
Various embodiments of the presently disclosed prosthetic heart valve may be more fully understood with reference to the following detailed description when read with the accompanying drawings, in which:
As used herein in connection with a prosthetic heart valve, the term “inflow end” refers to the end of the heart valve through which blood enters when the valve is functioning as intended, and the term “outflow end” refers to the end of the heart valve through which blood exits when the valve is functioning as intended. As used herein, the term “proximal” refers to the inflow end of a prosthetic heart valve or to elements of a prosthetic heart valve that are relatively close to the inflow end, and the term “distal” refers to the outflow end of a prosthetic heart valve or to elements of a prosthetic heart valve that are relatively close to the outflow end. As used herein, the terms “generally,” “substantially,” and “about” are intended to mean that slight deviations from absolute are included within the scope of the term so modified. Like numbers refer to similar or identical elements throughout. When used herein in the context of a prosthetic heart valve, or a component thereof, the lengthwise or axial direction refers to a direction parallel to a longitudinal axis passing through the center of the stent or heart valve. When used herein in the context of a prosthetic heart valve, or a component thereof, the circumferential direction refers to a direction extending along the circumference of the prosthetic heart valve.
Stent 102 may include one or more retaining elements 118 at outflow end 132, the retaining elements being sized and shaped to cooperate with retaining structures provided on a deployment device (not shown). The engagement of retaining elements 118 with the retaining structures on the deployment device may help maintain prosthetic heart valve 100 in assembled relationship with the deployment device, minimize longitudinal movement of the prosthetic heart valve relative to the deployment device during unsheathing or resheathing procedures, and help prevent rotation of the prosthetic heart valve relative to the deployment device as the deployment device is advanced to the target location and during deployment. One such deployment device is described in U.S. Patent Publication No. 2012/0078352, the entire contents of which are hereby incorporated by reference herein.
Stent 102 may also include a plurality of commissure attachment features 116 for mounting the commissures of the valve assembly to the stent. As can be seen in
Prosthetic heart valve 100 includes a valve assembly 104 positioned in the annulus section 140 of stent 102. Valve assembly 104 includes a plurality of leaflets 108 that collectively function as a one way valve by coapting with one another, and a cuff 106 positioned on the luminal surface of stent 102 surrounding leaflets 108. As prosthetic heart valve 100 is intended to replace the aortic valve (which ordinarily is a tri-leaflet valve), it is shown in
Although cuff 106 is shown in
In operation, prosthetic heart valve 100 described above may be used to replace a native heart valve, such as the aortic valve; a surgical heart valve; or a heart valve that has undergone a surgical procedure. Prosthetic heart valve 100 may be delivered to the desired site (e.g., near the native aortic annulus) using any suitable delivery device. During delivery, prosthetic heart valve 100 is disposed inside the delivery device in the collapsed condition. The delivery device may be introduced into the patient using any known percutaneous procedure, such as a transfemoral, transapical, or transseptal delivery procedure. Once the delivery device has reached the target site, the user may deploy prosthetic heart valve 100. Upon deployment, prosthetic heart valve 100 expands into secure engagement within the native aortic annulus. When prosthetic heart valve 100 is properly positioned inside the heart, it works as a one-way valve, allowing blood to flow in one direction and preventing blood from flowing in the opposite direction.
Although described as a single piece of material above, outer cuff 350 may comprise multiple pieces of material that, when joined together, form a similar shape and provide similar function as described above for the outer cuff. Also, rather than being formed of a single substantially rectangular piece of material that is wrapped around the circumference of stent 302, outer cuff 350 may be formed as a continuous annular web without side edges 354, 356. Preferably, outer cuff 350 has an axial height measured from its proximal edge 352 to its distal edge 358 that is approximately half the axial height of a cell 312 in the proximalmost row of cells in stent 302 as measured along the major axis of the cell between two of its apices when the cell is in an expanded condition. However, outer cuff 350 may have other suitable heights, such as the full axial height of a cell 312 in the proximalmost row of cells, or more or less than the full axial height of a cell 312 in the proximalmost row of cells. Still further, although inner cuff 306 and outer cuff 350 are described above as separate pieces of material joined to stent 302 and to each other, the cuffs may be formed integrally with one another from a single piece of material that is wrapped around the proximal edge of the stent, with the distal edge 358 of the outer portion of the cuff joined to the stent and/or to the inner portion of the cuff at attachment points S1 as described above. With this configuration, the proximal edge 352 of outer cuff 350 does not need to be sutured to stent 302, although it still may be preferable to provide such attachment. Inner cuff 306 and outer cuff 350 may be formed of the same or different materials, including any suitable biological material or polymer such as, for example, polytetrafluoroethylene (PTFE), ultra-high molecular weight polyethylene (UHMWPE), polyurethane, polyvinyl alcohol, silicone, or combinations thereof.
As shown in
In order to address the drawback noted above, the prosthetic heart valves of the present disclosure may incorporate features that better enable the cuff of the prosthetic heart valve to fill any gaps that may remain once the heart valve has been implanted in a native valve annulus. A stent 402, inner cuff 406 and outer cuff 450 incorporating one such feature is shown in
Fingers 460 are preferably formed integrally with the remainder of stent 402 and are substantially straight, with a first end 462 attached to a cell 412 of the stent, and a second free end 464. For example, if stent 402 is formed by laser cutting a single tube, as described above in connection with stent 102, fingers 460 may also be formed by laser cutting the same tube. Alternatively, fingers 460 may be formed separately and then attached to stent 402, for example by adhesives, sutures, welding, or otherwise. In the embodiment shown in
Preferably, fingers 460 are shape set, for example by heat setting, so that in the absence of any applied forces, the free ends 464 of the fingers extend radially outward from the respective cells 412 in which the fingers are positioned, as shown in
Each finger 460 may have a similar cross-sectional shape and thickness as the struts forming the remainder of stent 402. However, it may be beneficial for fingers 460, or at least a portion of the fingers, to be substantially thinner, narrower and/or weaker than the struts forming the remainder of stent 402. For example, if fingers 460 are very thick, wide or otherwise stiff or strong compared to the remainder of stent 402, the force exerted as the free ends 464 of fingers 460 are biased radially outward against native annulus 250 could cause the inflow end of stent 402 to deform, which may be undesirable. Where fingers 460 are not biased outwardly, the pressure produced as retrograde blood flow enters the space between inner cuff 406 and outer cuff 450 may be insufficient to deflect stiff and strong fingers 460 outwardly into gaps 200. By forming fingers 460 with a cross-sectional thickness and/or width that is less than the cross-sectional thickness and/or width, respectively, of the struts forming the remainder of stent 402, less force may be required to deflect the fingers radially outward and these potential problems can be avoided. In the embodiment of
Although fingers 460 are described as singular struts, the fingers may be formed in a number of alternate configurations, some of which are shown in
During the process of implanting a prosthetic heart valve in a native valve annulus, the position of the prosthetic heart valve may slip slightly from the desired position, whereupon calcium deposits in or around the native valve annulus may contact one or more fingers 460 and deform same in the circumferential or axial direction of stent 402. This deformation of any of fingers 460 may affect the functioning of the finger and may induce additional strain therein which could be detrimental to the long term functioning of the prosthetic heart valve. It therefore may be desirable to more securely support the free ends of fingers 460 to help prevent them from being damaged or deformed during valve implantation.
