Folding method

Abstract

Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, the valve is crimped on an inflatable balloon and between a proximal shoulder and a distal shoulder mounted on a shaft within the balloon. The crimping method can include a plurality of compression steps, with the valve being in a different axial position relative to the crimping jaws at each different step. In some methods, the valve can be partially extended out of the crimping jaws during certain crimping steps, such that crimping force is only applied to the portion of the valve that is inside the jaws. An exemplary crimping device can include two or more adjacent sets of jaws that close to different inner diameters, such that different portions of the valve are simultaneously compressed to different outer diameters during a single crimping step.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 041,050, filed June 18, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present application relates to crimping devices and methods for prosthetic heart valves, stents, and the like. Background Art

[0004] Cropping a prosthetic heart valve onto a catheter-based delivery system is typically accomplished using a crimping device having a set of jaws that, when closed, form a single, continuous surface that compresses the valve uniformly along its length to a smaller diameter. Typically, the entire valve is positioned within the jaws when they are closed, which applies the crimping force uniformly across the axial length of the valve and causes the entire valve to uniformly reduce to the same final crimped diameter at the same rate. Summary of the Invention

[0005] Disclosed herein are new devices and methods for crimping a prosthetic heart valve onto a delivery device. In some embodiments, the valve is crimped onto an inflatable balloon and between a proximal shoulder and a distal shoulder on a shaft mounted inside the balloon. The crimping methods disclosed herein may include multiple compression steps, wherein the valve is at a different axial position relative to the crimping jaws in each different step. In some methods, the valve may be partially extended outside the crimping jaws during certain crimping steps so that the crimping force is applied only to the portion of the valve that is inside the jaws. Exemplary crimping devices disclosed herein may include two or more sets of side-by-side jaws that close to different inner diameters such that different portions of the valve are simultaneously compressed to different outer diameters during a single crimping step.

[0006] An exemplary method may include any combination of the following steps: inserting a prosthetic heart valve into a folding device in a radially expanded state so that the valve is positioned within the folding jaws of the folding device; positioning an inflatable balloon of a delivery device within the valve; positioning the valve and delivery device in a first axial position wherein at least a portion of the distal shoulders of the valve and delivery device are located between the proximal and distal ends of the inner jaw of the jaw, and wherein the entire proximal shoulder is located proximal to the proximal end of the outer jaw of the jaw; closing and opening the jaws with the valve and delivery device in the first axial position such that the valve is at least partially folded between the proximal and distal shoulders on the balloon; repositioning the valve and delivery device from the first axial position to a second axial position wherein the first distal portion and at least a portion of the distal shoulder of the valve are located within the jaw, and wherein the first proximal portion and the proximal shoulder of the valve are located proximal to the proximal end of the outer jaw of the jaw. proximal to the first proximal portion; closing and opening the jaws with the valve and delivery device in the second axial position; repositioning the valve and delivery device from the second axial position to a third axial position, wherein the second distal portion and at least a portion of the distal shoulder of the valve are within the jaws, and the second proximal portion and the proximal shoulder of the valve are proximal to the proximal end of the outer jaw of the jaws, wherein the second distal portion is axially shorter than the first distal portion and the second proximal portion is axially longer than the first proximal portion; closing and opening the jaws with the valve and delivery device in the third axial position; repositioning the valve and delivery device from the third axial position to a fourth axial position, wherein the entire valve and at least a portion of the proximal shoulder are within the jaws, and the entire distal shoulder is distal to the distal end of the outer jaw of the jaws; and closing and opening the jaws with the valve and delivery device in the fourth position.

[0007] An exemplary crimping device may include: a first jaw having an open position and a fully closed position, wherein the first jaw has a first inner diameter when in the fully closed position; and a second jaw having an open position and a fully closed position, wherein the second jaw has a second inner diameter when in the fully closed position, and wherein the second inner diameter is smaller than the first inner diameter. The first jaw and the second jaw may be axially side-by-side, and / or in contact with each other. The first jaw may have an axial dimension that is larger than the second jaw, such as at least two times larger or at least five times larger. The first inner diameter and the second inner diameter may be selected to correspond to a desired outer diameter of a prosthetic heart valve to be crimped by the device. The first jaw and the second jaw may be actuated simultaneously using a common actuator, such as a handle pulled by a user.

[0008] The above and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1A An exemplary prosthetic heart valve is shown in a radially expanded state.

[0010] Figure 1B Shown in radial compression Figure 1A valve.

[0011] Figure 2 is a cross-sectional view of the distal end of an exemplary delivery device including a valve mounted on an expandable balloon in a radially compressed state.

[0012] Figure 3 An exemplary creasing device is shown in an open position.

[0013] Figure 4 Shown in closed position Figure 3 Crepe device.

[0014] Figure 5 is a cross-sectional view of the creping device in an open position with a radially expanded valve and a delivery device in a first axial position within the creping jaws.

[0015] Figure 6 Shown in closed position Figure 5 The crimping jaws have radially compressed the valve onto the delivery device at a first axial position.

[0016] Figure 7 Shown in a second axial position Figure 5 A valve wherein a distal portion of the valve is in the jaws and a proximal portion of the valve is outside the jaws.

