Expansion devices, systems, and methods for implants

Abstract

To provide an expansion device for an implant.SOLUTION: Devices, systems, and methods for expanding an implant utilizing an expansion device may be used. The implant deployment system can comprise an inflatable body portion configured to pressurize an inner surface of the implant to expand the implant and having a central body with a profile that decreases in diameter along a length of the central body. The expandable body may comprise a plurality of segments having varying expansion characteristics.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Application No. 62 / 971,086, filed February 6, 2020, which is incorporated herein by reference in its entirety.

[0002] SUMMARY The present disclosure describes systems, devices, and methods relating to implants, as well as dilation devices, systems, and methods. [Background technology]

[0003] Various diseases can affect an individual's body. Such diseases can be diseases of an individual's heart, including diseases of an individual's heart valves, including the aortic valve, mitral valve, tricuspid valve, and pulmonary valve. Stenosis, for example, is a common and serious valve disease that can affect the operation of the heart valves and the overall health of an individual.

[0004] Implants may be provided that can replace or repair portions of a patient's heart. Artificial implants, such as prosthetic heart valves, may be provided to replace portions of a patient's heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided.

[0005] The implant may be deployed percutaneously, minimally invasively, in a desired portion of a patient's body. Such deployment may be via a catheter, where the catheter may be deployed through the individual's vascular system.

[0006] During deployment of such implants, the implant must be expanded to provide an expanded configuration for such implants. Care must be taken to properly expand the implant to avoid over-expansion or under-expansion of such implants and to properly deploy such implants. Summary of the Invention [Problem to be solved by the invention]

[0007] The systems and methods of the present invention may relate to devices, systems, and methods for expanding an implant using an expansion device. Such devices, systems, and methods may include an expandable body configured to be expanded to expand the implant. In various embodiments, an expansion device for an implant may be provided. The expansion device may include an expandable body having a first end and a second end and a central body having a length positioned between the first end and the second end. The central body may be configured to pressurize the inner surface of the implant to expand the implant and may have a profile that decreases in diameter along its length from the first end to the second end. [Means for solving the problem]

[0008] In various embodiments, an expansion device for an implant may be provided. The expansion device may include an expandable body having a first end and a second end and a central body positioned between the first end and the second end and configured to pressurize an inner surface of the implant to expand the implant. The central body may include a plurality of segments, each of which may have a different profile. A plurality of imaging markers may each be configured to indicate the position of a respective one of the plurality of segments.

[0009] In various embodiments, an implant deployment system may be provided. The implant deployment system may include an implant configured to be deployed to a deployment site within a subject and having an implant with an angled inner profile facing an inner cavity of the implant. The implant deployment system may include an expandable body configured to be positioned within the inner cavity of the implant and having a central body configured to apply pressure against the implant to expand the implant, the central body having an angled profile to mate with the angled inner profile of the implant.

[0010] In various embodiments, an implant deployment system may be provided. The implant deployment system may include a deployment device having an elongate shaft for deploying an implant. The implant deployment system may include an expandable body coupled to the elongate shaft and having a first end and a second end, and a central body having a length positioned between the first end and the second end, the central body configured to pressurize an inner surface of the implant to expand the implant, the central body having a decreasing diameter profile along the length of the central body from the first end to the second end.

[0011] In various embodiments, an implant deployment system may be provided. The implant deployment system may include a deployment device having an elongate shaft for deploying an implant. The implant deployment system may include an expandable body coupled to the elongate shaft and having first and second ends and a central body positioned between the first and second ends and configured to pressurize an inner surface of the implant to expand the implant, the central body including a plurality of segments, each segment having a different profile from one another. The implant deployment system may include a plurality of imaging markers coupled to the elongate shaft, each configured to indicate the position of a respective one of the plurality of segments.

[0012] In various embodiments, a method may be provided that may include expanding an implant using an expandable body having a central body pressurized toward an interior surface of the implant, the expandable body having a first end and a second end and a central body positioned between the first end and the second end, the central body having a length and a profile that decreases in diameter along the length of the central body from the first end to the second end.

[0013] In various embodiments, a method may be provided that may include expanding an implant using an expandable body having a central body pressurized against an interior surface of the implant, the expandable body having a first end and a second end and a central body positioned between the first end and the second end, the central body comprising a plurality of segments, each segment having a different profile from one another.

[0014] The method can include aligning the implant with at least one imaging marker of a plurality of imaging markers, each configured to indicate a position of a respective one of the plurality of segments.

[0015] In various embodiments described herein, the systems, devices, and methods may be deployed or performed within a subject, including (but not limited to) medical patients, veterinary patients, animal models, cadavers, and simulators of the heart and vascular system (e.g., anthropomorphic phantoms and explant tissue).

[0016] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not limit, the present disclosure, in which like reference characters indicate corresponding features consistently throughout like embodiments. [Brief explanation of the drawings]

[0017] [Figure 1]FIG. 1 is a perspective view of an expansion device according to one embodiment of the present disclosure. [Figure 2] FIG. 2 is a cross-sectional view of the expansion device shown in FIG. 1. [Figure 3] 2 is a perspective view of the expansion device shown in FIG. 1 with an implant positioned around the expandable body portion. [Figure 4] FIG. 2 is a proximal end view of the dilation device shown in FIG. 1. [Figure 5] FIG. 2 is a distal end view of the expansion device shown in FIG. 1. [Figure 6] FIG. 1 is a cross-sectional view of an expansion device according to one embodiment of the present disclosure. [Figure 7] FIG. 1 is a cross-sectional view of an expansion device according to one embodiment of the present disclosure. [Figure 8] FIG. 1 is a cross-sectional view of an implant according to one embodiment of the present disclosure. [Figure 9] FIG. 1 is a cross-sectional view of an expansion device according to one embodiment of the present disclosure. [Figure 10] FIG. 1 is a side view of a deployment device according to one embodiment of the present disclosure. [Figure 11] FIG. 1 is a side view of a deployment device according to one embodiment of the present disclosure. [Figure 12] FIG. 12 is a side view of the deployment device shown in FIG. 11 with the sheath in a retracted position. [Figure 13] FIG. 12 is a side view of the deployment device shown in FIG. 11 with the sheath in a retracted position. [Figure 14] FIG. 1 is a schematic diagram of a deployment device approaching the aortic valve. [Figure 15] 1 is a schematic diagram of a dilation device for expanding the aortic valve leaflets. [Figure 16] FIG. 1 is a schematic diagram of an implant in place within an aortic valve annulus. [Figure 17] FIG. 1 is a schematic illustration of an implant in place within an aortic valve annulus and an expansion device according to one embodiment of the present disclosure. [Figure 18] 1 is a schematic illustration of an implant expanded within an aortic valve annulus by an expansion device apparatus according to one embodiment of the present disclosure. [Figure 19] FIG. 1 is a schematic illustration of a deployed implant according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0018] The following description and examples illustrate in detail some exemplary embodiments of the present disclosure. Those skilled in the art will recognize that there are numerous variations and modifications that fall within the scope of the present disclosure. Therefore, the description of some exemplary embodiments should not be considered to limit the scope of the present disclosure.

[0019] 1 illustrates a perspective view of a stretching device 10 relative to an implant, according to one embodiment of the present disclosure. The stretching device 10 may include an expandable body 12 having a first or proximal end 14, a second or distal end 16, and a central body 18 positioned between the first or proximal end 14 and the second or distal end 16 and having a length 20 (marked in FIG. 2).

[0020] A first or proximal end 14 of the expandable body 12 may be coupled to a shaft 22 of a deployment apparatus that may be utilized to deploy the expandable body 12 and, in various embodiments, may also be utilized to deploy an implant. A second or distal end 16 of the expandable body 12 forms the opposing end of the expandable body 12 and may comprise the tip of the expansion device 10.

[0021] The central body 18 may comprise a pressure portion of the expandable body 12 configured to apply pressure to the interior surface of the implant to expand the implant. The central body 18 may apply pressure to the implant to expand it, applying a force to the implant. The central body 18 may be configured to have an outer surface configured to contact and pressurize the implant. In various embodiments, the central body 18 may be covered by another structure and may further pressurize the interior surface of the implant through another structure.

[0022] FIG. 2 illustrates a cross-sectional view of the dilation device 10 along its midline. The central body 18 is shown as having a profile that decreases in diameter along the length 20 of the central body 18 from the first or proximal end 14 to the second or distal end 16. The profile is a tapered profile. The profile is an angled profile that angles downward in a direction toward the second or distal end 16. The profile angle may be a single angle that does not change along the length of the central body 18. In various embodiments, the angle may vary along the length of the central body 18, as shown in FIG. 6 for example. The profile of the central body 18 may have a step taper, such that a diameter 26 of the central body 18 near the first or proximal end 14 gradually decreases to a diameter 28 of the central body 18 near the second or distal end 16. The profile may be symmetrical about a longitudinal axis 24 around which the central body 18 extends.

