Apparatus and method for compressing and loading a stent

Abstract

An apparatus for radially compressing a stent may include a housing including a central opening and a first restriction located adjacent to the housing. The first restriction includes a first annular ring and a first plurality of arms extending radially inward from the first annular ring to define a first central opening. The apparatus may include a second restriction axially offset from the first restriction, the second restriction including a second annular ring and a second plurality of arms extending radially inward from the second annular ring to define a second central opening. Rotation of the annular ring relative to the housing changes the size of each central opening. The arms may shift between a first configuration and a second configuration by rotation of the annular ring relative to the housing.

Description

[Technical Field]

[0001]

[0001] The present disclosure relates to medical devices, systems, and methods for making and / or using the medical devices and / or systems. More particularly, the present disclosure relates to devices and / or methods for radially compressing and / or loading stents and / or stent devices, such as replacement heart valve implants.

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 254,695, filed October 12, 2021, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] Conventional stent crimping devices are used throughout the medical device industry to crimp balloon-expandable stents, self-expanding stents, replacement heart valve implants, and the like. Conventional stent crimping devices have a complex arrangement and / or difficult assembly of multiple parts and rely on complex interactions between many moving parts. Due to the aforementioned complexity and number of components required and / or used in conventional stent crimping devices, the cost of conventional stent crimping devices can be substantial. Each of the known devices and methods for compressing and / or crimping stents has certain advantages and disadvantages. There is currently a need for alternative devices and / or methods for crimping stents, stent devices, and / or other medical implants that may include stents (e.g., but not limited to, replacement heart valve implants). Summary of the Invention

[0003] In one embodiment, a device for radially compressing a stent may include a housing including a central opening and a first restriction located adjacent to the housing. The first restriction includes a first annular ring located coaxially with the central opening and a first plurality of arms extending radially inward from the first annular ring. The first plurality of arms define a first central opening located coaxially with the central opening of the housing. Rotation of the first annular ring relative to the housing changes the size of the first central opening.

[0004] Alternatively or additionally to any embodiment described herein, a first end of each of the first plurality of arms is connected to the first annular ring by a first living hinge disposed between the first end and the first annular ring.

[0005] Alternatively or additionally to any embodiment described herein, the second end of each of the first plurality of arms is fixed relative to the housing. Alternatively or additionally to any embodiment described herein, the second end of each of the first plurality of arms includes an opening formed therein.

[0006] Alternatively or additionally to any embodiment described herein, a fastener passes through the opening and engages the housing. Alternatively or additionally to any embodiment described herein, the opening is configured to engage a protrusion extending from the housing.

[0007] Alternatively or additionally to any embodiment described herein, an intermediate portion of each of the first plurality of arms is configured to engage an intermediate portion of a circumferentially adjacent one of the first plurality of arms to define the first central opening.

[0008] Alternatively or additionally to any embodiment described herein, the intermediate portion of each of the first plurality of arms includes a second living hinge. Alternatively or additionally to any embodiment described herein, the first plurality of arms are monolithically formed with the first annular ring from a single piece of material.

[0009] Alternatively or additionally to any of the embodiments described herein, in another embodiment, a device for radially compressing a stent may include a housing including a central opening and a first restriction located adjacent to the housing. The first restriction includes a first annular ring located coaxially with the central opening of the housing and a first plurality of arms extending radially inward from the first annular ring. The first plurality of arms define a first central opening located coaxially with the central opening of the housing. The first plurality of arms are configured to shift between a first configuration and a second configuration upon rotation of the first annular ring relative to the housing.

[0010] Alternatively or additionally to any embodiment described herein, in the first configuration, the first plurality of arms define a first size of the first central opening, and in the second configuration, the first plurality of arms define a second size of the first central opening that is smaller than the first size.

[0011] Alternatively or additionally to any embodiment described herein, each of the first plurality of arms engages with at least one other arm of the first plurality of arms when the first plurality of arms shifts from the first configuration to the second configuration.

[0012] Alternatively or additionally to any embodiment described herein, a first end of each of the first plurality of arms is fixedly attached to the first annular ring by a first living hinge.

[0013] Alternatively or additionally to any embodiment described herein, the device may include a second aperture axially offset from the first aperture. The second aperture includes a second annular ring coaxially positioned relative to the central opening of the housing and a second plurality of arms extending radially inward from the second annular ring. The second plurality of arms define a second central opening coaxially positioned relative to the central opening of the housing. The second plurality of arms are configured to shift between a first configuration and a second configuration upon rotation of the second annular ring relative to the housing.

[0014] Alternatively or additionally to any embodiment described herein, a method includes inserting a stent in a first configuration into a first iris including a first annular ring and a first plurality of arms extending radially inward from the first annular ring and defining a first central opening, and shifting the first plurality of arms from the first configuration to a second configuration by rotating the first annular ring relative to a housing disposed about the first annular ring, the first central opening having a first size in the first configuration and a second size smaller than the first size in the second configuration, wherein a first portion of the stent disposed within the first iris has a radially compressed configuration.

[0015] Alternatively or additionally to any example described herein, the method may include positioning a sheath adjacent to the first restriction with the first plurality of arms in the second configuration and the first portion of the stent disposed within the first restriction in the radially compressed configuration; rotating the first annular ring relative to the housing to shift the first plurality of arms from the second configuration to the first configuration; and moving the sheath over the stent and into the first restriction such that the first portion of the stent disposed within the first restriction is disposed within the sheath.

[0016] Alternatively or additionally to any embodiment described herein, the sheath has an inner diameter that is smaller than an outer diameter of the stent in the first configuration. Alternatively or additionally to any embodiment described herein, inserting the stent further comprises inserting the stent in the first configuration into the first aperture and inserting the stent into a second aperture axially offset from the first aperture, the second aperture including a second annular ring and a second plurality of arms extending radially inward from the second annular ring and defining a second central opening.

[0017] Alternatively or additionally to any embodiment described herein, the method may include shifting the second plurality of arms from a first configuration to a second configuration by rotating the second annular ring relative to the housing. The second central opening has a first size in the first configuration and a second size smaller than the first size in the second configuration. In the second configuration of the second plurality of arms, a second portion of the stent disposed within the second restriction has a radially compressed configuration.

[0018] Alternatively or additionally to any example described herein, a method may include positioning a sheath adjacent to the first restriction with the first plurality of arms in the second configuration and the first portion of the stent disposed within the first restriction in the radially compressed configuration; rotating the first annular ring relative to the housing to shift the first plurality of arms from the second configuration to the first configuration; moving the sheath over the stent into the first restriction such that the first portion of the stent disposed within the first restriction is disposed within the sheath; rotating the second annular ring relative to the housing to shift the second plurality of arms from the second configuration to the first configuration; and moving the sheath over the stent into the second restriction such that the second portion of the stent disposed within the second restriction is disposed within the sheath.

[0019] The above summary of some embodiments, aspects, and / or examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure, and the figures and detailed description more particularly exemplify these embodiments. [Brief explanation of the drawings]

[0020] [Figure 1-2] 1 and 2 illustrate selected embodiments of a device for radially compressing a stent. [Figure 3] FIG. 3 is an exploded view showing selected aspects of the device of FIGS. [Figure 4] FIG. 4 shows selected aspects of the first aperture of the device of FIGS. [Figure 5-7] 5-7 illustrate selected aspects relating to the functioning of the apparatus of FIGS. 1-4. [Figure 8-12] 8-12 are partial cross-sectional views illustrating selected aspects of a method for radially compressing a stent using the device of FIGS. 1-7. [Figure 13] FIG. 13 illustrates selected aspects of an alternative configuration of a device for radially compressing a stent. DETAILED DESCRIPTION OF THE INVENTION

[0021] The present disclosure may be more fully understood from consideration of the following detailed description in conjunction with the accompanying drawings. Aspects of the present disclosure are susceptible to various modifications and alternative forms. Particular aspects of the present disclosure are shown by way of example in the drawings and are described in detail below. However, it is not intended that aspects of the present disclosure be limited to the specific embodiments described below. Furthermore, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0022] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which like reference numerals indicate like elements in the several views. The detailed description and drawings are intended to illustrate exemplary embodiments of the present disclosure and are not intended to limit the disclosure. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in every drawing.

[0023] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​are assumed to be modified herein by the term "about," whether expressly stated or not. The term "about," in the context of numerical values, refers to a range of numerical values ​​that one of ordinary skill in the art would generally consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) may be assumed to have their ordinary and accustomed definition(s) that are understood from and consistent with the context of this specification, unless otherwise specified.

[0024] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although certain preferred dimensions, ranges, and / or values ​​for various components, features, and / or specifications are disclosed, those skilled in the art, having access to this disclosure, will understand that the desired dimensions, ranges, and / or values ​​may deviate from those explicitly disclosed.