Although in the foregoing description of the various embodiments of fingers 460 the distal edge 458 of outer cuff 450 is described as being connected to the free end of the finger, that is not necessarily the case. The distal edge 458 of cuff 450 may be connected to fingers 460 anywhere along the length of their struts 461 and 463. Moreover, while aperture or eyelets for attaching the free edge 458 of outer cuff 450 to fingers 460 are described as being positioned at the free ends of the fingers, those apertures or eyelets may be positioned at any position along the length of struts 461 and 463 at which it is desired to attach the free edge of the outer cuff.
As noted previously, fingers 460 may be located in the proximalmost annular row x of cells 412 of stent 402, as shown in
Notwithstanding the foregoing, there may be circumstances in which it is preferable to locate fingers 460 at a different position relative to stent 402. For example, it may be desirable to employ a relatively deep outer cuff 450, i.e., one in which distal edge 458 is positioned closer to commissure attachment features 416. In such event, the distal edge 458 of outer cuff 450 may be located at a position at which any reasonably sized fingers 460 in the proximalmost row x of cells 412 are unable to be attached to the distal edge of the outer cuff, or such fingers may be ineffective in urging the distal edge of the outer cuff radially outward and away from the remainder of stent 402. In that circumstance, it may be more appropriate to locate fingers 460 in the next adjacent annular row y of cells 412, as shown in
In addition to the axial length of outer cuff 450, there may be other considerations that dictate the positions at which fingers 460 are connected to stent 402. For example, when a prosthetic heart valve incorporating inner cuff 406 and outer cuff 450 is implanted in a native valve annulus, the pressure that builds between the cuffs from retrograde blood flow may tend to urge the struts at the proximal end of stent 402 radially inward, away from the native valve annulus, while at the same time urging the fingers 460 of the prosthetic heart valve radially outward against the native valve annulus. The inward deflection of the proximal end of stent 402 relative to fingers 460 results in a strain at the points at which the struts 461 and 463 of fingers 460 join the cell struts. As the pressure buildup between the cuffs occurs with each cardiac cycle, the strain induced in stent 402 occurs countless times during the use of the prosthetic heart valve and could result in premature failure of the stent. Positioning fingers 460 more distally on stent 402 may reduce the strain at these connection points. That is, since the inward deflection of stent 402 progressively diminishes moving away from the inlet end of the stent, by positioning fingers 460 farther from the inlet end of the stent, there will be less movement of the stent at the points at which struts 461 and 463 of the fingers join the cell struts. As a result of this lesser movement, the amount of strain induced in stent 402 at those connection points may be significantly reduced or eliminated.
The presence of fingers 460e (or any of fingers 460-460f described above) prevents the cells 412 in which the fingers are located from fully collapsing in the collapsed condition of stent 402. That is, in the collapsed condition of cells that do not include a finger 460 (and that do not include components of a valve assembly), strut 414b is able to lie immediately adjacent strut 414a, and strut 414d is able to lie immediately adjacent strut 414c. This full collapsing of cells 412 plainly is not possible for the cells containing a finger 460. As a result, stents 402 incorporating fingers 460 will tend to have a larger circumference in the collapsed condition in the annulus section in which the fingers are incorporated than stents that do not incorporate such fingers, and this larger circumference may make it more difficult to load the collapsed prosthetic heart valve into a delivery device. Moreover, the presence of an inner cuff and valve leaflets within the interior of stent 402 also makes it difficult to collapse the cells 412 in the annulus section of the stent sufficiently to enable loading of the valve into the delivery device. Accordingly, any reduction in the circumference of the prosthetic heart valve in the collapsed condition, particularly in the annulus section of the valve, would be desirable.
One technique for reducing the collapsed circumference of the prosthetic valve in the region of fingers 460 is to taper the width of the struts forming the cells in the annulus section of the stent. An example of this technique is illustrated in
It is generally known that the radial force exerted by the stent on the native valve annulus is important for holding a valve in place once implanted. Without wishing to be held to any particular theory, it is believed that the portions of the stent most important to radial force generation are at the ends of the cell struts at which one cell joins an adjacent cell (that is, where the apex of a cell in one annular row joins the apex of a cell in an adjacent annular row, or at the ancons where adjacent cells in an annular row join one another). In order to not diminish the radial force generated at these locations, it may be preferable to avoid tapering of the struts at their ends.
There are various ways in which the width of the stent struts can be tapered to achieve a reduced width. Three such arrangements are shown in
In some embodiments, the tapering of struts 414 described above may be performed only on the struts forming the cells 412 in which a finger 460 is located. However, to accommodate the inner cuff and valve leaflets within the interior of stent 402, it is preferable to taper each of the struts in the annulus section of the stent. Thus, for example, for prosthetic heart valves having two full rows of cells 412 between the inlet end of stent 402 and commissure attachment features 416, four circumferential rows of struts 414 may be tapered. For prosthetic heart valves having one full row of cells 412 and one half row of cells between the inlet end of stent 402 and commissure attachment features 416, as in
In addition to tapering the struts forming cells 412, it also may be desirable to taper the struts forming fingers 460. For example, for fingers 460 having a particular non-tapered strut width, the strut width may be tapered so that the tapered width is reduced by about 10% to about 90% compared to the non-tapered width, preferably by about 10% to about 35% compared to the non-tapered width. The tapering of the strut width in fingers 460 further diminishes the mass in the annulus section of stent 402 to enhance the ability of the stent to collapse to a small circumference.