[0023] The central body 18 may have a frustum shape as shown in Figures 1 and 2, which may include a conical frustum, or may include a frustum of another shape in various embodiments (e.g., a pyramidal shape or another shape).

[0024] The ends 14, 16 of the expandable body 12 may have a shape that reduces in profile to the diameter of the shaft or lumen that couples to the expandable body 12. For example, the second end or distal end 16 may couple to a distal portion of the central body 18 and taper to a diameter that is smaller than the diameter 28 of the distal portion of the central body 18 (e.g., the diameter of the inflation lumen 30). The distal end 16 may be configured to be atraumatic even if it comes into contact with a part of the subject. The proximal end 14 may couple to a proximal portion of the central body 18 and taper to a diameter that is smaller than the diameter 26 of the proximal portion of the central body 18 (e.g., the diameter of the shaft 22). The proximal end 14 may taper downward in a direction proximal to the proximal portion of the central body 18.

[0025] The expandable body 12 may be defined by a wall 32 that may form the exterior of the expandable body 12 and may enclose an internal cavity 34 that is configured to be filled with a fluid to expand the expandable body 12. The pressure of the fluid within the expandable body 12 may provide a force that allows the central body 18 or pressurized portion of the expandable body 12 to expand the implant. While the internal cavity 34 is shown in FIG. 2 as comprising a single cavity, other configurations may be utilized in various embodiments. For example, multiple chambers may be utilized that may be separate or in fluid communication with one another. In various embodiments, the expandable body 12 may comprise separate body portions, such as separate expandable bodies that may expand separately or together.

[0026] The wall 32 of the expandable body 12 may be configured such that the expandable body 12 is non-compliant. Thus, the expandable body 12 may be configured not to expand when an inflation pressure is met or exceeded, and the predetermined profile of the expandable body 12 may not change when the inflation pressure is reached or exceeded. The expandable body 12 may be preformed with a predetermined profile. The expandable body 12 may be configured not to expand beyond the predetermined profile of the expandable body 12 after inflation of the expandable body. For example, once the expandable body 12 reaches an inflation pressure, the diameters 26, 28 of the expandable body 12 may be configured not to further increase after additional inflation pressure is applied. In various embodiments, the expandable body 12 may be semi-compliant. In various embodiments, the expandable body 12 may be compliant, and the amount of fluid inflating the expandable body 12 may be controlled to control the size of the expandable body 12.

[0027] An inflation lumen 30 configured to inflate the expandable body 12 may be provided. The inflation lumen 30 may be configured to inflate an internal cavity 34 of the expandable body 12. The inflation lumen 30 may extend into the internal cavity 34 of the expandable body 12 and may include a channel 36 configured to pass a fluid therethrough to fill the internal cavity 34 and thus inflate the expandable body 12. Further, the inflation lumen 30 may be configured to withdraw fluid from the internal cavity 34 through the channel 36 to deflate the expandable body 12. The inflation lumen 30 may be in fluid communication with a port 38 (marked in FIG. 11 ) that may be utilized to admit fluid into and remove fluid from the inflation lumen 30 to control the inflation of the expandable body 12.

[0028] The expandable body 12 may be configured to be positioned in a lumen of a deployment device in an undeployed configuration, or may be configured to be inflated to a deployed configuration as shown in Figures 1-5. The inflation lumen 30 may be utilized to inflate the expandable body 12 to move the expandable body 12 to the deployed configuration, and may be utilized to deflate the expandable body 12 to move the expandable body 12 to the undeployed configuration.

[0029] The expandable body 12 may include multiple segments along the length of the central body 18. Each segment may comprise a portion of the central body 18 configured to pressurize the interior surface of the implant to expand it. The multiple segments may have different profiles from each other. The different profiles may be due to different maximum diameters of each segment. For example, as shown in FIG. 2, each of the multiple segments (e.g., segments 40a, 40b) has a maximum diameter that is different from the maximum diameters of each other segment. Segment 40a (shown in square brackets) of the central body 18 has an angled profile with a maximum diameter 42a at a proximal portion of segment 40a. Segment 40b (shown in square brackets) of the central body 18 has an angled profile with a maximum diameter 42b at a proximal portion of segment 40b that is larger than the maximum diameter 42a of segment 40a. This feature in FIG. 2 is due to the continuously tapered profile of the central body 18 along the length 20 of the central body. The implant surrounding segment 40b is therefore expanded to a larger diameter than the implant surrounding segment 40a. In various embodiments, the multiple segments may each have a different profile from each other segment of the multiple segments, or at least one segment of the multiple segments may have a different profile from another segment of the multiple segments. The segments of central body 18 may overlap one another, as shown in FIG. 2, or may be separated from one another.

[0030] Each of the segments shown in Figure 2 has a profile angle that is the same as the others, and this feature in Figure 2 is due to the single profile angle of the central body 18 along the length 20 of the central body 18.

[0031] The segments may have different profiles resulting in different maximum diameters, as well as different profile angles from one another in various embodiments, as shown, for example, in Figure 6. In various embodiments, the segments may have different profiles by having the same maximum diameter but different profile angles (e.g., extending outward to the same maximum diameter but at different angles). Furthermore, in various embodiments, the different profiles may result from different shapes of each segment; for example, a segment may have a straight profile shape as shown in Figure 2, while yet another segment may have a curved or other shape in various embodiments.

[0032] The segments can be configured to expand an implant, or multiple different implants, to various expanded diameters. For example, expandable body 12 can be configured to expand an implant to maximum diameter 42a or maximum diameter 42b depending on the implant's position on central body 18. When an implant is positioned on segment 40a, the implant expands to maximum diameter 42a. When an implant is positioned on segment 40b, the implant expands to maximum diameter 42b. In this manner, a user can select the degree to which the implant expands by selectively positioning the implant on central body 18.

[0033] Additionally, the segments can be configured with an angled profile to mate with the angled inner profile of the implant. FIG. 8 illustrates a cross-sectional view of one embodiment of an implant 46, also shown in FIG. 3, positioned on an expandable body portion 12. Features of the implant are not shown for clarity. For example, prosthetic heart valve leaflets may not be shown in FIG. 8 for clarity in an embodiment in which the implant 46 is a prosthetic heart valve. The implant 46 has an angled inner profile facing an inner cavity 47 of the implant 46. The implant 46 has a second or distal end 54 that is narrower than a first or proximal end 50 and has an inner surface 53 that forms an angled inner profile from the distal end 54 to the proximal end 50. The implant 46 may be considered a "V"-shaped implant, or otherwise an implant having a conical frustum inner shape, or may comprise another shaped frustum (e.g., a pyramidal or other shape) in various embodiments. The implant may have an outer profile that is the same as the inner profile, or may be different in various embodiments. The implant 46 can be configured to expand to an enlarged inner diameter 55 as shown in FIG.

[0034] The segments of the central body 18 may have a profile that mates with the inner profile of the implant 46. The profile angle of each segment may be the same as the profile angle of the angled inner profile to mate with the angled inner profile, or may be a slightly different angle to mate directly with the angled inner profile. Mating with the angled inner profile may allow for a large surface area of ​​contact between the outer surface of the segment and the inner surface 53 of the implant. FIG. 3, for example, illustrates a perspective view of the expandable body 12 including two implants 44, 46 extending around respective segments 42c, 42d of the central body 18. The central body 18 is positioned within the inner cavities of the implants 44, 46. The implants 44, 46 may each have different diameters of expansion and may have different inner profiles due to different lengths of the implants 44, 46 and different diameters at the proximal and distal ends 48, 50 and 52, 54 of the implants 44, 46, respectively. Implant 44 has a diameter at proximal end 48 that is smaller than the diameter at proximal end 50 of implant 46, which is smaller than the diameter at distal end 54 of implant 46. The angles of the inner profiles of implants 44, 46 are the same.

[0035] Segments 42c, 42d may have angled profiles to mate with the angled inner profiles of implants 44, 46. Thus, as shown in FIG. 3 , the profile of segment 42c mates with the angled inner profile of implant 44, and the profile of segment 42d mates with the angled inner profile of implant 46. Thus, a large contact surface area exists between the outer surfaces of segments 42c, 42d and the inner surfaces of the respective implants 44, 46. The large contact surface area may improve the ability of expandable body 12 to apply a force to expand the respective implants 44, 46.