[0025] As used in this specification and the appended claims, the singular form "a," "an," or "an" includes plural referents unless the context clearly dictates otherwise. As used in this specification and the claims, the term "or" generally includes "and / or" unless the context clearly dictates otherwise. For ease of understanding, some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within the disclosed embodiment(s). Each instance of a feature may include and / or be encompassed by a singular disclosure unless expressly stated to the contrary. For brevity and clarity, not all elements of the present disclosure are necessarily shown in every figure or described in detail below. However, it will be understood that the following description may apply equally to any and / or all of multiple components, where more than one is present, unless expressly stated to the contrary. Also, for clarity, not all instances of some elements or features are shown in every figure.

[0026] Relative terms such as "proximal," "distal," "advancing," "retracting," and variations thereof may generally be considered with respect to the positioning, orientation, and / or movement of various elements relative to a user / operator / pilot of a device, with "proximal" and "retracting" indicating or referring to being closer to or toward the user, and "distal" and "advancing" indicating or referring to being farther from or away from the user. In some instances, the terms "proximal" and "distal" may be assigned arbitrarily to facilitate understanding of the present disclosure, and such examples may be readily apparent to those skilled in the art. Additionally, other relative terms such as "axial," "circumferential," "longitudinal," "lateral," "radial," and / or variations thereof generally refer to directions and / or orientations relative to a central longitudinal axis of the disclosed structures or devices.

[0027] The term "range" may be understood to mean the maximum measure of a stated or specified dimension, unless the range or dimension in question is preceded by or specified as "minimum," which may be understood to mean the minimum measure of the stated or specified dimension. For example, an "outer range" may be understood to mean the outer dimension. Also, for example, a "radial range" may be understood to mean the radial dimension. Also, for example, a "longitudinal range" may be understood to mean the longitudinal dimension. Each instance of "range" may vary (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and may be apparent to one of ordinary skill in the art from the context of a particular use. Generally, a "range" may be considered the maximum possible dimension measured according to the intended use, and a "minimum range" may be considered the minimum possible dimension measured according to the intended use. In some examples, "extent" may generally be measured perpendicularly in a plane and / or cross-section, but may also be measured variously, such as, without limitation, at an angle, radially, circumferentially (e.g., along an arc), etc., as may become apparent from the particular context.

[0028] The terms "monolithic" and "single" generally refer to one or more elements made from or consisting of a single structure or base unit / element. Monolithic and / or single structure shall exclude structures and / or features made by assembling or joining together multiple separate elements.

[0029] It should be noted that references herein to “embodiments,” “some embodiments,” “other embodiments,” etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include that particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with one embodiment, those skilled in the art will recognize that the particular feature, structure, or characteristic also applies in connection with other embodiments, unless expressly stated to the contrary, whether explicitly described or not. That is, it is intended that the various individual elements described below, even if not explicitly shown in specific combinations, can be combined or arranged with each other to form other or additional embodiments, or to complement and / or enhance the described embodiments, as would be understood by those skilled in the art.

[0030] For purposes of clarity, certain numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout this specification and / or claims to name and / or distinguish between various described and / or claimed features. This numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, variations and departures from previously used numerical nomenclature may be made for brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second," "third," etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or designation in each instance will be apparent to one of ordinary skill in the art.

[0031] For ease of understanding, some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within the disclosed embodiment(s). Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For example, a reference to an "arm," "aperture," or other feature may equally refer to two or more instances and quantities of that feature unless expressly stated to the contrary. Thus, it may be understood that the following description may equally apply to any and / or all of two or more components present in a device, etc., unless expressly stated to the contrary.

[0032] Also, in any given figure, some features may not be shown or may be shown diagrammatically for clarity and / or brevity. Additional details regarding some components and / or method steps may be shown in more detail in other figures. The devices and / or methods disclosed herein may provide several desirable features and advantages, as described in more detail below. For purposes of this disclosure, the following description relates to devices and methods for radially compressing a stent and is so described for brevity. However, this is not intended to be limiting, and those skilled in the art will recognize that the following description is also applicable to stent devices or medical implants, including stents, with no or minimal change to the structure and / or scope of the present disclosure. Similarly, the devices and methods disclosed herein may have applications and uses for other medical devices.

[0033] 1-3 illustrate an embodiment of an apparatus 100 for radially compressing a stent. The apparatus 100 can include a housing 110 including a central opening 112 (e.g., FIG. 3 ). In some embodiments, the apparatus 100 can include a first restriction 120 located adjacent to the housing 110. In at least some embodiments, the first restriction 120 can be located at least partially within the housing 110. In some embodiments, the apparatus 100 can include a spacer plate 130 located adjacent to the housing 110. In at least some embodiments, the spacer plate 130 can be located at least partially within the housing 110. In some embodiments, the apparatus 100 can include a second restriction 140 located adjacent to the housing 110. In at least some embodiments, the second restriction 140 can be located at least partially within the housing 110. In some embodiments, the apparatus 100 can include a cover plate 150 located adjacent to the housing 110. In some embodiments, the cover plate 150 may be located at least partially within the housing 110 .

[0034] In some embodiments, the spacer plate 130 may be non-rotatable relative to the housing 110. In some embodiments, the spacer plate 130 may engage with the housing 110 described herein to prevent relative rotation therebetween. In some embodiments, the cover plate 150 may be removably secured to the housing 110. In some embodiments, the cover plate 150 may be non-rotatable relative to the housing 110. In one example, the cover plate 150 may be removably secured to the housing 110 using one or more fasteners (not shown). In another example, the cover plate 150 and / or one or more protrusions extending from the cover plate 150 may be configured to engage with one or more slots or other features formed in the housing 110 to removably secure the cover plate 150 to the housing 110. Other configurations are also contemplated.

[0035] In some embodiments, first aperture 120 may be movable relative to housing 110, spacer plate 130, and / or cover plate 150. In some embodiments, at least a portion of first aperture 120 may be configured to rotate relative to housing 110, spacer plate 130, and / or cover plate 150.

[0036] In some embodiments, the second aperture 140 may be movable relative to the housing 110, the spacer plate 130, and / or the cover plate 150. In some embodiments, at least a portion of the second aperture 140 may be configured to rotate relative to the housing 110, the spacer plate 130, and / or the cover plate 150. In some embodiments, at least a portion of the second aperture 140 may be configured to rotate relative to the first aperture 120. Thus, in at least some embodiments, the first aperture 120 and the second aperture 140 may be movable independently of one another. In some embodiments, the first aperture 120 may be movable and / or configured to rotate relative to the housing 110, the spacer plate 130, and / or the cover plate 150 independently of the second aperture 140. In some embodiments, the second aperture 140 may be movable and / or configured to rotate relative to the housing 110, the spacer plate 130, and / or the cover plate 150 independently of the first aperture 120.

[0037] In some embodiments, the first aperture 120 and the second aperture 140 may be movable and / or configured to rotate together, in conjunction with, and / or simultaneously relative to the housing 110, the spacer plate 130, and / or the cover plate 150. In some embodiments, the first aperture 120 and the second aperture 140 may be movable and / or configured to rotate together, in conjunction with, and / or simultaneously relative to the housing 110, the spacer plate 130, and / or the cover plate 150 at one time, in one direction, or during a particular step of a method disclosed herein. The first aperture 120 and the second aperture 140 may also be movable and / or configured to rotate independently of one another at different times, in different directions, or during a particular step of a method disclosed herein. Other configurations are also contemplated.

[0038] 2 illustrates selected aspects of device 100 excluding cover plate 150. In some embodiments, device 100 can include a fastener 160 engaged with housing 110. In some embodiments, fastener 160 can be removable from and / or configured to disengage from housing 110. Fastener 160 can be configured to engage first aperture 120, spacer plate 130, second aperture 140, and / or cover plate 150. In some embodiments, device 100 can include multiple fasteners 160 engaged with housing 110. In some embodiments, multiple fasteners 160 can be removable from and / or configured to disengage from housing 110. Other configurations are also contemplated.

[0039] In some embodiments, device 100 may include a protrusion 162 extending from housing 110. In some embodiments, protrusion 162 may be fixedly attached to housing 110. In some embodiments, protrusion 162 may be removable from and / or configured to disengage from housing 110. Protrusion 162 may be configured to engage first aperture 120, spacer plate 130, second aperture 140, and / or cover plate 150. In some embodiments, device 100 may include multiple protrusions 162 extending from housing 110. In some embodiments, multiple protrusions 162 may be fixedly attached to housing 110. In some embodiments, multiple protrusions 162 may be removable from and / or configured to disengage from housing 110. Other configurations are also contemplated.

