Capsule guide tube for loading systems for loading a heart valve prosthesis into a delivery device

Abstract

A capsule guide tube for use with a loading system for loading a heart valve prosthesis into a delivery device includes an unlocked configuration and a locked configuration. The capsule guide tube includes a body and a locking member. The body is a one-piece tube configured to be disposed around a distal portion of the delivery device. The locking member is configured to releasably secure the body to a delivery device. The locking member includes a proximal end, a distal end, and a lock central passageway, wherein with the capsule guide tube in the locked configuration, the lock central passageway includes a distal portion having a first diameter configured to be disposed around a proximal portion of the body and a proximal portion having a second diameter and configured to be disposed around a portion of a delivery device, wherein the second diameter is smaller than the first diameter.

Description

CAPSULE GUIDE TUBE FOR LOADING SYSTEMS FOR LOADING A HEART VALVE PROSTHESIS INTO A DELIVERY DEVICEFIELD

[0001] The present technology is generally related to loading systems and methods for loading medical devices into a delivery device.BACKGROUND

[0002] Transcatheter implantable medical devices, such as heart valve prostheses, stents, scaffolds, and other intervention devices, are loaded into delivery devices to such as catheters to be delivered to a treatment site within a patient’s vasculature. Some implantable medical devices that contain organic tissue, e.g., bovine and porcine, require onsite installation onto the delivery device. Thus, it is desirable to make loading the implantable medical device onto the delivery device as easy as possible. Further, some current commercial systems in some cases may be subject to undesirable events during loading, such as valve inversion, valve infolding, and / or crown overlap. Thus, it is desirable to minimize the occurrence of such undesirable events.BRIEF SUMMARY

[0003] The techniques and devices of this disclosure generally relate to loading systems for loading a heart valve prosthesis into a delivery device.

[0004] In an example hereof, the present disclosure relates to a capsule guide tube for use with a loading system for loading a heart valve prosthesis into a delivery device. The capsule guide tube includes: a body configured to be disposed around a distal portion of the delivery device, the body being a one-piece tube having a proximal end, a distal end, and a body central passageway extending from the proximal end to the distal end; and a locking member configured to releasably secure the body to a delivery device, wherein the locking member includes a proximal end, a distal end, and a lock central passageway. With the capsule guide tube in a locked configuration, the lock central passageway includes a distal portion having a first diameter configured to be disposed around a proximal portion of the body and a proximal portion having a second diameter and configured to be disposed around a portion of a delivery device, wherein the second diameter is smaller than the first diameter.

[0005] In another example, in the capsule guide tube according to any of the preceding or following examples, the locking member comprises a first section and a second section divided longitudinally, wherein the locking member includes a first state wherein the first section and the second section are separated such that the lock central passageway is not complete and a second state wherein the first section and the second section are releasably secured to each other such that the lock central passageway is complete, wherein the first state corresponds to an unlocked configuration of the capsule guide tube and the second state corresponds to the locked configuration of the capsule guide tube.

[0006] In another example, in the capsule guide tube according to any of the preceding or following examples, the first section includes a first circumferential half of the lock central passageway, and the second section includes a second circumferential half of the lock central passageway such that the lock central passageway is completed with the locking member in the second state.

[0007] In another example, in the capsule guide tube according to any of the preceding or following examples, the first section includes first and second circumferential edges surfaces and the second section includes third and fourth circumferential edge surfaces, wherein in the first state the first and second circumferential edges surfaces do not abut the third and fourth circumferential edges surfaces, and in the second state the first circumferential edge surface abuts the third circumferential edge surface and the second circumferential edge surface abuts the fourth circumferential edge surface.

[0008] In another example, in the capsule guide tube according to any of the preceding or following examples, the first circumferential edge surface includes a protrusion, the third circumferential edge surface includes a recess, and in the second state the protrusion is disposed within the recess.

[0009] In another example, in the capsule guide tube according to any of the preceding or following examples, the first section of the locking member includes a tab extending radially inward from an inner surface of the distal portion of the locking member, and wherein the proximal portion of the body includes a body recess, and wherein in the locked configuration the tab of the locking member is disposed in the body recess.

[0010] In another example, in the capsule guide tube according to any of the preceding or following examples, the locking member further comprises a hinge coupling together the firstsection and the second section of the locking member, wherein the first section and the second section are configured to be rotated away from each other in the first state and are configured to be rotated towards each other in the second state.

[0011] In another example, in the capsule guide tube according to any of the preceding or following examples, the locking member further comprises a releasable lock configured to lock the first section to the second section in the second state.

[0012] In another example, in the capsule guide tube according to any of the preceding or following examples, a proximal portion of the lock central passageway of the locking member is configured to selectively transition the locking member between the first state and the second state.

[0013] In another example, in the capsule guide tube according to any of the preceding or following examples, the locking member includes a rotatable actuator configured to selectively transition the locking member between the first state and the second state.

[0014] In another example, in the capsule guide tube according to any of the preceding or following examples, the releasable lock is a latch / catch lock.

[0015] In another example hereof, a system comprises: a delivery device for delivering a heart valve prosthesis to a treatment site, the delivery device including an outer shaft and a capsule coupled to a distal portion of the outer shaft and extending distally therefrom, wherein the capsule has a larger diameter than the outer shaft proximal of the capsule; and a capsule guide tube configured to be releasably coupled to the delivery device during loading of the heart valve prosthesis into the capsule, the capsule including an unlocked configuration and a locked configuration. The capsule guide tube comprises a body disposed around the capsule of the delivery device; and a locking member configured to releasably secure the body to the delivery device, wherein in the locked configuration the locking member includes a lock central passageway including a distal portion having a first diameter an disposed around a proximal portion of the body, and a proximal portion having a second diameter smaller than the first diameter and disposed around the outer shaft of the delivery device proximal of the capsule of the delivery device.

[0016] In another example, in the system according to any of the preceding or following examples, in the locked configuration the locking member exerts a radially inward force on the outer shaft proximal of the capsule to secure the capsule guide tube to the delivery device.

[0017] In another example, in the system according to any of the preceding or following examples, the locking member comprises a first section and a second section divided longitudinally, the locking member includes a first state wherein the first section and the second section are separated such that the lock central passageway is not complete and a second state wherein the first section and the second section are releasably secured to each other such that the lock central passageway is complete, and the first state corresponds to the unlocked configuration and the second state corresponds to the locked configuration.

[0018] In another example, in the system according to any of the preceding or following examples, the first section includes a first circumferential half of the lock central passageway, and the second section includes a second circumferential half of the lock central passageway such that the lock central passageway is completed with the locking member in the second state.

[0019] In another example, in the system according to any of the preceding or following examples, the first section includes first and second circumferential edges surfaces and the second section includes third and fourth circumferential edge surfaces, wherein in the first state the first and second circumferential edges surfaces do not abut the third and fourth circumferential edges surfaces, and in the second state the first circumferential edge surface abuts the third circumferential edge surface and the second circumferential edge surface abuts the fourth circumferential edge surface.

[0020] In another example, in the system according to any of the preceding or following examples, the first circumferential edge surface includes a protrusion, the third circumferential edge surface includes a recess, and in the second state the protrusion is disposed within the recess.

[0021] In another example, in the system according to any of the preceding or following examples, the first section of the locking member includes a tab extending radially inward from an inner surface of the distal portion of the locking member, and wherein the proximal portion of the body includes a body recess, and wherein in the locked configuration the tab of the locking member is disposed in the body recess.

[0022] In another example, in the system according to any of the preceding or following examples, the locking member further comprises a hinge coupling together the first section and the second section of the locking member, wherein the first section and the second section are configured to be rotated away from each other in the first state and are configured to be rotated towards each other in the second state.

[0023] In another example, in the system according to any of the preceding or following examples, the locking member further comprises a releasable lock configured to lock the first section to the second section in the second state.

[0024] In another example, in the system according to any of the preceding or following examples, the locking member comprises a first longitudinal section and a second longitudinal section divided radially, wherein the locking member includes a first state wherein the first longitudinal section and the second longitudinal section are separated such that the lock central passageway is not complete and a second state wherein the first longitudinal section and the second longitudinal section are releasably secured to each other such that the lock central passageway is complete, wherein the first state corresponds to the unlocked configuration and the second state corresponds to the locked configuration.

[0025] In another example, in the system according to any of the preceding or following examples, the first longitudinal section includes a plurality of locking arms extending proximally therefrom, wherein each locking arm of the plurality of locking arms includes a first end and a second end.

[0026] In another example, in the system according to any of the preceding or following examples, the lock central passageway adjacent to the second ends of the plurality of locking arms includes a first diameter that is larger than an outer diameter of the outer shaft of the delivery device and in the locked configuration the lock central passageway adjacent to the second ends of the plurality of locking arms includes a second diameter that is smaller than the outer diameter of the outer shaft of the delivery device.

[0027] In another example, in the system according to any of the preceding or following examples, the first longitudinal section of the locking member includes a first thread and the second longitudinal section of the locking member includes a second thread, wherein the first thread is configured to engage the second thread to transition the capsule guide tube to the locked configuration.

[0028] In another example, in the system according to any of the preceding or following examples, the releasable lock is a latch / catch lock.

[0029] In another example hereof, the present disclosure relates to a capsule guide tube for use with a loading system for loading a heart valve prosthesis into a delivery device. The capsule guide tube includes: a body and a locking member. The body is configured to be disposed around a distal portion of the delivery device, and includes a proximal end, a distal end, and a body centralpassageway extending from the proximal end to the distal end. The locking member is configured to releasably secure the body to the delivery device, and includes a proximal end, a distal end, and a lock central passageway. With the capsule guide tube in a locked configuration, the locking member is disposed around a proximal portion of the body such that the locking member applies a radially inward force to the proximal portion of the body and a distal portion of the body is not radially compressed by the locking member.

[0030] In another example, in the capsule guide tube according to any of the preceding or following examples, with the capsule guide tube in the unlocked configuration, a proximal portion of the central passageway of the body includes a first diameter that is smaller than an outer diameter of a proximal portion of a capsule of the delivery device such that in the locked configuration, the proximal portion of the body applies a radially inward force on the proximal portion of the capsule.

[0031] In another example, in the capsule guide tube according to any of the preceding or following examples, with the capsule guide tube in the unlocked configuration, the lock central passageway of the locking member includes a first diameter and a proximal portion of the body includes a second diameter, wherein the second diameter is larger than the first diameter such that in the locked configuration the locking member applies a radially inward force on the proximal portion of the body.

[0032] In another example, in the capsule guide tube according to any of the preceding or following examples, the body further includes a first thread and the locking member further includes a second thread, wherein the first thread is configured to engage the second thread to transition the capsule guide tube to the locked configuration.

[0033] In another example, in the capsule guide tube according to any of the preceding or following examples, the first thread is on an outer surface of body and the second thread is on an inner surface of the locking member.

[0034] In another example, in the capsule guide tube according to any of the preceding or following examples, the first thread is on an inner surface of body and the second thread is on an outer surface of the locking member.

[0035] In another example hereof, a system comprises: a delivery device for delivering a heart valve prosthesis to a treatment site, the delivery device including an outer shaft and a capsule coupled to a distal portion of the outer shaft and extending distally therefrom, wherein the capsulehas a larger diameter than the outer shaft proximal of the capsule; and a capsule guide tube configured to be releasably coupled to a proximal portion of the capsule of the delivery device during loading of the heart valve prosthesis into the capsule, the capsule guide tube including an unlocked configuration and a locked configuration. The capsule guide tube comprises: a body disposed around the capsule of the delivery device, wherein a portion of the body is configured to releasably secure the body to the delivery device, wherein in the locked configuration the body includes a central passageway including a distal portion having a first diameter and disposed around a distal portion of the capsule of the delivery device and a proximal portion of the central passageway of the body having a second diameter smaller than the first diameter and disposed around a proximal portion of the capsule of the delivery device.

[0036] In another example, the system according to any of the preceding or following examples further includes a locking member configured to lock the capsule guide tube in the locked configuration.

[0037] In another example, in the system according to any of the preceding or following examples, the locking member includes a butterfly compression lock configured to selectively lock the capsule guide tube in the locked configuration.

[0038] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0039] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the present disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings are not to scale.

[0040] FIG. 1 depicts a perspective illustration of an example loading system for use with a medical device.

[0041] FIGS. 2A and 2B depict illustrations of an example delivery device into which a heart valve prosthesis may be loaded using the loading devices disclosed herein.

[0042] FIG. 3 A depicts a side view illustration of a portion of a loading device for use with a medical device, according to embodiments hereof.

[0043] FIG. 3B depicts a cross-sectional view of the capsule guide tube of FIG. 3 A, taken at a line A-A of FIG. 3 A, according to embodiments hereof.

[0044] FIG. 3C depicts a cross-sectional view of the capsule guide tube of FIG. 3 A, taken at a line B-B of FIG. 3 A, according to embodiments hereof.

[0045] FIG. 3D depicts a cross-sectional view of another embodiment of the capsule guide tube of FIG. 3A, taken at a line B-B of FIG. 3A, according to embodiments hereof.

[0046] FIG. 4A depicts a side view illustration of the capsule guide tube of FIG. 3 A in a locked configuration, according to embodiments hereof.

[0047] FIG. 4B depicts a cross-sectional view of the capsule guide tube of FIG. 3A in the locked configuration, taken at a line A-A of FIG. 4A, according to embodiments hereof.

[0048] FIG. 4C depicts a cross-sectional view of the capsule guide tube of FIG. 3A in the locked configuration, taken at a line B-B of FIG. 4A, according to embodiments hereof.