[0036] As shown in FIG. 3 , the expandable body 12 can expand the implant to various expanded diameters. The implant 44 can be expanded to a maximum diameter 56 of the distal segment 42c, and the implant 46 can be expanded to a maximum diameter 58 of the proximal segment 42d. Thus, the same expandable body 12 can be configured to expand different implants to different expanded diameters. Furthermore, the expandable body 12 can be configured to expand the same implant to different expanded diameters. The implant 44 can be expanded, for example, to diameter 56, and the user can determine the characteristics of the implant 44, such as the level of expansion quality of the implant 44 at diameter 56. If the user chooses to further expand the implant 44, the expandable body 12 can be deflated to reduce the force applied to the implant 44 by segment 42c, and then the expandable body 12 can be slid distally to position the implant 44, for example, around segment 42d. The user can then re-inflate the expandable body 12, if necessary, to expand the implant 44 to diameter 58. Thus, the expandable body portion 12 can be utilized to gradually expand the implant by varying the position of the implant on the central body 18 .

[0037] Implants 44, 46 can each be configured to expand to an enlarged inner diameter after deployment. The enlarged inner diameter 55 of implant 46 is shown, for example, in FIG. 8 . Central body 18 can therefore include segments (as shown) having maximum diameters 56, 58 that are the same as the enlarged inner diameters of the respective implants 44, 46. Further, with respect to implant 44, central body 18 includes segment 42d having a maximum diameter greater than the enlarged inner diameter of implant 44. With respect to implant 46, central body 18 includes segment 42c having a maximum diameter less than the enlarged inner diameter of implant 46. Thus, various implants having different enlarged inner diameters can be expanded using expansion device 10. Furthermore, central body 18 has a length greater than the lengths of implants 44, 46, thereby allowing for variable positioning of central body 18 relative to implants 44, 46.

[0038] Referring again to FIG. 2 , the expansion device 10 may include multiple imaging markers 60. Each of the multiple imaging markers 60 may be configured to indicate the location of a respective one of the multiple segments. The imaging markers 60 may include radiopaque markers or other forms of markers configured to be imaged. For example, the imaging markers 60 may include echogenic markers configured to be visible under echocardiography or another form of x-ray or ultrasound imaging. The imaging markers 60 may be configured to be visible under fluoroscopy or another form of imaging. The imaging markers 60 may be spaced apart from one another along the length of the central body 18. The imaging markers 60 may be spaced apart from one another along the longitudinal axis 24 of the expandable body 12. The imaging markers 60 may be equally spaced apart from one another, or other spacing may be utilized. The imaging markers 60 may surround the longitudinal axis 24 of the expandable body 12.

[0039] The imaging marker 60 may be positioned within the inner cavity 34 as shown in FIG. 2 or may be positioned on the inflation lumen 30. In various embodiments, the imaging marker 60 may be positioned elsewhere. For example, the imaging marker 60 may be positioned on the inflatable body portion 12 in various embodiments. FIG. 9 illustrates, for example, an embodiment in which the imaging marker 61 is positioned on the wall 32 of the inflatable body portion 12 and extends circumferentially around the axis 24. The imaging marker 61 may be located, for example, on the interior of the wall 32. The wall 32 may include multiple layers (e.g., a double layer, a triple layer, etc.), and the imaging marker 61 may be positioned between such layers. The imaging marker 61 may also be positioned on the surface of the wall 32 (e.g., printed on the wall 32) if desired. Other configurations may be utilized as desired.

[0040] 3 , the imaging markers 60 may be configured to indicate the position of a respective one of the multiple segments, with each imaging marker 60 corresponding to the position of a respective segment. The position of each marker of the multiple imaging markers 60 may indicate the position of a respective one of the multiple segments. For example, imaging marker 60a may be positioned at a proximal portion of segment 42c and thus indicate the end of segment 42c and thus the position of segment 42c. Imaging marker 60b may be positioned at a proximal portion of segment 42d and thus indicate the end of segment 42d and thus the position of segment 42d. Each of the multiple imaging markers 60 may be configured to be positioned at an appropriate location relative to the implant to indicate the position of a respective one of the multiple segments (e.g., at the segment or at the end of the segment, among other locations). Thus, a user may image the imaging markers 60a,b during a deployment procedure and align the implant 44 with marker 60a so that the user knows that the implant 44 is positioned around segment 42c. The user may know the correspondence between the imaging marker 60 and the position of the segment and may therefore be able to position the implant 44 relative to the imaging marker 60 to ensure that the implant 44 is on the desired segment of the expandable body portion 12.

[0041] As another example, after a user aligns the implant 44 with the imaging marker 60a and expands the implant 44 to the maximum diameter 56, the user may desire to further expand the implant 44. The user may then deflate the expandable body portion 12 and then slide the expandable body portion 12 distally until the imaging marker 60b is aligned with the implant 44. The user may then expand the implant 44 to the maximum diameter 58 (e.g., if the implant 44 is configured to expand to the maximum diameter 58). The user may count the number of imaging markers 60 between marker 60a and marker 60b to recognize that the implant 44 extends around the segment 42d. In various embodiments, the sequential numbering of the imaging markers 60 may indicate the maximum diameter or other characteristic of the respective segment. For example, each sequentially aligned imaging marker 60 may represent an additional millimeter of the maximum diameter or another size of diameter. Thus, a user can count three imaging markers and recognize that three additional or fewer millimeters of maximum diameter are provided by that segment of expandable body portion 12. Additional characteristics of expandable body portion 12 can be indicated by imaging markers 60. For example, the angle of the segment can be indicated by imaging markers 60, with each sequential imaging marker 60 representing an additional degree or another change in angle of the angled profile. The imaging markers 60 can directly indicate characteristics of expandable body portion 12, for example, by the imaging markers being formed in the shape of letters, words, numbers, or other markings that indicate the characteristic.

[0042] The imaging markers 60 may serve as discrete, spaced apart scale marks for aligning or realigning the position of the expandable body portion 12 relative to the implant.

[0043] Figure 4 illustrates a first or proximal end view of the expandable body 12. Figure 5 illustrates a second or distal end view of the expandable body 12.

[0044] FIG. 6 illustrates an embodiment of an expandable body in which each of the multiple segments has a profile angle that is different from the profile angles of the other multiple segments. The expandable body 62 is configured similarly to the expandable body 12 and includes a first or proximal end 64, a second or distal end 66, and a central body 68 having a length and positioned between the first or proximal end 64 and the second or distal end 66. The central body 68 may comprise a pressurizing portion of the expandable body 62 configured to pressurize the inner surface of the implant to expand it. The central body 68 is illustrated as having a profile that decreases in diameter along the length of the central body 68 from the first or proximal end 64 to the second or distal end 66. The profile is a tapered profile and angled downward in the direction toward the distal end 66. The profile angle varies along the length of the central body.

[0045] At least one of the plurality of segments has a profile angle that is different from the profile angle of another of the plurality of segments. For example, segment 70b can have a profile angle that is greater than the profile angle of adjacent segment 70a. Furthermore, segment 70c can have a profile angle that is greater than the profile angles of adjacent segments 70b and 70a. Each of segments 70a-70c also has a larger diameter that is different from the maximum diameter of the other segments. The various angles of segments 70a-70c can be utilized to expand various implants having profile angles that match the profile angles of the respective segments 70a-70c. For example, the same expandable body portion 62 can be used to expand different implants. Furthermore, in various embodiments, the various angles of segments 70a-70c can be utilized to expand the same implant at different angles, if desired by the user. For example, a user may initially expand the implant with the high-angled segment 70c to rapidly expand the implant. The user may then wish to expand the same implant with a lower angle segment 70a to expand the implant more slowly in the later stages of deployment.

[0046] Similar to the imaging marker 60, the imaging markers 72a to 72c can be used to indicate the positions of the respective segments 70a to 70c.

[0047] 7 illustrates one embodiment of an expandable body in which each segment has a different maximum diameter than the other segments. Expandable body 74 is configured similarly to expandable body 12 and includes a first or proximal end 76, a second or distal end 78, and a central body 80 having a length and positioned between first or proximal end 76 and second or distal end 78. Central body 80 may comprise a pressurizing portion of expandable body 74 configured to pressurize the interior surface of the implant to expand it. Central body 80 is illustrated as having a decreasing diameter profile along the length of central body 80 from proximal end 76 to distal end 78.