[0040] FIG. 3 is an exploded view illustrating selected aspects of the device 100. As described above, the housing 110 can include a central opening 112 formed therein. In some embodiments, the cover plate 150 can include a cover plate opening 156. The cover plate opening 156 can be aligned with and / or coaxial with the central opening 112 of the housing 110. In some embodiments, the cover plate 150 can include multiple openings extending along the periphery of the cover plate 150. The multiple openings can be configured to receive fasteners therein to removably secure and / or attach the cover plate 150 to the housing 110. The housing 110 can include multiple corresponding holes or recesses that align with the multiple openings in the cover plate 150 and are configured to receive the fasteners. In one example, the multiple fasteners can be externally threaded screws or other threaded fasteners, and the multiple corresponding holes or recesses can include internal threads configured to threadably engage the externally threaded screws or other threaded fasteners. Other configurations and / or fastener types are contemplated. Some suitable, but non-limiting, examples of materials that may be used for the housing 110 and / or cover plate 150 are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc.

[0041] In some embodiments, the first aperture 120 may include a first annular ring 122 that is coaxially positioned relative to the central opening 112 of the housing 110. In some embodiments, the first annular ring 122 may be positioned adjacent to the housing 110. In some embodiments, the first annular ring 122 may be positioned at least partially within the housing 110. In some embodiments, the first aperture 120 and / or the first annular ring 122 may have a substantially circular outer periphery.

[0042] First aperture 120 may include a first plurality of arms 124 extending radially inward from first annular ring 122. First plurality of arms 124 may define a first central opening 126 of first aperture 120. First central opening 126 may be aligned with and / or coaxial with central opening 112 of housing 110. Several aspects of first aperture 120 and / or elements of first aperture 120 are shown in detail in FIG. 4 .

[0043] A first end of each of the first plurality of arms 124 may be connected to the first annular ring 122 by a first living hinge 123 disposed between the first end and the first annular ring 122. In some embodiments, the first end of each of the first plurality of arms 124 may be directly connected to the first annular ring 122 by the first living hinge 123. In some embodiments, the first end of each of the first plurality of arms 124 may be fixedly attached to the first annular ring 122 by the first living hinge 123. In some embodiments, the second end of each of the first plurality of arms 124 may be fixed relative to the housing 110. In some embodiments, the second end of each of the first plurality of arms 124 may include an opening 128 formed therein. In some embodiments, a fastener 160 passes through the opening 128 to engage with the housing 110. In some embodiments, opening 128 can be configured to engage with a protrusion 162 extending from housing 110. In at least some embodiments, the second end of each of first plurality of arms 124 can be configured to rotate around fastener 160 and / or protrusion 162 when first annular ring 122 rotates relative to housing 110.

[0044] 4 , an intermediate portion 129 of each of the first plurality of arms 124 can be configured to engage an intermediate portion of a circumferentially adjacent one of the first plurality of arms 124 to define a first central opening 126. The intermediate portion 129 of each of the first plurality of arms 124 can include a second living hinge 125. In some embodiments, the first plurality of arms 124 can be integrally and / or monolithically formed with the first annular ring 122 from a single piece of material. In at least some embodiments, the first living hinge 123 and the second living hinge 125 of each of the first plurality of arms 124 can be configured to resiliently bend, deflect, and / or curve to allow relative movement between the portions of the arms on either side of the first living hinge 123 and / or second living hinge 125. Some suitable, but non-limiting, examples of materials that may be used to form the first aperture 120, the first annular ring 122, the first plurality of arms 124, etc., are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc.

[0045] In some embodiments, first iris 120 may be manufactured using one or more of a variety of methods. In some embodiments, first iris 120 may be machined. In some embodiments, first iris 120 may be cut using a water jet. In some embodiments, first iris 120 may be laser cut. In some embodiments, first iris 120 may be injection molded. In some embodiments, first iris 120 may be cast. Other manufacturing methods are also contemplated.

[0046] In some embodiments, the first aperture 120 may include a first lever 121 fixedly attached to and / or extending radially outward from the first annular ring 122. In some embodiments, the first lever 121 may extend radially outward from the substantially circular outer periphery of the first aperture 120 and / or the first annular ring 122. In at least some embodiments, the first lever 121 may include a first cavity 127 formed therein. The first lever 121 may extend radially outward along a first radius extending outward from the center of the first central opening 126. Additionally, the first lever 121 may include a first side 121A facing laterally in a first direction from the first radius and a second side 121B disposed generally opposite the first side 121A and facing laterally in a second direction from the first radius generally opposite the first direction. In at least some embodiments, the first cavity 127 may be disposed between the first side 121A and the second side 121B of the first lever 121. In some embodiments, the first cavity 127 may be disposed radially between the first side 121A and the second side 121B of the first lever 121. In some embodiments, the first cavity 127 may be located directly radially between the first side 121A and the second side 121B of the first lever 121. The purpose and / or use of the first side 121A and / or second side 121B of the first lever 121 may become apparent below.

[0047] Returning to FIG. 3 , in some embodiments, the apparatus 100 may include a spacer plate 130. In some embodiments, the spacer plate 130 may include a central opening 132 formed therein. In some embodiments, the central opening 132 of the spacer plate 130 may be aligned with and / or coaxially positioned relative to the central opening 112 of the housing 110 and / or the first central opening 126 of the first aperture 120. In some embodiments, the spacer plate 130 may be axially disposed between the first aperture 120 and the housing 110 relative to an axis extending through the central opening 112 of the housing 110 and the first central opening 126 of the first aperture 120. In some embodiments, the spacer plate 130 may be configured to slide axially within the housing 110. The housing 110 may include a notch or recess 114 formed in a sidewall of the housing 110. The spacer plate 130 may include a locking tab 134 projecting radially outward from the spacer plate 130. The locking tabs 134 may be configured to engage with the recesses 114 in the housing 110 to prevent relative rotation between the spacer plate 130 and the housing 110. In some embodiments, the spacer plate 130 may include a plurality of holes 138 formed therein. The plurality of holes 138 are configured to receive and / or engage with the fasteners 160 and / or protrusions 162.

[0048] In some embodiments, the spacer plate 130 can have a substantially circular periphery. In at least some embodiments, the spacer plate 130 can include a protrusion 131 extending radially outward from the spacer plate 130. In some embodiments, the protrusion 131 can extend radially outward from the substantially circular periphery of the spacer plate 130. In some embodiments, the protrusion 131 can include a first stop element 136 protruding axially and / or upwardly from an upper surface of the protrusion 131 and / or the spacer plate 130. In some embodiments, the first stop element 136 can be configured to engage and / or be received by a first cavity 127 of the first lever 121 of the first aperture 120 to lock the first aperture 120 and / or the first plurality of arms 124 in the first configuration. In at least some embodiments, the first configuration of the first aperture 120 and / or the first plurality of arms 124 can be an open configuration or a radially expanded configuration. In a first configuration of the first aperture 120 and / or the first plurality of arms 124, the first plurality of arms 124 and / or the intermediate portion 129 of each of the first plurality of arms 124 may define a first size of the first central opening 126.

[0049] In some embodiments, device 100 may not have a spacer plate 130. In some embodiments, first restriction 120 may be located directly adjacent to the upwardly facing surface of housing 110 that defines central opening 112. Such a configuration may be useful when radially compressing a stent having a relatively short and / or limited length, or when only a portion of the stent needs to be radially compressed.

[0050] In some embodiments, the apparatus 100 may include a second aperture 140. The second aperture 140 may be axially offset from the first aperture 120. In some embodiments, the second aperture 140 may be spaced apart from the first aperture 120. In some embodiments, the second aperture 140 may be spaced apart from the first aperture 120 by a spacer plate 130. In some embodiments, the second aperture 140 may include a second annular ring 142 located coaxially with respect to the central opening 112 of the housing 110. In some embodiments, the second annular ring 142 may be located adjacent to the housing 110. In some embodiments, the second annular ring 142 may be located at least partially within the housing 110. In some embodiments, the second aperture 140 and / or the second annular ring 142 may have a substantially circular periphery.

[0051] The second aperture 140 may include a second plurality of arms 144 extending radially inward from the second annular ring 142. The second plurality of arms 144 may define a second central opening 146 of the second aperture 140. The second central opening 146 may be aligned with and / or coaxially located relative to the central opening 112 of the housing 110, the central opening 132 of the spacer plate 130, and / or the first central opening 126 of the first aperture 120. Some aspects of the second aperture 140 and / or elements of the second aperture 140 may be substantially the same as or similar to the elements of the first aperture 120 shown in FIG.