[0017] Figure 8 Shown in the third axial position Figure 5 A valve in which a shorter distal portion of the valve is in the jaws and a longer proximal portion of the valve is outside the jaws.

[0018] Figure 9 Shown in the fourth axial position Figure 5 A valve in which the entire valve is in the jaws and the distal shoulder of the delivery device is outside the jaws.

[0019] Figure 10 An exemplary creasing device is shown having two sets of creasing jaws that close to two different diameters.

[0020] Figure 11 is in closed position Figure 10 Cross-sectional view of the device.

[0021] Figure 12 yes Figure 10 Another cross-sectional view of the device.

[0022] Figure 13 yes Figure 10 Yet another cross-sectional view of the device. DETAILED DESCRIPTION

[0023] General considerations

[0024] It should be understood that the prosthetic heart valves described herein may be suitable for delivery and implantation into any native valve annulus of the heart (e.g., the aortic, pulmonary, mitral, and tricuspid anns) and may be used with any of a variety of delivery devices that deliver the prosthetic valve using any of a variety of delivery routes (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.). The folding devices disclosed herein may be used with any suitable type of prosthetic heart valve, including those described herein, and may be used with any of a variety of delivery devices that deliver the prosthetic valve using any of a variety of delivery routes.

[0025] For the purpose of this description, certain aspects, advantages and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus and systems should not be construed as being restrictive in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, both individually and in various combinations and sub-combinations with each other. The methods, apparatus and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages exist or problems be solved. The technology from any example may be combined with the technology described in any one or more other examples. Given that the principles of the disclosed technology are applicable to many possible embodiments, it should be recognized that the illustrative embodiments are merely preferred examples and should not be considered to limit the scope of the disclosed technology.

[0026] Although the operations of some disclosed embodiments are described in a specific sequential order for ease of presentation, it should be understood that this description encompasses reordering unless a specific order is required by specific language set forth below. For example, operations described sequentially may in some cases be reordered or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are highly abstract representations of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific embodiment and are readily discernible to those of ordinary skill in the art.

[0027] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "including" means "comprising." As used herein, "and / or" means "and" or "or," as well as "and" and "or." Furthermore, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected, and do not exclude the presence of intervening elements between coupled or associated items in the absence of specific language to the contrary.

[0028] Directional and other relative designations (e.g., inside, outside, up, down, etc.) may be used to facilitate the discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms such as "inside," "outside," "up," "down," "interior," "exterior," etc. may be used. Where applicable, such terms are used to provide a certain descriptive clarity when dealing with relative relationships, particularly with respect to example embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the "upper" portion can become the "lower" portion simply by turning the object over. However, it is still the same part, and the object remains the same.

[0029] The valves and frames disclosed herein are described using an axial direction defined by the centerline of the annular frame and the overall direction of blood flow from the inflow end to the outflow end, a radial direction defined as radiating perpendicularly from the centerline of the frame, and a circumferential direction perpendicular to the axial and radial directions and extending around the centerline of the frame. The crimping devices and crimping jaws disclosed herein are described using axial and radial directions defined by the axial and radial dimensions of the valve crimped by the device. The term "inner" refers to objects, surfaces, and areas that are close to the centerline of the frame or device, and the term "outer" refers to objects, surfaces, and areas that are farther from the centerline of the frame or device.

[0030] In view of the many possible implementations to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the technology and should not be taken as limiting the scope of the technology, which is at least as broad as the appended claims.

[0031] Examples of the disclosed technology

[0032] Sometimes it may be desirable to compress certain areas of a valve, stent, or similar device to a smaller diameter, such as to prevent apex snagging or forming a football-like shape and to facilitate catheter insertion. Some crimping devices disclosed herein include stacked, side-by-side jaw sets that can move independently or together to crimp the device to different diameters along its length. The use of stacked jaw sets capable of independent movement offers several advantages over current designs. Some embodiments can achieve a continuous, consistent jaw surface during part of the crimping process, which can be crucial for preventing damage to the frame due to snagging during axial expansion, while allowing the jaw segments to compress a region to a smaller diameter at the end of the process. This allows the user to do things like tuck in the apex to prevent snagging or form a football-like shape to facilitate insertion or device loading. Some crimping devices accomplish this without requiring the operator to perform any additional operations beyond the basic ones used in conventional crimping devices. As the handle is rotated, the crimping jaws can begin their movement together and end at different stop positions. These features can improve device performance without requiring a complex, multi-stage crimping procedure.

[0033] In addition to the new crimping device, a new method is described herein that can also be used to crimp the device in a more desirable manner using a conventional crimper having only one set of jaws. In conventional crimping methods, an expanded device is placed inside a crimping orifice, and uniform jaws compress the device uniformly to a compressed state, so that all portions of the device are radially compressed at the same rate and to the same diameter, and then the jaws are released. The resulting shape of the crimped device may not be uniform because some portions of the device may deform more than other portions or recoil more than other portions. Therefore, the final shape of the crimped device is inherent - based on the structure of the device (e.g., the amount of material inside the valve frame, the thickness of the frame, the outer skirt, etc.). However, this conventional method can result in the crimped device having undesirable shape properties, which can have harmful consequences for the patient. For example, portions of the device that extend outward excessively can get stuck on the sheath, vessel, or native valve area and can prevent the device from successfully advancing to the implantation site.