Although the foregoing describes various embodiments of fingers for coupling the distal edge 458 of cuff 450 to one or more points in a cell 412, other alternatives may be suitable for this purpose. For example, the fingers may be formed with a longer length in the collapsed condition of stent 402 than the fingers described above in connection with
In another alternative, one or more sutures may take the place of the fingers. That is, one or more sutures may be attached between a cell 412 and the distal edge 458 of outer cuff 450 in a configuration similar to finger 460 (single suture), similar to finger 460a (one or more sutures forming a “V” shape), or similar to finger 460b (one or more sutures forming a “Y” shape). Further, it should be understood that the various fingers shown in, and described in connection with,
In addition to tapering the struts 414 in the annulus section of stent 402, other modifications to the stent to improve its performance are contemplated herein. In that regard, during the percutaneous delivery of the prosthetic heart valve to the implantation site, the heart valve may have to navigate through a tortuous path, including the tight curve of the aortic arch. In order to facilitate the navigation of these pathways, it may be desirable to configure the prosthetic heart valve so that it more easily bends when traversing a tight curve. This may be achieved by tapering the struts in the transition section or aortic section of stent 402, as shown in
Yet a further modification to stent 402 is illustrated in
The problem solved by the fingers described above may be solved with additional or alternative features, such as the use of two outer cuffs. For example,
In the configuration described directly above, the attachment of second outer cuff 550b to first outer cuff 550a should not inhibit the first outer cuff from billowing outwardly as retrograde blood flow along the abluminal surface of stent 502 enters the space between inner cuff 506 and the first outer cuff. The same retrograde blood flow may also cause second outer cuff 550b to billow outwardly with respect to first outer cuff 550a. Although first outer cuff 550a may be prevented from billowing outwardly from inner cuff 506 at attachment points S3, since attachment points S4 are circumferentially staggered with respect to attachment points S3, second outer cuff 550b will be able to billow outwardly from the first outer cuff and from inner cuff 506 at points that are radially aligned with attachment points S3. This point may be better understood from the top view of stent 502 having first and second outer cuffs 550a, 550b, as shown in
With the configuration described above, at least one pocket may be formed between inner cuff 506 and first outer cuff 550a, with a plurality of openings leading into the at least one pocket, the openings being positioned between adjacent attachment points S3. Similarly, at least one pocket may be formed between first outer cuff 550a and second outer cuff 550b, with a plurality of openings leading into the at least one pocket, the openings being positioned between adjacent attachment points S4.
Another potential issue that may arise with the outer cuff 350 of
Outer cuff 650 may include a plurality of groups of pleats 670. In the illustrated embodiment, outer cuff 650 includes nine groups of pleats 670 extending in the axial direction, with each group of pleats 670 being circumferentially aligned with a peak of distal edge 658.
Pleats 670a-c may be created by manually or otherwise folding outer cuff 650 back and forth on itself, and then applying heat and/or force, such as by a heated iron or a similar device, to set the shape of the pleats. With this configuration, the groups of pleats 670 retain their shape prior to implantation, allowing outer cuff 650 to remain taut over stent 302, which may reduce the forces encountered upon loading the prosthetic valve into a delivery device in a collapsed condition. It may be preferable to store such a prosthetic valve in a dry state to help the groups of pleats 670 retain their shape prior to implantation.
In
Instead of having groups of axial pleats 670, an outer cuff 750 may include at least one group of pleats 770 extending in the circumferential direction, as shown in
Outer cuff 750 may include one or more groups of pleats 770. In the illustrated embodiment, outer cuff 750 includes one group of circumferential pleats 770, with the individual pleats extending mostly or entirely along the circumference of outer cuff 750 from one side edge 754 to the other side edge 756.
Although outer cuffs with axial pleats or circumferential pleats are described above, other types of pleats that provide for additional space between the outer cuff and the inner cuff are possible. For example, rather than being substantially axial or substantially circumferential, pleats could be folded so they extend at an oblique angle to both the axial and the circumferential directions. For example, if circumferential pleats are thought of as being at an angle of approximately 0 degrees relative to the circumferential direction and axial pleats are thought of as being at an angle of approximately 90 degrees relative to the circumferential direction, pleats having an angle of about 45 degrees or other intermediate angles between 0 degrees and 180 degrees relative to the circumferential direction may be used. In one example, the pleats may be angled so they are substantially aligned with struts 312c or struts 312d of stent 302 (
In another alternative, both axial pleats and circumferential pleats may be used in a single cuff. For example, groups of axial pleats 670 may first be formed in an outer cuff, with a group of circumferential pleats 770 formed next. Alternately, circumferential pleats 770 may first be created in an outer cuff with axial pleats 670 formed next. The combination of axial and circumferential pleats may allow the outer cuff to billow out to a greater degree than a cuff having only axial or only circumferential pleats. It should also be understood that any of the pleated cuffs described herein may be used in combination with a stent having any of the fingers described herein.