[0052] A first end of each of the second plurality of arms 144 may be connected to the second annular ring 142 by a first living hinge 143 disposed between the first end and the second annular ring 142. In some embodiments, the first end of each of the second plurality of arms 144 may be directly connected to the second annular ring 142 by the first living hinge 143. In some embodiments, the first end of each of the second plurality of arms 144 may be fixedly attached to the second annular ring 142 by the first living hinge 143. In some embodiments, the second end of each of the second plurality of arms 144 may be fixed relative to the housing 110. In some embodiments, the second end of each of the second plurality of arms 144 may include an opening 148 formed therein. In some embodiments, a fastener 160 passes through the opening 148 to engage with the housing 110. In some embodiments, opening 148 can be configured to engage with a protrusion 162 extending from housing 110. In at least some embodiments, the second end of each of second plurality of arms 144 can be configured to rotate about fastener 160 and / or protrusion 162 when second annular ring 142 rotates relative to housing 110.

[0053] Similar to the first aperture 120 shown in FIG. 4 , the intermediate portion of each of the second plurality of arms 144 of the second aperture 140 can be configured to engage with the intermediate portion of a circumferentially adjacent one of the second plurality of arms 144 to define a second central opening 146. The intermediate portion of each of the second plurality of arms 144 can include a second living hinge 145. In some embodiments, the second plurality of arms 144 can be integrally and / or monolithically formed with the second annular ring 142 from a single piece of material. In at least some embodiments, the first living hinge 143 and the second living hinge 145 of each of the second plurality of arms 144 can be configured to resiliently bend, deflect, and / or curve to allow relative movement between the portions of each arm on either side of the first living hinge 143 and / or second living hinge 145. In a preferred configuration, the first aperture 120 can be fabricated from a polymeric material. Some suitable, but non-limiting, examples of materials that may be used to form the second aperture 140, the second annular ring 142, the second plurality of arms 144, etc., are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc.

[0054] In some embodiments, second iris 140 may be manufactured using one or more of a variety of methods. In some embodiments, second iris 140 may be machined. In some embodiments, second iris 140 may be cut using a water jet. In some embodiments, second iris 140 may be laser cut. In some embodiments, second iris 140 may be injection molded. In some embodiments, second iris 140 may be cast. Other manufacturing methods are also contemplated.

[0055] In some embodiments, for example, as seen in FIG. 3 , the second aperture 140 may include a second lever 141 fixedly attached to and / or extending radially outward from the second annular ring 142. In some embodiments, the second lever 141 may extend radially outward from the substantially circular periphery of the second aperture 140 and / or the second annular ring 142. In at least some embodiments, the second lever 141 may include a second cavity 147 formed therein. The second lever 141 may extend radially outward along a second radius extending outward from the center of the second central opening 146. Also, similar to the first aperture 120 shown in FIG. 4 , the second lever 141 may include a first side facing laterally in a first direction from the second radius and a second side disposed generally opposite the first side and facing laterally in a second direction from the second radius generally opposite the first direction. In at least some embodiments, the second cavity 147 may be disposed between the first and second sides of the second lever 141. In some embodiments, the second cavity 147 may be disposed radially between the first and second sides of the second lever 141. In some embodiments, the second cavity 147 may be located directly radially between the first and second sides of the second lever 141. The purpose and / or use of the first and / or second sides of the second lever 141 may become apparent below.

[0056] In some embodiments, the protrusion 131 of the spacer plate 130 can include a second stop element (not shown) that protrudes axially and / or downwardly from the underside of the protrusion 131 and / or spacer plate 130 opposite the first stop element 136. In some embodiments, the second stop element can be configured to engage and / or be received by the second cavity 147 of the second lever 141 of the second aperture 140 to lock the second aperture 140 and / or the second plurality of arms 144 in the first configuration. In at least some embodiments, the first configuration of the second aperture 140 and / or the second plurality of arms 144 can be an open configuration or a radially expanded configuration. In a first configuration of the second aperture 140 and / or the second plurality of arms 144, the second plurality of arms 144 and / or an intermediate portion of each of the second plurality of arms 144 may define a first size of the second central opening 146.

[0057] 5-7 illustrate selected aspects related to the function and / or operation of device 100. For clarity, cover plate 150 is not shown. Illustrated reference numbers may not be explicitly described with respect to FIGS. 5-7 (and vice versa), but the above-described descriptions associated with those reference numbers (e.g., with respect to FIGS. 1-4) may apply. To explain the operation of device 100, FIG. 5 will be compared with FIG. 7 below, with a brief return to FIG. 6.

[0058] FIG. 5 illustrates the first aperture 120 and / or the first plurality of arms 124 in a first configuration. The first lever 121 may extend radially outward from the first annular ring 122 through a side opening in the housing 110. The first lever 121 may be movable and / or rotatable relative to the housing 110 within the side opening. The first cavity 127 of the first lever 121 of the first aperture 120 engages and / or receives the first stop element 136 of the protrusion 131 of the spacer plate 130 to lock the first aperture 120 and / or the first plurality of arms 124 in the first configuration. The first plurality of arms 124 define a first central opening 126. In the first configuration, the first plurality of arms 124 define a first size of the first central opening 126. Similarly, although not explicitly visible, the second aperture 140 and / or the second plurality of arms 144 are also in a first configuration. The second lever 141 may extend radially outward from the second annular ring 142 through a side opening in the housing 110. The second lever 141 may be movable and / or rotatable relative to the housing 110 within the side opening. A second cavity 147 of the second lever 141 of the second aperture 140 engages and / or receives a second stop element on the protrusion 131 of the spacer plate 130, thereby locking the second aperture 140 and / or the second plurality of arms 144 in the first configuration. The second plurality of arms 144 define a second central opening 146. In the first configuration, the second central opening 146 has a first size.

[0059] Rotating the first annular ring 122 of the first aperture 120 relative to the housing 110 can change the size of the first central opening 126, as seen in FIG. 7 . In at least some embodiments, the first plurality of arms 124 can be configured to shift between a first configuration and a second configuration by rotating the first annular ring 122 relative to the housing 110. In some embodiments, rotation of the first annular ring 122 relative to the housing 110 can be achieved by shifting and / or rotating the first lever 121 relative to the housing 110. In some embodiments, the first plurality of arms 124 can be configured to shift between the first configuration and the second configuration by clockwise rotation of the first annular ring 122 and / or the first lever 121 relative to the housing 110, as can be seen by comparing FIGS. 5 and 7 . In the second configuration, the first plurality of arms 124 defines a second size of the first central opening 126 that is smaller than the first size. 5 and 7 , each of the first plurality of arms 124 may engage with at least one other arm of the first plurality of arms 124 when the first plurality of arms 124 shifts from the first configuration to the second configuration. In some embodiments, the intermediate portion 129 of each of the first plurality of arms 124 may engage with the intermediate portion 129 of at least one other arm of the first plurality of arms 124 when the first plurality of arms 124 shifts from the first configuration to the second configuration to define the first central opening 126. In some embodiments, the intermediate portion 129 of each of the first plurality of arms 124 may engage with the intermediate portion of a circumferentially and / or immediately adjacent arm of the first plurality of arms 124 when the first plurality of arms 124 shifts from the first configuration to the second configuration to define the first central opening 126.

[0060] As shown in FIG. 7 , in the second configuration of the first aperture 120 and / or the first plurality of arms 124, the second side 121B of the first lever 121 engages and / or contacts the side of the first stop element 136 of the protrusion 131, preventing counterclockwise rotation of the first lever 121 relative to the housing 110 (without deflecting either the protrusion 131 or the first lever 121 away from the other), thereby locking the first aperture 120 and / or the first plurality of arms 124 in the second configuration.

[0061] Returning to FIG. 6 , the size of the second central opening 146 can be changed by rotating the second annular ring 142 of the second aperture 140 relative to the housing 110. In at least some embodiments, the second plurality of arms 144 can be configured to shift between a first configuration and a second configuration by rotating the second annular ring 142 relative to the housing 110. In some embodiments, the rotation of the second annular ring 142 relative to the housing 110 can be achieved by shifting and / or rotating the second lever 141 relative to the housing 110. In some embodiments, the second plurality of arms 144 can be configured to shift between a first configuration and a second configuration by clockwise rotation of the second annular ring 142 and / or the second lever 141 relative to the housing 110, as can be seen by comparing FIGS. 5 and 6 . In the second configuration, the second plurality of arms 144 defines a second size of the second central opening 146 that is smaller than the first size. 5 and 6 , each of the second plurality of arms 144 may engage with at least one other arm of the second plurality of arms 144 when the second plurality of arms 144 shifts from the first configuration to the second configuration. In some embodiments, an intermediate portion of each of the second plurality of arms 144 may engage with an intermediate portion of at least one other arm of the second plurality of arms 144 when the second plurality of arms 144 shifts from the first configuration to the second configuration to define the second central opening 146. In some embodiments, an intermediate portion of each of the second plurality of arms 144 may engage with an intermediate portion of a circumferentially and / or immediately adjacent arm of the second plurality of arms 144 when the second plurality of arms 144 shifts from the first configuration to the second configuration to define the second central opening 146.

