Patent Grant
11013595
The present application relates to embodiments of sealing elements for prosthetic heart valves and methods of making the same.
The heart can suffer from various valvular diseases or malformations that result in significant malfunctioning of the heart, and ultimately require replacement of the native heart valve with an artificial valve. Procedures in which radially collapsible transcatheter heart valves are percutaneously introduced in a compressed state on a catheter and expanded at the treatment location are gaining popularity, especially among patient populations for whom traditional surgical procedures pose a high risk of morbidity or mortality.
It can be important to reduce or prevent blood leakage past the prosthetic valve after implantation. Thus, transcatheter heart valves often include a sealing element such as a paravalvular leakage skirt to reduce the amount of leakage past the prosthetic valve. However, differences between the diameter of the prosthetic valve and the native annulus into which the valve is implanted, along with features of a particular patient's anatomy such as calcification, tissue prominences, recesses, folds, and the like, can make it difficult to achieve a seal between the prosthetic valve and the native annulus. Accordingly, there is a need for improved paravalvular sealing elements for prosthetic heart valves.
Certain embodiments of the disclosure concern prosthetic valves including various embodiments of sealing elements. In a representative embodiment, an implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame having an inflow end, an outflow end, and a longitudinal axis. A leaflet structure is positioned within the frame and secured thereto, and a sealing element is secured to the frame. The sealing element comprises a first woven portion extending circumferentially around the frame. The first woven portion comprises a plurality of interwoven filaments. The sealing element further comprises a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. At least a portion of the filaments exit the weave of the first woven portion and form loops extending radially outwardly from the frame.
In some embodiments, the filaments that form the loops extend from and return to the first woven portion.
In some embodiments, the first woven portion comprises a first row of loops, and the second woven portion comprises a second row of loops. The loops of the second row of loops can comprise filaments that extend from and return to the second woven portion.
In some embodiment, the loops of the second row of loops are circumferentially offset from the loops of the first row of loops.
In some embodiments, the plurality of interwoven filaments of the first woven portion further comprises at least one first filament interwoven with a plurality of second filaments, and a portion of the at least one first filament forms the loops of the first woven portion.
In some embodiments, the sealing element further comprises an intermediate sealing portion between the first and second woven portions. The intermediate sealing portion comprises a plurality of second filaments, and a portion of the at least one first filament extends along the longitudinal axis of the frame between the first woven portion and the second woven portion, and is interwoven with the second filaments of the intermediate sealing portion.
In some embodiments, a portion of the at least one first filament forms the loops of the second woven portion.
In some embodiments, the second filaments are warp yarns and the at least one first filament is a weft yarn.
In some embodiments, at least one of the warp and weft yarns comprise textured yarns.
In some embodiments, the warp and weft yarns comprise fibers having a diameter of from 1 μm to 20 μm to promote thrombus formation around the sealing element.
In some embodiments, the filaments that form the loops originate from the first woven portion and extend curvilinearly along the longitudinal axis of the frame to the second woven portion.
In some embodiments, the filaments that form the loops exit a weave of the first woven portion and are incorporated into a weave of the second woven portion such that the loops form a floating yarn portion between the first and second woven portions.
In some embodiments, the floating yarn portion comprises a first layer of loops and a second layer of loops radially outward of the first layer of loops.
In some embodiments, the sealing element comprises a first fabric strip, a second fabric strip, and a third fabric strip. A plurality of the filaments that form the loops extend between the first fabric strip and the second fabric strip, and a plurality of the filaments that form the loops extend between the second fabric strip and the third fabric strip. The sealing element is folded about the second fabric strip such that the first fabric strip and the third fabric strip are adjacent each other to form the first woven portion, the filaments extending between the first fabric strip and the second fabric strip form the first layer of loops, and the filaments extending between the second fabric strip and the third fabric strip form the second layer of loops.
In some embodiments, the sealing element is secured to the frame such that the filaments that exit the weave of the first woven portion form the loops when the frame is in the expanded configuration, and are pulled straight when the frame is in the collapsed configuration.
In another representative embodiment, a method comprises mounting any of the prosthetic valves herein to a distal end portion of a delivery apparatus, advancing the delivery apparatus through a patient's vasculature to the heart, and expanding the prosthetic valve in a native heart valve of the heart such that the prosthetic valve regulates blood flow through the native heart valve.