[0034] Some methods disclosed herein involve purposefully shaping the device through a multi-stage creping process, which can allow practitioners to achieve a more desirable creping profile to navigate the device through the anatomy to the implantation site. This shifts the shape of the creped device from being solely determined by the device design to being also controlled by the optimized manufacturing process. For example, this can reduce the likelihood of adverse events caused by the valve becoming stuck on the sheath, vessel, or annulus.

[0035] A desired folding profile is one in which the leading edge of the device is maximally protected. This protection can result from a combination of the diameter of the distal end of the delivery system relative to the diameter of the distal edge of the device being folded onto the delivery system. Targeted folding of certain portions of the device can help achieve this desired folding profile. For example, using a prosthetic heart valve as an exemplary device to be folded, targeted folding can be achieved by positioning only certain axial segments of the valve within the folding jaws, such that one axial segment is subjected to compressive force, while portions distal to and / or proximal to the jaws are not directly subjected to the folding force from the jaws. This can concentrate the folding force on only one axial segment of the valve, rather than distributing it evenly across the entire axial length of the valve. This can result in a smaller post-folding diameter for the targeted portion of the valve, such as the distal or leading edge of the valve. Folding the leading edge to a smaller diameter can help the leading edge be more protected by the distal portion of the delivery device, which can help the folded valve better pass through sheaths, vessels, etc. without becoming stuck.

[0036] Figure 1A An exemplary prosthetic heart valve 2 is shown that may be used in conjunction with the folding devices and folding methods disclosed herein. Valve 2 is but one example, and many other implantable devices may also be used, including stents, valves, frames, and any other radially compressible device. Such a device may include an annular frame, such as frame 4, which is radially compressible for mounting on a delivery device and thereafter radially expandable within the patient's body. Such frames may include self-expandable frames (e.g., made of a superelastic material) and balloon-expandable frames (e.g., made of cobalt-chromium alloy or stainless steel). The post-folding device may also include various other components, such as a leaflet structure 6, an inner skirt 8, and / or an outer skirt 10. Valve 2 may be configured to be positioned at the native aortic valve region of the heart, while other subject devices may be configured to be positioned at other cardiac locations or other parts of the body. In Figure 1A In the example shown, the outer skirt 10 is located at the blood inflow end of the valve 2, and the opposite end is the blood outflow end of the valve.

[0037] Figure 1A The valve 2 is shown in a radially expanded state, and Figure 1B The valve is shown in a radially compressed or creased state. In the creased state, the valve 2 has a smaller radial dimension (i.e., its outer diameter) and a longer axial dimension (i.e., its axial length). When in the creased state, some portions of the valve 2 may have slightly different outer diameters. For example, in some cases, the axial region including the outer skirt 10 may be slightly larger and have a larger outer diameter than other portions of the valve. However, using the techniques disclosed herein, the final creased state of the device can be better customized and controlled so that the outer diameter at different axial locations along the valve is not only a result of the device structure itself, but is also a result of the creased method used and / or the type of creased device used.

[0038] Figure 2 The distal portion of an exemplary delivery device is shown with the valve 2 folded thereon. Other delivery devices may also be used in conjunction with the technology disclosed herein. Figure 2 In the example of , the valve is folded onto the shaft 11 between the distal shoulder 14 and the proximal shoulder 16 on the inflatable balloon 12. The shoulders 14 and 16 can be positioned within the balloon 12 around the shaft 11. When the valve 2 is folded onto the delivery device, the shoulders 14, 16 can provide protection for the ends of the valve 2 to help prevent the ends of the valve from hooking on the catheter wall, vessel wall, or other structures when the valve is delivered. The shoulders can also help prevent the valve from migrating axially relative to the inner shaft 11. However, folding the ends of the valve (particularly the distal end of the valve adjacent the distal stop 14) to an outer diameter that is smaller than the rest of the valve can also help prevent the valve from hooking or migrating. When the valve 2 is delivered to the implantation site, the balloon 12 can be inflated to radially expand the valve and implant it in the aortic valve area (or other target location).

[0039] Figure 3 and Figure 4 An exemplary crimping device or crimper 20 for crimping a prosthetic heart valve onto a delivery device is illustrated. The crimper 20 includes an outer housing 22 and crimping jaws 24 having a central opening 26 and an actuation handle 28. The radially expanded valve is disposed in the opening 26 when the jaws 24 are open ( Figure 3 With the delivery device positioned within the expanded valve, handle 28 is actuated to close jaws 24 ( Figure 4 ) and crimp the valve onto the delivery device. Jaws 24 comprise several separate pieces that all move inward in unison to uniformly reduce the diameter of opening 26 and apply uniform crimping pressure around the valve. When handles 28 are released, the jaws open and the delivery device with the valve mounted thereon can be removed or repositioned for another round of crimping.

