Expandable stents

Abstract

According to various aspects and implementations, a stent is provided. The stent includes a plurality of struts connected in a plurality of rings of cells around a longitudinal axis, the stent to expand between a crimped state and an expanded state. A ratio of a size of the stent across the longitudinal axis from the crimped state to the expand state is between five and ten.

Description

Atty. Dkt. No.: 102590-0844 (CSDL.7357.10)EXPANDABLE STENTSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of and priority to U.S. Provisional Application No. 63 / 708,613, filed October 17, 2024, the disclosure of which is incorporated herein by reference in its entirety.BACKGROUNDTechnical Field10002] The technical field relates generally to an expandable stent and, more specifically, to an expandable stent for use in heart valve devices, and, further, pediatric prosthetic heart valve devices.Background Discussion[0003| Typical stents and prosthetic heart valve devices available on the market are constructed with geometries suitable for adults but are unsuitable for younger pediatric cardiac patients. Adult-sized replacement stents and heart valves often have a fixed geometry that is too large for use in children, which requires surgeons to modify an adult-sized device to fit into a child, often in the operating room during surgery. This is a difficult and complicated procedure that is performed by only a few skilled surgeons. Furthermore, the devices do not have the ability to grow with the pediatric patient, thus requiring multiple invasive procedures or open heart surgeries.

[0004] In addition, reliable deployment of stents or stented devices in subjects including pediatric or fetal subjects can be challenging. In various applications, current stents may lack the sizing, compressibility, or material properties to be effective.-1-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)SUMMARY[0005| Systems and methods in accordance with the present disclosure relate to a stent structure, such as a scaffold, that can be used alone or in support of the implantation of polymeric and tissue engineered valves, including for implantation in fetal populations.

[0006] Aspects and implementations are directed to a stent for use in a heart valve device. The stent can be expandable between a compressed state to allow for deployment of the stent in a needle and an expanded state to support a heart valve and / or heart valve device. The stent can be degradable and / or bioresorbable.[00O7| At least one aspect relates to a stent for use in a heart valve device. The stent includes a plurality of struts connected in a plurality of rings of cells around a longitudinal axis, the stent (e.g., the stent itself and / or one or more structures or sub-structures of the stent formed by the struts, such as the cells and / or rings) to expand between a crimped state and an expanded state. A ratio of a size of the plurality of struts across the longitudinal axis from the crimped state to the expand state is between five and ten.

[0008] At least one aspect relates to a stent deployment kit. The stent deployment kit can include a stent, a needle and a balloon catheter. The stent is bioresorbable and has a cylindrical shape, and is structured to be compressed to a diameter less than 2 mm from a diameter greater than 5 mm. The needle is sized to receive the compressed stent. The balloon catheter is sized to be received in the stent and to expand the stent to the diameter greater than 5 mm.[0009| At least one aspect relates to a bioresorbable stent. The bioresorbable stent includes a plurality of struts arranged in cylindrical honeycomb shape, the plurality of struts configured to actuate a size of the honeycomb shape between at least a first state and a second state.

[0010] Still other aspects, implementations, and advantages of these example aspects and implementations, are discussed in detail below. Moreover, it is to be understood that both the-2-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30) foregoing information and the following detailed description are merely illustrative examples of various aspects and implementations, and are intended to provide an overview or framework for understanding the nature and character of the claimed aspects and implementations.Implementations disclosed herein may be combined with other implementations, and references to “an implementation,” “an example,” “some implementations,” “some examples,” “an alternate implementation,” “various implementations,” “one implementation,” “at least one implementation,” “this and other implementations,” “certain implementations,” or the like are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described may be included in at least one implementation. The appearances of such terms herein are not necessarily all referring to the same implementation.BRIEF DESCRIPTION OF THE DRAWINGS[OOH | Various aspects of at least one implementation are discussed below with reference to the accompanying figures, which are not intended to be drawn to scale. The figures are included to provide an illustration and a further understanding of the various aspects and implementations, and are incorporated in and constitute a part of this specification, but are not intended as a definition of the limits of any particular implementation. The drawings, together with the remainder of the specification, serve to explain principles and operations of the described and claimed aspects and implementations. In the figures, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every figure. In the figures:[Q012J FIG. 1A is a schematic representation of a human heart showing locations where a stent or prosthetic heart valve device may be positioned in accordance with one or more aspects of the present disclosure;[0013 FIG. IB is a cross-sectional view of the heart in a plane with the valves, showing the anatomical location of the valves relative to each other;-3-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)[0014| FIG. 2 is a view of an expandable stent in accordance with one or more aspects of the present disclosure;