[0049] FIG. 4D depicts a cross-sectional view of the capsule guide tube of FIG. 3D in the locked configuration, taken at a line B-B of FIG. 4A, according to embodiments hereof.

[0050] FIG. 5 depicts a perspective, exploded illustration of the portion of the loading device of FIG. 3A, according to embodiments hereof.

[0051] FIG. 6A depicts a cross-sectional view of a first section of the loading device, taken at a line D-D of FIG. 5.

[0052] FIG. 6B depicts a cross-sectional view of a second section of the loading device, taken at a line E-E of FIG. 5.

[0053] FIG. 6C depicts a cross-sectional view of the second section of the loading device, taken at a line F-F of FIG. 5.

[0054] FIG. 7A depicts a side view illustration of a locking collar of the capsule guide tube of FIG. 3A, according to embodiments hereof.

[0055] FIG. 7B depicts a cross-sectional view of the locking collar of FIG. 7A, taken at the line F-F of FIG. 7A, according to embodiments hereof.

[0056] FIG. 8A depicts a side view illustration of another embodiment of a locking collar of the capsule guide tube of FIG. 3 A, according to embodiments hereof.

[0057] FIG. 8B depicts a cross-sectional view of the locking collar of FIG. 8A, taken at the line G-G of FIG. 8 A, according to embodiments hereof.

[0058] FIG. 9A depicts perspective view illustration of a loading cone of the portion of the loading device of FIG. 3 A, according to embodiments hereof.

[0059] FIG. 9B depicts a longitudinal cross-sectional illustration of the loading cone of FIG. 9A, according to embodiments hereof.

[0060] FIGS. 10A-10D depict illustrations of a method of releasably coupling the capsule guide tube and the loading cone of FIG. 3 A to a delivery device, according to embodiments hereof.

[0061] FIG. 11 depicts a perspective view of a capsule guide tube for use with a loading device, according to embodiments hereof.

[0062] FIG. 12 depicts a longitudinal cross-sectional view of the capsule guide tube of FIG. 11, according to embodiments hereof.

[0063] FIG. 13 depicts an exploded side view illustration of the capsule guide tube of FIG. 11, according to embodiments hereof.

[0064] FIG. 14 depicts a perspective view illustration of a locking member of the capsule guide tube of FIG. 11, according to embodiments hereof.

[0065] FIG. 15 depicts a perspective view illustration of a locking member of the capsule guide tube of FIG. 11, according to embodiments hereof.

[0066] FIGS. 16A-16C depict illustrations of a method of releasably coupling the capsule guide tube of FIG. 11 to a delivery device, according to embodiments hereof.

[0067] FIG. 17 depicts a longitudinal cross-sectional view of a loading device, according to embodiments hereof.

[0068] FIG. 18 depicts a cross-sectional view of the locking collar, taken at the line A-A of FIG.17, according to embodiments hereof.

[0069] FIGS. 19A-19C depict various embodiments of non-slip material on an inner surface of the loading device of FIG. 17, according to embodiments hereof.

[0070] FIGS. 20A-20B depict illustrations of a method of releasably coupling the loading device of FIG. 16 to a delivery device, according to embodiments hereof.

[0071] FIG. 21 depicts a longitudinal cross-sectional view of the loading device of FIG. 11, according to embodiments hereof.

[0072] FIG. 22 depicts a side view of the loading device of FIG. 17 including a frangible mechanism, according to embodiments hereof.

[0073] FIG. 23 depicts a perspective view of a capsule guide tube for a loading system according to embodiments hereof.

[0074] FIG. 24 depicts a longitudinal cross-sectional view of the capsule guide tube taken at the line A-A of FIG. 23 according to embodiments hereof.

[0075] FIG. 25 depicts an end perspective view of the locking member of the capsule guide tube disposed on the body of the capsule guide tube FIG. 23 according to embodiments hereof.

[0076] FIG. 26 depicts a side view of the locking member of the capsule guide tube of FIG. 23 according to embodiments hereof.

[0077] FIGS. 27A-27B depict illustrations of a method of releasably coupling the capsule guide tube of FIG. 23 to a delivery device according to embodiments hereof.

[0078] FIGS. 28A-28B depict illustrations of a releasable lock and a hinge for a lock member of the capsule guide tube according to embodiments hereof.

[0079] FIG. 29 depicts an exploded side view illustration of a capsule guide tube according to embodiments hereof.

[0080] FIGS. 30A-30B depict illustrations of a method of releasably coupling the capsule guide tube of FIG. 29 to a delivery device, according to embodiments hereof.

[0081] FIG. 30C depicts illustrations of a capsule guide tube and a method of releasably coupling the capsule guide tube to a delivery device, according to embodiments hereof.

[0082] FIG. 30D depicts an exploded side view illustration of the capsule guide tube of FIG. 30C.

[0083] FIG. 31 depicts an exploded side view illustration of a capsule guide tube according to embodiments hereof.

[0084] FIGS. 32A-32B depict illustrations of a method of releasably coupling the capsule guide tube of FIG. 31 to a delivery device, according to embodiments hereof.

[0085] FIG. 33 depicts an exploded side view illustration of a capsule guide tube according to embodiments hereof.

[0086] FIG. 34A depicts an end view of a locking member of the capsule guide tube of FIG. 33 in the unlocked configuration.

[0087] FIG. 34B depicts an end view of a locking member of the capsule guide tube of FIG. 33 in the locked configuration.

[0088] FIGS. 35A-35B depict illustrations of a method of releasably coupling the capsule guide tube of FIG. 33 to a delivery device, according to embodiments hereof.

[0089] FIG. 36 depicts an exploded side view illustration of a capsule guide tube according to embodiments hereof.

[0090] FIGS. 37A-37C depict illustrations of a method of releasably coupling the capsule guide tube of FIG. 36 to a delivery device, according to embodiments hereof.

[0091] FIG. 38 depicts a perspective view illustration of a capsule guide tube according to embodiments hereof.

[0092] FIG. 39 depicts a partial exploded side view illustration of the capsule guide tube of FIG. 38, according to embodiments hereof.

[0093] FIGS. 40A-40B depict enlarged illustrations of a locking mechanism of the capsule guide tube of FIG. 38, according to embodiments hereof.

[0094] FIG. 41 depicts a side view illustration of a capsule guide tube in an unlocked configuration, according to embodiments hereof.

[0095] FIG. 42 depicts a side view illustration of the capsule guide tube of FIG. 41 in the locked configuration, according to embodiments hereof.

[0096] FIGS. 43A-43B depict illustrations of a releasable lock of the capsule guide tube of FIG. 41, according to embodiments hereof.

[0097] FIGS. 44A-44B depict the capsule guide tube of FIG. 41, according to embodiments hereof.

[0098] FIG. 45 depicts a perspective view illustration of a capsule guide tube according to embodiments hereof.

[0099] FIGS. 46A-46C depict illustrations of a method of releasably coupling the capsule guide tube of FIG. 45 to a delivery device, according to embodiments hereof.

[0100] FIG. 47 depicts a perspective view illustration of a capsule guide tube according to embodiments hereof.

[0101] FIG. 48A-48B depicts illustrations of the capsule guide tube of FIG. 47 in the unlocked configuration and the locked configuration, according to embodiments hereof.

[0102] FIGS. 49A-49D depict illustrations of a method of releasably coupling the capsule guide tube of FIG. 47 to a delivery device, according to embodiments hereof.DETAILED DESCRIPTION OF THE INVENTION

[0103] Specific embodiments of the present disclosure are now described with reference to the figures wherein like reference numbers indicate identical or functionally similar elements. The following detailed description describes examples of embodiments of the invention and is not intended to limit the present technology or the application and uses of the present technology. Although the description of embodiments hereof is in the context of a loading system for a transcatheter heart valve prosthesis, the present technology may also be used for other devices. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding Field, Background, Brief Summary, or the following Detailed Description.

[0104] The terms “distal” and “proximal,” when used in the following description to refer to a native vessel, native valve, or a device to be implanted into a native vessel or native valve, such as a heart valve prosthesis, are with reference to the direction of blood flow. Thus, “distal” and “distally” refer to positions in a downstream direction with respect to the direction of blood flow, and the terms “proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow. The terms “distal” and “proximal,” when used in the following description to refer to a catheter or similar device, such as a delivery device or a loading system used with a delivery device, are with reference to a position or direction relative to the treating clinician or handle of the delivery device. Thus, “distal” and “distally” refer to positions distant from or in a direction away from the clinician or handle and “proximal” and “proximally” refer to positions near or in a direction toward the clinician or handle.

[0105] Embodiments disclosed herein are directed to capsule guide tubes for use as a part of loading systems for loading a heart valve prosthesis into a delivery device. The capsule guide tubes are configured to be coupled to a capsule and / or an outer shaft of a delivery device, proximal of a capsule. The capsule guide tubes described herein are configured to prevent damage to hydrophilic coatings on an outer surface of the capsule of the delivery device, to permit radial expansion or flaring of the capsule during loading of the heart valve prosthesis to ease loading of the heart valve prosthesis into the capsule, and to prevent infolding of the heart valve prosthesis during the loading process.

[0106] FIG. 1 illustrates an example of a loading system 100. The loading system 100 may be similar to loading systems as described in, for example, and not by way of limitation, International Publication No. WO 2024 / 044597 (International Application No. PCT / US2023 / 072667) assigned to Medtronic, Inc. and incorporated by reference herein in its entirety. As illustrated in FIG. 1, the loading system 100 generally includes a capsule guide tube 110, a loading cone 130, a loading ring 150, a valve seat 170, and a tip guide tube 180. One skilled in the art will realize that FIG. 1 illustrates one example of a loading system and that the capsule guide tubes described herein may be used with other loading systems. For example, and not by way of limitation, the capsule guide tubes described herein may also be used with the loading system shown in FIG. 14 of International Publication No. WO 2024 / 044597, incorporated by reference herein.

[0107] The capsule guide tube 110 is configured to be disposed on a capsule of a delivery device, such as, but not limited to, the delivery device 200 shown in FIGS. 2A and 2B. The capsule guide tube 110 includes a locking member 116 configured to lock the capsule guide tube 110 to a capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. The locking member 116 is slidable over a tube or body of the capsule guide tube 110 and exerts an inward or compressive force on the capsule guide tube 110, which in turn applies a radially inward force to the capsule 206 of the delivery device, thereby releasably coupling or securing the capsule guide tube 110 to the capsule 206 of the delivery device 200 during loading of the heart valve prosthesis into the capsule 206.

[0108] The loading cone 130 includes a main body 145 including a first end 131, a second end 132, and a central passageway (not shown) extending from the first end 131 to the second end 132. The loading cone 130 is configured to facilitate loading of a transcatheter heart valve prosthesis into the capsule 206 of the delivery device 200. The loading cone 130 may also be referred to as a funnel and / or a loading funnel. The first end 131 may also be referred to as the distal end of the loading cone 130 and the second end 132 may be referred to as the proximal end, as when the loading cone 130 is in use with the delivery device 200, the second end 132 is nearer to the handle 202 than the first end 131 as measured along the longitudinal axis of the delivery device 200.

[0109] The loading system 100 further includes the loading ring 150. The loading ring 150 is configured to be releasably coupled to the loading cone 130 and to seat the transcatheter heartvalve prosthesis therein. The loading ring 150 may be configured to rotationally couple the loading ring 150 and the loading cone 130.

[0110] The valve seat 170 of the loading system 100 may include a lip or similar feature to couple the valve seat 170 to the loading ring 150, as described in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. The valve seat 170 may be configured to prevent longitudinal movement of the valve seat 170 with respect to the loading ring 150, yet the valve seat 170 is rotatable relative to the loading ring 150.

[0111] As noted above, the loading system 100 further includes the tip guide tube 180. The tip guide tube 180 is configured to maintain or prevent an outflow end of a catheter heart valve prosthesis from collapsing, radially inward during the loading process, as described in greater detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety.

[0112] With the example loading system 100 having been described, a brief description of an example delivery device 200 shown in FIGS. 2A and 2B is provided. As noted above, the delivery device 200 is merely an example delivery device that can be used with the loading systems described herein. Further, one skilled in the art will realize that FIGS. 2A and 2B illustrate one example of a delivery device, that existing components illustrated in FIGS. 2A and 2B may be removed and / or additional components may be added to the delivery device 200, and that the loading systems and capsule guide tubes described herein may be used with other delivery devices.

[0113] The delivery device 200 includes a handle 202, an outer shaft 204, an inner shaft 212, and a middle member 214, as described in greater detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. A distal portion of the outer shaft 204 is the capsule 206 mentioned above that is configured to surround a transcatheter heart valve prosthesis during delivery to the treatment site, e.g., a native heart valve, and the capsule 206 retracted from the transcatheter heart valve prosthesis to expose the transcatheter heart valve prosthesis such that it self-expands. In the example delivery device shown, the middle member 214 is disposed between the inner shaft 212 and the outer shaft 204, and the middle member 214 includes a retainer or spindle 210 attached to a distal portion thereof for receiving tabs (sometimes referred to as paddles or connectors) of a transcatheter heart valve prosthesis. As noted above, this is a brief description of an example delivery device 200. Due to the size of a transcatheter heart valve prosthesis, the capsule 206 of the delivery device 200, which must surround the transcatheterheart valve prosthesis, generally has a larger diameter, which may also be referred to as a larger cross-sectional area, than the outer shaft 204. Other parts shown in FIGS. 2A and 2B are not described in detail herein and are described in greater detail in International Publication No. WO 2024 / 044597 or would be apparent to those skilled in the art.