Referring to
In the illustrated example of outer cuff 850a in
Referring to
Still referring to
Referring to
Referring to
According to a first aspect of the disclosure, a prosthetic heart valve for replacing a native valve includes:
a stent having an inflow end, an outflow end, a plurality of cells formed by cell struts, a collapsed condition and an expanded condition;
a valve assembly disposed within the stent;
a first cuff annularly disposed adjacent the stent;
a second cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent radially outward of the first cuff and radially outward of the stent; and
a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end remote from the first end, the distal edge of the second cuff being coupled to the free ends of the fingers at spaced locations around a circumference of the stent, the free ends of the fingers being spaced radially outward of the corresponding cell in the expanded condition of the stent to position the distal edge of the second cuff radially outward of the corresponding cells of the stent at the spaced locations; and/or
the cell struts may have a strut thickness in a radial direction of the stent, and the fingers may have a thickness in the radial direction of the stent that is less than the strut thickness; and/or
the free ends of the fingers may be blunted; and/or
the free ends of the fingers may include an eyelet; and/or
the free ends of the fingers may include a cruciform structure; and/or
each of the fingers may be formed of a single strut; and/or
each of the fingers may include first and second struts each having a first end coupled to one of the plurality of cell struts and a second end, the second ends being coupled to one another; and/or
the first and second struts of each finger may collectively form a “V” shape; and/or
the distal edge of the second cuff may be coupled to an apex of the “V” shape; and/or
each of the fingers may further include a third strut extending from an apex of the “V” shape, the distal edge of the second cuff being coupled to the third strut; and/or
each of the cell struts may extend in an elongation direction, a first cell strut in each of the corresponding cells having a first width in a direction orthogonal to the elongation direction in first and second end portions of the first cell strut and a second width in the direction orthogonal to the elongation direction in a portion of the first cell strut intermediate the first and second end portions, the second width being less than the first width; and/or
each of the cell struts forming the corresponding cells may have the first width in the direction orthogonal to the elongation direction in first and second end portions of the cell strut and the second width in the direction orthogonal to the elongation direction in a portion of the cell strut intermediate the first and second end portions; and/or
the stent may include a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts in the annulus section extending in an elongation direction and having the first width in a direction orthogonal to the elongation direction in first and second end portions of the cell strut and the second width in the direction orthogonal to the elongation direction in a portion of the cell strut intermediate the first and second end portions; and/or
the stent may include a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts extending in an elongation direction, each of the cell struts in the annulus section having a first width in a direction orthogonal to the elongation direction of the cell strut, and each of the cell struts in the aortic section having a second width in a direction orthogonal to the elongation direction of the cell strut, the second width being less than the first width; and/or
each of the fingers in the expanded condition of the stent may curve toward the corresponding cell of the stent; and/or
the plurality of cells may include a first annular row of cells extending around a circumference of the stent adjacent the inflow end, each of the corresponding cells being in the first annular row of cells; and/or
the plurality of cells may include a first annular row of cells extending around a circumference of the stent adjacent the inflow end and a second annular row of cells extending around the circumference of the stent adjacent the first annular row of cells, each of the corresponding cells being in the second annular row of cells; and/or
the stent may include a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts in the aortic section extending in an elongation direction, selected ones of the cell struts in the aortic section having a first width in a direction orthogonal to the elongation direction in first and second end portions of the selected cell strut and a second width in the direction orthogonal to the elongation direction in a portion of the selected cell strut intermediate the first and second end portions, the second width being less than the first width; and/or
the plurality of cells may be arranged in annular rows of cells extending around a circumference of the stent, each of the selected ones of the cell struts being positioned in a single one of the annular rows; and/or
the stent may include a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts in the annulus section extending in an elongation direction, a first group of the cell struts in the annulus section being connected to one of the commissure attachment features at an attachment point, each of the cell struts in the first group having a first width in a direction orthogonal to the elongation direction at a spaced distance from the attachment point and a second width in the direction orthogonal to the elongation direction at the attachment point, the second width being greater than the first width; and/or
the stent may include a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts in the aortic section extending in an elongation direction, a first group of the cell struts in the aortic section being connected to one of the commissure attachment features at an attachment point, each of the cell struts in the first group having a first width in a direction orthogonal to the elongation direction at a spaced distance from the attachment point and a second width in the direction orthogonal to the elongation direction at the attachment point, the second width being greater than the first width.
According to another aspect of the disclosure, a prosthetic heart valve for replacing a native valve includes:
a stent having an inflow end, an outflow end, a plurality of cells formed by cell struts, a collapsed condition and an expanded condition;
a valve assembly disposed within the stent;
a first cuff annularly disposed adjacent the stent;
a second cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent and positioned radially outward of the first cuff and radially outward of the stent; and
a third cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the third cuff being annularly disposed about the stent and positioned radially outward of the second cuff, the distal edge of the second cuff being coupled to the stent at first attachment points spaced around a circumference of the stent, and the distal edge of the third cuff being coupled to the distal edge of the second cuff at second attachment points spaced around a circumference of the second cuff; and/or
each of the second attachment points may be positioned circumferentially between an adjacent pair of the first attachment points; and/or
the proximal edge of the second cuff and the proximal edge of the third cuff may be coupled to the inflow end of the stent substantially continuously along a circumference of the inflow end of the stent so that a first pocket is formed between the first cuff and the second cuff, and a second pocket is formed between the second cuff and the third cuff; and/or
a single suture may couple the proximal edge of the second cuff and the proximal edge of the third cuff to the inflow end of the stent; and/or
the second cuff may be adapted to billow outwardly of the first cuff upon retrograde blood flow into the first pocket, and the third cuff may be adapted to billow outwardly of the second cuff upon retrograde blood flow into the second pocket.
According to yet another aspect of the disclosure, a prosthetic heart valve for replacing a native valve includes:
a stent extending in an axial direction from an inflow end to an outflow end, the stent having a plurality of cells formed by cell strut, a collapsed condition and an expanded condition;
a valve assembly disposed within the stent;
a first cuff annularly disposed adjacent the stent; and
a second cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent radially outward of the first cuff and radially outward of the stent, the second cuff including a pleat formed by at least two folds in the second cuff; and/or
the folds of the pleat may be oriented in a circumferential direction of the stent; and/or
the second cuff may include two or more separate pleats spaced apart from one another in the axial direction of the stent; and/or
the folds of the pleat may be oriented in the axial direction of the stent; and/or
the second cuff may include a plurality of groups of pleats, each one of the groups of pleats being spaced apart from other ones of the groups of pleats in a circumferential direction of the stent.