[0048] The profile is a stepped profile. For example, each segment 82a-82c has a constant diameter along its length, and at least one of the plurality of segments 82a-82c has a different diameter than the other segments of the plurality of segments. Furthermore, each of the segments 82a-82c has a different diameter from the other segments. Segment 82b has a profile with a maximum diameter smaller than the maximum diameter of segment 82a. Segment 82c has a profile with a maximum diameter smaller than the maximum diameter of segment 82b. The different diameters of the segments 82a-82c can be utilized to expand various implants to different diameters. Furthermore, in various embodiments, the segments 82a-82c can be utilized to expand the same implant to various diameters. The implant can have an inner profile with a constant diameter, and thus each segment 82a-82c has a profile that matches the constant diameter profile of the implant. However, the segments 82a-82c can also be utilized to expand an implant with an angled profile, if desired.

[0049] Similar to the imaging marker 60, the imaging markers 84a to 84c can be used to indicate the positions of the segments 82a to 82c, respectively.

[0050] The expandable body portions disclosed herein may be delivered to a desired implant deployment location via a deployment device, which may be dedicated for use with the expandable body portion, or via a deployment device for the implant. For example, FIG. 10 illustrates an embodiment of a deployment device 90 for an implant. The deployment device 90 may include a handle 92, an elongated shaft 94 coupled to the handle 92, and an implant holding area surrounded by a capsule 96 at the end of the elongated shaft 94. The elongated shaft 94 may include a nose cone 98 at the distal end of the capsule 96. The deployment device 90 may include an actuation mechanism 100 for actuating operation of the deployment device 90, which may include releasing the implant from the capsule 96 and deflecting the elongated shaft 94 to a desired orientation. The deployment device 90 may further include an expansion device for expanding the native heart valve or for initially expanding the implant.

[0051] The inflatable body is coupled to the deployment device 90, for example, it may be coupled to the elongate shaft 94. The inflation lumen 30 shown in FIG. 2 may, for example, extend through a portion of the deployment device 90 and may be accessed via a port 102 or via another means.

[0052] FIG. 11 illustrates an embodiment of a deployment device 104 that may be utilized without the ability to release the implant. The deployment device 104 may include an elongate shaft 106 having a sheath 108 that covers the implant. The proximal end of the deployment device 104 may include a port 38 for accessing the inflation lumen. The elongate shaft 106 may be configured to be flexible so as to deflect to a desired portion of the subject. The elongate shaft 106 may be steerable, such as with an actuation mechanism that may be configured similarly to the actuation mechanism 100 shown in FIG. 10.

[0053] Referring to FIG. 12 , the sheath 108 may be retracted to expose the expandable body 12. The expandable body 12 may be in an undeployed, deflated, or unexpanded state. As shown, in such a configuration, the expandable body 12 is configured to be positioned within a lumen of a deployment device. The expandable body 12 may be inflated via the port 38, moving the expandable body 12 to a deployed, expanded, or expanded state having a larger diameter and size than the undeployed, deflated, or unexpanded state, for example, as shown in FIG. 13 . The expandable body 12 may then be deflated, and the sheath 108 may extend over and cover the expandable body 12.

[0054] The configuration of the deployment device may differ from that shown in Figures 10 to 13. Deployment device types other than those shown in Figures 10 to 13 may also be utilized.

[0055] 14-19 illustrate an exemplary method of utilizing the expansion device disclosed herein. The methods disclosed herein may differ from the steps shown in FIGS. 14-19. Referring to FIG. 14, the expansion device may be utilized in the deployment of an implant that is a prosthetic heart valve. The prosthetic heart valve may include a prosthetic aortic heart valve, or in various embodiments, another form of prosthetic heart valve, such as a mitral valve, tricuspid valve, or pulmonary heart valve. The implant, in various embodiments, may be utilized for repair, which may include repair of a portion of the heart, including heart valve repair. The implant, in various embodiments, may include other forms of medical implants, including stents, among others. The implant may be configured with an internal cavity within which an expandable body, as disclosed herein, is positioned. The method may include expanding the implant using an expandable body having a central body that is pressurized toward the interior surface of the implant. In various embodiments, other methods may also be utilized.

[0056] Figure 14 illustrates steps in one method of replacing an aortic heart valve. A deployment device 90, such as that shown in Figure 10, can be utilized to access the native aortic heart valve 110. The elongate shaft 94 can be deflected to allow the capsule 96 to access the native aortic heart valve 110 through the aortic arch.

[0057] After the elongate shaft 94 reaches the desired location within the heart, the capsule 96 can be retracted. Referring to Figure 15, an expansion device in the form of an expandable body can be expanded to press against the native heart valve leaflets 112 to enlarge the aortic annulus. In various embodiments, the expansion device embodiments disclosed herein can be utilized to perform such operations.

[0058] 16, the implant 114 may then be partially deployed, which may include releasing the implant 114 from the capsule 96. The implant 114 may not yet be in a fully expanded or deployed configuration, allowing a user to axially position the implant 114 within the aortic valve annulus. The implant 114 as shown comprises a replacement aortic heart valve. The implant 114 has an angled profile similar to the profiles of the implants 44, 46 shown in FIG. 3. The implant 114 may be configured similarly to the implants 44, 46 shown in FIG. 3.

[0059] 16 , an expandable body disclosed herein, such as expandable body 12, can be positioned within an internal cavity of implant 114. Expandable body 12 can be in an undeployed, unexpanded, or uninflated state, and thus the position of expandable body 12 can be configured to vary axially with respect to implant 114. A user may be able to select one of the segments of expandable body 12 with which implant 114 will expand. A user may select such a segment based on various criteria disclosed herein, which may include the desired expansion diameter of implant 114 or the profile of implant 114. For example, in an embodiment in which implant 114 is to expand to a certain diameter, a segment of expandable body 12 having a corresponding diameter is used to expand implant 114. A user may select a segment for expanding the implant based on the desired expansion diameter of the implant. Furthermore, in an embodiment in which implant 114 has an internal angled profile, a segment of expandable body 12 that fits that profile may be used to expand implant 114.

[0060] To determine which segment of the expandable body 12 will expand the implant 114, the multiple imaging markers 60 may be imaged. For example, fluoroscopy, echocardiography, or other imaging methods may be utilized. A user may identify at least one of the multiple segments based on the imaged multiple imaging markers 60. The user may select which segment of the expandable body 12 will expand the implant 114 by examining the imaging markers 60 and sliding the uninflated expandable body 12 relative to the implant 114 to a predetermined location relative to the implant 114. The implant may be aligned with at least one of the multiple imaging markers 60. For example, as shown in FIG. 17 , the imaging marker 60 may be aligned with a proximal portion of the implant 114 corresponding to the segment to be expanded to enlarge the implant 114. The uninflated expandable body 12 may be slid until the desired imaging marker 60 is aligned with the portion of the implant 114 and the segment of the expandable body 12 is selected.

[0061] The segments of the expandable body 12 can be used to expand the implant 114 based on the local anatomy near the deployment site (eg, the size of the aortic annulus).

[0062] In various embodiments, a segment of the expandable body 12 that is not expanded may be used for an initial expansion operation, then a second segment of the expandable body 12 that is not expanded may be used for a second expansion operation, and so on. Thus, the implant 114 may be gradually expanded by various segments of the expandable body 12. In various embodiments, the user may gradually expand the expandable body 12, check the diameter and desired position of the implant 114, and then continue to expand the expandable body 12 in a series of steps.

[0063] The expandable body portion 12 may be utilized in a post-balloon dilation procedure in which the implant 114 may have previously been expanded via another dilation device.

[0064] The expandable body 12 may eventually be inflated as shown in FIG. 18 . Inflating may include inflating a selected one of the segments to the maximum diameter of the selected one of the segments to expand the implant. As described, the expandable body 12 may be non-compliant, such that the expandable body 12 does not expand beyond a set diameter of the expandable body 12. The selected one of the segments may be configured not to expand beyond the maximum diameter of the selected one of the segments. Thus, the expandable body 12 may be fully inflated through a port (e.g., port 102 as shown in FIG. 10 ), and the expandable body 12 may have the correct diameter to expand the implant 114. Thus, concerns regarding overexpansion of the implant 114 or underexpansion of the implant 114 due to an incorrectly inflated expandable body 12 may be alleviated. Furthermore, in one embodiment where the central body 18 of the expandable body portion 12 has an angled profile to mate with the angled inner profile of the implant 114, a relatively large contact surface area can then be utilized for uniform application of an expansion force to the implant 114.

[0065] The expandable body 12 may then be deflated and withdrawn. The expandable body 12 may then be withdrawn along with the deployment device 90. In an embodiment in which a separate deployment device is utilized for the expandable body 12, such deployment device may then be withdrawn as well.

[0066] 19, the implant 114 may remain deployed within the aortic annulus. Other forms of methods may be utilized as desired.