[0114] FIGS. 3A-10E illustrate a capsule guide tube 310 and a loading cone 370 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. FIGS. 3A-3D illustrate the capsule guide tube 310 in an unlocked configuration. FIGS. 4A-4D illustrate the capsule guide tube 310 in a locked configuration. FIGS. 5-9 illustrate various components of the capsule guide tube 310 and the loading cone 370. FIGS. 10A-10E illustrate the operation and interaction of the capsule guide tube 310 with a capsule and an outer shaft of a delivery device. The capsule guide tube 310 is configured to be releasably coupled to an outer shaft of a delivery device, proximal to a capsule of the delivery device when the capsule guide tube 310 is in the locked configuration.

[0115] The capsule guide tube 310 includes a tube or body 312 and a locking member 314. In embodiments herein, the body 312 of the capsule guide tube 310 is configured to be disposed on the capsule 206 and a distal portion the outer shaft 204 of the delivery device 200. The locking member 314 is slidable over a portion of the body 312 and exerts a radially inward or compressive force on a proximal portion of the body 312, which in turn applies a radially inward force to the outer shaft 204 of the delivery device 200, thereby releasably coupling or securing the capsule guide tube 310 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206, via friction.

[0116] The body 312 of the capsule guide tube 310 includes a first (distal) end 316, a second (proximal) end 318, and a central passageway 320 extending from the first end 316 to the second end 318. The body 312 includes a first (distal) section 322 and a second (proximal) section 324, as shown in FIG. 5. The first section 322 extends from the first end 316 of the body 312 to a second end 317 of the first section 322. In embodiments herein, the first section 322 of the body 312 is a tubular construction and includes a generally circular outer surface 331, as shown in FIGS. 3B and 4B. The first longitudinal section 322 includes a first portion 321 of the central passageway 320, defined by an inner surface 332 of the first longitudinal section 322. The first portion 321 of the central passageway 320 extends from the first end 316 of the body 312 to the second end 317 of the first longitudinal section 322. In embodiments herein, the first portion 321 of the centralpassageway 320 is shaped and sized to receive the capsule 206 of the delivery device 200. The first portion 321 of the central passageway 320 may be configured to permit radial expansion of the capsule 206 of the delivery device 200 disposed therein during loading of a heart valve prosthesis into the capsule 206. Accordingly, a first inner diameter DI of the first portion 321 of the central passageway 320, shown in FIGS. 3B and 4B, may be larger than an outer diameter of the capsule 206.

[0117] The second longitudinal section 324 of the body 312 extends from the second end 317 of the first longitudinal section 322 to the second end 318 of the body 312. The second longitudinal section 324 of the body 312 is configured to enable the capsule guide tube 310 to transition between the unlocked configuration and the locked configuration via the locking member 314, as will be described below. With the capsule guide tube 310 of the loading device 300 in the unlocked configuration, the second longitudinal section 324 of the body 312 does not form a complete circumference, as shown in FIG. 3A and FIGS. 3C-3D.

[0118] In embodiments herein, the body 312 of the capsule guide tube 310 may be formed of a first arm 326A and a second arm 326B, as shown in FIGS. 3A-3D, 4A-4D, 5, and 6A-6C. In embodiments herein, the first arm 326A and the second arm 326B are each approximately one- half of the body 312, divided generally longitudinally. In other words, in cross-section, the first arm 326A forms approximately a first circumferential half of the body 312, and the second arm 326B forms approximately a second circumferential half of the body 312.

[0119] Thus, the first arm 326A includes a first (distal) longitudinal section 322A and a second (proximal) longitudinal section 324A. Similarly, the second arm 326B includes a first (distal) longitudinal section 322B and a second (proximal) longitudinal section 324B. Thus, the first longitudinal section 322 of the body 312 is formed of the first longitudinal section 322A of the first arm 326A and the first longitudinal section 322B of the second arm 326B. In other embodiments, the first (distal) longitudinal section 322 may be formed as a single piece tube (i.e., without a longitudinal split) and the second (proximal) longitudinal section 324 may be formed as two arms 326A, 326B extending proximally from the first longitudinal section 322 to secure the capsule guide tube 310 to the outer shaft of the delivery system, as explained below. As can be seen in FIGS. 3A and 4A the first longitudinal sections 322A, 322B of the first and second arms 326A, 326B include walls with outer surfaces 331 A, 33 IB and inner surfaces 332A, 332B. In the first longitudinal sections 322A, 322B, the inner and outer surfaces 332A, 332B, 331 A, 33 IB mayhave generally the same shape in cross-section. In the embodiment, the shape is generally semicircular such that when the first and second arms 326 A, 326B are brought together, the combined inner surface 332 is generally circular in cross-section and the combined outer surface 331 is generally circular in cross-section. However, this is not meant to be limiting, and in other embodiments, the surfaces may be other shapes. For example, and not by way of limitation, the combined inner surface 332 may be other shapes, such as an oval shape, or other shapes to generally match the shape of the capsule 206 of the delivery device 300. Similarly, the combined outer surface 331 may be other shapes to generally match the inner surface of the locking member 314. As explained above, the inner surfaces 332A, 332B define the first portion 321 of the central passage 320, and the first portion 321 has a first diameter DI. As can be seen by comparing FIG. 3B (unlocked configuration) and FIG. 4B (locked configuration) the first diameter DI is approximately the same in the locked and unlocked configurations, as the locking member 314 secures the body 312 to the outer shaft 204 in the second longitudinal section 324 of the body 312.

[0120] As can be seen in FIGS. 3A, 3C, 3D, 4A, 4C, and 4D, the second (proximal) longitudinal section 324 defines a second portion 323 of the central passageway 320. As can be seen by comparing FIGS. 3C-3D (unlocked configuration) with FIGS. 4C-4D (locked configuration) the second portion 323 of the central passageway 320 becomes smaller when the capsule guide tube 310 is transitioned from the unlocked configuration to the locked configuration. In particular, as explained above, the second longitudinal section 324 of the body 312 is formed of the second longitudinal section 324A of the first arm 326A and the second longitudinal section 324B of the second arm 326B. As can be seen in FIGS. 3C-3D, 4C-4D, and 6B-6C the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B include walls with outer surfaces 336A, 336B and inner surfaces 337A, 337B, respectively. Further, the second longitudinal section 324A of the first arm 326A includes a first circumferential edge 334A and a second circumferential edge 335A joining the inner and outer surfaces 336A, 337A such that the inner and outer surfaces 336A, 337A form arcs. Similarly, the second longitudinal section 324B of the second arm 326B includes a first circumferential edge 334B and a second circumferential edge 335B joining the inner and outer surfaces 336B, 337B such that the inner and outer surfaces 336B, 337B form arcs. The first circumferential edges 334A, 334B are separated from each other by a gap 338 and the second circumferential edges 335A, 335B are separated from each other by a gap 339. The gaps 338, 339 are generally equal. The gaps 338, 339 are larger with the capsule guide tube 310 in theunlocked configuration (see FIG. 6C) than with the capsule guide tube 310 in the locked configuration (FIG. 6B).

[0121] As explained briefly above, the outer shaft 204 is generally of a smaller diameter than the capsule 206. Thus, the second portion 323 of the central passageway 320 must compress to a second diameter D2 that is smaller than the first diameter DI of the first portion 321 of the central passageway 320. The second longitudinal sections 324A, 324B of the first and second arms 326A, 326B may have various shapes to enable such compression such that the second longitudinal sections 324A, 324B secure the capsule guide tube 310 against the outer shaft 204 of the delivery device 200. For example, in an embodiment shown in FIGS. 3C and 4C, the inner and outer surfaces 337A, 337B, 336A, 336B are substantially circular arcs. In such an embodiment, when the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B are moved towards each other, the second (proximal) portion 323 of the central passageway becomes generally oval in shape, as shown in FIG. 4C.

[0122] In another embodiment, shown in FIGS. 3D and 4D, the outer surfaces 336A, 336B of the second longitudinal sections 324A, 324B of the arms 326A, 326B are generally circular arcs. The inner surfaces 337A, 337B of the second longitudinal sections 324A, 324B of the arms 326A, 326B are arcs of a generally oval shape. In such an embodiment, when the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B are moved towards each other, the second (proximal) portion 323 of the central passageway becomes generally circular in shape, as shown in FIG. 4D.

[0123] Although two embodiments of the shapes of the outer and inner surfaces 336A, 336B, 337A, 337B of the second longitudinal sections 324A, 324B of the arms 326A, 326B have been shown and described, this is not meant to be limiting, and other shapes may be used provided that the second longitudinal section 324 of the body 312 can secure the capsule guide tube 310 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206.

[0124] As explained above, the second longitudinal sections 324A, 324B of the arms 326A, 326B of the body 312 include first and second circumferential edges 334A, 334B, 335A, 335B. As can be seen in FIG. 5, in the unlocked configuration, along the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B, the first circumferential edges 334A, 334B and the second circumferential edges 335 A, 335B each extends at an angle 91 relative to the central longitudinal axis CLA of the body 312, as shown in FIG. 3. In the embodiment shown, the angle01 is the same for both the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B, but on opposite sides of the central longitudinal axis CLA, as shown in FIG. 3. Thus, in the second longitudinal section 324 of the tube, the first and second circumferential edges 334A, 334B of the first arm 326A and the first and second circumferential edges 335A, 335B of the second arm 326B separate from each other in the direction towards the second end 318 of the body 312, i.e., proximally. In other words, in the unlocked configuration, the gaps 338, 339 described above become larger in the proximal direction, i.e., towards the second end 318. The gaps 338, 339 between the circumferential edges 334A, 335A of the second longitudinal section 324A of the first arm 326A and the circumferential edges 334B, 335B of the second longitudinal section 324B of the second arm 326B enlarge due to the arcs of the outer and inner surfaces 336A, 336B, 337A, 337B of the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B becoming shorter in the direction of the second end 318 of the body 312, i.e., proximally. Thus, as can be seen in FIGS. 3A and 5, the outermost edges of the outer surfaces 336A, 336B are parallel to the central longitudinal axis CLA while the circumferential edges 334A, 335A, 334B, 335B flare away from the central longitudinal axis CLA in the direction of the second end 318 of the body 312.

[0125] When the loading device 300 is in the locked configuration, the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B come together such that the circumferential edges 334A, 335A, 334B, 335B are generally parallel to the central longitudinal axis CLA of the body 312, the gaps 338, 339 are smaller than in the unlocked configuration, and the second portion 323 of the central passageway 320 is smaller than the first portion 321. The second longitudinal sections 324A, 324B of the first and second arms 326A are therefore formed with suitable flexibility to permit transition of the capsule guide tube 310 from the unlocked configuration and the locked configuration. Nonlimiting examples of materials suitable for the first and second arms 326 A, 326B include, but are not limited to polycarbonate, polyoxymethylene (e.g., Delrin®), or other materials suitable for the purposes described herein.

[0126] In embodiments herein, the first and second arms 326A, 326B include a plurality of guide rails 341A, 341B, 340C, 340D, as shown in FIGS. 5-6B. Each guide rail 341A, 341B, extends radially outward from the outer surface 336A of the first arm 326A and each guide rail 340C, 340D extends radially outward from the outer surface 336B of the second arm 326B. The guide rails 341A, 341B, 340C, 340D are generally disposed along the second (proximal)longitudinal section 324 of the body 312, but may extend into the first (distal) longitudinal section 322. Each guide rail 341 A, 34 IB of the first arm 326A is disposed adjacent to the corresponding first edge 334A or second edge 335A along the length of the second longitudinal section 324A, on generally opposite sides of the first arm 326A. In embodiments herein, each guide rail 341A, 341B is disposed generally parallel to the adjacent corresponding first circumferential edge 334A or second circumferential edge 335 A. Each guide rail 340C, 340D of the second arm 326B is disposed adjacent to the corresponding first circumferential edge 334B or second edge 335B along the length of the second longitudinal section 324B, on generally opposite sides of the second arm 326B. In embodiments herein, each guide rail 340C, 340D is disposed generally parallel to the adjacent corresponding first circumferential edge 334B or second circumferential edge 335B. In an embodiment, each guide rail 341A, 341B, 340C, 340D includes a first side surface 342A, 342B, 342C, 342D and an outer surface 343 A, 343B, 343C, 343D, respectively, as shown in in FIGS 6B- 6C. The first side surfaces 342A, 342B, 342C, 342D of the guide rails 341A, 341B, 340C, 340D face in a direction away from the corresponding circumferential edge 334A, 335A, 334B, 335B. The guide rails 341 A, 341B, 340C, 340D interact with the locking member 314 to transition the capsule guide tube 310 from the unlocked configuration to the locked configuration, as explained below.