According to yet a further aspect of the disclosure a prosthetic heart valve for replacing a native valve includes:
a stent having an inflow end, an outflow end, a plurality of cells formed by cell struts, a collapsed condition and an expanded condition;
a valve assembly disposed within the stent;
a first cuff annularly disposed adjacent the stent; and
a second cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent radially outward of the first cuff and radially outward of the stent, the distal edge including a plurality of peaks and a plurality of troughs, each trough connecting a pair of adjacent peaks, a distalmost portion of each peak being directly coupled to at least one of the first cuff and the stent; and/or
the distalmost portion of each peak is coupled to at least one of the first cuff and the stent by a suture; and/or
the plurality of peaks and the plurality of troughs each have a curved edge; and/or
the plurality of peaks and the plurality of troughs each have a straight edge; and/or
each peak includes a base at a proximalmost portion of the peak, the base having a first width in a circumferential direction of the stent, the distalmost portions of two adjacent peaks being spaced apart a second width in the circumferential direction of the stent, the second width being greater than the first width; and/or
the base of each peak and the distalmost portion of each peak are spaced apart a first height in a longitudinal direction of the stent, the first height being equal to the second width; and/or
a proximalmost portion of each peak has a first width in a circumferential direction of the stent, and proximalmost portions of two adjacent troughs are spaced apart a second width in the circumferential direction of the stent, the first width being smaller than the second width; and/or
the first width is between one half and one fifth the second width; and/or
each peak has a first height in a longitudinal direction of the stent, and each trough has a second height in the longitudinal direction of the stent, the first height being greater than the second height; and/or
the plurality of cells include a first annular row of cells and a second annular row of cells, the first annular row of cells being positioned closer to the inflow end of the stent than is the second annular row of cells, each cell in the first annular row having a strut in common with a cell in the second annular row; and/or
the distal edge of the second cuff is aligned with the struts in common when the stent is in the expanded condition; and/or
each of the struts in common extends a first height in a longitudinal direction of the stent when the stent is in the expanded condition, and the distalmost portion of each peak is spaced apart from a proximalmost portion of each trough a second height in the longitudinal direction of the stent, the second height being greater than the first height.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. For example, features of one embodiment described above may be combined with features of other embodiments described above.
This application claims the benefit of the filing dates of U.S. Provisional Patent Application No. 62/379,869 filed Aug. 26, 2016 and U.S. Provisional Patent Application No. 62/505,371 filed May 12, 2017, the disclosures of which are both hereby incorporated by reference herein.
Number | Name | Date | Kind |
---|---|---|---|
3657744 | Ersek | Apr 1972 | A |
4275469 | Gabbay | Jun 1981 | A |
4491986 | Gabbay | Jan 1985 | A |
4759758 | Gabbay | Jul 1988 | A |
4878906 | Lindemann et al. | Nov 1989 | A |
4922905 | Strecker | May 1990 | A |
4994077 | Dobben | Feb 1991 | A |
5411552 | Andersen et al. | May 1995 | A |
5415664 | Pinchuk | May 1995 | A |
5480423 | Ravenscroft et al. | Jan 1996 | A |
5843167 | Dwyer et al. | Dec 1998 | A |
5855601 | Bessler et al. | Jan 1999 | A |
5935163 | Gabbay | Aug 1999 | A |
5961549 | Nguyen et al. | Oct 1999 | A |
6045576 | Starr et al. | Apr 2000 | A |
6077297 | Robinson et al. | Jun 2000 | A |
6083257 | Taylor et al. | Jul 2000 | A |
6090140 | Gabbay | Jul 2000 | A |
6214036 | Letendre et al. | Apr 2001 | B1 |
6264691 | Gabbay | Jul 2001 | B1 |
6267783 | Letendre et al. | Jul 2001 | B1 |
6368348 | Gabbay | Apr 2002 | B1 |
6419695 | Gabbay | Jul 2002 | B1 |
6458153 | Bailey et al. | Oct 2002 | B1 |
6468660 | Ogle et al. | Oct 2002 | B2 |
6488702 | Besselink | Dec 2002 | B1 |
6517576 | Gabbay | Feb 2003 | B2 |
6533810 | Hankh et al. | Mar 2003 | B2 |
6582464 | Gabbay | Jun 2003 | B2 |
6610088 | Gabbay | Aug 2003 | B1 |
6623518 | Thompson et al. | Sep 2003 | B2 |
6652578 | Bailey et al. | Nov 2003 | B2 |
6685625 | Gabbay | Feb 2004 | B2 |
6716244 | Klaco | Apr 2004 | B2 |
6719789 | Cox | Apr 2004 | B2 |
6730118 | Spenser et al. | May 2004 | B2 |
6783556 | Gabbay | Aug 2004 | B1 |
6790230 | Beyersdorf et al. | Sep 2004 | B2 |
6814746 | Thompson et al. | Nov 2004 | B2 |
6830584 | Seguin | Dec 2004 | B1 |
6869444 | Gabbay | Mar 2005 | B2 |