[0040] Figure 5-9 Exemplary creasing steps are illustrated. Various novel multi-stage creasing methods may include Figure 5-9 Any combination of the steps and / or other operations exemplified in the examples. For example, Figure 5-9 All the steps in may be performed sequentially. In some methods, Figure 7 steps, or may not include Figure 8 steps, or may not include Figure 9 In other examples, in addition to or instead of Figure 5-9 In the steps shown in , an additional creping step is performed.

[0041] exist Figure 5-9 In the figure, the crepe jaws 40 are illustrated as simple rectangles, which represent a general annular array of crepe jaws, such as Figure 3 and 4 . Jaw 40 includes a first axial end 70 and an opposite second axial end 72. The valve can be inserted into jaw 40 from either axial end. Although jaw 40 includes a plurality of individual jaw members that abut one another to form an annular structure, the radially inner surfaces of jaw 40 can collectively be summarized as forming a smooth, uniform diameter cylindrical inner surface extending between axial ends 70 and 72.

[0042] exist Figure 5 In the embodiment, the jaws 40 are open, similar to Figure 3 , and in Figure 6-9 In the case of a clamp, the jaws are closed, similar to Figure 4 .exist Figure 5 In the embodiment of the present invention, a radially expanded valve 42 is positioned within the jaws 40, wherein a delivery device is positioned within the valve. The valve is positioned so that the proximal end (right side) of the valve is approximately flush with the first axial end 70 of the jaws, and the delivery device is positioned to match the position of the valve. The delivery device in this example includes an inner shaft 44, an inflatable balloon 46, a proximal shoulder 48, and a distal shoulder 50. The valve is axially oriented between these two shoulders. The distal shoulder 50 is at least partially positioned within the jaws 40, while the proximal shoulder 48 is positioned proximal to the first axial end 70 of the outer jaw of the jaws.

[0043] Figure 6 Shown in the gripper 40 from Figure 5 The valve is then closed in the position of the inner shaft 44 and the configuration after radial compression of the valve between the shoulders 48 and 50 around the balloon 46. In this crimping step, the entire valve is within the jaws and receives uniform crimping contact from the jaws across the valve. Figure 6 After reopening in the closed configuration, the valve remains radially compressed due to the plastic deformation of the valve frame 60 (eg, a cobalt-chromium alloy frame).

[0044] exist Figure 7 In the delivery device and valve have been Figure 6 After the folding step, it is moved axially. Figure 7 In the configuration of , the distal portion of the valve remains within the jaws, while the proximal portion of the valve is outside the first axial ends 70 of the jaws. For example, in this position, the valve may be approximately half within the jaws and half outside the jaws. Figure 7 As shown, the blood inflow end of the valve including the outer skirt 62 is located within the jaws. This is also the distal end of the valve that is mounted on the delivery device. Figure 7 In the embodiment of the present invention, the distal portion of the valve receives the second fold from the jaws, while the proximal portion of the valve does not. This can result in the distal portion of the valve having an outer diameter that is smaller than the proximal portion of the valve (although this diameter difference is not shown in the figure).

[0045] exist Figure 8 In the delivery device and valve have been Figure 7 After the folding step, it is further moved axially. Figure 8 In the configuration of the valve, the distal portion of the valve is still within the jaws, although the axial length of the distal portion within the jaws is shorter than Figure 7 Similarly, the axial length of the proximal portion of the valve outside the first axial end 70 of the clamp is longer than Figure 7 For example, in this position, the valve may be approximately one-quarter inside the jaws and three-quarters outside the jaws. Figure 8 As shown, about half of the outer skirt 62 is within the jaws, and only this portion of the valve receives folds from the jaws. This can result in the distal end of the valve having an even smaller outer diameter.

[0046] exist Figure 6 、 7 During the crimping steps of 8 and 9, the distal shoulder may also be radially compressed by the jaws - depending on the size and configuration of the shoulder and the degree to which the jaws are radially closed. In some embodiments, the shoulder may have grooves or other features that allow it to be radially compressed. The shoulder may be made of an elastic material that elastically deforms under compression and then returns to its original shape when the compression is released. This allows the jaws to compress the distal end of the valve to an outer diameter that is smaller than the outer diameter of the distal shoulder, because the shoulder can re-expand to a diameter slightly larger than the distal end of the valve after the compression from the jaws is released. This allows the distal end of the valve to be "tucked in" behind the distal shoulder, so that the shoulder shields the distal end of the valve from snagging or getting stuck during delivery. In some embodiments, the proximal end of the valve and the proximal shoulder 48 may also be like this.

[0047] Figure 9 Another crimping step is illustrated wherein at least a portion of the proximal shoulder 48 is within the jaws and compressed along with the proximal end of the valve. Figure 9 In the position of , the entire valve is within the jaws, with the distal end of the valve aligned with the second axial end 72 of the jaws. At least a portion of the proximal shoulder 48 is also within the jaws, while the distal shoulder 50 is outside the jaws. Figure 9 The folding steps are Figure 6-8 After the pre-folding step (or at least after Figure 6 When the valve is compressed radially (after the compression step), the entire valve may have been compressed radially, so this step may be more of a finishing step to compress the valve again to prevent any part of the valve from protruding or bulging. Figure 7 and 8 The separate crimping step may result in a slight expansion of the free proximal end of the valve, and Figure 9The complete crimping step can compress the proximal end again to ensure that the valve is completely crimped as desired. In addition, the proximal end of the balloon 46 is compressed while the distal end of the balloon is outside the jaws, as shown in FIG. Figure 9 In the embodiment of the present invention, it is advantageous to cause the fluid within the balloon to move distally into the free distal end of the balloon and partially inflate the distal end of the balloon. Partially inflating the distal end of the balloon can cause the balloon to bulge slightly outward beyond the diameter of the distal end of the valve and thereby help protect the distal end of the valve from snagging or getting stuck during delivery.