[0067] While the steps disclosed herein are disclosed with respect to an expandable body 12, other configurations of expansion devices and expandable bodies disclosed herein may be used as well. While the deployment apparatus shown in FIG. 10 is disclosed as being utilized, other configurations of deployment apparatus may be utilized, such as those shown in FIGS. 11-13, among others. A deployment apparatus other than that utilized to deliver an implant to a desired location within a subject may be utilized to deploy the expansion apparatus disclosed herein. Features of the deployment apparatus illustrated in FIGS. 11-13, such as the sheath, inflation lumen, ports, and expansion device retention area, may be utilized with any of the deployment apparatus embodiments of the systems and methods disclosed herein.

[0068] Although the steps disclosed herein are described with respect to deploying a prosthetic aortic valve, these steps may be utilized for various other forms of heart valves and other forms of implants. The implants may include, among other things, stents or filters, or diagnostic devices. The deployment apparatus disclosed herein may be utilized not only to deploy implants, but also to utilize and deploy embodiments of the expansion devices disclosed herein. The implant may extend, for example, around the shaft 22 shown in FIG. 2 and may be deployed from a deployment apparatus including the expansion devices disclosed herein. The expansion devices disclosed herein may be coupled to a deployment apparatus, such as the apparatus shown in FIG. 10, which may deploy the expansion devices.

[0069] The deployment apparatus may be configured to deploy implants in the form of prosthetic heart valves, or may be configured to deploy other forms of implants, such as stents or filters, or diagnostic devices, among other things.

[0070] Other forms of implants, such as stents or filters, among others, can be configured similarly to the implants disclosed herein. For example, implants utilized in accordance with embodiments herein can have an angled inner profile as described herein, or can have other profiles as desired. For example, in various embodiments, the implant can have a uniform inner profile. The implant can be configured to expand radially outward from an axis that the implant surrounds, e.g., the longitudinal axis of the implant.

[0071] In various embodiments, the orientation of the expandable body disclosed herein may be reversed with respect to the deployment device. Thus, in one embodiment, such as that shown in FIG. 1 , the expandable body 12 may be reversed so that the first or proximal end 14 is in a distal-facing configuration and the second or distal end 16 is in a proximal-facing configuration. Thus, in such a configuration, the first or proximal end 14 is the distal-facing end and the second or distal end 16 is the proximal-facing end. Any of the embodiments of the expandable body disclosed herein may be so utilized. In such a configuration, opposing orientations of the implant may be provided. Thus, other forms of delivery, such as transapical deployment (e.g., for the aortic valve) or deployment of an implant into a native valve with opposite flow through the native valve, such as transseptal delivery to a native mitral valve, may be utilized. Thus, in various embodiments, the orientation of the expandable body and implant may be reversed from the positions shown herein as desired to achieve desired results.

[0072] The systems disclosed herein may include implant deployment systems or other forms of systems that may utilize the components disclosed herein. For example, an implant and an expandable body as disclosed herein may comprise an implant deployment system. An expandable body and a deployment device as disclosed herein may comprise an implant deployment system. Other forms of systems may also be provided. The components disclosed herein may be utilized separately or in combination in various embodiments.

[0073] The inflatable body may be utilized in a variety of subjects and procedures. Subjects include (but are not limited to) medical patients, veterinary patients, animal models, cadavers, and simulators of the heart and vascular system (e.g., anthropomorphic phantoms and explant tissue). Procedures include (but are not limited to) medical procedures and training procedures.

[0074] The deployment devices and devices and systems disclosed herein can be used in a variety of procedures, which may include transcatheter aortic valve implantation (TAVI). The deployment devices and systems disclosed herein can be utilized for transarterial access, including transfemoral access, to a subject's heart. In various embodiments, the deployment devices can be utilized for mitral valve, tricuspid valve, and pulmonary replacement and repair as well. The deployment systems can be utilized for transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transcervical procedures. Transapical procedures, among others, can also be utilized.

[0075] The methods as disclosed herein may be utilized in locations that do not utilize native valves, including, among other locations (parts of a subject may be other arteries, blood vessels, or other vascular systems), including the pulmonary artery and vena cava, among other locations. An implant, such as a stent or other form of implant, may be delivered to such parts of a subject.

[0076] Users as disclosed herein may include, among other users, surgeons, doctors, or other medical professionals.

[0077] Features of the embodiments may be modified, substituted, omitted, or combined.

[0078] Additionally, the methods herein are not limited to the methods specifically described, but may include methods utilizing the systems and devices disclosed herein.

[0079] Method steps may be modified, omitted, or added to the systems, apparatus, and methods disclosed herein.

[0080] Features of the embodiments disclosed herein may be implemented independently of the deployment device or independently of other components disclosed herein. Various devices of the system may be implemented independently.

[0081] Finally, while aspects of the present specification have been emphasized by reference to specific embodiments, it should be understood that those skilled in the art will readily appreciate that these disclosed embodiments are merely illustrative of the principles of the subject matter disclosed herein. Accordingly, it should be understood that the disclosed subject matter is not limited in any way to the particular methodology, protocols, and / or reagents, etc., described herein. Accordingly, various modifications or variations of the disclosed subject matter or alternative configurations can be made in accordance with the teachings herein without departing from the spirit of the specification. Finally, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the systems, devices, and methods disclosed herein, which are defined solely by the claims. Therefore, the systems, devices, and methods are not limited to exactly as shown and described.

[0082] Several various embodiments of the systems, apparatus, and methods are described herein, including the best mode known to the inventors for carrying out the same. Of course, variations on these described embodiments will become apparent to those skilled in the art after reading the above description. The inventors expect that skilled artisans will adopt such variations as appropriate, and the inventors intend for the systems, apparatus, and methods to be practiced otherwise than as specifically described herein. Accordingly, the systems, apparatus, and methods include all modifications and equivalents of the subject matter recited in the appended claims as permitted by applicable law. Furthermore, unless otherwise indicated herein or clearly contradicted by context, any combination of the above-described embodiments in all its possible variations is encompassed by the systems, apparatus, and methods.

[0083] The grouping of alternative embodiments, elements, or steps of systems, devices, and methods is not to be construed as limiting. Each group member may be referenced and claimed individually or in any combination with other group members disclosed herein. It is recognized that one or more group members may be included in, or deleted from, a group for reasons of convenience and / or patentability. When such inclusion or deletion is made, the specification is deemed to include the group as modified, and accordingly conforms to all Markush group descriptions used in the appended claims.

[0084] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, properties, terms, and the like used in the specification and claims are to be understood as being modified in all instances by the word "about." As used herein, the word "about" means that the feature, item, quantity, parameter, property, or term so modified encompasses approximations that may vary and still be able to perform the desired operation or process described herein.

[0085] Unless otherwise specified herein or clearly contradicted by context, the words "a," "an," "the," and similar referents when used in the context of describing systems, apparatus, and methods (particularly in the appended claims) should be construed to cover both the singular and the plural. All methods described herein can be performed in any suitable order unless otherwise specified herein or clearly contradicted by context. Any examples provided herein, or the use of exemplary language (e.g., "etc."), are intended only to further highlight the systems, apparatus, and methods and do not impose a limitation on the scope of the systems, apparatus, and methods unless otherwise recited in the claims. No language herein should be construed as indicating any non-claimed element essential to the practice of the systems, apparatus, and methods.

[0086] All patents, patent publications, and other publications referenced or identified herein are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing the compositions and methods described in such publications, which may be used in connection with, for example, the systems, apparatus, and methods. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or presentation of the contents of these documents are based on the information available to the applicant and do not constitute any admission as to the correctness of the dates or contents of these documents.