[0015] FIG. 3 is a view of the expandable stent of FIG. 2 in a flat state in accordance with one or more aspects of the present disclosure; and10016] FIG. 4 is a schematic diagram of components of a stent kit in accordance with one or more aspects of the present disclosure.

[0017] FIG. 5 is a diagram of components of a stent system in accordance with one or more aspects of the present disclosure.

[0018] FIG. 6 is a diagram of a stent expanded by a catheter in accordance with one or more aspects of the present disclosure.DETAILED DESCRIPTION]0019| Tubular prosthetic devices used to maintain, open, or dilate blood vessels or other biological lumens are generally referred to as stents. Stent constructions generally include cylindrical frames that define a plurality of openings. Stents can include expandable stents, such as balloon expandable stents. Balloon expandable stents rely on plastic deformation for expansion and are typically expanded via an inflation force, such as a balloon catheter. Balloon expandable stents can be coupled with a balloon catheter. For example, balloon expandable stents can be placed onto a balloon catheter as part of a crimping process that transitions the stent to a collapsed configuration, and can be expanded when the balloon is inflated in the blood vessel or other tissue lumen to the expanded configuration. Stents in accordance with the present disclosure can be made of materials and / or structures to allow for smaller sizes in the expanded configuration relative to typical stents, while having sufficient strength to support the biological lumens and / or heart valve devices, and can be nondegradable, degradable and / or bioresorbable according to a predetermined timeline consistent with therapeutic criteria for the stents. The stents can, for example, be sized for in utero and / or fetal intervention procedures. The stents can-4-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30) allow for deployment of an operational valve to support natural growth and development of a heart.

[0020] As explained above, surgeons often must modify adult-sized heart valve replacement devices to fit young children, especially infants. Typical devices are configured for fully grown organs and blood vessels and therefore do not have sizes that are suitable for children. Furthermore, the transcatheter delivery systems and processes currently used for adults may be detrimental or physically impossible for use in the blood vessels of children, especially those under age 5-6, including for addressing infant, neonatal, fetal, and / or in utero conditions.

[0021] The stents disclosed and described herein are designed to address several of the problems highlighted above regarding the use of the stent alone or with typical heart valve replacement devices. The stents of this disclosure, for example, can be sized for deployment into biological lumens of infants and / or in fetal interventions, and can degrade or be absorbed by the subject, as appropriate, such as in a targeted time window for deployment of a heart valve device in the subject. These stents can be capable of expansion to a size useful for older children and adult applications.

[0022] The stents of the present disclosure are also useful in patients in which the heart and blood vessels have incorrectly grown. For example, the stents of the present disclosure can be degradable and / or bioresorbable, to avoid reliance on permanently deployed stents. The stents can be reinflated and / or further inflated (e.g., by balloon catheter) to reduce the need for replacement with additional stents.|0023] The aspects disclosed herein in accordance with the present disclosure are not limited in their application to the details of construction and the arrangement of components set forth in the following description or illustrated in the accompanying drawings. These aspects are capable of assuming other implementations and of being practiced or of being carried out in various ways. Examples of specific implementations are provided herein for illustrative purposes only and are not intended to be limiting. In particular, acts, components, elements, and-5-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30) features discussed in connection with any one or more implementations are not intended to be excluded from a similar role in any other implementations.