[0048] Figure 10-13 An exemplary crimping device 100 is illustrated that includes two sets of jaws that close to two different minimum diameters. The device 100 can be used to crimp a valve onto a delivery device while simultaneously compressing one section of the valve to a larger outer diameter and a second section of the valve to a smaller outer diameter using a single crimping operation. The device 100 can include a support base 102, an outer housing 104 having a handle 122, an inner frame 108, a first set of jaws 110, and a second set of jaws 112. The base, outer housing, and inner frame can form a central opening 118 that passes through the device and is configured to receive the valve and the delivery device. The two sets of jaws 110, 112 can be configured to receive the valve and the delivery device. Figure 12 shown positioned side by side and aligned with the central opening 118 .

[0049] The outer housing 104 includes slots 132 in the sides, and the extensions 130 of the inner frame 108 extend into the slots 132. Similarly, the lateral aspects of the jaws 110, 112 engage the inner frame 108 through a series of extensions and slots. When the handle 122 is actuated, the outer housing rotates relative to the base 102, causing both sets of jaws to close simultaneously.

[0050] The jaws 110 and 112 have an open configuration in which they form a wide opening aligned with the central opening 118, and the jaws also each have a closed configuration in which they form a smaller, constricted opening, wherein the first set of jaws 110 forms a first constricted opening 114 and the second set of jaws 112 forms a second constricted opening 116 having a smaller diameter than the first constricted opening.

[0051] When the valve is crimped onto the delivery device using the apparatus 100, the portion of the valve within the second set of jaws 112 is compressed to a smaller diameter than the portion of the valve within the first set of jaws 110. For example, the distal or leading end of the valve can be crimped to a smaller diameter by the second set of jaws while the proximal portion of the valve is crimped by the first set of jaws when mounted on the delivery device. The benefits of crimping the distal leading end of the valve to a smaller diameter are described elsewhere herein, such as with respect to multi-stage crimping methods. The benefit of using a multi-jaw crimper to accomplish this is that it can be accomplished in a single crimping step with one compression step, as opposed to multiple steps using a conventional crimper.

[0052] Other Examples of the Disclosed Technology

[0053] Based on the above embodiments of the disclosed subject matter, the present application discloses other examples listed below. It should be noted that a single feature of an example or more than one feature and combination of the example and optionally a combination with one or more features of one or more other examples are further examples that also fall within the disclosure of the present application.

[0054] Example 1. A method for folding a prosthetic heart valve onto a delivery device, comprising: inserting the valve into a folding device in a radially expanded state so that the valve is positioned within a folding jaw of the folding device, the folding jaw having a proximal end and a distal end; positioning an inflatable balloon of the delivery device within the valve, the delivery device including a proximal shoulder and a distal shoulder positioned within the balloon; positioning the valve and the delivery device in a first axial position wherein the valve and at least a portion of the distal shoulder are between the proximal and distal ends of the inner jaw of the jaw, and wherein the entire proximal shoulder of the delivery device is proximal to the proximal end of the outer jaw of the jaw; closing and opening the jaws with the valve and the delivery device in the first axial position such that the valve is at least partially folded between the proximal and distal shoulders on the balloon; repositioning the valve and the delivery device from the first axial position to a second axial position wherein the first distal portion of the valve and at least a portion of the distal shoulder are within the jaw, and wherein the first proximal portion of the valve and at least a portion of the distal shoulder are within the jaw, and wherein the first proximal portion of the valve and at least a portion of the distal shoulder are within the jaw. the proximal portion and the proximal shoulder being proximal to the proximal end of the outer jaw of the jaw; closing and opening the jaws with the valve and delivery device in the second axial position; repositioning the valve and delivery device from the second axial position to a third axial position, wherein the second distal portion and at least a portion of the proximal shoulder of the valve are within the jaws, and the second proximal portion and the proximal shoulder of the valve are proximal to the proximal end of the outer jaw of the jaw, wherein the second distal portion is axially shorter than the first distal portion and the second proximal portion is axially longer than the first proximal portion; closing and opening the jaws with the valve and delivery device in the third axial position; repositioning the valve and delivery device from the third axial position to a fourth axial position, wherein the entire valve and at least a portion of the proximal shoulder of the delivery device are within the jaws, and the entire distal shoulder of the delivery device is distal to the distal end of the outer jaw of the jaw; and closing and opening the jaws with the valve and delivery device in the fourth position.

[0055] Example 2. The method of any example herein, in particular example 1, wherein the first distal portion of the valve comprises an outer skirt of the valve.

[0056] Example 3. The method of any example herein, in particular any of examples 1-2, wherein the first distal portion of the valve constitutes approximately half of the axial length of the valve.