[0127] In embodiments herein, the first end 316 of the body 312 includes a first thread 347 on an outer surface thereof, as shown in FIG. 5. Accordingly, a first portion 347A of the first thread 347 is disposed on the first arm 326A of the body 312 and a second portion 347B of the first thread 347 is disposed on the second arm 326B. The first thread 347 is configured to engage a second thread 394 of the loading cone 370 as described below. The first thread 347 may be formed, for example, and not by way of limitation, as an integral section of the outer surface 331 A, 33 IB of the first arm 326A and the second arm 326B, respectively, or as a separate unit, coupled to the first arm 326A and the second arm 326B for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While the first thread 347 is shown with a specific gender, hardness, thread, form, thread, angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0128] The first arm 326A and the second arm 326B of the body 312 may be coupled together and aligned via a plurality of matching or corresponding protrusions or tabs 344 and recesses 346. Thus, each tab 344 aligns with and is received within a corresponding recess 346. In anembodiment, the plurality of tabs 344 extend from the first edge 334A and the second edge 335A of the first section 322A of the first arm 326A. The corresponding plurality of recesses 346 are disposed in the wall of the second arm 326B along the first edge 334B and the second edge 335B of the first section 322B of the second arm 326B. While shown in FIG. 5 with a specific number of tabs 344 of specific shapes and in specific locations on the first arm 326A and a corresponding number of recesses 346 with corresponding shapes in corresponding locations on the second arm 326B, this is not meant to be limiting, and any number of tabs of any shape, and a corresponding number of recesses may be disposed on the first or second edges 334, 335 of the first longitudinal sections 322A, 322B of the first and second arms 326A, 326B, respectively, in any combination and location. The plurality of tabs 344 may be formed, for example, and not by way of limitation, as an integral portion of the first and / or second circumferential edges 334, 335, or as separate units, coupled to the first and / or second circumferential edges 334, 335 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. Each recess 346 may be formed, for example, and not by way of limitation, as an integral portion of the first and / or second circumferential edges 334, 335, or may be formed, for example, and not by way of limitation, by machining, cutting, or any other suitable method.

[0129] The locking member 314 of the capsule guide tube 310 is a generally tubular structure as shown in FIGS. 7A-7B. The locking member 314 is slidable over the body 312 of the capsule guide tube 310. The locking member 314 includes a first (proximal) end 348, a second (distal) end 350, and a passageway 352 extending from the first end 348 to the second end 350. In embodiments herein, the locking member 314 includes a plurality of deflecting rails 354A, 354B, 354C, 354D, extending radially inward from an inner surface 358 of the locking member 314, as shown in FIGS. 7A-7B. In the embodiment shown, each deflecting rail 354 extends from the first end 348 to the second end 350, but this is not meant to be limiting, and the deflecting rails 354 may extend along only a portion of the length of the locking member 314. Each deflecting rail 354 includes a first side surface 360. The first side surface 360 of each deflecting rail 354 is configured to engage or abut a side surface 342 of a corresponding guide rail 340 of the body 312. The deflecting rails 354 of the locking member 314 and the guide rails 340 of the body 312 are spaced around the inner surface 358 and the outer surface 336 of the locking member 314 and body 312, respectively, such that when the first side surface 360 of each deflecting rail 354 engages the side surface 342 of the corresponding guide rail 340, the second longitudinal sections 324A, 324B ofthe first and second arms 326A, 326B are brought closer together a desired amount to secure the capsule guide tube 310 to the outer shaft 204 or the delivery device 200, proximal of the capsule 206. The plurality of deflecting rails 354 of the locking member 314 may each be formed, for example, and not by way of limitation, as an integral portion of the locking member 314 or as separate units coupled to the inner surface 358 of the locking member 314 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate.

[0130] In another embodiment, the locking member 314 may include a plurality of channels 454A, 454B, 454C, 454D extending radially outward from an inner surface of the locking member 314, i.e., into the wall of the locking member 314, as shown in FIGS. 8A-8B. Each channel 454 is configured to receive a corresponding guide rail 340 of the body 312. In the embodiment shown, each channel 454 extends from the first end 348 to the second end 350 of the locking member 314. Each channel 454 is configured to receive a corresponding guide rail 340 of the body 312, to transition the capsule guide tube 310 from the unlocked configuration and the locked configuration. The channels 454 of the locking member 314 and the guide rails 340 of the body 312 are spaced around the inner surface 358 and the outer surface 336 of the locking member 314 and body 312, respectively, such that when the channels 454 of the locking member 314 engage guide rails 340, the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B are brought closer together a desired amount to secure the capsule guide tube 310 to the outer shaft 204 or the delivery device 200, proximal of the capsule 206. The plurality of channels 454 may be formed, for example, and not by way of limitation, as an integral portion of the locking member 314, or may be formed, for example, and not by way of limitation, by machining, cutting, or any other suitable method.

[0131] While described here in with four (4) deflecting rails 354 or channels 454, this is not meant to be limiting, and in other embodiments more or fewer deflecting rails and / or channels may be utilized in any combination such that the quantity of deflecting rails 354 and / or channels 454 of the locking member 314 are equal to the quantity of corresponding guide rails 340 of the body 312 of the capsule guide tube 310.

[0132] The locking members 314 described herein may be formed of any material suitable for locking the capsule guide tube 310 to the outer shaft 204 of the delivery device 200. For example, and not by way of limitation, the locking member 314 may be formed of a hard polymer materialsuch as, but not limited to high shore hardness polymers (ABS, PC,), metals (SS, Alum), glass, translucent polycarbonate (e.g., Makrolon 2458), acrylic (e.g., PMMA), and / or PETG.

[0133] The loading cone 370 is a schematic example of a loading cone and includes a main body 372 and a collar 386. The main body includes a first (distal) end 374, a second (proximal) end 376, and a central passageway 378 extending from the first end 374 to the second end 376, as shown in FIGS. 9A-9B. In the embodiment shown, the main body 372 is tapered from the first end 374 to the second end 376, However, in other embodiments, the main body 372 may include other shapes, such as cylindrical portions at either end thereof, such as for coupling to other parts of a loading system. In the embodiment shown, both an outer surface of the main body 372 and the central passageway 378 are tapered. However, this is not meant to be limiting, and only the central passageway 378 needs to be tapered. The central passageway 378 is tapered in a direction towards the second end 376 of the main body 372 such that the central passageway 378 adjacent to the first end 374 is larger than the central passageway 378 adjacent to the second end 376. The loading cone 370 may be formed of any suitable material, as will be understood by persons skilled in the art.

[0134] The collar 386 is coupled to the main body 372 adjacent to the second end 376 of the main body 372. The collar 386 is configured to receive the first end 316 of the body 312 of the capsule guide tube 310. The collar 386 is a generally tubular structure and includes a first end 388, a second end 390, and a passageway 392 extending from the first and 388 to the second and 390. In embodiments herein, the passageway 392 of the collar 386 is larger than the central passageway 378 of the main body 372 adjacent to the second end 376 of the main body 372 in order to accommodate the capsule guide tube 310 therein. In embodiments herein, the collar 386 includes a second thread 394 on an inner surface 396 of the collar 386 defining the passageway 392. The second thread 394 is configured to engage the first thread 347 of the body 312 of the capsule guide tube 310 to releasably couple the loading cone 370 to the body 312. The second thread 394 may be formed, for example, and not by way of limitation, as an integral section of the inner surface 396 of the collar 386, or as a separate unit coupled to the collar 386 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While the second thread 394 is shown with a specific gender, hardness, thread, form, thread, angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0135] As noted above, the loading cone 370 described herein is merely an example showing the second thread 394 for coupling the capsule guide tube 310 to the loading cone 370. The loading cone 370 may be any loading cone that includes a tapered inner surface for radially compressing a transcatheter heart valve prosthesis. For example, and not by way of limitation, the loading cone 370 may be any of the loading cones described in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety.

[0136] With an understanding of the components above, it is now possible to describe their interaction as a method to releasably couple the capsule guide tube 310 and the loading cone 370 to a delivery device, such as the delivery device 200 described previously.

[0137] In a step of the method, the first arm 326A and the second arm 326B of the body 312 of the capsule guide tube 310 are each disposed on the capsule 206 and a distal portion of the outer shaft 204 of the delivery device 200. The capsule 206 of the delivery device 200 is disposed within the first portion 321 of the central passageway 320 within the first longitudinal sections 322A, 322B of the first and second arms 326A, 326B of the body 312, as shown in FIG. 10A. A distal portion of the outer shaft 204 of the delivery device 200 is disposed in the second portion 323 of the central passageway 320 between the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B of the body 312.

[0138] In another step of the method, the locking member 314 is placed onto the first sections 322A, 322B of the first and second arms 326A, 326B of the body 312, as shown in FIG. 10B. In greater detail, the first end 316 of the body 312 is received within the second end 350 of the locking member 314. The locking member 314 is translated or moved relative to the body 312 in a direction towards the second end 318 of the body 312. The locking member 314 is rotationally oriented relative to the body 312 such that the first side surface 360 of each deflecting rail 354 is adjacent to a side surface 342 of the corresponding guide rail 340 of the second longitudinal section 324 of the body 312. Although described as a separate step herein, the capsule guide tube 310 may be placed over the capsule 206 and the outer shaft 204 with the locking member 314 already disposed around the body 312, with the locking member 314 disposed adjacent to the first (distal) end 316 of the body 312.

[0139] In another step of the method, the loading cone 370 is releasably coupled to the first end 316 of the body 312 of the capsule guide tube 310, as shown in FIG. 10C. In the embodiment herein, the second end 390 of the collar 386 of the loading cone 370 is disposed adjacent to thefirst and 316 of the body 312 of the capsule guide tube 310. The loading cone 370 is rotated in a first direction RD 1 such that the second thread 394 of the loading cone 370 engages the first thread 347 of the body 312 to releasably couple the loading cone 370 to the body 312 of the capsule guide tube 310. In FIG. 10C, the loading device 300 is in the unlocked configuration, however, this is not meant to be limiting. In other embodiments of the method, the loading cone 370 and the capsule guide tube 310 may be coupled together after the capsule guide tube 310 is in the locked configuration secured to the outer shaft 204 of the delivery device 200, as described below.

[0140] In another step of the method, the capsule guide tube 310 is transitioned from the unlocked configuration to the locked configuration, as shown in FIG. 10D. The locking member 314 is translated or moved in a first longitudinal direction LD1 towards the second end 318 of the body 312. As the locking member 314 moves in the first longitudinal direction LD1, each deflecting rail 354 of the locking member 314 imparts a force onto the corresponding side surface 342 of each guide rail 340 of the first and second arms 326 A, 326B. The force imparted onto each side surface 342 of each guide rail of the first and second arms 326A, 326B deflects, bends, or deforms the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B in a direction towards the central longitudinal axis CLA, which may also be described as towards each other or radially inwardly. The locking member 314 is translated in the first longitudinal direction LD1 until the inner surfaces 337A, 337B of the second longitudinal sections 324A, 324B of the first and second arms 326A, 326B engage an outer surface of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, to releasably couple or secure the capsule guide tube 310 to the outer shaft 204 of the delivery device 200.

[0141] With the capsule guide tube 310 of the loading device 300 releasably secured to the distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, additional components of a loading system including, but not limited to a loading ring, a valve seat, a tip guide tube, and a loading tray may be utilized with the capsule guide tube 310, the loading cone 370 (or a similar loading cone), and the delivery device 200 to load a heart valve prosthesis into the capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. As explained therein, the capsule guide tube 310 is secured to the delivery device 200 (in this embodiment to the outer shaft 204) such that the capsule guide tube 310 moves distally with the outer shaft 204 and capsule 206 to push the loading cone over the transcatheter heart valveprosthesis while maintaining the heart valve prosthesis longitudinally stationary to radially compress the heart valve prosthesis and load the heart valve prosthesis into the capsule 206.

[0142] Releasably securing the capsule guide tube 310 to a distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, instead of to the capsule 206, prevents the capsule guide tube 310 from damaging a coating, such as a hydrophilic coating, on an outer surface of the capsule 206 during loading of a heart valve prosthesis therein. Releasably securing the capsule guide tube 310 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206, instead of to the capsule 206, also permits radial expansion or flaring of the capsule 206 during loading of the heart valve prosthesis therein, easing loading of the heart valve prosthesis into the capsule 206 of the delivery device 200.

[0143] FIGS. 11-16C illustrate another capsule guide tube 410 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. FIGS. 11-13 illustrate various components of the capsule guide tube 410. FIG. 14 illustrates an embodiment of a locking member of the capsule guide tube 410 interacting with a body of the capsule guide tube 410. FIG. 15 illustrates another embodiment of a locking member of the capsule guide tube 410 interacting with a body of the capsule guide tube 410. FIGS. 16A-16C illustrate a method for releasably securing the capsule guide tube 410 to a delivery device. The capsule guide tube 410 is configured to be releasably coupled to, secured to, or locked to an outer shaft of a delivery device, proximal of a capsule of the delivery device. The capsule guide tube 410 includes an unlocked configuration wherein the capsule guide tube 410 is not releasably secured to the outer shaft of the delivery device, and a locked configuration wherein the capsule guide tube 410 is releasably secured to the outer shaft of the delivery device.

[0144] In an embodiment, the capsule guide tube 410 includes a body 412, a coupling member 413, and a locking member 414, as shown in FIGS. 11-13. In embodiments herein, the body 412 of the capsule guide tube 410 is configured to be disposed on a distal portion of the delivery device. The locking member 414 is slidable over a portion of the body 412 and exerts an inward or compressive force on a portion of the body 412, which in turn applies a radially inward force to the outer shaft of the delivery device, thereby releasably coupling, locking, or securing the capsule guide tube 410 to the outer shaft of the delivery device, proximal of the capsule, via friction.