6893460 | Spenser et al. | May 2005 | B2 |
6908481 | Cribier | Jun 2005 | B2 |
6951573 | Dilling | Oct 2005 | B1 |
7018406 | Seguin et al. | Mar 2006 | B2 |
7025780 | Gabbay | Apr 2006 | B2 |
7137184 | Schreck | Nov 2006 | B2 |
7147661 | Chobotov et al. | Dec 2006 | B2 |
7160322 | Gabbay | Jan 2007 | B2 |
7195641 | Palmaz et al. | Mar 2007 | B2 |
7247167 | Gabbay | Jul 2007 | B2 |
7267686 | DiMatteo et al. | Sep 2007 | B2 |
7276078 | Spenser et al. | Oct 2007 | B2 |
7311730 | Gabbay | Dec 2007 | B2 |
7320704 | Lashinski et al. | Jan 2008 | B2 |
7329278 | Seguin et al. | Feb 2008 | B2 |
7374573 | Gabbay | May 2008 | B2 |
7381218 | Schreck | Jun 2008 | B2 |
7381219 | Salahieh et al. | Jun 2008 | B2 |
7452371 | Pavcnik et al. | Nov 2008 | B2 |
7510572 | Gabbay | Mar 2009 | B2 |
7510575 | Spenser et al. | Mar 2009 | B2 |
7524331 | Birdsall | Apr 2009 | B2 |
7534261 | Friedman | May 2009 | B2 |
RE40816 | Taylor et al. | Jun 2009 | E |
7585321 | Cribier | Sep 2009 | B2 |
7628805 | Spenser et al. | Dec 2009 | B2 |
7682390 | Seguin | Mar 2010 | B2 |
7708775 | Rowe et al. | May 2010 | B2 |
7731742 | Schlick et al. | Jun 2010 | B2 |
7748389 | Salahieh et al. | Jul 2010 | B2 |
7780725 | Haug et al. | Aug 2010 | B2 |
7799069 | Bailey et al. | Sep 2010 | B2 |
7803185 | Gabbay | Sep 2010 | B2 |
7824442 | Salahieh et al. | Nov 2010 | B2 |
7837727 | Goetz et al. | Nov 2010 | B2 |
7846203 | Cribier | Dec 2010 | B2 |
7846204 | Letac et al. | Dec 2010 | B2 |
7892281 | Seguin et al. | Feb 2011 | B2 |
7914569 | Nguyen et al. | Mar 2011 | B2 |
7959666 | Salahieh et al. | Jun 2011 | B2 |
7959672 | Salahieh et al. | Jun 2011 | B2 |
7972378 | Tabor et al. | Jul 2011 | B2 |
7988724 | Salahieh et al. | Aug 2011 | B2 |
7993394 | Hariton et al. | Aug 2011 | B2 |
8016877 | Seguin et al. | Sep 2011 | B2 |
D648854 | Braido | Nov 2011 | S |
8048153 | Salahieh et al. | Nov 2011 | B2 |
8052741 | Bruszewski et al. | Nov 2011 | B2 |
8052749 | Salahieh et al. | Nov 2011 | B2 |
8052750 | Tuval et al. | Nov 2011 | B2 |
8062355 | Figulla et al. | Nov 2011 | B2 |
8075611 | Millwee et al. | Dec 2011 | B2 |
D652926 | Braido | Jan 2012 | S |
D652927 | Braido et al. | Jan 2012 | S |
D653341 | Braido et al. | Jan 2012 | S |
D653342 | Braido et al. | Jan 2012 | S |
D653343 | Ness et al. | Jan 2012 | S |
D654169 | Braido | Feb 2012 | S |
D654170 | Braido et al. | Feb 2012 | S |
8137398 | Tuval et al. | Mar 2012 | B2 |
8142497 | Friedman | Mar 2012 | B2 |
D660432 | Braido | May 2012 | S |
D660433 | Braido et al. | May 2012 | S |
D660967 | Braido et al. | May 2012 | S |
8182528 | Salahieh et al. | May 2012 | B2 |
8221493 | Boyle et al. | Jul 2012 | B2 |
8230717 | Matonick | Jul 2012 | B2 |
8231670 | Salahieh et al. | Jul 2012 | B2 |
8252051 | Chau et al. | Aug 2012 | B2 |
8308798 | Pintor et al. | Nov 2012 | B2 |
8313525 | Tuval et al. | Nov 2012 | B2 |
8323335 | Rowe et al. | Dec 2012 | B2 |
8323336 | Hill et al. | Dec 2012 | B2 |
8343213 | Salahieh et al. | Jan 2013 | B2 |
8348995 | Tuval et al. | Jan 2013 | B2 |
8348996 | Tuval et al. | Jan 2013 | B2 |
8348998 | Pintor et al. | Jan 2013 | B2 |
8366769 | Huynh et al. | Feb 2013 | B2 |
8403983 | Quadri et al. | Mar 2013 | B2 |
8408214 | Spenser | Apr 2013 | B2 |
8414643 | Tuval et al. | Apr 2013 | B2 |
8425593 | Braido et al. | Apr 2013 | B2 |
8449599 | Chau et al. | May 2013 | B2 |
8449604 | Moaddeb et al. | May 2013 | B2 |
8454686 | Alkhatib | Jun 2013 | B2 |
8500798 | Rowe et al. | Aug 2013 | B2 |
8568474 | Yeung et al. | Oct 2013 | B2 |
8579962 | Salahieh et al. | Nov 2013 | B2 |
8579966 | Seguin et al. | Nov 2013 | B2 |
8585755 | Chau et al. | Nov 2013 | B2 |
8591575 | Cribier | Nov 2013 | B2 |
8597349 | Alkhatib | Dec 2013 | B2 |
8603159 | Seguin et al. | Dec 2013 | B2 |
8603160 | Salahieh et al. | Dec 2013 | B2 |
8613765 | Bonhoeffer et al. | Dec 2013 | B2 |
8623074 | Ryan | Jan 2014 | B2 |
8652204 | Quill et al. | Feb 2014 | B2 |
8663322 | Keranen | Mar 2014 | B2 |
8668733 | Haug et al. | Mar 2014 | B2 |
8685080 | White | Apr 2014 | B2 |
8728154 | Alkhatib | May 2014 | B2 |
8747459 | Nguyen et al. | Jun 2014 | B2 |
8764820 | Dehdashtian et al. | Jul 2014 | B2 |
8784481 | Alkhatib et al. | Jul 2014 | B2 |
8795357 | Yohanan et al. | Aug 2014 | B2 |
8801776 | House et al. | Aug 2014 | B2 |
8808356 | Braido et al. | Aug 2014 | B2 |
8828078 | Salahieh et al. | Sep 2014 | B2 |
8834563 | Righini | Sep 2014 | B2 |
8840663 | Salahieh et al. | Sep 2014 | B2 |
8876894 | Tuval et al. | Nov 2014 | B2 |
8876895 | Tuval et al. | Nov 2014 | B2 |
8940040 | Shahriari | Jan 2015 | B2 |
8945209 | Bonyuet et al. | Feb 2015 | B2 |
8961595 | Alkhatib | Feb 2015 | B2 |
8974523 | Thill et al. | Mar 2015 | B2 |
8974524 | Yeung et al. | Mar 2015 | B2 |
8986375 | Garde et al. | Mar 2015 | B2 |
D730520 | Braido et al. | May 2015 | S |
D730521 | Braido et al. | May 2015 | S |
D732666 | Nguyen et al. | Jun 2015 | S |
D755384 | Pesce et al. | May 2016 | S |
D802764 | Erzberger et al. | Nov 2017 | S |