[0062] As can be inferred from FIG. 6 , in the second configuration of the second aperture 140 and / or the second plurality of arms 144, the second side of the second lever 141 engages and / or contacts the side of the second stop element of the protrusion 131, thereby preventing counterclockwise rotation of the second lever 141 relative to the housing 110 (without deflecting either the protrusion 131 or the second lever 141 away from the other), thereby locking the second aperture 140 and / or the second plurality of arms 144 in the second configuration.

[0063] 6, the first aperture 120, the first lever 121, and / or the first plurality of arms 124 can move, shift, and / or actuate independently of the second aperture 140, the second lever 141, and / or the second plurality of arms 144. Thus, at some time and / or under some circumstances, the first central opening 126 can be a first size while the second central opening 146 is a second size, or vice versa.

[0064] 7 , the first lever 121 of the first aperture 120 and the second lever 141 of the second aperture 140 are both rotated clockwise relative to the housing 110, shifting the first aperture 120 and / or the first plurality of arms 124 and the second aperture 140 and / or the second plurality of arms 144 to the second configuration. The first stop element 136 and the second stop element of the spacer plate 130 may function to prevent counterclockwise rotation of the first lever 121 and the second lever 141, respectively, to lock the first aperture 120 and / or the first plurality of arms 124 and the second aperture 140 and / or the second plurality of arms 144, respectively, in the second configuration.

[0065] Referring again to Figures 5 and 7, the movement and / or motion of the first plurality of arms 124 can be seen. As discussed herein, in Figure 5, the first plurality of arms 124 are in a first configuration. Clockwise rotation of the first lever 121 and / or the first annular ring 122 causes the end of each of the first plurality of arms 124 and / or the first living hinge 123 to shift in a clockwise direction as well. The second end of each of the first plurality of arms 124 is held in a fixed position relative to the housing 110 by the fastener 160 and / or the protrusion 162, so that when the first lever 121 and / or the first annular ring 122 is rotated, it pivots about the fastener 160 and / or the protrusion 162. The first living hinge 123 and the second living hinge 125 of each of the first plurality of arms 124 may bend, deflect, and / or curve resiliently to facilitate pivotal movement of the first plurality of arms 124. When the first lever 121 and / or the first annular ring 122 rotates clockwise, each of the first plurality of arms 124 is prevented from rotating equally and / or uniformly about the central axis of the first central opening 126 by having their second ends fixed in place by fasteners 160 and / or protrusions 162. The lengths of various portions of each of the first plurality of arms 124 remain fixed and / or constant, and the first living hinge 123 and the second living hinge 125 cooperate with the various portions of each arm to form a linkage connecting the second ends to the first annular ring 122. The first living hinge 123 and the second living hinge 125 of each of the first plurality of arms 124 may each form a hinge or pivot point within each of the first plurality of arms 124 .

[0066] Due to size (e.g., width, thickness), bulk, and / or stiffness, the portion of each arm connecting the second end of each arm to the intermediate portion 129 of each of the first plurality of arms 124 remains substantially straight. As can be seen by comparing FIGS. 5 and 7 , clockwise rotation of the first lever 121 and / or the first annular ring 122 can cause the intermediate portion 129 to shift radially inward relative to the first annular ring 122, thereby changing the size of the first central opening 126 defined by the first plurality of arms 124. In the first configuration shown in FIG. 5 , the portion of each of the first plurality of arms 124 connected to the first annular ring 122 by the first living hinge 123 and / or extending between the first living hinge 123 and the second living hinge 125 can be oriented at an oblique angle relative to the first annular ring 122. As the first lever 121 and / or the first annular ring 122 rotate clockwise toward the second configuration, the portions of each of the first plurality of arms 124 connected to the first annular ring 122 by the first living hinge 123 and / or extending between the first living hinge 123 and the second living hinge 125 may shift toward an angle normal or near perpendicular to the first annular ring 122, as seen in FIG. 7 .

[0067] While not clearly visible in FIGS. 5 and 6 , it can be understood that the movement and / or motion of second plurality of arms 144 is similar or substantially the same as the movement and / or motion of first plurality of arms 124. Using a living hinge to shift the constriction and / or arms from a first configuration to a second configuration (and vice versa) can reduce the complexity and part count of conventional stent crimping devices. Accordingly, the cost of such devices can also be reduced. Additionally, in some embodiments, device 100 can enable a stent to be loaded into a sheath without multiple movements or advancements of the stent through device 100, thereby reducing the number of steps required to cover the stent, reducing or eliminating multiple crimping steps, and / or reducing the chance of damaging the stent. In some embodiments, device 100 can be reusable after appropriate sterilization. In some embodiments, device 100 can be disposable and / or classified or used as a single-use device.

[0068] It is also envisioned that device 100 may include additional restriction(s), additional intervening spacer plates, etc. to accommodate (in the first configuration and / or the compressed configuration) stents having longer lengths and / or varying outer diameters. For example, in some embodiments, the second size of first central opening 126 may be the same as the second size of second central opening 146, and the additional central opening(s) of the additional restriction(s) may have a second size that is the same as the second size of first central opening 126 and / or second central opening 146. In some embodiments, the second size of the first central opening 126 may be different from the second size of the second central opening 146, and the additional central opening of the additional aperture may have a second size that is the same as the second size of the first central opening 126 and the second central opening 146, may have a second size that is the same as the second size of one of the first central opening 126 and the second central opening 146, or may have a second size that is different from the second size of the first central opening 126 and the second central opening 146. Other configurations are also contemplated.

[0069] In some embodiments, the first restriction 120 and / or an intermediate portion of the first plurality of arms 124, the second restriction 140 and / or an intermediate portion of the second plurality of arms 144, and / or an additional restriction and / or an intermediate portion of the plurality of arms of the additional restriction may be axially shaped or tapered to accommodate a stent having an outer surface that is axially curved or tapered.

[0070] In some embodiments, the first restriction 120 can have a first axial thickness and the second restriction 140 can have a second axial thickness. In some embodiments, the first axial thickness can be equal to the second axial thickness. In some embodiments, the first axial thickness can be different from the second axial thickness. In some embodiments, the first axial thickness can be less than the second axial thickness. In some embodiments, the first axial thickness can be greater than the second axial thickness. In some embodiments, the additional restrictions can each have an axial thickness. The axial thickness of any additional restrictions can be equal to, greater than, or less than the first axial thickness and / or the second axial thickness, as desired, to accommodate stents having different sizes, different lengths, and / or different radial compression requirements along their lengths.

[0071] 8-12 are cross-sectional views of device 100 illustrating selected aspects of a method for radially compressing a stent. Device 100 may include elements and / or features generally described herein. To improve clarity and understanding, some elements or features of device 100 are not shown or are not shown in their entirety.

[0072] 8 shows a cross-sectional view of an apparatus 100 for radially compressing a stent as described herein. The apparatus 100 can include a housing 110 defining a central opening 112. In some embodiments, at least a portion of the central opening 112 can have an inner diameter that tapers radially outward in an axial direction. In some embodiments, the central opening 112 can have a substantially constant inner diameter. In some embodiments, the central opening 112 can have an inner diameter that is generally constant along a portion of its axial length and tapered along different portions of its axial length. Other configurations are also contemplated.

[0073] The apparatus 100 may include a first aperture 120 including a first plurality of arms 124 (e.g., FIG. 3 ) that define a first central opening 126. The first central opening 126 may have a first size in a first configuration of the first plurality of arms 124 and a second size in a second configuration of the first plurality of arms 124. The apparatus 100 may include a spacer plate 130 that includes and / or defines a central opening 132. In at least some embodiments, the central opening 132 may have a generally fixed size. The apparatus 100 may include a second aperture 140 including a second plurality of arms 144 (e.g., FIG. 3 ) that define a second central opening 146. The second central opening 146 may have a first size in a first configuration of the second plurality of arms 144 and a second size in a second configuration of the second plurality of arms 144.

[0074] A method of radially compressing a stent may include inserting stent 200 in a first configuration into first central opening 126 of first restriction 120, as seen in FIG. 9 . In some embodiments, stent 200 may be in an expanded configuration in the first configuration. In some embodiments, stent 200 may be in a partially collapsed state in the first configuration. For example, in some embodiments, device 100 may include a loading funnel (not shown) configured to partially collapse stent 200 as stent 200 is inserted into first central opening 126 of first restriction 120 and / or central opening 112 of housing 110. In some embodiments, the loading funnel may be configured to be releasably attached to housing 110. For example, in the view shown in FIG. 9 , the loading funnel may be configured to be inserted into housing 110 from the right side of the view until at least a portion of the loading funnel is positioned adjacent to and / or engaged with housing 110 so as to be proximate central opening 112. In some embodiments, the method may include inserting the stent 200 into and / or through the central opening 112 of the housing 110 before inserting the stent 200 in a first configuration into the first central opening 126 of the first aperture 120.