[0145] The body 412 of the capsule guide tube 410 includes a first (distal) end 416, a second (proximal) end 418, and a central passageway 420 extending between the first end 416 and thesecond end 418. The body 412 includes a first longitudinal section 422, a second longitudinal section 424, and a third longitudinal section 427. The first longitudinal section 422 extends from the first end 416 to a second end 417 of the first longitudinal section 422. The first longitudinal section 422 of the body 412 is a tubular construction and may include a tapered outer surface 430. In embodiments herein, the outer surface 430 of the first longitudinal section 422 is tapered in a direction towards the first end 416 of the body 412 such that a first outer diameter OD1 of the outer surface 430 adjacent to the first end 416 of the body 412 is smaller than a second outer diameter OD2 of the outer surface 430 adjacent to the second end 417 of the first longitudinal section 422 of the body 412. The first longitudinal section 422 includes or defines a first portion 421 of the central passageway 420. The first portion 421 of the central passageway 420 extends from the first end 416 of the body 412 to the second end 417 of the of the first longitudinal section 422. In embodiments herein, the first portion 421 of the central passageway 420 may include a first or tapered section 421A and a second or cylindrical section 421B. The first section 421A is tapered in a direction towards the second section 42 IB of the first portion 421 of the central passageway 420 such that a first inner diameter ID1 of the first section 421 A adjacent to the first end 416 of the body 412 is larger than a second inner diameter ID2 of the first section 421A adjacent to the second section 421B of the first portion 421 of the central passageway 420. In embodiments herein, the second section 42 IB of the first portion 421 of the central passageway 420 is cylindrical with a third inner diameter ID3. In an embodiment, the third inner diameter ID3 is equal to the second inner diameter ID2 of the first section 421 A adjacent the second section 421B.

[0146] The second longitudinal section 424 of the body 412 extends from a first end 419 adjacent to the second end 417 of the first longitudinal section 422 to a second end 419 of the second longitudinal section 424. In embodiments herein, the second longitudinal section 424 of the body 412 is a tubular construction and includes a generally circular outer surface 431. The second longitudinal section 424 includes a second portion 423 of the central passageway 420 extending from the first end 419 of the second longitudinal section 424 to a second end 402 of the second longitudinal section 424 of the body 412. In embodiments herein, the second portion 423 of the central passageway 420 is shaped and sized to receive a corresponding capsule of a delivery device. The second portion 423 of the central passageway 420 may be configured to permit radial expansion of the capsule of the delivery device disposed therein during loading of a heart valveprosthesis into the capsule. Accordingly, a fourth inner diameter ID4 of the second portion 423 of the central passageway 420 may be larger than an outer diameter of the capsule of a delivery device disposed therein. Further, in embodiments, the fourth inner diameter ID4 of the second portion 423 of the central passageway 420 may be larger than the third inner diameter ID3 of the second section 42 IB of the first portion 421 of the central passageway 420, thereby forming a shoulder 438 at the junction of the second section 421B of the first portion 421 and the second portion 423, as shown in FIG. 12.

[0147] The third longitudinal section 427 of the body 412 extends from a first end 404 adjacent to the second end 402 of the second longitudinal section 424 to the second end 418 of the body 412. The third longitudinal section 427 is a tubular construction and may include a tapered outer surface 437. The outer surface 437 of the third longitudinal section 427 may be tapered in a direction towards the second end 418 of the body 412 such that a third outer diameter OD3 at the first end 404 of the third longitudinal section 427 of the body 412 is larger than a fourth outer diameter OD4 at the second end 418 of the body 412. The third longitudinal section 427 includes a third portion 429 of the central passageway 420. The third portion 429 of the central passageway 420 extends from the first end 404 of the third longitudinal section 427 to the second end 418 of the body 412. The third portion 429 of the central passageway 420 includes a fifth inner diameter ID5. The fifth inner diameter ID5 of the third portion 429 of the central passageway 420 is generally equal to an outer diameter of the outer shaft of the delivery device disposed therein. Thus, when the loading device 400 is in the locked configuration with the delivery device disposed therein, an inner surface 436 of the third longitudinal section 427 contacts or engages the outer surface of the outer shaft of the delivery device to releasably secure the capsule guide tube 410 to the delivery device, via friction.

[0148] The body 412 of the capsule guide tube 410 may be formed of a first arm 426A and a second arm 426B. In embodiments herein, the first arm 426A and the second arm 426B are each approximately one-half of the body 412, divided generally longitudinally. Thus, the first arm 426A includes a first end 416A corresponding to the first end 416 of the body 412, and a second end 418A corresponding to the second end 418 of the body 412. The first arm 426A includes a first longitudinal section 422A corresponding to the first longitudinal section 422 of the body 412, a second longitudinal section 424A corresponding to the second longitudinal section 424 of the body 412, and a third longitudinal section 427A corresponding to the third longitudinal section 427 ofthe body 412. Similarly, the second arm 426B of the body 412 includes a first end 416B corresponding to the first end 416 of the body 412, and a second end 418B corresponding to the second end 418 of the body 412. The second arm 426B includes a first longitudinal section 422B corresponding to the first longitudinal section 422 of the body 412, a second longitudinal section 424B corresponding to the second longitudinal section 424 of the body 412, and a third longitudinal section 427B corresponding to the third longitudinal section 427 of the body 412.

[0149] The coupling member 413 of the capsule guide tube 410 is a generally tubular structure as shown in FIGS. 11-13. The coupling member 413 includes a first (distal) end 440, a second (proximal) end 442, and a passageway 444 extending from the first end 440 to the second end 442. The passageway 444 is sized to receive the second and / or third sections 424, 427 of the body 412. The coupling member 413 is configured to provide structural rigidity to the body 412 of the capsule guide tube 410 such that a distal portion of the first arm 426 A does not separate from the second arm 426B during loading of a heart valve prosthesis therein. In an embodiment, the coupling member 413 may be coupled to a portion of an outer surface 43 IB of the second longitudinal section 424 of the second arm 426B. The coupling member 413 may be coupled to the second arm 426B such that the first end 440 of the coupling member 413 is adjacent to a shoulder 456 that connects the outer surface 430 at the second end 417 of the first longitudinal section 422 to the outer surface 431 of the second longitudinal section 424 of the body 412. With the coupling member 413 coupled to the second arm 426B of the body 412, the passage 444 of the coupling member 413 is configured to slidably receive the second and / or third sections 424A, 427A of the first arm 426A, as described below. The coupling member 413 may be coupled to the second arm 426B by methods, including, but not limited to adhesives, welding, or any other suitable coupling method. While the coupling member 413 is described herein as coupled to the second arm 426B of the body 412, this is not meant to be limiting, and the coupling member 413 may be coupled to the first arm 426A and configured to slidably receive a portion of the second arm 426B. Further, in other embodiments, the coupling member 413 may simply be disposed over the distal portions of the first and second arms 426A, 426B without being attached thereto.

[0150] While described herein with the coupling member 413, in an embodiment, the first arm 426A and the second arm 426B may be formed with sufficient rigidity or stiffness to prevent separation of the distal portion of the first arm 426A from the second arm 426B during loading of a heart valve prosthesis, and the coupling member 413 may be omitted from the capsule guide tube410. Further, in other embodiments, the body 412 may include threads to be coupled to a loading cone, as described above.

[0151] In embodiments herein, the locking member 414 of the capsule guide tube 410 is a generally tubular structure as shown in FIG. 13. The locking member 414 includes a first end 448, a second end 450, and a passageway 452 extending from the first end 448 to the second end 450. The passageway 452 of the locking member 414 is defined by an inner surface 496 having a sixth inner diameter ID6, wherein the sixth inner diameter ID6 is larger than the fourth outer diameter OD4 at the second end 418 of the body 412 and smaller than the third outer diameter OD3 at the first end 404 of the third longitudinal section 427 of the body 412. The locking member 414 is movable over the third longitudinal section 427 of the body 412 and exerts a radially inward force on a portion of the third longitudinal section 427 of the body 412 to releasably secure the capsule guide tube 410 to the outer shaft of the delivery device, proximal of the capsule of the delivery device. In other words, the locking member 414 is moved from the unlocked configuration with the locking member 414 disposed adjacent the second end 418 of the body 412 wherein the inner surface 496 does not exert a radially inward force on the body 412 to the locked configuration with the locking member 414 disposed adjacent the first end 404 of the third longitudinal section 427 wherein the inner surface 496 exerts a radially inward force on the body 412.

[0152] In embodiments herein, the locking member 414 may be secured in the locked configuration in a variety on non-limiting examples. In an embodiment, as shown in FIG. 14, the third longitudinal section 427 of the body 412 includes protrusions 447 (only one protrusion is shown in FIG. 14) extending radially outward from the outer surface 437 thereof that interact with slots 494 in the locking member 414 to secure the locking member 414 to the third longitudinal section 427 of the body 412. In the embodiment shown, the slots 494 are L-shaped such that the locking member 414 is secured to the body 412 a twist lock manner. Although the embodiment described herein includes two protrusions 447 and two slots 494, this is not meant to be limiting, and more or fewer protrusions and slots may be utilized. Further, the particular shape of the protrusions 447 and the slots 494 are examples only, and not meant to be limiting.

[0153] In another embodiment, shown in FIG. 15, the outer surface 437 of the third longitudinal section 427 of the body 412 includes first threads 462 and the inner surface 496 of a locking member 414’ includes second threads 464. To secure the locking member 414’ to the third longitudinal section 427 of the body 412 and apply the radially inward pressure to secure thecapsule guide tube 410 to the outer shaft 204 of the delivery device 200, the locking member 414’ is rotated such that the first threads 462 and the second threads 464 engage. The locking member 414’ is rotated to move the locking member 414 distally (towards the first end 416) along the third longitudinal section 427 of the body 412.

[0154] Other devices and methods for securing the locking member 414 to the third longitudinal section 427 of the body 412 may also be utilized.

[0155] The operation and interaction of the various components of the capsule guide tube 410 to releasably couple the capsule guide tube 410 to the outer shaft of a delivery device, for example, to the outer shaft 204 of the delivery device 200, will now be described.

[0156] In a step of the method, the second arm 426B of the body 412 with the coupling member 413 disposed around the second longitudinal section 424 thereof and the locking member 414 disposed around the third longitudinal section 427 thereof is disposed over a distal end of the delivery device 200. In greater detail, the distal end of the delivery device 200 is disposed through the passageway 452 of the locking member 414 and through the passageway 444 of the coupling member 414 of the capsule guide tube 410 such that the capsule 206 is disposed adjacent to an inner surface 432B of the second longitudinal section 424B of the second arm 426B and the distal portion of the outer shaft 204 of the delivery device 200 is disposed adjacent to an inner surface 437B of the third longitudinal section 427B of the second arm 426B, as shown in FIG. 16A.

[0157] In another step of the method, the first arm 426A of the body 412 is placed adjacent to the capsule 206 and the distal portion of the outer shaft 204 of the delivery device 200, opposite the second arm 426B. In greater detail, the second end 418A of the first arm 426A is slidingly disposed through the first end 442 and the passageway 444 of the coupling member 413, as indicated by arrow Al in FIG. 16A. The first arm 426A is translated in a first longitudinal direction LD1 towards the locking member 414, i.e., proximally, along an outer surface of the capsule 206 and the outer shaft 204 of the delivery device 200, and slidingly disposed through the first end 448 and the passageway 452 of the coupling member 414. The first arm 426A is translated in proximally until the shoulder 456 of the first arm 426A of the body 412 abuts the first end 442 of the coupling member 413. After this step in the method, the capsule guide tube 410 is disposed around the distal end of the delivery device 200, with the capsule guide tube 410 in the unlocked configuration, as shown in FIG. 16B.

[0158] In another step of the method, the locking member 414 is moved in a second longitudinal direction LD2, i.e., distally, opposite the first longitudinal direction LD1, as shown in FIG. 16C. As the locking member 414 moves over the third longitudinal section 427 of the body 412 in the second longitudinal direction LD2, the inner surface 496 of the locking member 414 exerts an increasing radially inward or compressive force on the third longitudinal section 427 of the body 412 of the capsule guide tube 410 as the first end 448 of the locking member 414 approaches the first end 404 of the third longitudinal section 427 of the body 412 due to the outer diameter of the third longitudinal section 427 increasing in the distal direction. This inward compressive force on the body 412 in turn applies a radially inward force on the outer shaft 204 of the delivery device 200, thereby releasably coupling or securing the capsule guide tube 410 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206, via friction.

[0159] Although in the embodiments described the locking member 414, 414’ applies radially inward pressure due to the third longitudinal section 427 of the body 412 having an outer diameter that tapers in the proximal direction, this is not meant to be limiting. In other embodiments, the outer diameter of the third longitudinal section 427 of the body 412 may be marginally smaller than the outer diameter of the outer shaft of the delivery device such that when the locking member 414, 414’ is moved over the third longitudinal section 427 to close the arms of the third longitudinal section 427A, 427B, the third longitudinal section grips the outer shaft of the delivery device, proximal of the capsule. In other embodiments, a tapered inner surface of the third longitudinal section 427 may include graduated ridges to grip the outer shaft when the third longitudinal section 427 is closed by the locking member 414, 414’.

[0160] It is noted that the manner in which the locking member 414 is moved distally depends on the specific embodiment of the locking member. For example, if the locking member is the locking member 414 described with respect to FIG. 14, the locking member 414 is translated distally over the third longitudinal section 427 of the body 412. In another step of the method, the locking member 414 of FIG. 15 is rotated such that protrusions 447 align with slots 494. After the protrusions 447 enter the slots 494, the locking member 414 is rotated to secure the protrusions 447 with the slots 494, thereby securing the locking member 414 to the body 412. If the locking member is the locking member 414’ described with respect to FIG. 15, the locking member 414’ is rotated such that the second threads 464 on the inner surface 496 of the locking member 414’ engage the first threads 462 on the outer surface of the third longitudinal section 427 of the body412. Continued rotation of the locking member 414’ advances the locking member 414’ distally along the first threads 462.