In another representative embodiment, a method of making a sealing element for a prosthetic heart valve comprises weaving at least one weft yarn together with a plurality of warp yarns to form a first woven portion, dropping the at least one weft yarn from a weave of the first woven portion, and looping the at least one weft yarn around a removable warp yarn. The removable warp yarn is spaced apart from the first woven portion, and the at least one weft yarn is looped around the removable warp yarn such that the at least one weft yarn extends over, and is not interwoven with, warp yarns disposed between the first woven portion and the removable warp yarn. The method further comprises reincorporating the at least one weft yarn into the weave of the first woven portion such that the at least one weft yarn forms a loop that extends from and returns to the first woven portion, and removing the removable warp yarn from the sealing element to release the loop formed by the at least one weft yarn.
In some embodiments, before removing the removable warp yarn, the method further comprises repeating the weaving, the dropping, the looping, and the reincorporating to form a plurality of loops about a circumference of the sealing element.
In some embodiments, the method further comprises shape-setting the plurality of loops such that the loops extend outwardly from the sealing element.
In some embodiments, the method further comprises before removing the removable warp yarn, weaving the at least one weft yarn together with warp yarns such that the at least one weft yarn extends beyond the removable warp yarn and forms a second woven portion spaced apart from the first woven portion. The method further comprises dropping the at least one weft yarn from a weave of the second woven portion, and looping the at least one weft yarn around a second removable warp yarn that is spaced apart from the second woven portion. The at least one weft yarn can be looped around the second removable warp yarn such that the at least one weft yarn extends over, and is not interwoven with, warp yarns disposed between the second woven portion and the second removable warp yarn. The method can further comprise reincorporating the at least one weft yarn into the weave of the second woven portion such that the at least one weft yarn forms a second loop that extends from and returns to the second woven portion.
The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
The present disclosure concerns embodiments of sealing elements for implantable prosthetic devices, such as prosthetic heart valves. The present inventors surprisingly have discovered that effective sealing can be accomplished by sealing elements including a plurality of filaments, such as yarns and/or fibers, that extend from the sealing element and are configured to prompt a biological response at the cellular level to promote thrombogenesis around the sealing element.
For example, the sealing elements described herein can be configured as fabric skirts including woven portions from which filaments or yarns extend, and which can contact and/or conform to the surrounding anatomy to enhance the sealing properties of the skirt. In certain configurations, the filaments are bound at both ends and form loops that extend radially outwardly from the skirt. As used herein, the term “loop” refers to a closed or partially open curve formed by a yarn or other filament. In some embodiments, the yarns that form the loops extend from and return to the same fabric portion of the skirt. In such configurations, the loops can be arranged in one or more rows extending circumferentially around the skirt. In other configurations, the yarns extend from one fabric portion to another spaced-apart fabric portion such that the loops are arrayed circumferentially around the valve and are oriented along a longitudinal axis of the valve. In still other embodiments, the filaments are bound at one end, and have free ends that extend outwardly from the skirt.
In such configurations, the filaments can be configured to slow retrograde blood flow past the valve. Features such as the diameter, shape, surface texturing, coatings, etc., of the filaments can induce thrombus formation around the filaments to enhance the sealing properties of the skirt.
The frame 12 can be made of any of various biocompatible materials, such as stainless steel or a nickel titanium alloy (“NiTi”), for example Nitinol. With reference to
The lattice struts 26 can be pivotably coupled to one another. In the illustrated embodiment, for example, the end portions of the struts 26 forming the apices 28 at the outflow end 18 and at the inflow end 16 of the frame can have a respective opening 32. The struts 26 also can be formed with apertures 34 located between the opposite ends of the struts. Respective hinges can be formed at the apices 28 and at the locations where struts 26 overlap each other between the ends of the frame via fasteners 36, which can comprise rivets or pins that extend through the apertures 32, 34. The hinges can allow the struts 26 to pivot relative to one another as the frame 12 is expanded or contracted, such as during assembly, preparation, or implantation of the prosthetic valve 10. For example, the frame 12 (and, thus, the prosthetic valve 10) can be manipulated into a radially compressed or contracted configuration, coupled to a delivery apparatus, and inserted into a patient for implantation. Once inside the body, the prosthetic valve 10 can be manipulated into an expanded state and then released from the delivery apparatus, as described in greater detail below with reference to
As illustrated in
In the illustrated embodiment, the skirt 30 can comprise a plurality of outwardly extending filaments configured as loops 44 (also referred to as looped filaments). The loops 44 can extend from an outer surface 46 of the main portion 38. In certain embodiments, the loops 44 can be arranged in rows or tiers 48 that extend circumferentially around the frame 12, and are spaced apart from one another along the longitudinal axis 24. For example, in the illustrated embodiment, the loops 44 are arranged in three rows 48, with a first row 48A being adjacent the inflow edge portion 40 of the skirt, and the rows 48B, 48C being located above the first row 48A along the longitudinal axis 24 of the valve. In other embodiments, the skirt 30 can include more or fewer rows of loops, depending upon the particular characteristics desired. For example, the skirt 30 can include a single row of loops 44 (e.g., adjacent the inflow end of the frame), or a plurality of rows of loops along substantially the entire height dimension of the skirt 30.