[0024] FIG. 1A is a schematic representation of a heart 10. As shown in FIG. 1A, the heart includes two atria and two ventricles: a right atrium 110 and a left atrium 112, and a right ventricle 114 and a left ventricle 116. The heart 10 also includes an aorta 118. Disposed between the left atrium 112 and the left ventricle 116 is the mitral valve 120, which is a dual-flap (two leaflet) valve that opens as a result of increased pressure in the left atrium as it fills with blood. As atrial pressure increases, the mitral valve opens and blood passes into the left ventricle in the direction indicated by the arrow shown in FIG. 1A. The aortic valve 122 has three leaflets and functions to maintain unidirectional blood flow between the left ventricle and the aorta. The aortic valve is effectively a one-way valve between the heart and the rest of the body since blood is pumped from the left ventricle, through the aortic valve, and into the aorta, which in turn supplies blood to all of the organs in the body. The pulmonary valve 124 is also a three leaflet valve and is positioned between the right ventricle and the pulmonary artery, which transports deoxygenated blood to the lungs from the heart. The tricuspid valve 126 is a three leaflet valve that forms the boundary between the right atrium and the right ventricle and functions to prevent back flow of blood into the right atrium. As described further herein, stent 200 can be used to address conditions of the heart 10, including but not limited to atresia of the pulmonary artery. Pulmonary atresia is a congenital defect that can be detected in utero. This defect can include the improper formation of the pulmonary valve 124, leading to insufficient blood flow to the lungs. Throughout the development process, pulmonary atresia can alter the natural formation of the heart 10 to redirect blood flow to the lungs via other means, leading to more drastic complications such as single ventricle defects. In utero intervention can provide an opportunity to replace the insufficient pulmonary valve 124 with an operational valve that can support the natural growth and development of the biventricular heart. For example, stent 200 can allow for support for the heart 10 for treatment of the pulmonary valve 124, such as to allow for deployment of a replacement heart valve device, among other methods of treatment.-6-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)[0025| For example, problems may occur with any one or more of the heart valves discussed above in human patients, especially in children. For instance, heart valve disease or congenital birth defects may cause the valve to function improperly or inadequately, such as by having holes or leaking, or the valve may be too narrow or completely closed. When this happens, a prosthetic heart valve device may be implanted into the patient to replace the defective valve. The prosthetic heart valves described below may be used to replace any one or more of the native heart valves shown in FIG. 1 A.[00261 FIG. IB shows a cross section of the heart in a plane with the valves, showing the anatomical location of the valves relative to each other. The annulus 190 is the “ring” of tissue around the valve where the leaflets in the respective valve attach. The annulus 190 may be the ring of tissue around any of the valves discussed in FIG. 1A. In some implementations, the annulus may be a ring of tissue in a blood vessel.

[0027] Referring briefly to FIGS. 2-4, systems and methods in accordance with the present disclosure include stents that can be compressible or expandable, and can be nondegradable, degradable and / or resorbable in biological tissues. Such stents can allow for heart valve devices to be deployed in applications including but not limited to addressing pulmonary atresia. For example, such stents can be compressed to an appropriate size for deployment into relatively small heart lumens, and can be permanent or degradesuch as by being absorbed by tissue over target timelines. The stents described herein can be used to address conditions including but not limited to pulmonary atresia, such as by supporting the heart (e.g., heart 10 described with reference to FIGS. 1 A and IB) or one or more lumens thereof, including to allow for delivery of a replacement heart valve device.