[0057] Example 4. The method of any example herein, particularly any of examples 1-3, wherein the second distal portion of the valve comprises a distal portion of the outer skirt.

[0058] Example 5. The method of any example herein, in particular any of examples 1-4, wherein the second distal portion of the valve constitutes approximately one quarter of the axial length of the valve.

[0059] Example 6. The method of any example herein, particularly any of examples 1-5, wherein the valve is oriented about the delivery device with the blood inflow end of the valve adjacent the distal shoulder and the blood outflow end of the valve adjacent the proximal shoulder.

[0060] Example 7. The method of any example herein, particularly any of examples 1-6, wherein closing and opening the jaws with the valve and delivery device in the first axial position comprises radially compressing and releasing the distal shoulder.

[0061] Example 8. The method of any example herein, particularly any of examples 1-7, wherein closing and opening the jaws with the valve and delivery device in the second axial position comprises radially compressing and releasing the distal shoulder.

[0062] Example 9. The method of any example herein, particularly any of examples 1-8, wherein closing and opening the jaws with the valve and delivery device in the third axial position comprises radially compressing and releasing the distal shoulder.

[0063] Example 10. The method of any example herein, particularly any of examples 1-9, wherein closing and opening the jaws with the valve and delivery device in the fourth axial position comprises radially compressing and releasing the proximal shoulder.

[0064] Example 11. The method of any example herein, in particular any of Examples 1-10, wherein closing the jaws with the valve and delivery device in a fourth axial position compresses the proximal portion of the balloon and causes the fluid in the balloon to move distally into the distal portion of the balloon, which is distal to the distal end of the outer jaw of the jaws.

[0065] Example 12. The method of Example 11, wherein the fluid displaced distally into the distal portion of the balloon causes the distal portion of the balloon to partially inflate and radially expand.

[0066] Example 13. The method of Example 12, wherein the distal portion of the balloon radially expands to a diameter greater than a post-crease diameter of the distal end of the valve.

[0067] Example 14. The method of any of the examples herein, in particular any of Examples 1-13, further comprising, after closing and opening the jaws with the valve and delivery device in a fourth axial position, removing the delivery device and valve from the folding device, wherein the valve is folded between the proximal shoulder and the distal shoulder on the balloon, and inserting the delivery device and valve into the patient's body.

[0068] Example 15. A method for folding a prosthetic heart valve onto a delivery device, comprising: inserting the valve into a folding device in a radially expanded state so that the valve is positioned within a folding jaw of the folding device, the folding jaw having a proximal end and a distal end; positioning an inflatable balloon of the delivery device within the valve, the delivery device including a proximal shoulder and a distal shoulder positioned within the balloon; positioning the valve and the delivery device in a first axial position wherein a first distal portion and at least a portion of the distal shoulder of the valve are between the proximal and distal ends of the inner jaw of the jaw, and wherein the first proximal portion and the proximal shoulder of the valve are proximal to the proximal end of the outer jaw of the jaw; closing and opening the jaws with the valve and the delivery device in the first axial position such that the valve is at least partially folded between the proximal and distal shoulders on the balloon; repositioning the valve and the delivery device from the first axial position to a second axial position wherein a second distal portion and at least a portion of the distal shoulder of the valve are within the jaw, and wherein the second distal portion and at least a portion of the distal shoulder of the valve are within the jaw, and wherein the second distal portion and at least a portion of the distal shoulder of the valve are within the jaw the proximal portion and the proximal shoulder being proximal to the proximal end of the outer jaw of the jaw, wherein the second distal portion is axially shorter than the first distal portion and the second proximal portion is axially longer than the first proximal portion; closing and opening the jaws with the valve and delivery device in the second axial position; repositioning the valve and delivery device from the second axial position to a third axial position with most of the valve and at least a portion of the proximal shoulder of the delivery device within the jaws and the distal shoulder of the delivery device distal to the distal end of the outer jaw of the jaw; and closing and opening the jaws with the valve and delivery device in the third axial position; wherein closing the jaws with the valve and delivery device in the third axial position compresses the proximal portion of the balloon and causes fluid in the balloon to move distally into the distal portion of the balloon, which is distal to the distal end of the outer jaw of the jaw, wherein the fluid moving distally into the distal portion of the balloon causes the distal portion of the balloon to inflate and radially expand.

[0069] Example 16. The method of any example herein, in particular Example 15, wherein the fluid moving distally into the distal portion of the balloon causes the distal portion of the balloon to radially expand to a diameter greater than the post-fold diameter of the distal end of the valve.

[0070] Example 17. The method of any example herein, in particular any of Examples 15-16, wherein the first distal portion of the valve comprises an outer skirt of the valve.

[0071] Example 18. The method of any example herein, in particular any of Examples 15-17, wherein the first distal portion of the valve constitutes approximately half of the axial length of the valve.

[0072] Example 19. The method of any example herein, in particular any of Examples 15-18, wherein the second distal portion of the valve comprises a distal portion of the outer skirt.

[0073] Example 20. The method of any example herein, in particular any of Examples 15-19, wherein the second distal portion of the valve constitutes approximately one quarter of the axial length of the valve.