D802765 | Erzberger et al. | Nov 2017 | S |
D802766 | Erzberger et al. | Nov 2017 | S |
20020036220 | Gabbay | Mar 2002 | A1 |
20030023303 | Palmaz et al. | Jan 2003 | A1 |
20030050694 | Yang et al. | Mar 2003 | A1 |
20030130726 | Thorpe et al. | Jul 2003 | A1 |
20030236567 | Elliot | Dec 2003 | A1 |
20040049262 | Obermiller et al. | Mar 2004 | A1 |
20040093075 | Kuehne | May 2004 | A1 |
20040111111 | Lin | Jun 2004 | A1 |
20040210304 | Seguin et al. | Oct 2004 | A1 |
20040260389 | Case et al. | Dec 2004 | A1 |
20050096726 | Sequin et al. | May 2005 | A1 |
20050137682 | Justino | Jun 2005 | A1 |
20050137695 | Salahieh et al. | Jun 2005 | A1 |
20050137697 | Salahieh et al. | Jun 2005 | A1 |
20050203605 | Dolan | Sep 2005 | A1 |
20050240200 | Bergheim | Oct 2005 | A1 |
20050256566 | Gabbay | Nov 2005 | A1 |
20060008497 | Gabbay | Jan 2006 | A1 |
20060074484 | Huber | Apr 2006 | A1 |
20060122692 | Gilad et al. | Jun 2006 | A1 |
20060149360 | Schwammenthal et al. | Jul 2006 | A1 |
20060161249 | Realyvasquez et al. | Jul 2006 | A1 |
20060173532 | Flagle et al. | Aug 2006 | A1 |
20060178740 | Stacchino et al. | Aug 2006 | A1 |
20060195180 | Kheradvar et al. | Aug 2006 | A1 |
20060206202 | Bonhoeffer et al. | Sep 2006 | A1 |
20060241744 | Beith | Oct 2006 | A1 |
20060241745 | Solem | Oct 2006 | A1 |
20060259120 | Vongphakdy et al. | Nov 2006 | A1 |
20060259137 | Artof et al. | Nov 2006 | A1 |
20060265056 | Nguyen et al. | Nov 2006 | A1 |
20060276813 | Greenberg | Dec 2006 | A1 |
20060276874 | Wilson et al. | Dec 2006 | A1 |
20070010876 | Salahieh et al. | Jan 2007 | A1 |
20070027534 | Bergheim et al. | Feb 2007 | A1 |
20070043435 | Seguin et al. | Feb 2007 | A1 |
20070055358 | Krolik et al. | Mar 2007 | A1 |
20070067029 | Gabbay | Mar 2007 | A1 |
20070093890 | Eliasen et al. | Apr 2007 | A1 |
20070100435 | Case et al. | May 2007 | A1 |
20070118210 | Pinchuk | May 2007 | A1 |
20070213813 | Von Segesser et al. | Sep 2007 | A1 |
20070233228 | Eberhardt et al. | Oct 2007 | A1 |
20070244545 | Birdsall et al. | Oct 2007 | A1 |
20070244552 | Salahieh et al. | Oct 2007 | A1 |
20070288087 | Fearnot et al. | Dec 2007 | A1 |
20080021552 | Gabbay | Jan 2008 | A1 |
20080039934 | Styrc | Feb 2008 | A1 |
20080071369 | Tuval et al. | Mar 2008 | A1 |
20080082164 | Friedman | Apr 2008 | A1 |
20080097595 | Gabbay | Apr 2008 | A1 |
20080114452 | Gabbay | May 2008 | A1 |
20080125853 | Bailey et al. | May 2008 | A1 |
20080140189 | Nguyen et al. | Jun 2008 | A1 |
20080147183 | Styrc | Jun 2008 | A1 |
20080154355 | Benichou et al. | Jun 2008 | A1 |
20080154356 | Obermiller et al. | Jun 2008 | A1 |
20080243245 | Thambar et al. | Oct 2008 | A1 |
20080255662 | Stacchino et al. | Oct 2008 | A1 |
20080262602 | Wilk et al. | Oct 2008 | A1 |
20080269879 | Sathe et al. | Oct 2008 | A1 |
20090099653 | Sun et al. | Apr 2009 | A1 |
20090112309 | Jaramillo et al. | Apr 2009 | A1 |
20090138079 | Tuval et al. | May 2009 | A1 |
20090234443 | Ottma et al. | Sep 2009 | A1 |
20090276027 | Glynn | Nov 2009 | A1 |
20100004740 | Seguin et al. | Jan 2010 | A1 |
20100036484 | Hariton et al. | Feb 2010 | A1 |
20100049306 | House et al. | Feb 2010 | A1 |
20100087907 | Lattouf | Apr 2010 | A1 |
20100131055 | Case et al. | May 2010 | A1 |
20100168778 | Braido | Jul 2010 | A1 |
20100168839 | Braido et al. | Jul 2010 | A1 |
20100168844 | Toomes et al. | Jul 2010 | A1 |
20100185277 | Braido et al. | Jul 2010 | A1 |
20100191326 | Alkhatib | Jul 2010 | A1 |
20100204781 | Alkhatib | Aug 2010 | A1 |
20100204785 | Alkhatib | Aug 2010 | A1 |
20100217382 | Chau et al. | Aug 2010 | A1 |
20100234940 | Dolan | Sep 2010 | A1 |
20100249911 | Alkhatib | Sep 2010 | A1 |
20100249923 | Alkhatib et al. | Sep 2010 | A1 |
20100256737 | Pollock et al. | Oct 2010 | A1 |
20100286768 | Alkhatib | Nov 2010 | A1 |
20100298931 | Quadri et al. | Nov 2010 | A1 |
20110029072 | Gabbay | Feb 2011 | A1 |
20110054466 | Rothstein et al. | Mar 2011 | A1 |
20110098800 | Braido et al. | Apr 2011 | A1 |
20110098802 | Braido et al. | Apr 2011 | A1 |
20110137397 | Chau et al. | Jun 2011 | A1 |
20110172765 | Nguyen et al. | Jul 2011 | A1 |
20110208283 | Rust | Aug 2011 | A1 |
20110264196 | Savage et al. | Oct 2011 | A1 |
20110264206 | Tabor | Oct 2011 | A1 |
20120035722 | Tuval | Feb 2012 | A1 |
20120078347 | Braido et al. | Mar 2012 | A1 |
20120101572 | Kovalsky et al. | Apr 2012 | A1 |
20120123529 | Levi et al. | May 2012 | A1 |
20120197390 | Alkhatib | Aug 2012 | A1 |
20120303116 | Gorman, II et al. | Nov 2012 | A1 |
20130274873 | Delaloye et al. | Oct 2013 | A1 |
20140121763 | Duffy et al. | May 2014 | A1 |
20140155997 | Braido | Jun 2014 | A1 |
20140194981 | Menk et al. | Jul 2014 | A1 |
20140214159 | Vidlund et al. | Jul 2014 | A1 |
20140228946 | Chau et al. | Aug 2014 | A1 |
20140277417 | Schraut et al. | Sep 2014 | A1 |
20140303719 | Cox et al. | Oct 2014 | A1 |
20140324164 | Gross et al. | Oct 2014 | A1 |
20140343670 | Bakis et al. | Nov 2014 | A1 |
20140343671 | Yohanan et al. | Nov 2014 | A1 |