[0028] Implanting polymeric heart valves minimally invasively can require a stent (e.g., a scaffold) that can support the valve through its implantation inside of the vessel. To achieve proper implantation, a scaffold can be required to compress (e.g., be compressible) to a size that allows the scaffold to fit within catheters or needles that navigate to the implantation site. From there, the scaffold can be expanded via a balloon catheter to place the device inside of the-7-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30) patient. In pediatric and fetal populations, this can require scaffolds that can be crimped down as small as 1.25 - 2 mm around a balloon catheter and expanded to vessels 7 mm in diameter, for example and without limitation.10029] Stent devices and / or scaffolds and corresponding systems and methods in accordance with the present disclosure can support the implantation of polymeric and tissue engineered valves, such as for implantation in fetal populations. The stent can have, for example and without limitation, an expanded diameter that starts at 7.77 mm and a crimped diameter that can be as small as 1.25 mm, allowing for delivery through a 17-gauge needle (e.g., as depicted in FIG. 5) or a 4 Fr catheter sheath. The stent can be expandable by a thin-walled balloon catheter. The stent can have a thin wall, e.g., under about 130 microns, which can allow the stent to fit within a 17 gauge needle and around the balloon catheter without significant resistance when crimped. The stent can be utilized in pediatric (e.g., neonatal and infant) populations and be continually expanded as needed with the growing patient. This could help in cases of pulmonary valve insufficiency in newborns, where a replacement polymeric or tissue engineered valve would be mounted onto the scaffold and placed via a catheter. The stent can have minimal foreshortening (e.g., less than 2-3 mm), which can allow for easier alignment within the pulmonary annulus when deploying. The stent can be used for applications including but not limited to treatment of pulmonary stenosis and coarctation of the aorta, where the stent would be placed into the vessel and expanded to return the lumen to full patency. As the child grows, the stent could be reinflated with a balloon catheter, which can reduce the need for replacement with additional stents, as the same stent would remain in the body, with minimally invasive expansions. The bioresorbable stents can allow for placement and replacement of stents without any permanent implant left in the body. This can reduce the potential side effects that result from leaving stents implanted, and can prevent issues from stent-in-stent deployment for reintervention purposes if restenosis occurs.[0030| Stents in accordance with the present disclosure can have useful material properties for visualization and / or deployment. For example, the stents can be made of a material that is visualizable by ultrasound. The stents can be made of a material that allows for -8-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30) useful degradation and / or absorption times, e.g., on the order of weeks and / or months (e.g., 4 to 12 weeks; 5 to 9 weeks; 6 to 8 weeks) or months (e g., 1-2 months; 3-6 months; 2-8 months), as compared to materials such as magnesium alloy that do not satisfy such criteria. The stents can be made of struts structured in a manner to have appropriate geometric profiles and / or stiffness for compression, expansion, and / or supporting heart valve devices.[0031 j FIGS. 2 and 3 depict an example of a stent 200. The stent 200 can be implemented as an expandable stent, and can be implemented as a degradable and / or bioresorbable stent. The stent 200 can operate as a scaffold structure.[0032J The stent 200 can be used for scaffolding for pediatric heart valves; for example, implementing the stent 200 using stainless steel can allow for placement and continuous reinflation of the stent 200. The stent 200 can be used for pulmonary atresia, pulmonary stenosis, or other abnormalities of the cardiovascular system. The stent 200 can be deployed in various anatomical lumens. Implementing the stent 200 using bioresorbable material can allow for temporary deployment of the stent 200 (e.g., to avoid the stent 200 being a permanent structure at the deployment location). The stent 200 can be used in applications that may include valves, such as polymer-based valves, or may be independent of a valve.[00331 The stent 200 is depicted in FIG. 2 in a first state. The first state can be an expanded state, e.g., a state in which the stent 200 is manufactured in, and in which valves can be sutured into the stent 200 and / or upon an expansion force applied on the stent 200, e.g., by catheter 408 described with reference to FIG. 4. The stent 200 can be compressed from the first state to a second state, in which the stent 200 has a lesser diameter than in the first state. For example, the second state can be a crimped state. The stent 200 can be in the first state, e.g., the expanded state, prior to crimping and / or insertion into a delivery device, such as a catheter. The stent 200 can be compressed to the second state to be sized for insertion into needle 404.[0034} The stent 200 can include a plurality of struts 204. The struts 204 can be elongated members. The struts 204 can be thin, such as to have a greater length than diameter-9-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)(e.g., at least five times greater length than diameter). The struts 204 can be resilient. A stiffness of the stent 200 can correspond to a stiffness of each strut 204 and the geometry of the struts 204. The struts 204 can have a width (e.g., in a circumferential direction of the struts 204), which can be a constant width, or can vary in width. The struts 204 can be of a same length, or can be of different lengths.[0035J The struts 204 can be structured into a plurality of cells 208. For example, each cell 208 can include edges defined by the struts 204. At least a subset of the cells 208 can be closed cells, e g., each edge of the cell 208 is connected at respective ends with another edge. In some implementations, the cells 208 have six edges, e.g., to form hexagonal structures. For example, the cells 208 can form a honeycomb structure, such as where each edge of the cell 208 includes a corresponding strut 204. The struts 204 can be arranged around an axis 202, e.g., a longitudinal axis. The stent 200 can be symmetrical around the axis 202, such as to be circumferentially symmetrical. The geometry of the cells 208 can allow for greater strength (e.g., stiffness) of the stent 200 while reducing material usage and / or weight for the stent 200. The cells 208 can have a greater length in a direction parallel with the axis 202 than a width in a direction perpendicular to the direction parallel with the axis 202. The struts 204 can be interconnected, such as to each connect with one or more other struts 204 and / or each be connected with multiple other struts 204. Struts 204 from adjacent cells 208 can be in contact with one another along their length. The struts 204 can be sized to form the cells 208 to have identical sizes, or to have varied sizes (e g., where rings 212 may be of the same size or different sizes).[0036 The stent 200 can include a plurality of rings 212. The rings 212 can be formed by groups of cells 208 around a circumference 214 of the stent 200. The circumference 214 can be defined through the rings 212 around the axis 202. The rings 212 can be formed by loop of cells 208 along the circumference 214 and / or around the axis 202. A ratio of a size of the plurality of rings 212, across the axis 202, between the crimped state and the expanded state can be between five and ten, for example. The cells 208 can have multiple sides corresponding to associated struts 204 and rings 212. For example, cell(s) 208 and ring(s) 212 can be connected -10-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30) such that a first cell 208 of a first ring 212 is connected with a second cell 208 of the first ring 212, such as on a first side of the first cell 208, with a third cell 208 of the first ring 212 on a second side of the first ring 212 opposite the first side, and a fourth cell 208 of a second ring 212 of the plurality of rings 212 adjacent to the first ring 212.