In particular embodiments, the skirt 30 can comprise a cloth material, such as a woven or knitted fabric.
Still referring to
At the first edge portion 40, the warp yarn 52 can double back again, and a fifth portion 52E can extend in a direction toward the second edge portion 42. The fifth portion 52E can be incorporated into the weave through the semi-woven portion 55A and the woven strip 54B until it reaches an upper edge 58 of the woven strip 54B, at which point a sixth portion 52F can exit, or be “dropped” from, the weave. The sixth portion 52F can extend or float above the warp yarns 50 of the semi-woven portion 55B for a distance d2 in a direction toward the second edge portion 42. The sixth portion 52F can then loop around a removable warp yarn 50B, and a seventh portion 52G of the weft yarn can extend in a direction back toward the first edge portion 40 outside of the weave.
When the seventh portion 52G reaches the upper edge 58 of the woven strip 54B, the seventh portion 52G can be reincorporated into the weave such that the warp yarns of the woven strip 54B extend over and under the seventh portion 52G. When the seventh portion 52G reaches a lower edge portion 60 of the woven strip 54B, the weft yarn can double back, and an eighth portion 52H can extend in a direction toward the second edge portion 42. The eighth portion 52H can be incorporated into the weave through the semi-woven portion 55B and the woven strip 54C until the eighth portion reaches an upper edge portion 62 of the woven strip 54C. At this point, a ninth portion 52I can exit the weave and extend a distance d3 over the warp yarns 50 of the semi-woven portion 55C toward the second edge portion 42. At the woven strip 54D, the ninth portion 52I can loop around a removable warp yarn 50C, and a tenth weft yarn portion 52J can extend back toward the first edge portion 40 outside of the weave.
When the tenth portion 52J reaches the upper edge 62 of the woven strip 54C, the weft yarn can be reincorporated into the weave such that an eleventh weft yarn portion 52K extends back to the first edge portion 40 in the weave. When the portion 52k reaches the first edge portion 40, the weft yarn can double back, and the foregoing pattern can be repeated along a length of the fabric (e.g., to the right in
When the weave pattern has been repeated a selected number of times (e.g., to produce a fabric having length corresponding to the circumference of the prosthetic valve), the removable warp yarns 50A-50C can be removed from the weave. For example, in the embodiment illustrated in
Thus, removing the warp yarns 50A-50C results in a plurality of looped filaments 44 arranged in the three rows 48A-48C extending lengthwise along the skirt 30, as described above.
Meanwhile, although the loops 44 are shown axially aligned in
In certain embodiments, when the fabric has been removed from the loom and the removable warp yarns 50A-50C have been removed from the weave, the loops 44 can be shape-set such that they extend out of the plane of the fabric (e.g., transverse to the longitudinal axis of the valve and, thus, to the direction of flow through the valve). For example, referring again to
In certain configurations, one or both of the warp and weft yarns 50, 52 can also comprise textured yarns. A representative example is illustrated in
For example, blood cells typically range in size from 2 μm to 15 μm. For example, the diameter of red blood cells typically ranges from 6 μm to 8 μm, and the diameter of platelets typically ranges from 2 μm to 3 μm. Thus, utilizing fibers 72 having a diameter sized to approximately match the diameter of blood cells (e.g., 1 μm to 20 μm) can promote interaction between the fibers and blood cells at the cellular level. For example, the fibers 72 can be configured to promote thrombus formation along the skirt 30, and along the looped filaments 44 in particular, thereby improving the sealing characteristics of the skirt.