[0087] Illustrative Embodiments In view of the above-described implementations of the disclosed subject matter, the present application discloses the following additional embodiments: It should be noted that a feature of one embodiment in isolation, or multiple features of an embodiment in combination, and optionally, a combination with one or more features of one or more additional embodiments, are also further embodiments that fall within the scope of the present application disclosure. [Example]

[0088] 1. An expansion device for an implant, comprising: an expandable body portion having a length, the expandable body portion having a first end and a second end, and a central body positioned between the first end and the second end, the central body being configured to pressurize an inner surface of the implant to expand the implant, the expandable body portion having a profile that decreases in diameter along the length of the central body from the first end to the second end. [Example]

[0089] The expansion device of example 1, wherein the profile is a tapered profile. [Example]

[0090] The expansion device of example 1 or example 2, wherein the profile is an angled profile. [Example]

[0091] An expansion device as described in any one of Examples 1 to 3, wherein the central body comprises a plurality of segments, and at least one of the plurality of segments has a profile angle that is different from the profile angle of another of the plurality of segments. [Example]

[0092] The expansion device according to any one of Examples 1 to 4, wherein the central body comprises a plurality of segments, each of the segments having a profile angle that is the same as the other segments. [Example]

[0093] The expansion device of example 4 or example 5, wherein each of the plurality of segments has a maximum diameter that is different from the maximum diameter of each of the plurality of segments. [Example]

[0094] An expansion device described in any one of Examples 1 to 6, wherein the central body comprises a plurality of segments and further comprises a plurality of imaging markers each configured to indicate the position of a respective one of the plurality of segments. [Example]

[0095] An expansion device as described in Example 7, wherein at least one of the multiple imaging markers includes a radiopaque marker. [Example]

[0096] An expansion device as described in Example 7 or Example 8, wherein at least one of the multiple imaging markers is positioned within an inner cavity of the expandable body portion or on a wall of the expandable body portion. [Example]

[0097] An expansion device as described in any one of Examples 1 to 9, wherein the central body comprises a plurality of segments each having a constant diameter, and at least one of the plurality of segments has a different diameter than another of the plurality of segments. [Example]

[0098] The expansion device of any one of Examples 1 to 10, wherein the expandable body is non-compliant. [Example]

[0099] The expansion device of any one of Examples 1 to 10, wherein the expandable body is semi-compliant. [Example]

[0100] 13. The expansion device of any one of Examples 1 to 12, wherein the expandable body is coupled to the elongate shaft of the deployment apparatus to deploy the implant, the expandable body being configured to be in an undeployed configuration and configured to be inflated to the deployed configuration, and further comprising an inflation lumen for inflating the interior cavity of the expandable body. [Example]

[0101] The expansion device of any one of Examples 1 to 13, wherein the expandable body is configured not to expand beyond a defined profile of the expandable body after expansion of the expandable body. [Example]

[0102] The expansion device of any one of Examples 1 to 14, wherein the first end of the expandable body is a proximal end and the second end of the expandable body is a distal end. [Example]

[0103] 1. An expansion device for an implant, comprising: an expandable body having a central body positioned between a first end and a second end and between the first end and the second end and configured to pressurize an inner surface of the implant to expand the implant, the central body comprising a plurality of segments, each segment having a different profile from the others; and a plurality of imaging markers, each configured to indicate the position of one segment of the plurality of segments. [Example]

[0104] An expansion device as described in Example 16, wherein the multiple imaging markers include radiopaque markers. [Example]

[0105] An expansion device as described in Example 16 or Example 17, wherein the imaging markers are spaced apart from each other along the longitudinal axis of the expandable body portion. [Example]

[0106] An expansion device according to any one of Examples 16 to 18, wherein at least one of the plurality of segments has a profile angle that is different from the profile angle of another of the plurality of segments. [Example]

[0107] The expansion device according to any one of Examples 16 to 18, wherein each of the plurality of segments has a profile angle that is the same as the other segments. [Example]

[0108] The expansion device according to any one of Examples 16 to 20, wherein each of the plurality of segments has a maximum diameter different from the maximum diameters of the other plurality of segments. [Example]

[0109] 22. The expansion device according to any one of Examples 16 to 21, wherein the position of each of the plurality of imaging markers indicates the position of one of the plurality of segments. [Example]

[0110] The expansion device of any one of Examples 16 to 22, wherein the central body has a tapered profile. [Example]

[0111] The expansion device of any one of Examples 16 to 23, wherein the central body has an angled profile. [Example]

[0112] An expansion device as described in any one of Examples 16 to 24, wherein the multiple imaging markers are positioned within an inner cavity of the expandable body portion or positioned on a wall of the expandable body portion. [Example]

[0113] The expansion device of any one of Examples 16 to 25, wherein the expandable body is non-compliant. [Example]

[0114] The expansion device of any one of Examples 16 to 25, wherein the expandable body is semi-compliant. [Example]

[0115] The expansion device of any one of Examples 16 to 27, wherein the expandable body is coupled to the elongate shaft of the deployment apparatus to deploy the implant, the expandable body being configured to be in an undeployed configuration and to be inflated to the deployed configuration, and further comprising an inflation lumen for inflating the inner cavity of the expandable body. [Example]

[0116] The expansion device of any one of Examples 16 to 28, wherein the expandable body is configured not to expand beyond the defined profile of the expandable body after expansion of the expandable body. [Example]

[0117] The expansion device of any one of Examples 16 to 29, wherein the first end of the expandable body is a proximal end and the second end of the expandable body is a distal end. [Example]

[0118] 1. An implant deployment system comprising: an implant configured to be deployed to a deployment site within a subject's body, the implant having an angled inner profile facing an inner cavity of the implant; an expandable body configured to be positioned within an inner cavity of an implant and configured to apply pressure against the implant to expand the implant, the expandable body having a central body having an angled profile to mate with the angled inner profile of the implant. [Example]

[0119] 32. The implant deployment system of Example 31, wherein the implant has a length and the central body has a length that is greater than the length of the implant. [Example]

[0120] The implant deployment system of Example 31 or Example 32, wherein the central body comprises a plurality of segments, each segment having a different profile from the others. [Example]

[0121] 34. The implant deployment system of Example 33, wherein the implant is configured to expand to an enlarged inner diameter, and at least one segment of the plurality of segments has a maximum diameter equal to the enlarged inner diameter. [Example]

[0122] The implant deployment system of example 33 or example 34, wherein the implant is configured to expand to an enlarged inner diameter and at least one segment of the plurality of segments has a maximum diameter greater than the enlarged inner diameter. [Example]

[0123] An implant deployment system as described in any one of Examples 33 to 35, wherein the implant is configured to expand to an enlarged inner diameter and at least one segment of the plurality of segments has a maximum diameter that is smaller than the enlarged inner diameter. [Example]

[0124] An implant deployment system according to any one of Examples 33 to 36, further comprising a plurality of imaging markers each configured to indicate the position of a respective one of the plurality of segments. [Example]

[0125] An implant deployment system as described in Example 37, wherein each of the multiple imaging markers is configured to be positioned in an appropriate position relative to the implant to indicate the position of a respective one of the multiple segments. [Example]

[0126] 39. The implant deployment system of any one of Examples 31-38, wherein the profile of the central body has a profile angle that is the same angle as the profile angle of the angled inner profile. [Example]

[0127] 40. The implant deployment system of any one of Examples 31 to 39, wherein the implant comprises a prosthetic heart valve. [Example]

[0128] An implant deployment system according to any one of Examples 31 to 40, further comprising a deployment device having an elongate shaft coupled to the expandable body portion. [Example]

[0129] The implant deployment system of any one of Examples 31 to 41, wherein the expandable body portion is non-compliant. [Example]

[0130] The implant deployment system of any one of Examples 31 to 41, wherein the expandable body portion is semi-compliant. [Example]

[0131] An implant deployment system as described in any one of Examples 31 to 43, wherein the expandable body portion is configured to be in an undeployed configuration and configured to be expanded to an expanded configuration. [Example]

[0132] An implant deployment system as described in any one of Examples 31 to 44, wherein the expandable body portion is configured not to expand beyond the defined profile of the expandable body portion after expansion of the expandable body portion. [Example]

[0133] 1. An implant deployment system comprising: a deployment device for deploying the implant, the deployment device having an elongated shaft; 1. An implant deployment system comprising: an expandable body coupled to an elongate shaft and having a first end and a second end, and a central body positioned between the first end and the second end and having a length, the central body configured to pressurize an inner surface of the implant to expand the implant, the central body having a profile that decreases in diameter along the length of the central body from the first end to the second end. [Example]

[0134] The implant deployment system of Example 46, wherein the profile is a tapered profile. [Example]

[0135] The implant deployment system of Example 46 or Example 47, wherein the profile is an angled profile. [Example]

[0136] An implant deployment system as described in any one of Examples 46 to 48, wherein the central body comprises a plurality of segments, and at least one of the plurality of segments has a profile angle that is different from the profile angle of another of the plurality of segments. [Example]

[0137] An implant deployment system according to any one of Examples 46 to 49, wherein the central body comprises a plurality of segments, each of the segments having a profile angle that is the same as the other segments. [Example]

[0138] An implant deployment system as described in Example 49 or Example 50, wherein each of the multiple segments has a maximum diameter that is different from the maximum diameters of each of the multiple segments. [Example]

[0139] An implant deployment system described in any one of Examples 46 to 51, wherein the central body comprises a plurality of segments and further comprises a plurality of imaging markers each configured to indicate the position of a respective one of the plurality of segments. [Example]

[0140] An implant deployment system as described in Example 52, wherein the multiple imaging markers include radiopaque markers. [Example]