[0037] As depicted in FIGS. 2 and 3, some of the struts 204, e.g., first struts 204, such as horizontally adjacent struts 204 (which can be parallel or about parallel with the axis 202), can be common between adjacent (e.g., neighboring) cells 208 in a given ring 212, or can be provided by two adjacent struts 204 that are in contact along a majority of the length of the adjacent struts 204. Some of the struts 204, e.g., second struts, such as struts 204 transverse to the axis 202, can join at ends 216 that are contiguous with struts 204 from adjacent rings 212. The second struts 204 can be at an angle (e.g., non-parallel and non-perpendicular angle) to the first struts 204. The stent 200 can have various numbers of rings 212 based on factors such as a target size for a heart valve device to be supported by the stent 200. As depicted in FIGS. 2 and 3, the stent 200 can have two rings 212.

[0038] The struts 204 can be configured to actuate a size of the stent 200, such as of a honeycomb structure of the stent (e.g., corresponding to cells 208), from the crimped state to one or more expanded states. For example, based on one or more factors that may include an increase of force and / or pressure on the stent 200 from within the stent 200 (e.g., due to a balloon catheter, and / or a decrease in external force and / or pressure on the stent), the struts 204 can adjust in coupling with one another to allow for an increase in the size, such as to change in relative angle between the struts 204 and / or expand the stent 200. The stent 200 can expand amongst a plurality of states, e.g., from the crimped state (such as where the stent 200 is sized to fit through a needle, such as through a needle with an inner diameter less than 2 mm) to any of a plurality of expanded states of any of various greater sizes than the crimped state. The plurality of expanded states can correspond to the degradation and / or absorption times described herein, such as on the order of weeks to months (e.g., up to 6 months). For example and without limitation, the stent 200 can have a first expanded state expected to correspond to a 3 month old, a second, larger expanded state to correspond to a 6 month old.-11-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)[0039| For example, the stent 200 can have a length 220 (e.g., in the expanded state) greater than or equal to 6 millimeters (mm) and less than or equal to 16 mm. The length can be greater than or equal to 8 mm and less than or equal to 12 mm. The length can be about 10 mm. The length 220 can correspond to a size of the struts 204 and / or number of rings 212, and can be selected based on factors such as the target size for the heart valve device.[0040J As noted above, the stent 200 (including one or more structures or sub-structures of the stent 200, such as the cells 208 and / or rings 212) can be compressed from the first state to the second state and / or expanded from the second state to the first state. The compression or expansion of the stent 200 can result in a change in geometry of the struts 204 (e.g., a length, volume, and / or size, for example, of one or more struts 204 and / or the struts 204 collectively) to accommodate a lesser volume bounded by the struts 204, such as to accommodate changes in relative angles amongst struts 204.[00411 The stent 200 can be structured to have reduced or minimized foreshortening (e.g., even while having a closed-cell structure). The foreshortening can be a difference in the length 220 between the crimped state and the expanded state. Due to factors such as the geometry of the struts 204 of the stent 200, the foreshortening can be less than forty percent of the length 220. The foreshortening can be less than twenty percent of the length 220. The foreshortening can be less than one percent of the length 220. The foreshortening can be greater than 0.01 percent and less than twenty percent of the length 220.