[0074] Example 21. The method of any example herein, particularly any of Examples 15-20, wherein the valve is oriented about the delivery device with the blood inflow end of the valve adjacent the distal shoulder and the blood outflow end of the valve adjacent the proximal shoulder.

[0075] Example 22. The method of any example herein, in particular any of Examples 15-21, wherein closing and opening the jaws with the valve and delivery device in the first axial position comprises radially compressing and releasing the distal shoulder.

[0076] Example 23. The method of any example herein, in particular any of Examples 15-22, wherein closing and opening the jaws with the valve and delivery device in the second axial position comprises radially compressing and releasing the distal shoulder.

[0077] Example 24. The method of any example herein, in particular any of Examples 15-23, wherein closing and opening the jaws with the valve and delivery device in the third axial position comprises radially compressing and releasing the proximal shoulder.

[0078] Example 25. An apparatus for folding a prosthetic heart valve, comprising: a first jaw having an open position and a fully closed position, wherein the first jaw has a first inner diameter when in the fully closed position; and a second jaw having an open position and a fully closed position, wherein the second jaw has a second inner diameter when in the fully closed position; wherein the second inner diameter is smaller than the first inner diameter.

[0079] Example 26. The device of any example herein, in particular example 25, wherein the first jaw and the second jaw are axially side-by-side.

[0080] Example 27. The device of any example herein, in particular any of examples 25-26, wherein the first jaw and the second jaw are in contact with each other.

[0081] Example 28. The device of any example herein, particularly any of examples 25-27, wherein the first jaw has a larger axial dimension than the second jaw.

[0082] Example 29. The device of any example herein, in particular any of Examples 25-28, wherein the first inner diameter and the second inner diameter are selected to correspond to a desired outer diameter of a prosthetic heart valve to be folded by the device.

[0083] Example 30. The device of any example herein, in particular any of examples 25-29, wherein the first jaw and the second jaw are actuated simultaneously using a common actuator.

[0084] Example 31. Any example herein, in particular any device of Examples 25-30, wherein the device is configured to fold a valve, wherein the blood outflow end of the valve contacts the first jaw and the blood inflow end of the valve contacts the second jaw, so that the blood inflow end of the valve is compressed to an outer diameter smaller than the blood outflow end of the valve.

[0085] Example 32. Any of the examples herein, in particular any of Examples 25-31, wherein the device is configured to fold a valve, wherein the blood inflow end of the valve contacts the first jaw and the blood outflow end of the valve contacts the second jaw, such that the blood outflow end of the valve is compressed to an outer diameter smaller than the blood inflow end of the valve.

[0086] Example 33. The device of any example herein, particularly any of examples 25-32, wherein the first jaw is at least twice as wide as the second jaw along the axial dimension.

[0087] Example 34. The device of any example herein, in particular any of examples 25-33, wherein the first jaw is at least five times wider than the second jaw along the axial dimension.

[0088] Example 35. The device of any example herein, in particular any of examples 25-34, wherein the inner diameter of the first jaw is at least twice as large as the inner diameter of the second jaw.

[0089] Example 36. The device of any example herein, particularly any of examples 25-35, wherein the second jaw in the fully closed position comprises a tapered inner surface having an inner diameter that varies along at least a portion of its axial length.

[0090] Example 37. The device of any example herein, in particular any of examples 25-36, wherein the first jaw and the second jaw in the open position have equal inner diameters.

Claims

1. A method of crimping a prosthetic heart valve onto a delivery device, comprising: inserting the valve into a pleating device in a radially expanded state such that the valve is positioned within pleating jaws of the pleating device, the pleating jaws having a proximal end and a distal end; positioning an expandable balloon of the delivery device within the valve, the delivery device comprising a proximal shoulder and a distal shoulder positioned within the balloon; positioning the valve and the delivery device in a first axial position wherein the valve and at least a portion of the distal shoulder are positioned within the jaws between the proximal and distal ends of the jaws, and wherein the entire proximal shoulder of the delivery device is positioned proximal to the proximal end of the jaws outside the jaws; closing and opening the jaws with the valve and delivery device in the first axial position such that the valve is at least partially creased between the proximal and distal shoulders on the balloon; repositioning the valve and delivery device from the first axial position to a second axial position wherein the first distal portion of the valve and at least a portion of the distal shoulder are within the jaws and wherein the first proximal portion of the valve and the proximal shoulder are outside the jaws proximal to the proximal end of the jaws; closing and opening the jaws with the valve and delivery device in the second axial position; repositioning the valve and delivery device from the second axial position to a third axial position wherein a second distal portion of the valve and at least a portion of the distal shoulder are within the jaws and a second proximal portion of the valve and the proximal shoulder are outside the jaws proximal to the proximal end of the jaws, wherein the second distal portion is axially shorter than the first distal portion and the second proximal portion is axially longer than the first proximal portion; closing and opening the jaws with the valve and delivery device in the third axial position; repositioning the valve and delivery device from the third axial position to a fourth axial position wherein the entire valve and at least a portion of a proximal shoulder of the delivery device are within the jaws and wherein the entire distal shoulder of the delivery device is outside the jaws distal to the distal end of the jaws; as well as The jaws are closed and opened with the valve and delivery device in the fourth axial position.