20140350668 | Delaloye et al. | Nov 2014 | A1 |
20140350669 | Gillespie et al. | Nov 2014 | A1 |
20150018944 | O'Connell et al. | Jan 2015 | A1 |
20150142104 | Braido | May 2015 | A1 |
20150148893 | Braido et al. | May 2015 | A1 |
20150320556 | Levi et al. | Nov 2015 | A1 |
20150335429 | Morriss et al. | Nov 2015 | A1 |
Number | Date | Country |
---|---|---|
19857887 | May 2005 | DE |
10121210 | Nov 2005 | DE |
102005003632 | Aug 2006 | DE |
202008009610 | Dec 2008 | DE |
0850607 | Jul 1998 | EP |
1000590 | May 2000 | EP |
1584306 | Oct 2005 | EP |
1598031 | Nov 2005 | EP |
1360942 | Dec 2005 | EP |
1926455 | Jun 2008 | EP |
2537487 | Dec 2012 | EP |
2847800 | Jun 2004 | FR |
2850008 | Jul 2004 | FR |
9117720 | Nov 1991 | WO |
9716133 | May 1997 | WO |
9832412 | Jul 1998 | WO |
9913801 | Mar 1999 | WO |
2001028459 | Apr 2001 | WO |
2001049213 | Jul 2001 | WO |
0154625 | Aug 2001 | WO |
2001056500 | Aug 2001 | WO |
200176510 | Oct 2001 | WO |
0236048 | May 2002 | WO |
0247575 | Jun 2002 | WO |
2002067782 | Sep 2002 | WO |
2003047468 | Jun 2003 | WO |
2005070343 | Aug 2005 | WO |
06073626 | Jul 2006 | WO |
2007053243 | May 2007 | WO |
2007071436 | Jun 2007 | WO |
08070797 | Jun 2008 | WO |
2010008548 | Jan 2010 | WO |
2010008549 | Jan 2010 | WO |
2010096176 | Aug 2010 | WO |
2010098857 | Sep 2010 | WO |
2015126711 | Aug 2015 | WO |
2015152980 | Oct 2015 | WO |
Entry |
---|
Andersen, H. R., et al., “Transluminal implantation of artificial heart valves”, European Heart Journal, (1992), vol. 13, Issue 5, 704-708. |
Andersen, Henning Rud, “Transluminal Catheter Implanted Prosthetic Heart Valves”, International Journal of Angiology 7:102-106, 1998. |
Buellesfeld et al., “Treatment of paravalvular leaks through inverventional techniques”, Department of Cardiology, Ben University Hospital 2011. |
Christoph H. Huber, et al., “Direct-Access Valve Replacement”, Journal of the American College of Cardiology, vol. 46, No. 2, (Jul. 19, 2005). |
De Cicco, Giuseppe, et al., “Aortic valve periprosthetic leakage: anatomic observations and surgical results”, The Annals of thoracic surgery 79.5 (2005): 1480-1485. |
Dewey et al., “Transapical aortic valve implantation: an animal feasibility study”; The annals of thoracic surgery 2006; 82: 110-6 (Feb. 13, 2006). |
Gössl et al., “Percutaneous treatment of aortic and mitral valve paravalvular regurgitation”, Current cardiology reports 15.8, 2013: 1-8. |
Heat Advisor, “Heart repairs without surgery. Minimally invasive procedures aim to correct valve leakage”, Sep. 2004, PubMed ID 15586429. |
Hourihan et al., “Transcatheter Umbrella Closure of Valvular and Paravalvular Leaks”, Journal of the American College of Cardiology, vol. 20, No. 6, pp. 1371-1377, (1992). |
John G. Webb et al., “Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery”, Circulation, 2006; 113:842-850 (Feb. 6, 2006). |
Knudsen, L.L., et al., “Catheter-implanted prosthetic heart valves”, The International Journal of Artificial Organs, vol. 16, No. 5 1993, pp. 253-262. |
M. J. Mack, “Minimally invasive cardiac surgery”, Surgical Endoscopy, 2006, 20:S488-S492, DOI: 10.1007/s00464-006-0110-8 (presented Apr. 24, 2006). |
Moazami, Nader, et al., “Transluminal Aortic Valve Placement”, ASAIO Journal, (1996); 42:M381-M385. |
Muñoz et al., “Guidance of treatment of perivalvular prosthetic leaks”, Current cardiology reports 16.1, Jan. 2014: 1-6. |
Quaden, Rene et al., “Percutaneous aortic valve replacement: resection before implantation”, 836-840, European J. of cardio-thoracic Surgery, 27 (2005). |
Rohde et al., “Resection of Calcified Aortic Heart Leaflets In Vitro by Q-Switched 2μm Microsecond Laser Radiation”, Journal of Cardiac Surgery, 30: 157-162, 2015, doi: 10.1111/jocs.12481. |
Ruiz, Carlos, “Overview of PRE-CE Mark Transcatheter Aortic Valve Technologies”, Euro PCR, dated May 25, 2010. |
Samuel V. Lichtenstein et al., “Transapical Transcatheter Aortic Valve Implantation in Humans”, Circulation. 2006; 114: 591-596 (Jul. 31, 2006). |
Samuel V. Lichtenstein, “Closed heart surgery: Back to the future”, The Journal of Thoracic and Cardiovascular Surgery, 2006, vol. 131, No. 5, pp. 941-943. |
Swiatkiewicz, Iwona, et al., “Percutaneous closure of mitral perivalvular leak”, Kardiologia polska 67.7 (2009): 762. |
Textbook “Transcatheter Valve Repair”, 2006, pp. 165-186. |
Walther et al., “Transapical approach for sutureless stent-fixed aortic valve implantation: experimental results”, European Journal of Cardio-thoracic Surgery 29 (2006) 703-708 (Jan. 30, 2006). |
Zegdi, Rachid, MD, PhD et al., “Is It Reasonable to Treat All Calcified Stenotic Aortic Valves With a Valved Stent?”, 579-584, J. of the American College of Cardiology, vol. 51, No. 5, Feb. 5, 2008. |
International Search Report for Application No. PCT/US2017/048580 dated Nov. 16, 2017. |
Number | Date | Country | |
---|---|---|---|
20180055631 A1 | Mar 2018 | US |
Number | Date | Country | |
---|---|---|---|
62505371 | May 2017 | US | |
62379869 | Aug 2016 | US |