[0042] One or more struts 204 can have a thickness (e.g., wall thickness) to allow for the stent 200 to be compressible and to receive (e g., in the compressed and / or expanded states) the catheter in an interior volume of the stent 200. For example, the thickness of the struts 204 can be greater than or equal to 20 microns and less than or equal to 300 microns. The thickness can be greater than or equal to 40 microns and less than or equal to 200 microns. The thickness can be greater than or equal to 150 microns and less than or equal to 40 microns. The thickness can be about 120 microns. The thickness can be a radial thickness, such as a radial wall thickness of the one or more struts 204.-12-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)[0043| Referring further to FIG. 2, the stent 200 (e.g., the struts 204) can be made from at least one of a degradable (e g., biodegradable) or bioresorbable material. For example, the stent 200 can be made partially or entirely from a metal alloy, such as at least one of stainless steel (which can be biocompatible) or a zinc or magnesium alloy. The stent 200 can be made from a biocompatible material.[0044J As depicted in FIG. 3, one or more struts 204 of the cells 208 can vary in width at various points along the struts 204. For example, the second struts 204 can have a center 304, a first end 308, and a second end 312. The center 304 can have a greater width than at least one of the first end 308 or the second end 312. The second strut 204 can decrease in width, e.g., continually decrease in width, from the center 304 towards the at least one of the first end 308 or the second end 312. The selective widths of the second struts 204 can facilitate making the stent 200 lightweight and expandable while retaining sufficient strength for compression, expansion, and / or deployment in the valve of the subject. Along with the geometry of the struts 204 and cells 208, the selective widths can also allow for the stent 200 to maintain a flat or planar configuration in the crimped state to facilitate more effective delivery (e.g., using needle 404 as described with reference to FIG. 4).[0045| FIG. 4 depicts an example of a stent deployment kit 400. The stent 200 can be provided in the stent deployment kit 400 in the first state, and can be deployed in the second state. For example, the stent deployment kit 400 can include the stent 200, and can include a needle 404. The needle 404 can be sized to be inserted into and / or along a lumen in a subject, such as a heart of the subject. The needle 404 can have a predetermined size, such as a predetermined gauge. As an example, the needle 404 can be a 17-gauge needle, or can be a needle of various other gauges. As depicted in FIG. 4, the stent 200 is inserted in the needle 404.10046] Referring further to FIG. 4, the stent deployment kit 400 can include a catheter 408. The catheter 408 can be a balloon catheter. For example, the catheter 408 can be configured to be disposed in the interior volume of the stent 200, and can receive fluid (e.g., saline or other fluid) inside the catheter 408 to be expanded against the interior of the stent 200.-13-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)The stent 200 can be placed on the catheter 408, e.g., as part of the crimping process. As such, the catheter 408 can expand the stent 200 from the second state to the first state, such as to a size to operate as a scaffold for supporting the lumen of the subject and / or a heart valve device disposed in the lumen. FIG. 5, for example, depicts an example of the crimped stent 200 on a pediatric balloon catheter 408, passing through a 17 gauge trocar needle 404 having an inner diameter of 1.067 mm, and FIG. 6, for example, depicts an example of the stent 200 being expanded upon operation of the catheter 408.