In certain configurations, the warp and weft yarns can comprise a variety of biocompatible materials, such as natural fibers (e.g., silk, cotton, etc.), synthetic polymeric materials (e.g., polyethylene terephthalate (PET), Nylon, polytetrafluoroethylene (PTFE), etc.), or metals (e.g., Nitinol, gold, etc.). In other embodiments, the skirt 30 need not comprise a woven fabric, but can comprise a thin polymeric film or laminate with which the looped filaments are integrally formed, or to which the looped filaments are attached.
The skirt 30 can provide a number of significant advantages over known skirt embodiments. For example, the loops 44 can obstruct the flow of blood past the valve, reducing the velocity and volume of blood that leaks past the valve after implantation. The flow obstruction provided by the loops 44 can increase the dwell time of blood near the skirt. This, together with the fiber diameters described above, can induce thrombus formation and promote sealing between the skirt and the surrounding tissue.
Additionally, the loops 44 can be flexible, allowing the loops to conform to the shape of the surrounding anatomy. Because the loops 44 extend radially outwardly from the surface of the skirt 30, the free end portions of the loops can also extend into folds and crevices in the surrounding anatomy to promote a more complete seal. Moreover, when the prosthetic valve is implanted in the native aortic valve, blood around the exterior of the valve can apply force to the loops 44 during ventricular diastole in a direction that is opposite to the direction of blood flow through the valve. This can enhance the bending of the loops 44 away from the skirt 30, further enhancing the sealing properties. Additionally, by extending outwardly from the exterior of the valve, the loops 44 can also block thrombi from moving past the valve, reducing the likelihood of stroke.
In certain embodiments, the yarns 106 can comprise any of a variety of hydrophobic surface treatments or coatings in order to promote separation of the fibers 110 and increase the surface area of the fringed portion 104. In other embodiments, the yarns 106 can comprise hydrophilic surface treatments, such as polyethylene glycol (PEG), or other coatings that covalently bond to the fibers. The yarns 106 can also comprise coatings or treatments to promote a biological response (e.g., thrombus formation) from blood in contact with the yarns, and/or lubricious coatings such as Serene™ lubricious coatings available from Surmodics, Inc. In other embodiments, an electrostatic charge can be applied to the yarns 106 such that the fibers 110 repel each other to increase the separation of the fibers. In still other embodiments, the fibers 110 can be textured fibers, as described above with respect to the embodiment of
With reference to
In another configuration illustrated in
The prosthetic valve 200 can comprise an inner skirt 211 secured to an interior surface of the frame, and an outer sealing element configured as a skirt 212 disposed around the exterior of the frame 202. In the illustrated configuration, the skirt 212 can comprise a first circumferentially-extending portion 214 situated adjacent the inflow end 206 of the frame and a second circumferentially-extending portion 216. The circumferential portions 214, 216 can be spaced apart from each other along a longitudinal axis 218 of the frame, and coupled together by a plurality of filaments 220. The filaments 220 can extend longitudinally along the outside of the frame between the portions 214, 216, and can curve outwardly from the frame when the frame is in the expanded configuration to form loops. The looped filaments 220 can be configured to promote sealing by obstructing blood flow past the skirt and increasing the dwell time of blood in the vicinity of the filaments, as described above.
In certain configurations, the circumferential portions 214, 216 can be configured as one or more strips of woven fabric. The filaments 220 can be yarns that are incorporated into the fabric of the portions 214 and 216, and extend axially therebetween. The skirt 212 illustrated in
For example,
In the illustrated configuration, the first fabric strip 226A can comprise warp and weft yarns woven together. At an edge portion 230 of the fabric strip 226A, the yarns 220 can exit the weave and extend or “float” to the second fabric strip 226B to form the floating yarn portion 228A. When the floating yarns 220 reach the second fabric strip 226B, the yarns can be reincorporated into the woven fabric of the strip 226B. At an edge portion 232 of the fabric strip 226B, the yarns 220 can exit the weave again, and extend or float from the strip 226B to the strip 226C to form the floating yarn portion 228B. When the floating yarns 220 reach the fabric strip 226C, they can be reincorporated into the weave of the fabric strip 226C. In certain configurations, the yarns 220 are warp yarns, although the yarns 220 may also be weft yarns, or a combination of warp and weft yarns, depending upon the particular application.