[0141] An implant deployment system as described in Example 52 or Example 53, wherein the multiple imaging markers are positioned within an inner cavity of the expandable body portion or on a wall of the expandable body portion. [Example]

[0142] An implant deployment system described in any one of Examples 46 to 54, wherein the central body comprises a plurality of segments each having a constant diameter, and at least one of the plurality of segments has a different diameter than another of the plurality of segments. [Example]

[0143] The implant deployment system of any one of Examples 46 to 55, wherein the expandable body portion is non-compliant. [Example]

[0144] The implant deployment system of any one of Examples 46 to 55, wherein the expandable body portion is semi-compliant. [Example]

[0145] An implant deployment system as described in any one of Examples 46 to 57, wherein the expandable body portion is configured to be in an undeployed configuration and to be inflated to an expanded configuration, and further comprises an inflation lumen for inflating the inner cavity of the expandable body portion. [Example]

[0146] An implant deployment system as described in any one of Examples 46 to 58, further comprising an implant, wherein the central body has an angled profile to mate with the angled inner profile of the implant. [Example]

[0147] An implant deployment system described in any one of Examples 46 to 59, wherein the first end of the expandable body portion is a proximal end and the second end of the expandable body portion is a distal end. [Example]

[0148] 1. An implant deployment system comprising: a deployment device for deploying the implant, the deployment device having an elongated shaft; an expandable body having a central body coupled to the elongate shaft and positioned between a first end and a second end and between the first end and the second end, the expandable body being configured to pressurize an inner surface of the implant to expand the implant, the central body comprising a plurality of segments, each segment having a different profile from the others; a plurality of imaging markers coupled to the elongate shaft, each configured to indicate the position of a respective one of the plurality of segments. [Example]

[0149] An implant deployment system as described in Example 61, wherein the multiple imaging markers include radiopaque markers. [Example]

[0150] An implant deployment system as described in Example 61 or Example 62, wherein the multiple imaging markers are spaced apart from each other along the longitudinal axis of the expandable body portion. [Example]

[0151] An implant deployment system described in any one of Examples 61 to 63, wherein at least one segment of the plurality of segments has a profile angle that is different from the profile angle of another segment of the plurality of segments. [Example]

[0152] An implant deployment system according to any one of Examples 61 to 63, wherein each of the plurality of segments has a profile angle that is the same as the other segments. [Example]

[0153] An implant deployment system according to any one of Examples 61 to 65, wherein each of the plurality of segments has a maximum diameter different from the maximum diameters of the other plurality of segments. [Example]

[0154] 67. An implant deployment system according to any one of Examples 61 to 66, wherein the position of each marker among the plurality of imaging markers indicates the position of a respective one of the plurality of segments. [Example]

[0155] An implant deployment system according to any one of Examples 61 to 67, wherein the central body has a tapered profile. [Example]

[0156] An implant deployment system according to any one of Examples 61 to 68, wherein the central body has an angled profile. [Example]

[0157] An implant deployment system described in any one of Examples 61 to 69, wherein the multiple imaging markers are positioned within the inner cavity of the expandable body portion or on the wall of the expandable body portion. [Example]

[0158] The implant deployment system of any one of Examples 61 to 70, wherein the expandable body portion is non-compliant. [Example]

[0159] The implant deployment system of any one of Examples 61 to 70, wherein the expandable body portion is semi-compliant. [Example]

[0160] An implant deployment system as described in any one of Examples 61 to 72, wherein the expandable body portion is configured to be in an undeployed configuration and to be inflated to an expanded configuration, and further comprises an inflation lumen for inflating the inner cavity of the expandable body portion. [Example]

[0161] An implant deployment system as described in any one of Examples 61 to 73, further comprising an implant, wherein the central body has an angled profile to mate with the angled inner profile of the implant. [Example]

[0162] An implant deployment system described in any one of Examples 61 to 74, wherein the first end of the expandable body portion is a proximal end and the second end of the expandable body portion is a distal end. [Example]

[0163] 1. A method of expanding an implant, comprising: utilizing an expandable body having a central body pressurized toward an interior surface of the implant, the expandable body having a first end and a second end and a central body positioned between the first end and the second end, the central body having a length and a profile that decreases in diameter along the length of the central body from the first end to the second end. [Example]

[0164] 77. The method of example 76, wherein the central body comprises a plurality of segments, and the method further comprises selecting one segment of the plurality of segments to expand the implant. [Example]

[0165] 78. The method of example 77, wherein each of the plurality of segments has a maximum diameter that is different from the maximum diameter of each of the plurality of segments. [Example]

[0166] The method of Example 77 or Example 78, further comprising selecting one segment of the plurality of segments to expand the implant based on the diameter to be reached when the implant is expanded. [Example]

[0167] The method of any one of Examples 77-79, further comprising expanding the implant by inflating a selected one of the plurality of segments to a maximum diameter of the selected one of the plurality of segments. [Example]

[0168] 81. The method of any one of Examples 77-80, wherein a selected one of the plurality of segments is configured not to expand beyond a maximum diameter of the selected one of the plurality of segments. [Example]

[0169] 82. The method of any one of Examples 77 to 81, further comprising identifying at least one segment among the plurality of segments based on the plurality of imaged imaging markers. [Example]

[0170] 83. The method of Example 82, further comprising aligning the implant with at least one imaging marker of the plurality of imaging markers. [Example]

[0171] 84. The method of any one of Examples 76-83, wherein the central body has a tapered profile and the implant comprises a prosthetic heart valve. [Example]

[0172] The method of any one of Examples 76 to 84, wherein the first end of the expandable body is a proximal end and the second end of the expandable body is a distal end. [Example]

[0173] Expanding the implant using an expandable body having a central body that is pressurized toward an interior surface of the implant, the expandable body having a first end and a second end and a central body positioned between the first end and the second end, the central body comprising a plurality of segments, each segment having a different profile from one another; and aligning the implant with at least one imaging marker of a plurality of imaging markers, each configured to indicate the position of a respective one of the plurality of segments. [Example]

[0174] The method of example 86, wherein the multiple imaging markers include radiopaque markers. [Example]

[0175] The method described in Example 86 or Example 87, wherein the multiple imaging markers are spaced apart from one another along the longitudinal axis of the expandable body portion. [Example]

[0176] 89. The method of any one of Examples 86-88, wherein at least one segment of the plurality of segments has a profile angle that is different from the profile angle of another segment of the plurality of segments. [Example]

[0177] 89. The method of any one of Examples 86-88, wherein each segment of the plurality of segments has a profile angle that is the same as the other segments. [Example]

[0178] 91. The method of any one of Examples 86-90, wherein each of the plurality of segments has a maximum diameter that is different from the maximum diameter of each of the plurality of segments. [Example]

[0179] 92. The method of any one of Examples 86-91, wherein the central body has a tapered profile and the implant comprises a prosthetic heart valve. [Example]

[0180] The method of any one of Examples 86 to 92, wherein the central body has an angled profile. [Example]

[0181] identifying at least one segment of the plurality of segments based on the plurality of imaged markers; The method of any one of Examples 86-93, further comprising selecting one segment of the plurality of segments to expand the implant. [Example]

[0182] The method of any one of Examples 86 to 94, wherein the first end of the expandable body is a proximal end and the second end of the expandable body is a distal end. [Explanation of symbols]

[0183] 10 Expansion Devices 12 Main body 14 first end or proximal end 16 Second or distal end 18 Centrosome 20 length 22 shaft 24 Longitudinal Axis 26, 28 diameter 30 Inflated Lumen 32 Wall 34 Inner cavity 36 channels 38 ports 40a, 40b segments 42a, 42b maximum diameter 42c, 42d segments 46, 44 Implants 47 Inner cavity 50, 48 First end or proximal end 53 Inner 54, 52 second or distal end 55 Enlarged inner diameter 56 Maximum diameter 58 Maximum diameter 60 Imaging marker 60a Imaging marker 60b Imaging marker 61 Imaging marker 62 Expandable body 64 first end or proximal end 66 Second or distal end 68 Centrosome 70a, 70b, 70c segments 72a~c Imaging marker 74 Expandable body 76 First or proximal end 78 Second or Distal End 80 Centrosome Segments 82a-c 84a~c Imaging marker 90 Deployment device 92 Handle 94 Thin Shaft 96 capsules 98 Nosecone 100 Operating mechanism Port 102 104 Deployment device 106 Thin Shaft 108 Sheath 110 Native aortic heart valve 112 Native Heart Valve Leaflets 114 Implants

Claims

1. 1. An expansion device for an implant, comprising:

1. An expansion device comprising: an expandable body having a first end, a second end, and a central body having a length positioned between the first end and the second end, the central body being configured to pressurize an inner surface of the implant to expand the implant, the central body having a profile that decreases in diameter along the length of the central body from the first end to the second end.