[0047] Having now described some illustrative examples, it is apparent that the foregoing is illustrative and not limiting, having been presented by way of example. In particular, although many of the examples presented herein involve specific combinations of method acts or system elements, those acts and those elements can be combined in other ways to accomplish the same objectives. Acts, elements and features discussed in connection with one implementation are not intended to be excluded from a similar role in other implementations or implementations.

[0048] The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including” “comprising” “having” “containing” “involving” “characterized by” “characterized in that” and variations thereof herein, is meant to encompass the items listed thereafter, equivalents thereof, and additional items, as well as alternate implementations consisting of the items listed thereafter exclusively. In one implementation, the systems and methods described herein consist of one, each combination of more than one, or all of the described elements, acts, or components.[Q049] Any references to implementations or elements or acts of the systems and methods herein referred to in the singular can also embrace implementations including a plurality of these elements, and any references in plural to any implementation or element or act herein can also embrace implementations including only a single element. References in the singular or plural form are not intended to limit the presently disclosed systems or methods, their components, acts, or elements to single or plural configurations. References to any act or-14-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30) element being based on any information, act or element can include implementations where the act or element is based at least in part on any information, act, or element.

[0050] Any implementation disclosed herein can be combined with any other implementation or embodiment, and references to “an implementation,” “some implementations,” “one implementation” or the like are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described in connection with the implementation can be included in at least one implementation or embodiment. Such terms as used herein are not necessarily all referring to the same implementation. Any implementation can be combined with any other implementation, inclusively or exclusively, in any manner consistent with the aspects and implementations disclosed herein.[0051 | Where technical features in the drawings, detailed description or any claim are followed by reference signs, the reference signs have been included to increase the intelligibility of the drawings, detailed description, and claims. Accordingly, neither the reference signs nor their absence have any limiting effect on the scope of any claim elements.

[0052] Systems and methods described herein may be embodied in other specific forms without departing from the characteristics thereof. Further relative parallel, perpendicular, vertical or other positioning or orientation descriptions include variations within + / - 10% or + / -10 degrees of pure vertical, parallel or perpendicular positioning. References to “approximately,” “about” “substantially” or other terms of degree include variations of + / - 10% from the given measurement, unit, or range unless explicitly indicated otherwise. Coupled elements can be electrically, mechanically, or physically coupled with one another directly or with intervening elements. Scope of the systems and methods described herein is thus indicated by the appended claims, rather than the foregoing description, and changes that come within the meaning and range of equivalency of the claims are embraced therein.-15-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)[0053| The term “coupled” and variations thereof includes the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent or fixed) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members coupled directly with or to each other, with the two members coupled with each other using a separate intervening member and any additional intermediate members coupled with one another, or with the two members coupled with each other using an intervening member that is integrally formed as a single unitary body with one of the two members. If “coupled” or variations thereof are modified by an additional term (e.g., directly coupled), the generic definition of “coupled” provided above is modified by the plain language meaning of the additional term (e.g., “directly coupled” means the joining of two members without any separate intervening member), resulting in a narrower definition than the generic definition of “coupled” provided above. Such coupling may be mechanical, electrical, or fluidic.|0054[ References to “or” may be construed as inclusive so that any terms described using “or” may indicate any of a single, more than one, and all of the described terms. References to at least one of a conjunctive list of terms may be construed as an inclusive OR to indicate any of a single, more than one, and all of the described terms. For example, a reference to “at least one of ‘A’ and ‘B’” can include only ‘A’, only ‘B’, as well as both ‘A’ and ‘B’. Such references used in conjunction with “comprising” or other open terminology can include additional items.[0055J Modifications of described elements and acts such as variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations can occur without materially departing from the teachings and advantages of the subject matter disclosed herein. For example, elements shown as integrally formed can be constructed of multiple parts or elements, the position of elements can be reversed or otherwise varied, and the nature or number of discrete elements or positions can be altered or varied. Other substitutions, modifications, changes and omissions can also be made in the design, operating conditions and arrangement of the disclosed elements and operations without departing from the scope of the present disclosure.-16-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (CSDL.6047.30)[0056| References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below”) are merely used to describe the orientation of various elements in the FIGURES. It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure.