[0161] With the capsule guide tube 410 secured to the distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, additional components of a loading system including, but not limited to a loading cone, a loading ring, a valve seat, a tip guide tube, and a loading tray may be utilized to load a heart valve prosthesis into the capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. As explained therein, the capsule guide tube 410 is secured to the delivery device 200 (in this embodiment to the outer shaft 204) such that the capsule guide tube 410 moves distally with the outer shaft 204 and capsule 206 to push the loading cone over the transcatheter heart valve prosthesis while maintaining the heart valve prosthesis longitudinally stationary to radially compress the heart valve prosthesis and load the heart valve prosthesis into the capsule 206.

[0162] Releasably securing the capsule guide tube 410 to a distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, instead of to the capsule 206, prevents the capsule guide tube 410 from damaging a coating, such as a hydrophilic coating, on an outer surface of the capsule 206 during loading of a heart valve prosthesis therein. Releasably securing the capsule guide tube 410 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206, instead of to the capsule 206, also permits radial expansion or flaring of the capsule 206 during loading of the heart valve prosthesis therein, easing loading of the heart valve prosthesis into the capsule 206 of the delivery device 200.

[0163] FIGS. 17-22 illustrate a capsule guide tube for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. The embodiments of FIGS. 17-22 include a non-slip coating on an inner surface of the body of the capsule guide tube, as explained below. Those skilled in the art will recognize that the non-slip coatings described with respect to FIGS. 17-22 may be used with any capsule guide tube, such as, but not limited to, the capsule guide tubes described above and the capsule guide tubes described in International Publication No. WO 2024 / 044597, assigned to Medtronic, Inc., which is incorporated by reference herein in its entirety. FIGS. 17-19C illustrate various components of a capsule guide tube. FIGS. 20A-20B illustrate the operation of the capsule guide tube with a capsule of a delivery device. FIG. 21 illustrates a capsule guide tube configured to be secured to an outershaft of a delivery device, proximal to a capsule, and having a non-slip coating. FIG. 22 illustrates embodiments of a capsule guide tube with a frangible mechanism.

[0164] In embodiments herein, as shown in FIG. 17, a capsule guide tube 510 includes a body 512 and a locking member 514. In embodiments herein, the body 512 of the capsule guide tube 510 is configured to be disposed on a distal portion of the delivery device. The locking member 514 is slidable over a portion of the body 512 to transition the capsule guide tube 510 from an unlocked configuration to a locked configuration. In the locked configuration, the locking member 514 exerts an inward or compressive force on a portion of the body 512, which in turn applies a radially inward force to the delivery device, thereby releasably coupling, locking, or securing the capsule guide tube 510 to the delivery device, as described above and in International Publication No. WO 2024 / 044597, incorporated by reference herein.

[0165] The body 512 of the capsule guide tube 510 includes a first (distal) end 516, a second (proximal) end 518, and a central passageway 520 extending between the first end 516 and the second end 518. The body 512 may be generally tubular and includes an outer surface 531 and an inner surface 532 defining the central passageway 520. The body 512 includes a first longitudinal section 522 and a second longitudinal section 524. The first longitudinal section 522 extends from the first end 516 to a second end 517 of the first longitudinal section 522. The first longitudinal section 522 includes or defines a first portion 521 of the central passageway 520. The first portion 521 of the central passageway 520 extends from the first end 516 of the body 512 to the second end 517 of the first longitudinal section 522. In embodiments herein, the first portion 521 of the central passageway 520 may include a first or tapered section 521 A and a second or cylindrical section 521B. In embodiments herein, the first section 521A of the central passageway 520 is tapered in a direction towards the second section 52 IB of the central passageway 520 such that a first inner diameter ID1 adjacent to the first end 516 of the body 512 is larger than a second inner diameter ID2 adjacent to the second section 521B of the central passageway 520. In embodiments herein, the second section 52 IB of the central passageway 520 is cylindrical with the second inner diameter ID2. Those skilled in the art will recognize that other embodiments for the first longitudinal section 522 may be utilized without departing from the scope of the invention.

[0166] The second longitudinal section 524 of the body 512 extends from a first end 519 adjacent to the second end 517 of the first longitudinal section 522 to the second end 518 of the body 512. In embodiments herein, the second longitudinal section 524 of the body 512 is a tubularconstruction and includes a second portion 523 of the central passageway 520 extending from the first end 519 of the second longitudinal section 524 to the second end 518 of the body 512. In embodiments herein, the second portion 523 of the central passageway 520 is shaped and sized to receive a corresponding capsule of a delivery device. In embodiments herein, the second portion 523 of the central passageway 520 includes a third inner diameter ID3, wherein the third inner diameter ID3 is generally equal to or slightly larger than an outer diameter of the capsule of the delivery device to be disposed therein. In an embodiment, when the capsule guide tube is in the locked configuration with the delivery device disposed therein, an inner surface 532 of the second longitudinal section 524 is configured to contact or engage the outer surface of the capsule of the delivery device to releasably secure the capsule guide tube 510 to the delivery device, as described below.

[0167] In embodiments herein, the locking member 514 of the capsule guide tube 510 is a generally tubular structure as shown in FIG. 17. The locking member 514 includes a first end 548, a second end 550, and a passageway 552 extending from the first end 548 to the second end 550. The locking member 514 is slidable over a portion of body 512. The locking member 514 is configured to exert a radially inward force on a portion of the second longitudinal section 524 of the body 512 when the capsule guide tube 510 is in the locked configuration. The locking member 514 and the body 512 may include features disclosed above or in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety, to lock the locking member in the locked configuration and / or to secure the capsule guide tube 510 to the delivery device. For example, and not by way of limitation, the relative diameters of the passageway 552 of the locking member 514 and the outer diameter of the body 512 may change such that the locking member applies a radially inward force on the body. In another non-limiting example, the body 512 may include bumps, such as the proximal and distal bumps disclosed in International Publication No. WO 2024 / 044597.

[0168] In the embodiment shown in FIGS. 17-20C, the locking member 514 is movable towards the second (proximal) end 518 of the body 512 to transition the capsule guide tube 510 from the unlocked configuration to the locked configuration, as described in the embodiments above. However, this is not meant to be limiting, and the locking member 514 may instead be movable towards the first (distal) end 516 to transition the capsule guide tube 510 from the unlocked configuration to the locked configuration, as described in the embodiments inInternational Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. Further, the capsule guide tube 510 may be configured such that the locking member 514 secures the capsule guide tube 510 to the capsule 206 of the delivery device 200, or to the outer shaft 204 of the delivery device 200 proximal of the capsule 206.

[0169] In the embodiments of FIGS. 17-20C, the capsule guide tube 510 further includes a nonslip coating 503 disposed on the inner surface 532 of the second longitudinal section 524 of the body 512. The non-slip coating 503 is configured to be located on the portion of the inner surface 532 of the body 512 that is configured to contact the capsule of the delivery device. Thus, as can be seen at least in FIGS. 17, 19A, and 19B, the non-slip coating 503 is disposed along a distal portion of the inner surface 540 of the body 512. The non-slip coating 503 grips the capsule 206 of the delivery device 200 to limit relative longitudinal movement between the body 512 and the capsule 206. The non-slip coating thereby is configured to reduce the active clamping required to maintain the capsule guide tube 510 secured to the delivery device 200, while enabling expansion of the distal portion of the capsule guide tube 510 during loading. Thus, in the embodiment shown, the coating 503 may be particularly useful in portions of the capsule guide tube 510 that are not actively clamped to the delivery device 200.

[0170] The non-slip coating 503 may be formed as part of the body 512 or may be formed separately and coupled to the inner surface 532 of the body 512. For example, and not by way of limitation, the body 512 may be formed of a multi-shot injection molding process. In such a process, the body 512 may be injection molded and formed of materials such as, but not limited to, polycarbonate (e.g., Makrolon 2458), acrylic (e.g., PMMA), and / or PETG. The non-slip coating 503 may also be injection molded as part of the multi-shot injection molding process, and may be formed of materials such as, but not limited to, polyurethane or thermoplastic elastomers (TPE) such as polyether block amide (e.g. PEBAX® or VESTAMID®), which are suitable for injection molding and may be formulated to have non-slip properties. Multi-shot injection molding is an industry standard manufacturing process for multi material components. In the present example, such a multi-shot injection molding process may be implemented as described below. In a first step, the substrate (i.e., the outer shell or body 512) of the capsule guide tube 510 is injection molded from a material such as polycarbonate or acrylic. Features may be included in this molding to create a mechanical interlock with the non-slip portion. In a second step, the mold is transferred to a second chamber of the injection molding machine. The mold is positioned such that aninjection nozzle through which the non-slip material (e.g., the non-slip coating 503) to be injected is correctly positioned. In a third step, the non-slip material (polyurethane or thermoplastic elastomers) is injection molded, bonding to the substrate. In a fourth step, the finished component is ejected. In other embodiments, the non-slip coating 503 may be manufactured separately from the body 512 and applied to the inner surface 532 of the body 512. Materials such as, but not limited to silicone, polyvinyl chloride (PVC), ethyl vinyl acetate (EVA), and acrylic materials, or other materials with non-slip properties may be used for the non-slip coating 503. In this context, non-slip is used to generally to refer to polymeric materials which may exhibit the following: low durometer, amorphous structure, viscoelastic, having high surface energy relative to substrate, having surface texture properties conducive to increased surface area contact and / or mechanical interlocking with substrate, having surface chemistry properties such that Van der Walls (molecular attraction) forces occur between the non-slip material and material of the body 512. Non-slip materials as used herein may also be used to describe tackiness of the material such that the material of the non-slip coating 503 exhibits greater tackiness than the material of the body 512. Similarly, viscoelasticity is generally associated with tackiness such that in the embodiments described herein, the material of the non-slip coating exhibits greater viscoelasticity than the material of the body 512. The non-slip coating 503 may be coupled to the inner surface 532 of the body 512 by adhesives and / or press fit into a recess or recesses formed in the inner surface 532 of the body 512.

[0171] The non-slip coating 503 does not need to cover the entire portion of the inner surface 532 of the body 512 configured to contact the capsule of the delivery device. For example, and not by way of limitation, and as described above, the non-slip coating 503 is described as disposed on an inner surface of the second longitudinal section 524 of the body 512, which is at the distal end of the body 512. In embodiments, the non-slip coating 503 may be disposed only in the second longitudinal section 524. In another example, and not by way of limitation, as shown in FIG. 19A, the coating 503 may cover portions of the circumference of the inner surface 532 of the body 512. In the embodiment of FIG. 19A, there are two circumferential portions 503A, 5O3B of the coating 503 separated by circumferential gaps 505 A, 505B. However, this is not meant to be limiting, and the coating 503 may be separated into more circumferential portions, such as three circumferential portions, or four circumferential portions, or five circumferential portions, or six or more circumferential portions. In such embodiments, the circumferential portions may be longitudinallycontinuous such that the coating 503 is configured as longitudinal stripes along the inner surface 532 of the body. In another embodiment, the coating 503 may include circumferential rings 503 A- 503H separated longitudinal gaps 505A-505G, as shown in FIG. 19C. The quantity of circumferential rings and longitudinal gaps shown is not meant to be limiting, and there may be more or fewer circumferential rings and more or fewer longitudinal gaps. In such an embodiment, the circumferential rings 505A-505G may be continuous around the circumference of the inner surface 532 such that the circumferential rings 505A-505G are configured as circumferential stripes. Further, the embodiments of FIGS. 19A and 19C may be combined such that the coating 503 includes both circumferential gaps and longitudinal gaps. Thus, in embodiments, the coating 503 may cover at least 50%, or at least 60 %, or at least 70%, or at least 80% of the length of the second longitudinal section 524 (i.e., the length of the capsule of the delivery device configured to be disposed within the capsule guide tube 510). Also in embodiment, the coating 503 may cover at least 40%, or at least 50%, or at least 60%, or at least 70% of the total surface area of the inner surface 532 of the second longitudinal section 524 of the body 512.

[0172] In the embodiment of FIGS. 17-20B, the body 512 of the capsule guide tube 510 may include a first arm 526A and a second arm 526B, separated longitudinally, as explained in the embodiments above and in International Publication No. WO 2024 / 044597.

[0173] The operation and interaction of the various components of the capsule guide tube to releasably secure the capsule guide tube 510 to a delivery device, for example, the delivery device 200, will now be described. In a step of the method, a distal portion of the delivery device 200 is disposed within the capsule guide tube 510 with the capsule guide tube in the unlocked configuration, as shown in FIG. 20A. In the particular embodiment shown, the locking member 514 is disposed adjacent the first end 516 of the body 512 of the capsule guide tube 510 in the unlocked configuration. However, as explained above, this is not meant to be limiting. The capsule 206 of the delivery device 200 is received within the distal portion of the body 512, as shown in FIG. 20A.