[0075] In some embodiments, the method can include inserting the stent 200 in a first configuration into a second central opening 146 of a second aperture 140 that is axially offset from the first aperture 120. In some embodiments including a second aperture 140, the method can include inserting the stent 200 in the first configuration into a central opening 132 of a spacer plate 130. Also, although not explicitly shown, the method can include inserting the stent 200 into a cover plate opening 156 of a cover plate 150 (e.g., FIG. 3 ).

[0076] Stent 200 includes an expandable framework defining a central lumen that, in some embodiments, may be substantially cylindrical. In some embodiments, the expandable framework may have a substantially circular cross-section. In some embodiments, the expandable structure may have a non-circular cross-section (e.g., D-shaped, oval, etc.). In some embodiments, the non-circular expandable structure may be used to repair a mitral valve or another non-circular valve within a patient's heart or body. Some suitable, but non-limiting, examples of materials that may be used to form the expandable structure are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, and the like.

[0077] The stent 200 and / or the expandable structure can be configured to shift from a collapsed configuration to an expanded configuration. In some embodiments, the expandable structure can be self-expanding. In some embodiments, the expandable structure can be self-biased toward the expanded configuration. In some embodiments, the expandable structure can be mechanically expandable. In some embodiments, the expandable structure can be balloon expandable. Other configurations are also contemplated.

[0078] In some embodiments, the stent 200 may be part of a replacement heart valve implant. It may be understood that the replacement heart valve implant may be any type of heart valve (e.g., mitral valve, aortic valve, etc.). The replacement heart valve implant may be configured to allow unidirectional flow through the replacement heart valve implant from the inflow end to the outflow end. In some embodiments of the replacement heart valve implant, the stent 200 and / or the expandable structure may define a lower crown proximate the inflow end of the replacement heart valve implant, an upper crown proximate the outflow end of the replacement heart valve implant, and a plurality of stabilizing arches extending downstream from the outflow end.

[0079] In some embodiments, the replacement heart valve implant may include multiple valve leaflets disposed within a central lumen. The multiple leaflets may be coupled, fixed, and / or fixedly attached to the stent 200 and / or the expandable structure. In some embodiments, the multiple leaflets may be integrally formed with one another such that the multiple leaflets are formed as a single structure and / or monolithic unit. In some embodiments, the multiple leaflets may be integrally formed with other structures, such as inner and / or outer skirts, base structures, liners, etc. The multiple leaflets may be configured to substantially restrict fluid flow through the replacement heart valve implant in the closed position. For example, in some embodiments, the free edges of the multiple leaflets may move to coapt with one another in the closed position to substantially restrict fluid flow through the replacement heart valve implant. The free edges of the multiple leaflets may move away from one another in the open position to allow fluid flow through the replacement heart valve implant.

[0080] In some embodiments, the replacement heart valve implant can include an inner skirt. The inner skirt can be disposed on and / or extend along the inner surface of the stent 200 and / or the expandable structure. In at least some embodiments, the inner skirt can be fixedly attached to the stent 200 and / or the expandable structure. The inner skirt can direct fluid, such as blood, flowing through the replacement heart valve implant toward the leaflets. In at least some embodiments, the inner skirt can be fixedly attached to and / or integrally formed with the leaflets. The inner skirt can ensure that fluid flows through the central lumen and prevents fluid from flowing around the leaflets when they are in the closed position.

[0081] In some embodiments, the replacement heart valve implant can include an outer skirt. In some embodiments, the outer skirt can be disposed on and / or extend along the outer surface of the stent 200 and / or expandable structure. In some embodiments, the outer skirt can be disposed between the stent 200 and / or expandable structure and the native tissue to prevent fluids, such as blood, from flowing downstream around the stent 200 and / or expandable structure, ensuring that the leaflets can stop fluid flow when they are in a closed position.

[0082] In some embodiments, the leaflets may be constructed of a polymer, such as a thermoplastic polymer. In some embodiments, the leaflets may comprise at least 50 weight percent polymer. In some embodiments, the leaflets may be formed from bovine pericardium or other living tissue. Other configurations and / or materials are also contemplated.

[0083] In some embodiments, the inner skirt and / or outer skirt may comprise a polymer, such as a thermoplastic polymer. In some embodiments, the inner skirt and / or outer skirt may comprise at least 50 weight percent polymer. In some embodiments, one or more of the leaflets, the inner skirt, and / or the outer skirt may be formed from the same polymer or polymers. In some embodiments, the polymer may be polyurethane. In some embodiments, the inner skirt and / or outer skirt may be substantially impermeable to fluids. In some embodiments, the inner skirt and / or outer skirt may be formed from thin tissue (e.g., bovine pericardium, etc.). In some embodiments, the inner skirt and / or outer skirt may be formed from a coated textile material. In some embodiments, the inner skirt and / or outer skirt may be formed from a nonporous and / or impermeable textile material. Other configurations are also contemplated. Some suitable, but non-limiting, examples of materials that may be used to form the inner skirt and / or outer skirt, including, but not limited to, polymers, composites, etc., are described below.

[0084] In some embodiments, the stent 200 and / or replacement heart valve implant can have an outer extent in an unconstrained configuration (e.g., expanded configuration) of about 23 millimeters (mm), about 25 mm, about 27 mm, about 30 mm, etc. In some embodiments, the stent 200 and / or replacement heart valve implant can have an outer extent in a collapsed configuration of about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, etc. Other configurations are also contemplated.

[0085] The method may include rotating the first annular ring 122 of the first iris 120 relative to the housing 110 disposed about the first annular ring 122 to shift the first plurality of arms 124 from a first configuration to a second configuration, as seen in FIG. 10 , wherein the first central opening 126 has a first size in the first configuration (e.g., FIG. 9 ) and a second size smaller than the first size in the second configuration (e.g., FIG. 10 ). In some embodiments, the method may include rotating the first annular ring 122 of the first iris 120 clockwise relative to the housing 110 disposed about the first annular ring 122 to shift the first plurality of arms 124 from the first configuration to the second configuration. In the second configuration of the first plurality of arms 124, the first iris 120 and / or a first portion of the stent 200 disposed within the first central opening 126 may have a radially compressed configuration. In some embodiments, the method can include rotating the second annular ring 142 of the second aperture 140 relative to the housing 110 to shift the second plurality of arms 144 from a first configuration to a second configuration, wherein the second central opening 146 has a first size in the first configuration (e.g., FIG. 9 ) and a second size smaller than the first size in the second configuration (e.g., FIG. 10 ). In some embodiments, the method can include rotating the second annular ring 142 of the second aperture 140 clockwise relative to the housing 110 to shift the second plurality of arms 144 from the first configuration to the second configuration. In the second configuration of the second plurality of arms 144, the second aperture 140 and / or a second portion of the stent 200 disposed within the second central opening 146 can have a radially compressed configuration.

[0086] 10 , the method may include positioning the sheath 300 adjacent to the first aperture 120 with the first plurality of arms 124 in the second configuration and with a first portion of the stent 200 disposed within the first aperture 120 and / or the first central opening 126 in a radially compressed configuration. After positioning the sheath 300 adjacent to the first aperture 120, the method may include rotating the first annular ring 122 of the first aperture 120 relative to the housing 110 to shift the first plurality of arms 124 from the second configuration to the first configuration. In some embodiments, the method may include rotating the first annular ring 122 of the first aperture 120 counterclockwise relative to the housing 110 to shift the first plurality of arms 124 from the second configuration to the first configuration. The method may further include moving the sheath 300 over the stent 200 in the compressed configuration and into the first restriction 120 such that a first portion of the stent 200 disposed within the first restriction 120 is disposed within the lumen of the sheath 300, as seen in FIG. 11 . In some embodiments, the sheath 300 has an inner diameter that is smaller than the outer diameter of the stent 200 in the first configuration. Thus, in order to move the stent 200 into the lumen of the sheath 300, the stent 200 must be radially compressed.

[0087] In some embodiments, after moving the sheath 300 over the stent 200 and into the first restriction 120, the method may further include rotating the second annular ring 142 of the second restriction 140 relative to the housing 110 to shift the second plurality of arms 144 of the second restriction 140 from the second configuration to the first configuration. In some embodiments, the method may include rotating the second annular ring 142 of the second restriction 140 counterclockwise relative to the housing 110 to shift the second plurality of arms 144 of the second restriction 140 from the second configuration to the first configuration. The method may further include moving the sheath 300 over the stent 200 in the compressed configuration and into the second restriction 140 such that a second portion of the stent 200 disposed within the second restriction 140 is disposed within the lumen of the sheath 300, as seen in FIG. 12 .