Referring to
Referring to
With reference to
In the configuration illustrated in
In embodiments in which the portions 214, 216 of the skirt 212 extend parallel to the strut members 204 of the respective row to which they are secured, the skirt 212 can extend between even-numbered rows of strut members, odd-numbered rows of strut members, or from an odd-numbered row to an even-numbered row, or vice versa. For example, in the configuration illustrated in
In configurations in which the skirt extends from an odd-numbered row to an even-numbered row (or vice versa), the portions 214, 216 can be circumferentially offset from each other such that the yarns 220 extend at an angle to the longitudinal axis 218. For example, with reference to
In certain examples, the skirt 212 can comprise twisted yarns, or non-twisted yarns. The skirt 212 can also comprise core-spun yarns, in which wrapper fibers are spun around a core yarn. The wrapper fibers may be wispy or diffuse in order to increase the surface area of the core-spun yarn to promote a biological response, as described above. In certain embodiments, the skirt 212 can also include loops similar to the loops 44 of
In the illustrated configuration, the skirt 300 includes a single layer of longitudinally-extending yarns 306.
When the skirt 300 is secured to the frame, the first portion 302 can be folded around the inflow end portion 206 of the frame 202 such that the first portion is partially disposed within the frame. After implantation, blood can flow through the floating yarn portion 310 and drain from the skirt. In certain configurations, the skirt 300 can have a reduced crimp profile because the skirt is not folded before it is secured to the frame. In other configurations, the portions 302, 304 can be sized such that the floating yarn portion 310 is located on a lower or distal aspect of the skirt when the frame is expanded. For example,
The disclosed prosthetic valve embodiments can be radially collapsed and delivered to the heart percutaneously using any of a variety of catheter-based delivery systems. For example,
Initially, the prosthetic valve 10 can be in a radially collapsed configuration within a sheath 410 of the shaft 404. When the distal end of the delivery apparatus has been advanced through the patient's vasculature to the treatment site, the prosthetic valve 10 can be advanced from the sheath 410 using a rotatable actuator 412 on the handle 402. The prosthetic valve 10 can then be positioned at the treatment site, expanded, and deployed using a release assembly generally indicated at 414. Other delivery systems that can be used in combination with the prosthetic valve embodiments described herein can be found in US Patent Application Publication No. 2017/0065415 and US Patent Application Publication No. 2013/0030519, which are incorporated herein by reference.
The warp yarns 502A can also change direction where they form the loops 506. For example, in the embodiment of
In certain embodiments, the loops 506 can be formed using warp-knitting techniques. In certain examples, the first warp yarns 502A can comprise 20 denier, 18 filament (20d/18f) and/or 30d/18f texturized yarns. The second warp yarns 502B can comprise 20d/18f yarns twisted with 12 twists per inch (tpi). In certain examples, the weft yarns 504 can be 20d/18f yarns with 12 tpi. The warp and weft yarns can be made from any of various biocompatible polymers, such as PET, UHMWPE, PTFE, etc. In other embodiments, the warp and/or weft yarns can have any selected denier and/or filament count, and can be made from any suitable natural or synthetic material.
In some embodiments, loops may be formed on a prosthetic valve skirt by embroidery. In a representative embroidery technique, a yarn or thread is stitched to or through a base or foundation layer (e.g., a fabric), allowing a variety of shapes or patterns to be produced on the surface of the foundation layer.
As noted above, loops may be embroidered on the surface of the prosthetic valve skirt having any specified location, length, width, spacing, shape, and/or pattern.
The filaments 810 may comprise or originate from frayed yarns, textured yarns, etc. In certain embodiments, the fabric strips 806 of the sealing member 802 can comprise a yarn density of from 50 to 500 yarns per inch, 100 to 400 yarns per inch, 150 to 350 yarns per inch, or 150 to 300 yarns per inch. In certain embodiments, the fabric strips of the sealing member 802 can have a yarn density of 150 yarns per inch, or 300 yarns per inch. The yarns may have any suitable filament density, such as 5 to 100 filaments per yarn, 10 to 50 filaments per yarn, or 10 to 20 filaments per yarn. In particular embodiments, the yarns can comprise textured yarns having 18 filaments per yarn. The filaments may have thicknesses from 1 μm to 100 μm, 1 μm to 50 μm, or 1 μm to 20 μm. In particular embodiments, the filaments can have a thickness or diameter of 10 μm.