[0174] In another step of the method, the locking member 514 is translated in a proximal direction LD2 such that the locking member 514 move towards the second end 518 of the body 512, as shown in FIG. 20B. As the locking member 514 moves in the proximal direction LD2 over the second longitudinal section 524 of the body 512, the locking member 514 exerts an inward or compressive force on the proximal portion of the second longitudinal section 524 of the body 512of the capsule guide tube 510, which in turn applies a radially inward force to the capsule 206 of the delivery device 200. The radially inward force increases as the locking member 514 moves in the proximal direction LD2. The radially inward force releasably secures the capsule guide tube 510 to an outer surface of the capsule 206 of the delivery device 200. As can be seen in FIG. 20B, the non-slip coating 503 is disposed on the inner surface 532 of the body 512 in the distal portion of the body 512, distal of where the locking member 514 is actively clamping the body 512 to the capsule 206. The radially inward force exerted by the locking member 514 may be due to the outer diameter of the second longitudinal section 524 of the body 512 increasing in the proximal direction (as described above), and / or rails on the locking member 514 and body 512 (as described above), or other features known to those skilled in the art. The non-slip properties of the non-slip coating 503 impedes longitudinal movement of the capsule 206 relative to the capsule guide tube 510 such that the clamping force required to maintain the capsule guide tube 510 secured to the capsule 506 is less than without the non-slip coating 503. However, this is not meant to be limiting, and the non-slip coating 503 may also be disposed on the inner surface 532 of the body 512 in the portion that is actively clamped to the capsule 206 by the locking member 514.

[0175] While the embodiment described in FIGS. 17-20B show the capsule guide tube 510 secured to the capsule 206 of the delivery device, as discussed above, this is not meant to be limiting. For example, FIG. 21 shows a non-slip coating 403 as described with respect to FIGS. 17-20B applied to the capsule guide tube 410 described above with respect to FIG. 11. Similarly, a non-slip coating can be used with the capsule guide tube of FIG. 3. In the embodiment of FIG. 21, the non-slip coating 403 is disposed on an inner surface 432 of the body 412 adjacent the first end 416 of the body 412. The non-slip coating 403 is disposed on the inner surface 432 in the location where the capsule 206 is configured to be disposed. As described above, the locking member of the capsule guide tube 410 applies a radially inward force on a portion of the body 412 configured to surround the outer shaft 204 of the delivery device 200, proximal of the capsule 206. The non-slip coating 403 grips the capsule 206 of the delivery device 200 to limit relative longitudinal movement between the body 412 and the capsule 206. The non-slip coating 403 thereby is configured to reduce the active clamping required by the locking member 414 to maintain the capsule guide tube 410 secured to the delivery device 200, while enabling expansion of the distal portion of the capsule guide tube 410 during loading.

[0176] In the embodiments described above, the capsule guide tubes are configured to be placed over the capsule of the delivery device at the geographical location of the treatment (e.g., a hospital). In other embodiments, it may be beneficial to assemble the capsule guide tube to the delivery device at the manufacturing site and ship the delivery device with the capsule guide tube secured thereto. Such assembly at the manufacturing site may protect the capsule of the delivery device from damage during shipment and assembly by an end user and may prevent or limit contact between a hydrophilic coating on an outer surface of the capsule of the delivery device and a saline loading bath during loading of a heart valve prosthesis, thereby preventing premature activation of the hydrophilic coating on the capsule of the delivery device.

[0177] In pre-assembled embodiment herein, a capsule guide tube 610 includes a body 612 including a frangible mechanism 650. The body 612 may be similar to the embodiments described in any of the embodiments above or in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. However, in the embodiment of FIG. 22, a locking member is not needed. Instead, the body 612 of the capsule guide tube 610 is secured to the capsule 206 of the delivery device 200 at the manufacturing site. Thus, the body 612 further includes a first or distal end 616, a second or proximal end 218, and a central passageway 620 extending from the first end 616 to the second end 618. In the embodiment shown in FIG. 22, the capsule guide tube 610 further includes a non-slip coating 603 coupled to an inner surface 632 of the body 612, as described above. However, this is not meant to be limiting, and in other embodiments, the capsule guide tube 610 does not include a non-slip coating 603. The body 612 includes the frangible mechanism 650 configured to separate the body 612 into two longitudinal parts or otherwise enable the body to be removed from the delivery device. Thus, upon completion of loading the heart valve prosthesis into the capsule 206 of the delivery device 200, the user activates the frangible mechanism 650 to separate the body 612 to enable the body 612 to be removed from the delivery device 200, or to otherwise enable the body 612 to be removed from the delivery device 200. In the embodiment shown in FIG. 22, the frangible mechanism 650 is a perforated longitudinal junction coupling longitudinal halves of the body 612. However, this is not meant to be limiting. Further, although the body 612 is described as a single body 612, it may be assembled at the manufacturing site as two arms as described above, which are secured to each other at the manufacturing site. In such embodiments, the frangible mechanism 650 will enable the arms to be separated by the user after loading the heart valve prosthesis into the capsule 206 of the deliverydevice 200. Such a frangible mechanism 650 may be a perforation at the junction of the arms, a breakable bond between the arms (such as a weak weld or weak chemical connection), and / or a removable or peelable covering. In embodiments, the frangible mechanism may include a tab 652 that a user may pull to initiate breaking or peeling the frangible mechanism 650.

[0178] FIGS. 23-27B illustrate a capsule guide tube 710 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. FIGS. 23-26 illustrate various components of the capsule guide tube 710. FIGS. 27A-27B illustrate the operation of the capsule guide tube 710 with a delivery device. The capsule guide tube 710 is configured to be releasably coupled, secured, or locked to an outer shaft of the delivery device. The capsule guide tube 710 includes a tube or body 712 and a locking member 714 for securing the capsule guide tube 710 to the outer shaft of the delivery device.

[0179] In embodiments, the body 712 may be a one-piece (unitary), symmetrical, tubular shape that permits a distal portion of a capsule of the delivery device disposed therein to expand or flare symmetrically during loading of a heart valve prosthesis. It has been found by the inventors that enabling the capsule of the delivery device to radially expand a small amount during loading of the heart valve prosthesis into the capsule reduces node overlap and infolding of the heart valve prosthesis during such loading. Further, the body being a one-piece, symmetrical tubular shape enables symmetrical expansion of the body 712 during loading of the heart valve prosthesis into the capsule, which has also been found to reduce node overlap of the frame of the heart valve prosthesis and reduce infolding. As used herein, the term “one-piece” and / or “unitary” means that the body 712 is formed of a single piece rather than multiple pieces coupled to each other, such as the bodies of the capsule guide tubes described above that are formed as two halves. The body 712 includes a first (distal) end 716, a second (proximal) end 718, and a central passageway 720 extending from the first end 716 and the second end 718. The body 712 includes a first longitudinal section 722 and a second longitudinal section 724.

[0180] The first longitudinal section 722 extends from the first end 716 to a second end 717 of the first longitudinal section 722. In embodiments herein, the first longitudinal section 722 includes a tapered outer surface 730. The tapered outer surface 730 of first longitudinal section 722 is tapered in a direction towards the first end 716 of the body 712, i.e., distally, such that a second outer diameter OD2 adjacent to the second end 717 of the first longitudinal section 722 is larger than a first outer diameter GDI adjacent to the first end 716 of the body 712. The firstlongitudinal section 722 of the body 712 includes an inner surface 733 that defines a first portion 721 of the central passageway 720. The first portion 721 of the central passageway 720 extends from the first end 716 of the body 712 to the second end 717 of the first longitudinal section 722. In embodiments herein, the first portion 721 of the central passageway 720 may include a first or tapered section 721A and a second or cylindrical section 721B. In embodiments herein, the first section 721 A of the central passageway 720 is tapered in a direction towards the second section 72 IB of the central passageway 720, i.e., proximally, such that a first inner diameter ID 1 adjacent to the first end 716 of the body 712 is larger than a second inner diameter ID2 adjacent to the second section 72 IB of the central passageway 720. In embodiments herein, the second section 72 IB of the central passageway 720 is cylindrical with the second inner diameter ID2. The description herein of the first longitudinal section 722 is based on the first longitudinal section 722 interacting with a proximal end of a loading cone of a loading device, such as the loading cones described in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. Accordingly, the description of the first longitudinal section 722 of the body 712 is not meant to be limiting, and other configurations may be utilized to depending on the interaction of the distal end of the capsule guide tube 710 with a loading cone of the loading system. For example.

[0181] The second longitudinal section 724 of the body 712 extends from a first end 719 adjacent to the second end 717 of the first longitudinal section 722 to the second end 718 of the body 712. In embodiments herein, the second longitudinal section 724 of the body 712 is substantially cylindrical and includes an outer surface 731 having a third outer diameter OD3, wherein the third outer diameter OD3 is smaller than the second outer diameter OD2. Accordingly, a shoulder 735 is formed between the outer surface 730 at the second end 717 of the first longitudinal section 722 and the outer surface 731 at the first end 719 of the second longitudinal section 724 of the body 712. The second longitudinal section 724 further includes an inner surface 732 defining a second portion 723 of the central passageway 720 extending from the first end 719 of the second longitudinal section 724 to the second end 718 of the body 712. As described above, body 712 may have a one-piece shape, which may result in inner surface 732 being smooth, uninterrupted, and / or seamless around an entire circumference and length thereof. In embodiments herein, the second portion 723 of the central passageway 720 is shaped and sized to receive a corresponding capsule of a delivery device. In embodiments herein, the second portion 723 of thecentral passageway 720 includes a third inner diameter TD3, wherein the third inner diameter ID3 is generally slightly larger than an outer diameter of the capsule of the delivery device to be disposed therein. Thus, the second portion 723 of the central passageway 720 offers sufficient clearance to an outer surface of the capsule of the delivery device disposed therein to reduce or eliminate potential damage to a coating, such as a hydrophilic coating on the outer surface of the capsule of the delivery device. The one-piece (unitary) tubular shape of the body 712 also minimizes sharp edges to reduce potential damage to a coating disposed on the capsule of the delivery system. The tubular shape and clearance of the second portion 723 of the central passageway 720 relative to the capsule permits symmetrical expansion or flaring of a distal end of the capsule during loading of a heart valve prosthesis therein.

[0182] In the embodiment shown in FIG. 24, a proximal portion 737 of the body 712 includes a plurality of recesses 792. Each recess 792 is configured to receive a corresponding tab 790 of the locking member 714 to releasably couple the locking member 714 to the body 712, as described below. In the embodiment herein, the body 712 includes two recesses 792 disposed opposite each other around the circumference of the body 712, but this is not meant to be limiting, and there may be more of fewer recesses 792. Further, in the embodiment shown, the recesses 792 are rectangular in shape, but this is not meant to be limiting, and the recesses 792 may be other shapes to correspond with shapes of the corresponding tabs 790 of the member 714. Each recess 792 may be formed, for example, and not by way of limitation, integrally with formation of the body 712, or may be formed, for example, and not by way of limitation, by machining, cutting, or any other suitable method for removing material from the body 712. In the embodiment shown, the recesses 792 extend from the outer surface 731 to the inner surface 732 of the second longitudinal section 724 of the body 712 (z.e., are through-holes), but this is not meant to be limiting, and in other embodiments the recesses 792 may extend only part of the distance from the outer surface 731 of the second longitudinal section 724 of the body 712 to the inner surface 732.

[0183] In embodiments herein, the locking member 714 includes a first (distal) end 748, a second (proximal) end 750, and a central passageway 752 extending from the first end 748 to the second end 750. In embodiments herein, the locking member 714 may be formed of a first section 714A and a second section 714B, as shown in FIG. 26. In embodiments herein, the first section 714A and the second section 714B are each approximately half of the locking member 714, divided generally longitudinally (z.e., each section 714A, 714B is approximately a circumferential half ofthe locking member). The locking member 714 includes a first state wherein the first section 714A and the second section 714B are not assembled around the proximal portion 737 of the body 712, and a second state wherein the first section 714A and the second section 714B of the locking member 714 are releasably coupled to the proximal portion 737 of the body 712. The locking member 714 is configured to exert a radially inward force on a portion of an outer shaft of a delivery device, proximal of a capsule of the delivery device, to releasably couple the capsule guide tube 710 to the delivery device when the locking member 714 is in the second state such that the capsule guide tube 710 is in a locked configuration, as described below.

[0184] When the locking member 714 is in the second state, the central passageway 752 of the locking member 714 is stepped such that a distal portion 752A of the central passageway 752 has a fourth diameter ID4 and a proximal portion 752B of the central passageway 752 has a fifth diameter ID5, wherein the fifth diameter ID5 is smaller than the fourth diameter ID4. A shoulder 777 is defined between the distal portion 752A and the proximal portion 752B of the central passageway 752. In the embodiment shown, the outer surface of the locking member 714 is also stepped such that a proximal portion 772 thereof has a smaller outer diameter than a distal portion 770 thereof, but that is not meant to be limiting and the outer surface need not be stepped.

[0185] In the second state, the distal portion 752A of the central passageway 752 is configured to be disposed around the body 712 of the capsule guide tube 710 in the second state. Thus, the fourth diameter ID4 of the distal portion 752A of the central passageway 752 of the locking member 714 is approximately the same as or slightly larger than the third outer diameter OD3 of the proximal portion 737 of body 712 of the capsule guide tube 710. In the second state, the proximal portion 752B of the central passageway 752 of the locking member 714 is configured to be disposed around a distal portion of an outer shaft of a delivery device, proximal to a capsule of the delivery device. As explained above, the distal portion of the outer shaft of the delivery device is generally smaller in diameter than the capsule of the delivery device. Thus, in the second state of the locking member 714 (the locked configuration of the capsule guide tube 710), the proximal portion 752B of the central passageway 752 of the locking member 714 is sized to exert a radially inward force onto the outer shaft of the delivery device to releasably coupled the capsule guide tube 710 to the delivery device. In particular, the fifth diameter ID5 of the proximal portion 752B of the central passageway 752 of the locking member 714 is slightly smaller than the outer diameter of the distal portion of the outer shaft of the delivery device. Further, the shoulder 777 ofthe central passageway 752 is configured to abut against the second (proximal) end of the body 712 of the capsule guide tube 710.