[0088] In some embodiments, if the device 100 includes additional apertures, the above process of moving the sheath 300 into the first aperture 120 and the second aperture 140 may be repeated as appropriate to move the sheath 300 over additional portions of the stent 200 disposed within those apertures.

[0089] In some embodiments, if an additional length of stent 200 needs to be moved into sheath 300, stent 200 can be advanced through central opening 112 of housing 110, and first aperture 120 and second aperture 140 can be shifted again from the first configuration to the second configuration, and the process can be repeated.

[0090] In some embodiments, after sheath 300 is moved over stent 200 into second iris 140 so that the second portion of stent 200 disposed within second iris 140 is disposed within the lumen of sheath 300, sheath 300 and the first and second portions of stent 200 disposed within the first and second irises, respectively, may be advanced through central opening 112 of housing 110, and a separate sheath may be translated toward sheath 300 over the uncovered portion of stent 200 that remains outside of sheath 300 to cover at least a portion of the uncovered portion. Other configurations are also contemplated.

[0091] 13 shows an alternative configuration of an apparatus 400 for radially compressing a stent. The apparatus 400 can include a housing 410 including a central opening (not shown). In some embodiments, the apparatus 400 can include a first restriction 420 located adjacent to the housing 410. In at least some embodiments, the first restriction 420 can be located at least partially within the housing 410. In some embodiments, the apparatus 400 can include a cover plate (not shown) located adjacent to the housing 410. In some embodiments, the cover plate can be located at least partially within the housing 410.

[0092] In some embodiments, the cover plate may be removably secured to the housing 410. In some embodiments, the cover plate may be non-rotatable relative to the housing 410. In one example, the cover plate may be removably secured to the housing 410 using one or more fasteners. In another example, the cover plate and / or one or more protrusions extending from the cover plate may be configured to engage with one or more slots or other features formed in the housing 410 to removably secure the cover plate to the housing 410. Other configurations are also contemplated.

[0093] In some embodiments, first aperture 420 may be movable relative to housing 410 and / or the cover plate. In some embodiments, at least a portion of first aperture 420 may be configured to rotate relative to housing 410 and / or the cover plate.

[0094] In some embodiments, the apparatus 400 may include a fastener engaged with the housing 410. In some embodiments, the fastener may be removable from and / or configured to disengage from the housing 410. The fastener may be configured to engage the first aperture 420 and / or the cover plate. In some embodiments, the apparatus 400 may include multiple fasteners engaged with the housing 410. In some embodiments, the multiple fasteners may be removable from and / or configured to disengage from the housing 410. Other configurations are also contemplated.

[0095] In some embodiments, the device 400 may include a protrusion extending from the housing 410. In some embodiments, the protrusion may be fixedly attached to the housing 410. In some embodiments, the protrusion may be removable from and / or configured to disengage from the housing 410. The protrusion may be configured to engage the first aperture 120 and / or the cover plate. In some embodiments, the device 400 may include multiple protrusions extending from the housing 410. In some embodiments, the multiple protrusions may be fixedly attached to the housing 410. In some embodiments, the multiple protrusions may be removable from and / or configured to disengage from the housing 410. Other configurations are also contemplated.

[0096] In some embodiments, the cover plate may include a cover plate opening. The cover plate opening may be aligned with and / or coaxial with a central opening in the housing 410. In some embodiments, the cover plate may include multiple openings extending along the periphery of the cover plate. The multiple openings may be configured to receive fasteners therein for removably securing and / or attaching the cover plate to the housing 410. The housing 410 may include multiple corresponding holes or recesses that align with the multiple openings in the cover plate and are configured to receive the fasteners. In one example, the multiple fasteners may be externally threaded screws or other threaded fasteners, and the multiple corresponding holes or recesses may include internal threads configured to threadably engage the externally threaded screws or other threaded fasteners. Other configurations and / or fastener types are also contemplated. Some suitable, but non-limiting, examples of materials that may be used for the housing 410 and / or cover plate are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, and the like.

[0097] In some embodiments, the first aperture 420 may include a first annular ring 422 that is coaxial with the central opening of the housing 410. In some embodiments, the first annular ring 422 may be located adjacent to the housing 410. In some embodiments, the first annular ring 422 may be located at least partially within the housing 410. In some embodiments, the first aperture 420 and / or the first annular ring 422 may have a substantially circular outer periphery.

[0098] The first aperture 420 may include a first plurality of arms 424 extending radially inward from the first annular ring 422. The first plurality of arms 424 may define a first central opening 426 of the first aperture 420. The first central opening 426 may be aligned with and / or coaxial with the central opening of the housing 410. A first end of each of the first plurality of arms 424 may be connected to the first annular ring 422 by a first living hinge 423 disposed between the first end and the first annular ring 422. In some embodiments, the first end of each of the first plurality of arms 424 may be directly connected to the first annular ring 422 by the first living hinge 423. In some embodiments, the first end of each of the first plurality of arms 424 may be fixedly attached to the first annular ring 422 by the first living hinge 423. In some embodiments, the second end of each of the first plurality of arms 424 may be fixed relative to the housing 410. In some embodiments, the second end of each of the first plurality of arms 424 may include an opening formed therein. In some embodiments, a fastener engages with the housing 410 through the opening. In some embodiments, the opening may be configured to engage with a protrusion extending from the housing 410. In at least some embodiments, the second end of each of the first plurality of arms 424 may be configured to rotate around the fastener and / or the protrusion when the first annular ring 422 rotates relative to the housing 410.

[0099] In some embodiments, the intermediate portion 429 of each of the first plurality of arms 424 can be configured to engage with the intermediate portion of a circumferentially adjacent one of the first plurality of arms 424 to define the first central opening 426. The intermediate portion 429 of each of the first plurality of arms 424 can include a second living hinge 425. In some embodiments, the first plurality of arms 424 can be integrally and / or monolithically formed with the first annular ring 422 from a single piece of material. In at least some embodiments, the first living hinge 423 and the second living hinge 425 of each of the first plurality of arms 424 can be configured to resiliently bend, deflect, and / or curve to allow relative movement between the portions of the arms on either side of the first living hinge 423 and / or second living hinge 425. In a preferred configuration, the first aperture 420 can be made from a polymeric material. Some suitable, but non-limiting, examples of materials that may be used to form the first aperture 420, the first annular ring 422, the first plurality of arms 424, etc. are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc.

[0100] In some embodiments, first iris 420 may be manufactured using one or more of a variety of methods. In some embodiments, first iris 420 may be machined. In some embodiments, first iris 420 may be cut using a water jet. In some embodiments, first iris 420 may be laser cut. In some embodiments, first iris 420 may be injection molded. In some embodiments, first iris 420 may be cast. Other manufacturing methods are also contemplated.

[0101] In some embodiments, the first aperture 420 may include a first lever 421 fixedly attached to and / or extending radially outward from the first annular ring 422. In some embodiments, the first lever 421 may extend radially outward from a substantially circular outer periphery of the first aperture 420 and / or the first annular ring 422. The first lever 421 may extend radially outward along a first radius that extends outward from the center of the first central opening 426.

[0102] In some embodiments, first lever 421 can be configured to shift first aperture 420 and / or first plurality of arms 424 between a first configuration and a second configuration. In at least some embodiments, the first configuration of first aperture 420 and / or first plurality of arms 424 can be an open configuration or a radially expanded configuration. In the first configuration of first aperture 420 and / or first plurality of arms 424, first plurality of arms 424 and / or an intermediate portion 429 of each of first plurality of arms 424 can define a first size of first central opening 426.

[0103] The first lever 421 may extend radially outward from the first annular ring 422 through a side opening in the housing 410. The first lever 421 may be movable and / or rotatable relative to the housing 410 within the side opening in the housing 410.

[0104] Rotation of the first annular ring 422 of the first aperture 420 relative to the housing 410 can change the size of the first central opening 426. In at least some embodiments, the first plurality of arms 424 can be configured to shift between a first configuration and a second configuration by rotation of the first annular ring 422 relative to the housing 410. In some embodiments, rotation of the first annular ring 422 relative to the housing 410 can be achieved by shifting and / or rotating the first lever 421 relative to the housing 410. In some embodiments, the first plurality of arms 424 can be configured to shift between the first configuration and the second configuration by clockwise rotation of the first annular ring 422 and / or the first lever 421 relative to the housing 410. In the second configuration, the first plurality of arms 424 defines a second size of the first central opening 426 that is smaller than the first size. Each of the first plurality of arms 424 may engage with at least one other arm of the first plurality of arms 424 when the first plurality of arms 424 shifts from the first configuration to the second configuration. In some embodiments, the intermediate portion 429 of each of the first plurality of arms 424 may engage with the intermediate portion 429 of at least one other arm of the first plurality of arms 424 when the first plurality of arms 424 shifts from the first configuration to the second configuration to define the first central opening 426. In some embodiments, the intermediate portion 429 of each of the first plurality of arms 424 may engage with the intermediate portion of a circumferentially and / or immediately adjacent arm of the first plurality of arms 424 when the first plurality of arms 424 shifts from the first configuration to the second configuration to define the first central opening 426.