2. The method of claim 1, wherein the first distal portion of the valve comprises an outer skirt of the valve.

3. The method of claim 1 or claim 2, wherein the first distal portion of the valve constitutes approximately half of the axial length of the valve.

4. The method of claim 2, wherein the second distal portion of the valve comprises a distal portion of the outer skirt.

5. The method of any one of claims 1-2 and 4, wherein the second distal portion of the valve constitutes approximately one quarter of the axial length of the valve.

6. The method of any one of claims 1-2 and 4, wherein the valve is oriented about the delivery device with a blood inflow end of the valve adjacent the distal shoulder and a blood outflow end of the valve adjacent the proximal shoulder.

7. The method of any one of claims 1-2 and 4, wherein closing and opening the jaws with the valve and delivery device in the first axial position comprises radially compressing and releasing the distal shoulder.

8. The method of any one of claims 1-2 and 4, wherein closing and opening the jaws with the valve and delivery device in the second axial position comprises radially compressing and releasing the distal shoulder.

9. The method of any one of claims 1-2 and 4, wherein closing and opening the jaws with the valve and delivery device in the third axial position comprises radially compressing and releasing the distal shoulder.

10. The method of any one of claims 1-2 and 4, wherein closing and opening the jaws with the valve and delivery device in the fourth axial position comprises radially compressing and releasing the proximal shoulder.

11. The method of any one of claims 1-2 and 4, wherein closing the jaws with the valve and delivery device in the fourth axial position compresses the proximal portion of the balloon and causes fluid in the balloon to move distally into a distal portion of the balloon that is outside the jaws and distal to the distal ends of the jaws; wherein fluid moving distally into the distal portion of the balloon causes the distal portion of the balloon to partially inflate and radially expand; and The distal portion of the balloon is radially expanded to a diameter greater than the folded diameter of the distal end of the valve.

12. A method of crimping a prosthetic heart valve onto a delivery device, comprising: inserting the valve into a pleating device in a radially expanded state such that the valve is positioned within pleating jaws of the pleating device, the pleating jaws having a proximal end and a distal end; positioning an expandable balloon of the delivery device within the valve, the delivery device comprising a proximal shoulder and a distal shoulder positioned within the balloon; positioning the valve and the delivery device in a first axial position with the first distal portion of the valve and at least a portion of the distal shoulder within the jaws between the proximal and distal ends of the jaws, and with the first proximal portion of the valve and the proximal shoulder proximal to the proximal end of the jaws outside the jaws; closing and opening the jaws with the valve and delivery device in the first axial position such that the valve is at least partially creased between the proximal and distal shoulders on the balloon; repositioning the valve and delivery device from the first axial position to a second axial position wherein a second distal portion of the valve and at least a portion of the distal shoulder are within the jaws and a second proximal portion of the valve and the proximal shoulder are outside the jaws proximal to the proximal end of the jaws, wherein the second distal portion is axially shorter than the first distal portion and the second proximal portion is axially longer than the first proximal portion; closing and opening the jaws with the valve and delivery device in the second axial position; repositioning the valve and delivery device from the second axial position to a third axial position wherein a majority of the valve and at least a portion of the proximal shoulder of the delivery device are within the jaws and wherein the distal shoulder of the delivery device is outside the jaws distal to the distal end of the jaws; as well as closing and opening the jaws with the valve and delivery device in the third axial position; wherein closing the jaws with the valve and delivery device in the third axial position compresses the proximal portion of the balloon and causes the fluid in the balloon to move distally into the distal portion of the balloon, the distal portion of the balloon being distal to the distal ends of the jaws outside the jaws, wherein the fluid moving distally into the distal portion of the balloon causes the distal portion of the balloon to inflate and radially expand.

13. The method of claim 12, wherein the fluid moving distally into the distal portion of the balloon causes the distal portion of the balloon to radially expand to a diameter greater than the post-fold diameter of the distal end of the valve.

14. The method of claim 12 or claim 13, wherein the first distal portion of the valve comprises an outer skirt of the valve.

15. The method of claim 12 or claim 13, wherein the first distal portion of the valve constitutes approximately half of the axial length of the valve.

16. The method of claim 14, wherein the second distal portion of the valve comprises a distal portion of the outer skirt.

17. The method of any one of claims 12-13 and 16, wherein the second distal portion of the valve constitutes approximately one quarter of the axial length of the valve.

18. The method of any one of claims 12-13 and 16, wherein the valve is oriented about the delivery device with a blood inflow end of the valve adjacent the distal shoulder and a blood outflow end of the valve adjacent the proximal shoulder.

19. The method of any one of claims 12-13 and 16, wherein closing and opening the jaws with the valve and delivery device in the first axial position comprises radially compressing and releasing the distal shoulder.

20. The method of any one of claims 12-13 and 16, wherein closing and opening the jaws with the valve and delivery device in the second axial position comprises radially compressing and releasing the distal shoulder.

21. The method of any one of claims 12-13 and 16, wherein closing and opening the jaws with the valve and delivery device in the third axial position comprises radially compressing and releasing the proximal shoulder.

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