2. The expansion device of claim 1 , wherein the profile is a tapered profile.

3. The expansion device of claim 1 or claim 2, wherein the profile is an angled profile.

4. 4. The expansion device of claim 1, wherein the central body comprises a plurality of segments, and at least one of the plurality of segments has a profile angle that is different from a profile angle of another of the plurality of segments.

5. The expansion device of claim 1 , wherein the central body comprises a plurality of segments, each of the segments having a profile angle that is the same as the other segments.

6. The expansion device of claim 4 or claim 5, wherein each of the plurality of segments has a maximum diameter that is different from the maximum diameters of each of the plurality of segments.

7. The expansion device of any one of claims 1 to 6, wherein the central body comprises a plurality of segments and further comprises a plurality of imaging markers, each marker configured to indicate the position of a respective one of the plurality of segments.

8. The expansion device of claim 7 , wherein at least one imaging marker of the plurality of imaging markers includes a radiopaque marker.

9. The expansion device of claim 7 or claim 8, wherein at least one imaging marker of the plurality of imaging markers is positioned within an inner cavity of the expandable body portion or positioned on a wall of the expandable body portion.

10. 10. The expansion device of claim 1, wherein the central body comprises a plurality of segments each having a constant diameter, and at least one of the plurality of segments has a diameter different from another of the plurality of segments.

11. The expansion device of any one of claims 1 to 10, wherein the expandable body is non-compliant.

12. The expansion device of any one of claims 1 to 10, wherein the expandable body is semi-compliant.

13. 13. The expansion device of claim 1, wherein the expandable body is coupled to an elongate shaft of a deployment apparatus to deploy the implant, the expandable body being configured to be in an undeployed configuration and to be inflated to a deployed configuration, and further comprising an inflation lumen for inflating an inner cavity of the expandable body.

14. 14. The expansion device of claim 1, wherein the expandable body is configured not to expand beyond a defined profile of the expandable body after expansion of the expandable body.

15. 15. The expansion device of claim 1, wherein the first end of the expandable body is a proximal end and the second end of the expandable body is a distal end.

16. 1. An expansion device for an implant, comprising: an expandable body having a first end, a second end, and a central body positioned between the first end and the second end and configured to pressurize an inner surface of the implant to expand the implant, the central body comprising a plurality of segments, each segment having a different profile; a plurality of imaging markers, each configured to indicate the position of one of the plurality of segments; 1. An expansion device comprising:

17. The expansion device of claim 16 , wherein the plurality of imaging markers include radiopaque markers.

18. 18. The stretching device of claim 16 or 17, wherein the imaging markers are spaced apart from one another along the longitudinal axis of the expandable body.

19. 19. The stretching device of any one of claims 16 to 18, wherein at least one segment of the plurality of segments has a profile angle that is different from a profile angle of another segment of the plurality of segments.

20. 19. The stretching device of claim 16, wherein each segment of the plurality of segments has a profile angle that is the same as the other segments.

21. 21. The expansion device of any one of claims 16 to 20, wherein each segment of the plurality of segments has a maximum diameter that is different from the maximum diameters of each of the plurality of segments.

22. The expansion device according to any one of claims 16 to 21, wherein the position of each of the plurality of imaging markers indicates the position of a respective one of the plurality of segments.

23. 23. The expansion device of any one of claims 16 to 22, wherein the central body has a tapered profile.

24. 24. The expansion device of any one of claims 16 to 23, wherein the central body has an angled profile.

25. 25. The expansion device of any one of claims 16 to 24, wherein the plurality of imaging markers are positioned within an inner cavity of the expandable body or positioned on a wall of the expandable body.

26. 26. The expansion device of any one of claims 16 to 25, wherein the expandable body is non-compliant.

27. 26. The expansion device of any one of claims 16 to 25, wherein the expandable body is semi-compliant.

28. 28. The expansion device of any one of claims 16 to 27, wherein the expandable body is coupled to an elongate shaft of a deployment apparatus to deploy the implant, the expandable body being configured to be in an undeployed configuration and to be inflated to a deployed configuration, and further comprising an inflation lumen for inflating an interior cavity of the expandable body.

29. 29. The expansion device of any one of claims 16 to 28, wherein the expandable body is configured not to expand beyond a defined profile of the expandable body after expansion of the expandable body.

30. 30. The expansion device of any one of claims 16 to 29, wherein the first end of the expandable body is a proximal end and the second end of the expandable body is a distal end.

31. 1. An implant deployment system comprising: an implant configured to be deployed to a deployment site within a subject, the implant having an angled inner profile facing an inner cavity of the implant; an expandable body configured to be positioned within the interior cavity of the implant and configured to apply pressure against the implant to expand the implant, the expandable body having a central body with an angled profile to mate with the angled interior profile of the implant; 1. An implant deployment system comprising:

32. 32. The implant deployment system of claim 31, wherein the implant has a length and the central body has a length that is greater than the length of the implant.

33. 33. The implant deployment system of claim 31 or claim 32, wherein the central body comprises a plurality of segments, each segment having a different profile from the others.

34. 34. The implant deployment system of any one of claims 31 to 33, wherein the expandable body is configured to be in an undeployed configuration and configured to be expanded to a deployed configuration.

35. 35. The implant deployment system of any one of claims 31 to 34, wherein the expandable body is configured not to expand beyond a defined profile of the expandable body after expansion of the expandable body.

36. 1. An implant deployment system comprising: a deployment device for deploying the implant, the deployment device having an elongated shaft; an expandable body coupled to the elongate shaft, the expandable body having a first end, a second end, and a central body positioned between the first end and the second end and having a length, the central body configured to pressurize an inner surface of the implant to expand the implant, the central body having a decreasing diameter profile along the length of the central body from the first end to the second end; 1. An implant deployment system comprising:

37. 37. The implant deployment system of claim 36, wherein the profile is a tapered profile.

38. 38. The implant deployment system of claim 36 or claim 37, wherein the profile is an angled profile.

39. 39. The implant deployment system of any one of claims 36-38, wherein the central body comprises a plurality of segments, at least one of the plurality of segments having a profile angle that is different from a profile angle of another of the plurality of segments.

40. 40. The implant deployment system of any one of claims 36 to 39, wherein the central body comprises a plurality of segments, each segment of the plurality of segments having a profile angle that is the same as each other.

41. 41. The implant deployment system of claim 39 or claim 40, wherein each of the plurality of segments has a maximum diameter that is different from the maximum diameters of each of the plurality of segments.

42. 59. The implant deployment system of any one of claims 46 to 58, further comprising an implant, wherein the central body has an angled profile to mate with an angled inner profile of the implant.

43. 60. The implant deployment system of any one of claims 46 to 59, wherein the first end of the expandable body is a proximal end and the second end of the expandable body is a distal end.

44. 1. An implant deployment system comprising: a deployment device for deploying the implant, the deployment device having an elongated shaft; an expandable body coupled to the elongate shaft, the expandable body having a first end, a second end, and a central body positioned between the first end and the second end, the central body configured to pressurize an inner surface of the implant to expand the implant, the central body comprising a plurality of segments, each segment having a different profile from the others; a plurality of imaging markers coupled to the elongate shaft, each configured to indicate a position of a respective one of the plurality of segments; 1. An implant deployment system comprising:

45. 1. A method comprising: expanding an implant using an expandable body having a central body that is pressurized toward an interior surface of the implant, the expandable body having a first end, a second end, and a central body positioned between the first end and the second end, the central body having a length and a profile that decreases in diameter along the length of the central body from the first end to the second end.

46. 46. ​​The method of claim 45, wherein the central body comprises a plurality of segments, the method further comprising selecting one of the plurality of segments to expand the implant.

47. 47. The method of claim 46, wherein each segment of the plurality of segments has a maximum diameter that is different from the maximum diameter of each of the plurality of segments.

48. 48. The method of claim 46 or claim 47, further comprising expanding the implant by inflating the selected one of the plurality of segments to a maximum diameter of the selected one of the plurality of segments.

49. 49. The method of any one of claims 46 to 48, further comprising identifying at least one segment of the plurality of segments based on a plurality of imaged imaging markers.

50. 50. The method of claim 49, further comprising aligning the implant with at least one imaging marker of the plurality of imaging markers.

51. 51. The method of any one of claims 45 to 50, wherein the central body has a tapered profile and the implant comprises a prosthetic heart valve.

52. 52. The method of any one of claims 45 to 51, wherein the first end of the expandable body is a proximal end and the second end of the expandable body is a distal end.

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