[0105] 13, the first lever 421 is positioned in an intermediate position within the side opening of the housing 410. Thus, in the position shown in FIG. 13, the first aperture 420 and / or the first plurality of arms 424 are positioned between the first configuration and the second configuration.

[0106] As described herein, clockwise rotation of the first lever 421 and / or first annular ring 422 causes the end of each of the first plurality of arms 424 and / or the first living hinge 423 to similarly shift in a clockwise direction. The second end of each of the first plurality of arms 424 is held in a fixed position relative to the housing 410 by a fastener and / or protrusion, so that it pivots about the fastener and / or protrusion when the first lever 421 and / or first annular ring 422 is rotated. The first living hinge 423 and second living hinge 425 of each of the first plurality of arms 424 may bend, deflect, and / or curve resiliently to facilitate the pivoting movement of the first plurality of arms 424. As the first lever 421 and / or first annular ring 422 rotate clockwise, each of the first plurality of arms 424 is prevented from rotating equally and / or uniformly about the central axis of the first central opening 426 by having their second ends fixed in place by fasteners and / or protrusions. The lengths of the various portions of each of the first plurality of arms 424 remain fixed and / or constant, and the first living hinge 423 and the second living hinge 425 cooperate with the various portions of each arm to form a linkage connecting the second end to the first annular ring 422. The first living hinge 423 and the second living hinge 425 of each of the first plurality of arms 424 may each form a hinge or pivot point within each of the first plurality of arms 424.

[0107] Due to size (e.g., width, thickness), bulk, and / or stiffness, the portion of each arm connecting the second end of each arm to the intermediate portion 429 of each of the first plurality of arms 424 remains substantially straight. In at least one configuration of device 400, first aperture 420 may have a substantial thickness sufficient and adapted to radially compress a stent, such as, but not limited to, a self-expanding stent, a balloon-expandable stent, a self-expanding replacement heart valve implant, or a balloon-expandable replacement heart valve implant, in a single step and / or motion. As the thickness of first aperture 420 increases, the width and / or thickness of first living hinge 423 and / or second living hinge 425 may be varied so that first aperture 420 can function easily and smoothly without requiring the application of excessive force to first lever 421.

[0108] Rotation of the first lever 421 and / or the first annular ring 422 clockwise can change the size of the first central opening 426 defined by the first plurality of arms 424 by shifting the intermediate portion 429 radially inward relative to the first annular ring 422. For example, the portion of each of the first plurality of arms 424 connected to the first annular ring 422 by the first living hinge 423 and / or extending between the first living hinge 423 and the second living hinge 425 can be oriented at an oblique angle relative to the first annular ring 422. As the first lever 421 and / or the first annular ring 422 rotate clockwise toward the second configuration, the portions of each of the first plurality of arms 424 connected to the first annular ring 422 by the first living hinge 423 and / or extending between the first living hinge 423 and the second living hinge 425 may shift toward an angle close to normal or perpendicular to the first annular ring 422.

[0109] The use of a living hinge to shift first restriction 420 and / or first plurality of arms 424 from a first configuration to a second configuration (and vice versa) can reduce the complexity and part count of conventional stent crimping devices. Accordingly, the cost of such devices can also be reduced. Additionally, in some embodiments, device 400 can allow a stent to be loaded into a sheath without multiple movements or advancements of the stent through device 400, thereby reducing the number of steps required to cover the stent, reducing or eliminating multiple crimping steps, and / or reducing the chance of damage to the stent. In some embodiments, device 400 can be reusable after appropriate sterilization. In some embodiments, device 400 can be disposable and / or classified or used as a single-use device.

[0110] The various components of the devices disclosed herein and materials usable for the various elements of those components may include those generally associated with medical devices, as well as those associated with devices used with and / or associated with medical devices. For ease of explanation, reference will be made below to systems. However, this is not intended to limit the devices and methods described herein, and this description may also be applicable to other elements, members, components, or devices disclosed herein, such as, but not limited to, stents, expandable structures, first and / or second plurality of arms, annular rings, housings, and / or elements or components thereof.

[0111] In some embodiments, the system and / or its components may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials.

[0112] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf Atochem® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex® high density polyethylene, Marlex® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS American GrillonThe sheath may include any suitable material, including but not limited to, GRILAMID® available from Grilon, Inc., perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyisobutylene (PIB), polyisobutylene polyurethane (PIBU), polyurethane silicone copolymer (e.g., Elast-Eon® from AorTech Biomaterials or ChronoSil® from AdvanSource Biomaterials), ionomer, biocompatible polymer, other suitable material, blends, combinations, copolymers thereof, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0113] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic nitinol, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, HASTELLOY® C276 (e.g., UNS:N10276 such as HASTELLOY® alloys, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY® alloys, B2®, UNS:N10665), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®), platinum-rich stainless steel, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material.

[0114] It should be understood that the present disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly with respect to shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This includes, to the extent appropriate, using any feature of one illustrative embodiment in other embodiments. The scope of the present disclosure is, of course, defined in the language of the claims.

Claims

1. 1. A device for radially compressing a stent, comprising: a housing including a central opening; a plurality of protrusions extending from the housing; a first restriction located adjacent to the housing; the first restriction includes a first annular ring coaxially positioned with respect to the central opening and a first plurality of arms extending radially inward from the first annular ring; the first plurality of arms define a first central opening coaxially positioned relative to the central opening of the housing; a first end of each of the first plurality of arms connected to the first annular ring by a first living hinge disposed between the first end and the first annular ring; a second end of each of the first plurality of arms including an opening formed therein and configured to receive a corresponding one of the plurality of protrusions to secure the second end to the housing; an intermediate portion of each of the first plurality of arms configured to engage an intermediate portion of a circumferentially adjacent one of the first plurality of arms to define the first central opening, and the intermediate portion of each of the first plurality of arms includes a second living hinge; The device wherein rotation of the first annular ring relative to the housing changes the size of the first central opening.

2. 10. The apparatus of claim 1, wherein the first plurality of arms are monolithically formed with the first annular ring from a single piece of material.

3. 3. The apparatus of claim 1 or 2, wherein the first plurality of arms are configured to shift between a first configuration and a second configuration by rotation of the first annular ring relative to the housing.

4. further comprising a second restriction axially offset from the first restriction; the second restriction includes a second annular ring positioned coaxially with respect to the central opening of the housing and a second plurality of arms extending radially inward from the second annular ring; the second plurality of arms define a second central opening coaxially positioned relative to the central opening of the housing; 4. The apparatus of claim 3, wherein the second plurality of arms are configured to shift between a first configuration and a second configuration by rotation of the second annular ring relative to the housing.

5. 1. A method of radially compressing a stent, comprising: inserting a stent in a first configuration into a first aperture and into a second aperture axially offset from the first aperture, the first aperture including a first annular ring and a first plurality of arms extending radially inward from the first annular ring and defining a first central opening, and the second aperture including a second annular ring and a second plurality of arms extending radially inward from the second annular ring and defining a second central opening; shifting the first plurality of arms from a first configuration to a second configuration by rotating the first annular ring relative to a housing disposed about the first annular ring, wherein the first central opening has a first size in the first configuration and a second size smaller than the first size in the second configuration, and wherein in the second configuration of the first plurality of arms a first portion of the stent disposed within the first restriction has a radially compressed configuration; shifting the second plurality of arms from a first configuration to a second configuration by rotating the second annular ring relative to the housing, wherein the second central opening has a first size in the first configuration and a second size smaller than the first size in the second configuration, and wherein in the second configuration of the second plurality of arms a second portion of the stent disposed within the second restriction has a radially compressed configuration; positioning a sheath adjacent to the first restriction with the first plurality of arms in the second configuration and the first portion of the stent disposed within the first restriction in the radially compressed configuration; shifting the first plurality of arms from the second configuration to the first configuration by rotating the first annular ring relative to the housing; moving the sheath over the stent and into the first iris such that the first portion of the stent disposed within the first iris is disposed within the sheath; shifting the second plurality of arms from the second configuration to the first configuration by rotating the second annular ring relative to the housing; and moving the sheath over the stent and into the second iris such that the second portion of the stent disposed within the second iris is disposed within the sheath; A method for providing

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