[0057] The systems and methods described herein may be embodied in other specific forms without departing from the characteristics thereof. The foregoing implementations are illustrative rather than limiting of the described systems and methods. Scope of the systems and methods described herein is thus indicated by the appended claims, rather than the foregoing description, and changes that come within the meaning and range of equivalency of the claims are embraced therein.-17-4858-8831-0746.3

Claims

Atty. Dkt. No.: 102590-0838 (C SDL.6047.30)WHAT IS CLAIMED IS:CLAIMS1. A stent for use in a heart valve device, the stent comprising: a plurality of struts connected in a plurality of rings of cells around a longitudinal axis, the plurality of rings to expand between a crimped state and an expanded state, wherein a ratio of a size of the plurality of rings across the longitudinal axis from the crimped state to the expanded state is between five and ten.

2. The stent of claim 1, wherein the plurality of struts are made from a material to at least one of be absorbed into or degrade in a valve of a subject in a target time, the target time between 5 and 9 weeks.

3. The stent of claim 1, wherein the plurality of struts are made from at least one of stainless steel, magnesium alloy, zinc alloy, or polymer.

4. The stent of claim 1, wherein the size of the plurality of struts across the longitudinal axis in the crimped state is less than 6 millimeters (mm).

5. The stent of claim 1, wherein the plurality of struts, in the crimped state, are sized to fit within a needle sized to be deployed in a heart of a subject.

6. The stent of claim 1, wherein the plurality of struts form a cylindrical shape in the expanded state.

7. The stent of claim 1, wherein a first cell of a first ring of the plurality of rings is connected with a second cell of the first ring on a first side of the first cell, a third cell of the first ring on a second side of the first ring opposite the first side, and a fourth cell of a second ring of the plurality of rings adjacent to the first ring.-18-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (C SDL.6047.30)8. The stent of claim 1, wherein each cell of the plurality of rings of cells comprises six struts, wherein at least two struts of the six struts are in contact along their length with cells adjacent to each cell.

9. The stent of claim 1, wherein a length of each cell of the plurality of rings of cells in a first direction parallel with the longitudinal axis is greater than a width of each cell in a second direction perpendicular to the first direction.

10. The stent of claim 1, wherein at least a subset of the plurality of struts vary in width along the respective struts of the subsets of struts.

11. The stent of claim 1, wherein the stent is configured to accept a balloon catheter to cause the stent to expand from the crimped state to the expanded state.

12. A stent deployment kit, comprising: a stent with a cylindrical shape, the stent structured to be compressed to a diameter less than 2 mm from a diameter greater than 5 mm; a needle sized to receive the compressed stent; and a balloon catheter sized to be received in the stent and to expand the stent to the diameter greater than 5 mm.

13. The stent deployment kit of claim 12, further comprising a fetal heart valve.

14. The stent deployment kit of claim 12, wherein the stent comprises a metal alloy that is detectable by ultrasound.

15. The stent deployment kit of claim 12, wherein the stent comprises a plurality of struts forming the cylindrical shape.-19-4858-8831-0746.3Atty. Dkt. No.: 102590-0844 (C SDL.6047.30)16. The stent deployment kit of claim 12, wherein the stent comprises a plurality of rings of cells forming the cylindrical shape.

17. The stent deployment kit of claim 12, wherein the stent is made of a material to be absorbed by a biological tissue in a period of 5 weeks to 6 months.

18. A stent, comprising: a plurality of struts arranged in a honeycomb shape that is cylindrical, the plurality of struts configured to actuate a size of the honeycomb shape between at least a first state and a second state.

19. The stent of claim 18, wherein the plurality of struts are structured to be compressed from the first state to the second state, a ratio of a diameter of the plurality of struts between the first state and the second state is between four and ten.

20. The stent of claim 18, wherein a wall thickness of one or more struts of the plurality of struts is less than 300 microns.-20-4858-8831-0746.3

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