For example, in the illustrated configuration, the sealing member 1000 can comprise a first woven portion 1002A. Moving in a direction along the positive y-axis, the sealing member 1000 can further comprise a second woven portion 1004A, a floating yarn portion 1006A, a second woven portion 1004B, a floating yarn portion 1006B, a second woven portion 1004C, a floating yarn portion 1006C, a second woven portion 1004D, a floating yarn portion 1006D, a second woven portion 1004E, a first woven portion 1002B, a second woven portion 1004F, a floating yarn portion 1006E, a second woven portion 1004G, and a first woven portion 1002C at the opposite end of the sealing member from the first woven portion 1002A. In other words, the first woven portion 1002B and each of the floating yarn portions 1006A-1006E can be located between two second woven portions 1004 such that the first woven portion 1002B and each of the floating yarn portions 1006A-1006E are bounded or edged in a direction along the x-axis by respective second woven portions 1004.
Referring to
Each of the first yarns 1008 and the second yarns 1010 can comprise a plurality of constituent filaments 1012 that are spun, wound, twisted, intermingled, interlaced, etc., together to form the respective yarns. Exemplary individual filaments 1012 of the second yarns 1010 can be seen in
The second yarns 1010 can be texturized yarns comprising a plurality of texturized filaments 1012. For example, the filaments 1012 of the second yarns 1010 can be texturized, for example, by twisting the filaments, heat-setting them, and untwisting the filaments as described above. In some embodiments, the second yarns 1010 can have a denier of from about 1 D to about 200 D, about 10 D to about 100 D, about 10 D to about 80 D, or about 10 D to about 70 D. In some embodiments, a filament count of the second yarns 1010 can be from 1 filament per yarn to about 100 filaments per yarn, about 10 to about 80 filaments per yarn, about 10 to about 60 filaments per yarn, or about 10 to about 50 filaments per yarn. In particular embodiments, the second yarns 1010 can have a denier of about 68 D and a filament count of about 36 filaments per yarn.
The first yarns 1008 and the second yarns 1010 can be woven together to form the woven portions of the sealing member, as noted above. For example, in the first woven portions 1002A-1002C, the first and second yarns 1008, 1010 can be woven together in a plain weave pattern in which the second yarns 1010 (e.g., the weft yarns) pass over a first yarn 1008 (e.g., a warp yarn) and then under the next first yarn in a repeating pattern. This weave pattern is illustrated in detail in
In the second woven portions 1004A-1004G, the first and second yarns 1008, 1010 can be interwoven in another pattern that is different from the weave pattern of the first woven portions 1002A-1002C. For example, in the illustrated embodiment, the first and second yarns 1008, 1010 can be woven together in a leno weave pattern in the second woven portions 1004A-1004G.
In the half-leno weave illustrated in
In certain embodiments, each of the second woven portions 1004A-1004G can comprise the leno weave pattern described above. In other embodiments, one or more of the second woven portions 1004A-1004G may be configured differently, such as by incorporating more or fewer first yarns 1008 in the leno weave, having multiple leno ends woven around multiple groupings of yarns 1008, etc. In yet other embodiments, a chemical locking method can be used where the leno weave and/or a plain weave includes warp yarns having core-sheath construction filaments. The sheath of the individual filaments can be made of low-melt temperature polymers such as biocompatible polypropylene, and the core of the filaments be made of another biocompatible polymer such as polyester. After the weaving process, the heat setting process described below can enable the softening and/or melting of the sheath. Upon cooling, the softened sheath polymer can bond the core polyester filaments together. This can create a bonded body enabling locking of the woven structure.
Referring again to
In the illustrated embodiment, each of the woven portions 1002A-1002C and 1004A-1004G, and each of the floating yarn portions 1006A-1006E can have width dimensions in the y-axis direction. The widths of the constituent portions can be configured such that the overall length L1 (
The first woven portion 1002B can have a width W2. With reference to
The second woven portions 1004A-1004G can have widths W3 (
With reference to
The cumulative effect of the floating yarn portions 1006A-1006E increasing in width from the initial width W4 to the second width W5 is that the overall axial dimension of the sealing member 1000 can increase from the initial length L1 (
In certain embodiments, the floating yarn portions 1006A-1006E can be configured such that the sealing member 1000 can elongate by about 10% to about 500%, about 10% to about 300%, about 10% to about 200%, about 10% to about 100%, about 10% to about 80%, or about 10% to about 50%. In particular embodiments, the floating yarn portions 1006A-1006E can be configured to allow the sealing member 1000 to elongate by about 30%, corresponding to the elongation of the frame 1022 between the expanded and crimped configurations. As noted above, the increase in width of the floating yarn portions 1006A-1006E can also result in a corresponding decrease in thickness of the floating yarn portions, reducing the crimp profile of the prosthetic valve during delivery.
In some embodiments, the first and second yarns 1008 and 1010 can comprise any of various biocompatible thermoplastic polymers such as PET, Nylon, ePTFE, UHMWPE, etc., or other suitable natural or synthetic fibers. In certain embodiments, the sealing member 1000 can be woven on a loom, and can then be heat-treated or heat-set to achieve the desired size and configuration. For example, depending upon the material selected, heat-setting can cause the sealing member 1000 to shrink. Heat-setting can also cause a texturizing effect, or increase the amount of texturizing, of the second yarns 1010. After heat treatment, the openings 1016 can be created in the first woven portion 1002B (e.g., by laser cutting), and the sealing member can be incorporated into an outer covering such as the covering 1018 for assembly onto a prosthetic valve. In some embodiments, the openings 1016 can also be created before heat treatment.
The loops, filaments, floating portions, etc., of the prosthetic sealing members described herein can be configured to promote a biological response in order to form a seal between the prosthetic valve and the surrounding anatomy, as described above. In certain configurations, the sealing elements described herein can be configured to form a seal over a selected period of time. For example, in certain embodiments, the open, porous nature of the loops, filaments, yarns, etc., can allow a selected amount of paravalvular leakage around the prosthetic valve in the time period following implantation. The amount paravalvular leakage past the seal structure may be gradually reduced over a selected period of time as the biological response to the loops, filaments, yarns, etc., causes blood clotting, thrombus formation, etc. In some embodiments, the sealing members, and in particular the loops, filaments, yarns, etc., of the paravalvular sealing structure, may be treated with one or more agents that inhibit the biological response to the sealing structures. For example, in certain embodiments, the loops, filaments, yarns, etc., may be treated with heparin. In certain embodiments, the amount or concentration of the agent(s) may be selected such that the agents are depleted after a selected period of time (e.g., days, weeks, or months) after valve implantation. As the agent(s) are depleted, the biological response to the loops, filaments, yarns, etc., of the sealing structures may increase such that a paravalvular seal forms gradually over a selected period of time. This may be advantageous in patients suffering from left atrial remodeling (e.g., due to mitral regurgitation), by providing an opportunity for the remodeling to reverse as regurgitation past the prosthetic valve is gradually reduced.
In a first representative example, an acute animal trial was conducted in which prosthetic heart valves including various skirts of the type shown in
Prior to implantation, the prosthetic valves were partially crimped, and a stack of annuloplasty rings (e.g., two concentrically stacked annuloplasty rings) were attached around the exterior of the prosthetic valves by suturing. Each stack of annuloplasty rings had a plastic cable tie cinched around the bodies of the annuloplasty rings. The stacks of annuloplasty rings were attached to the prosthetic valves such that the heads of the cable ties were located between the outer skirt of the prosthetic valve and the bodies of the annuloplasty rings. In other words, the heads of the cable ties served to space the bodies of the annuloplasty rings away from the prosthetic valves such that an axially-extending channel was defined between the outer skirt and the annuloplasty rings on both sides of the cable tie head in order to induce paravalvular leakage past the prosthetic valves. For the control prosthetic valve without an exterior skirt, the head of the cable tie spaced the annuloplasty rings away from the exterior surface of the prosthetic valve frame.
The prosthetic valves were implanted in a surgical procedure. A baseline amount of paravalvular leakage through the space between the prosthetic valve frame and the stack of annuloplasty rings was determined using echocardiography and/or angiography while the patient was heparinized. Heparinization was then reversed (e.g., by administration of protamine sulfate), and paravalvular leakage was then assessed using echocardiography and angiography over a period of 5 to 30 minutes. The prosthetic valves were then surgically retrieved.
For the first prosthetic valve having the skirt with the yarn density of 300 yarns per inch, no paravalvular leakage was observed before or after heparin reversal. Upon explant, the space between the outer skirt and the attached annuloplasty rings had become completely sealed by thrombus formation, and the head of the cable tie had become at least partially encapsulated by one or more thrombi.
For the second prosthetic valve having the skirt with the yarn density of 150 yarns per inch, paravalvular leakage having an angiographic grade of 2+ was observed by echocardiography, and a grade of 1+ by angiography, before heparin reversal. As used herein, reference to “paravalvular leakage” or “regurgitation” graded at, e.g., 1+, 2+, 3+, or 4+ refers to the angiographic grading guidelines provided by the American Society of Echocardiography using assessment techniques including, for example, echocardiography, angiography, color flow Doppler, fluoroscopy, etc. (Zoghbi et al., ASE Guidelines and Standards: Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation—A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance, Journal of the American Society of Echocardiography, April 2017). After heparin reversal, no paravalvular leakage was detected by either echocardiography or angiography. Upon explant, the space between the outer skirt and the attached annuloplasty rings had become completely sealed by thrombus formation, and the head of the cable tie had become at least partially encapsulated by one or more thrombi.
For both the first and second prosthetic valves including fringed skirts, the immediate acute reduction in paravalvular leakage may be attributable to interaction between blood and the yarn filaments. The continued gradual reduction in paravalvular leakage observed for the second prosthetic valve post-heparin reversal may be attributable to a continued cellular-level biological response resulting in thrombus formation and sealing. For the first prosthetic valve with the yarn density of 300 yarns per inch, the sealing of the space between the frame and the annuloplasty rings occurred nearly immediately. For the second prosthetic valve with the yarn density of 150 yarns per inch, the time to full closure or sealing of the space between the frame and the annuloplasty rings (e.g., no detectable paravalvular leakage) was 5 to 30 minutes.
For the control prosthetic valve that had no outer skirt, paravalvular leakage having a grade of 2+ or greater was observed under heparinization. After heparin reversal, paravalvular leakage having an angiographic grade of 2+ to 3+ was observed. Upon explant, the space between the annuloplasty rings and the frame of the prosthetic valve was fully open or patent, and no appreciable biological sealing had occurred.
Any of the sealing element embodiments disclosed herein can be used in combination with any of the disclosed prosthetic heart valve and/or frame embodiments. A prosthetic heart valve can also include any of the sealing elements described herein, or portions thereof, in any combination.
For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.
Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.
As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.
In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, in certain configurations the lower end of the valve is its inflow end and the upper end of the valve is its outflow end.
As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device toward the user, while distal motion of the device is motion of the device away from the user. The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.
Unless otherwise indicated, all numbers expressing quantities of components, molecular weights, percentages, temperatures, times, and so forth, as used in the specification or claims are to be understood as being modified by the term “about.” Accordingly, unless otherwise indicated, implicitly or explicitly, the numerical parameters set forth are approximations that can depend on the desired properties sought and/or limits of detection under test conditions/methods familiar to those of ordinary skill in the art. When directly and explicitly distinguishing embodiments from discussed prior art, the embodiment numbers are not approximates unless the word “about” is recited. Furthermore, not all alternatives recited herein are equivalents.
In some examples, values, procedures, or apparatus may be referred to as “lowest,” “best,” “minimum,” or the like. It will be appreciated that such descriptions are intended to indicate that a selection among many alternatives can be made, and such selections need not be better, smaller, or otherwise preferable to other selections.
In the description, certain terms may be used such as “up,” “down,” “upper,” “lower,” “horizontal,” “vertical,” “left,” “right,” and the like. These terms are used, where applicable, to provide some clarity of description when dealing with relative relationships. But, these terms are not intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” surface can become a “lower” surface simply by turning the object over. Nevertheless, it is still the same object.
In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is at least as broad as the following claims.
The present application claims priority to and the benefit of U.S. Provisional Application No. 62/544,704, filed on Aug. 11, 2017, which is incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20190046314 A1 | Feb 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62544704 | Aug 2017 | US |