[0186] Further, a plurality of protrusions 778 may extend radially inward from the inner surface 776 of the proximal portion 772 of the locking member 714 defining the proximal portion 752B of the central passageway 752, as best seen in FIG. 25. The protrusions 778 may assist in engaging or gripping an outer surface of the outer shaft of the delivery device when locking member 714 is in the second state and the capsule guide tube 710 is in the locked configuration. The particular embodiment shown in FIGS. 23-26 show four protrusions 778, each extending longitudinally from along the inner surface 776 of the proximal portion 772 of the locking member 714, however this is not meant to be limiting, and more or fewer protrusions 778 may be utilized, and they may be different lengths than shown.

[0187] As briefly explained above, and best shown in FIG. 26, the locking member 714 may include the plurality of protrusions or tabs 790. In the embodiment shown, there are two tabs 790, one on each of the first and second sections 714A, 714B of the locking member. Each tab 790 is configured to be received by the corresponding recess 792 of the body 712 described above. A first tab 790A extends radially inward from the inner surface 774 of the distal portion 770 of the first section 714A defining the distal portion 752A of the central passageway 752. A second tab 790B extends radially inward from the inner surface 774 of the distal portion 770 of the first section 714B defining the distal portion 752A of the central passageway 752. The tabs 790 are generally rectangular in shape corresponding to the shape of the recesses 792 described above. However, this is not meant to be limiting, and other shapes may be utilized. Further, while two tabs 790 are shown, more or fewer tabs 790 may be utilized. Each tab 790 may be formed, for example, and not by way of limitation, as an integral portion of corresponding first or second section 714A, 714B of the locking member 714 or as separate units, coupled to the corresponding first or second section 714A, 714B by methods such as, but not limited to adhesives, welding, or other methods as appropriate.

[0188] In the embodiment of FIGS. 23-26, the first section 714A and the second section 714B of the locking member 714 may be coupled together and aligned via a plurality of matching or corresponding protrusions or tabs 782 and recesses 784. Each protrusions 782 aligns with and is received within a corresponding recess 784 when the locking member 714 is transitioned to the second state (locked configuration). In an embodiment, the plurality of protrusions 682 extendfrom a circumferential edge surfaces 786A, 786B of the distal portion 770 of the first section 714A. The corresponding plurality of recesses 784 are disposed in correspondence circumferential edge surfaces 788A, 788B of the distal portion 770 of the second section 714B. When the locking member 714 is in the second state (locked configuration), the circumference edge surfaces 786A, 786B of the first section 714A abut the correspondence circumferential edge surfaces 788A, 788B of the second section 714B such that each protrusion 782 is received within the corresponding recess 784. While shown in FIG. 26 with a specific number of protrusions 782 of specific shapes and in specific locations on the first section 714A, and a corresponding number of recesses 784 with corresponding shapes in corresponding locations on the second section 714B of the locking member 714, this is not meant to be limiting, and any number of protrusions of any shape, and an equal number of corresponding recesses may be utilized in any combination and in suitable locations. The plurality of protrusions 782 may be formed, for example, and not by way of limitation, as an integral portion of the first section 714A (i.e., formed as one-piece, unitary) or as separate pieces, coupled to the first section 714A by methods such as, but not limited to adhesives, welding, or other methods as appropriate. Each recess 784 may be formed, for example, and not by way of limitation, integrally with the formation of the second section 714B, or may be formed, for example, and not by way of limitation, by machining, cutting, or any other suitable method for removing material from the second section 714B. In other embodiments, in addition to or instead of the protrusions 782 and recesses 784 formed in the distal portions 770 of the first and second sections 714A, 714B, protrusions and recesses may be formed on the proximal portions 772 of the first and second sections. Further, other devices and methods for securing the first and second sections 714A, 714B to each other and to the outer shaft of the delivery device may be utilized.

[0189] The operation and interaction of the various components of the capsule guide tube 710 releasably couple the capsule guide tube 710 to an outer shaft of a delivery device, for example, the outer shaft 204 of the delivery device 200 described previously, will now be described. As shown in FIG. 27A, in a step of the method, a distal portion of the delivery device 200 is disposed within the body 712 of the capsule guide tube 710 with the capsule guide tube 710 in the unlocked configuration. In greater detail, the distal portion of the delivery device 200 is received within the second (proximal) end 718 of the body 712 of the capsule guide tube 710 and advanced in a distal or first longitudinal direction LD1 such that the distal end of the capsule 206 of the delivery device 200 abuts or is adjacent to the first (distal) end 719 of the second longitudinal section 724 of thebody 712, with the capsule 206 of the delivery device 200 disposed within the second portion 723 of the central passageway 720. It is noted that instead of advancing the delivery device 200 distally, the body 712 may be advanced proximally over the capsule 206, or both the delivery device 200 may be advanced distally and the body 712 advanced proximally.

[0190] In another step in the method, the first and second sections 714A, 714B of the locking member 714 are disposed over the proximal portion 737 of the body 712 of the capsule guide tube 710 and a portion of the delivery device 200, as shown in FIG. 27B. In more detail, the first section 714A and the second section 714B are disposed around the proximal portion 737 of the body 712 and a distal portion of the outer shaft 204 of the delivery device 200, with the circumferential edge surfaces 786A, 786B of the first section 714A facing the corresponding circumferential edge surfaces 788A, 788B of the second section 714B. The first and second sections 714A, 714B are brought together such that the plurality of protrusions 782 of the first section 714A are received within the corresponding recesses 784 of the second section 714B, the circumferential edge surfaces 786A, 786B abut the corresponding circumferential edge surfaces 788A, 788B, and the first and second tabs 790A, 790B of the first and second sections 714A, 714B are received within the corresponding recesses 792A, 792B of the body 712. Thus, the locking member 714 is secured to the body 712 and the distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, such that the proximal portion 737 of the body 712 is received within the distal portion 752A of the central passageway 752 of the locking member 714, and a distal portion of the outer shaft 204 of the delivery device 200 is received within the proximal portion 752B of the central passageway 752 of the locking member 714. Further, the proximal portion 752B of the central passageway 752 of the locking member 714 exerts a radially inward force on the distal portion of the outer shaft 204 of the delivery device, proximal of the capsule 206, to secure the capsule guide tube 710 to the delivery device 200 during loading of the heart valve prosthesis into the capsule 206 of the delivery device 200.

[0191] With the capsule guide tube 710 secured to the distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, additional components of a loading system including, but not limited to a loading cone, a loading ring, a valve seat, a tip guide tube, and a loading tray may be utilized to load a heart valve prosthesis into the capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. As explained therein, the capsule guide tube 710is secured to the delivery device 200 (in this embodiment to the outer shaft 204) such that the capsule guide tube 710 moves distally with the outer shaft 204 and the capsule 206 to push the loading cone over the transcatheter heart valve prosthesis while maintaining the heart valve prosthesis longitudinally stationary to radially compress the heart valve prosthesis and load the heart valve prosthesis into the capsule 206.

[0192] As noted above, one particular, non-limiting embodiment of the locking member 714 has been described. Other similar locking members may be utilized. For example, and not by way of limitation, in other embodiments, the first and second sections 714A, 714B of the locking member 714 may be attached together adjacent corresponding circumference edge surfaces 786A, 788A by a hinge 886 or similar mechanism, as shown in FIG. 28A. In the unlocked configuration shown in FIG. 28, the other circumferential edges surfaces 786B, 788B of the first and second sections are separated from each other. To transition the locking member 714 from the unlocked configuration to the locked configuration, the first and second sections 714A, 714B are rotated about the hinge 886 as indicated by the rotational arrow R1 such that the circumferential edge surfaces 786A, 788B about each other and the circumferential edge surfaces 786B, 788B abut each other. The first and second sections 714A, 714B can then be releasably locked to each other, such as by a releasable lock 888. In embodiments, the releasable lock 888 may be a catch / latch lock, as shown in FIGS. 28A and 28B, but this is not meant to be limiting. As would be understood by skilled in the art, other releasable locks may be utilized.

[0193] FIGS. 29-30B illustrate another capsule guide tube 810 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. FIG. 29 illustrates various components of the capsule guide tube 810. FIGS. 29-30B illustrate a method for releasably securing the capsule guide tube 810 to a delivery device 200. The capsule guide tube 810 is configured to be releasably coupled to, secured to, or locked to a proximal portion of a capsule 206 of the delivery device 200. The capsule guide tube 810 includes an unlocked configuration wherein the capsule guide tube 810 is not releasably secured to the capsule 206 of the delivery device 200, and a locked configuration wherein the capsule guide tube 810 is releasably secured to the proximal portion of the capsule 206 of the delivery device 200. In embodiments herein, the proximal portion of the capsule 206 is uncoated on an outer surface thereof. Therefore, releasably securing the capsule guide tube 810 to the proximal portionof the capsule 206 of the delivery device 200 will not damage a coating on a distal portion of the capsule.

[0194] In an embodiment, the capsule guide tube 810 includes a body 812 and a locking member 814, as shown in FIG. 29. The body 812 of the capsule guide tube 810 is configured to be disposed on a distal portion of the delivery device 200, in particular, on the capsule 206. The locking member 814 is configured to be threadably engaged over a portion of the body 812 and to exert an inward or compressive force on a portion of the body 812, which in turn applies a radially inward force to the proximal portion of the capsule 206 of the delivery device 200, thereby releasably coupling, locking, or securing the capsule guide tube 810 to the capsule 206 of the delivery device 200, proximal of a coating on a distal portion of an outer surface of the capsule 206, via friction.

[0195] The body 812 of the capsule guide tube 810 includes a first (distal) end 816, a second (proximal) end 818, and a central passageway 820 extending between the first end 816 and the second end 818. The body 812 includes a first longitudinal section 822 and a second longitudinal section 824. The first longitudinal section 822 extends from the first end 816 to a second end 817 of the first longitudinal section 822. The first longitudinal section 822 of the body 812 is a tubular construction and includes a generally circular outer surface 830. The first longitudinal section 822 includes or defines a first portion 821 of the central passageway 820. The first portion 821 of the central passageway 820 extends from the first end 816 of the body 812 to the second end 817 of the first longitudinal section 822. In embodiments herein, the first portion 821 of the central passageway 820 may be configured (e.g., sized) to permit radial expansion of the capsule 206 of the delivery device 200 disposed therein during loading of a heart valve prosthesis into the capsule 2006. Accordingly, a first inner diameter ID1 of the first portion 821 of the central passageway 820 may be larger than an outer diameter of a distal portion of the capsule 206 of the delivery device 200 disposed therein.

[0196] The second longitudinal section 824 of the body 812 extends from a first end 819 adjacent to the second end 817 of the first longitudinal section 822 to the second end 818 of the body 812. In embodiments herein, the second longitudinal section 824 of the body 812 is a tubular construction and includes an outer surface 831. The second longitudinal section 824 includes a second portion 823 of the central passageway 820 extending from the first end 819 of the second longitudinal section 824 to the second end 818 of the body 812. In embodiments herein, the secondportion 823 of the central passageway 820 is shaped and sized to receive a corresponding proximal portion of a capsule of a delivery device. The second portion 823 of the central passageway 820 includes a second inner diameter ID2 equal to or slightly smaller than an outer diameter of a proximal portion of the capsule 206 of the delivery device 200 disposed therein. Thus, when the capsule guide tube 810 is in the locked configuration with the delivery device 200 disposed therein, an inner surface of the second longitudinal section 824 contacts or engages the outer surface of the proximal portion of the capsule 206 of the delivery device 200 to releasably secure the capsule guide tube 810 to the delivery device 200, via friction. In some embodiments, the “proximal portion of the capsule” may refer to a portion of the capsule 206 without a coating on an outer surface thereof, however, this is not meant to be limiting.

[0197] In embodiments herein, the second longitudinal section 824 includes a first thread 862 on the outer surface 831 thereof. The first thread 862 extends radially outward from the outer surface 831 of the second longitudinal section 824 and is configured to engage a second thread 864 of the locking member 814 as described below. The first thread 862 may be formed for example, and not by way of limitation, as an integral portion of the second longitudinal section 824, or as a separate unit coupled to the outer surface 831 of the second longitudinal section 824 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. A first outer diameter OD1 of the second longitudinal section 824 refers to the outer diameter of the second longitudinal section 824 of the body 812 with the first thread 862. While the first thread 862 is shown in FIGS. 29-30B with a specific gender, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0198] The body 812 of the capsule guide tube 810 may be formed of a first arm 826A and a second arm 826B. In embodiments herein, the first arm 826 A and the second arm 826B are each approximately one-half of the body 812, divided generally longitudinally. Thus, the first arm 826A includes a first end 816A corresponding to the first end 816 of the body 812, and a second end 818A corresponding to the second end 818 of the body 812. The first arm 826A includes a first longitudinal section 822A corresponding to the first longitudinal section 822 of the body 812 and a second longitudinal section 824A corresponding to the second longitudinal section 824 of the body 812. Similarly, the second arm 826B of the body 812 includes a first end 816B corresponding to the first end 816 of the body 812, and a second end 818B corresponding to the second end 818of the body 812. The second arm 826B includes a first longitudinal section 822B corresponding to the first longitudinal section 822 of the body 812 and a second longitudinal section 824B corresponding to the second longitudinal section 824 of the body 812.

[0199] In embodiments herein, the locking member 814 of the capsule guide tube 810 is a generally tubular structure as shown in FIG. 29. The locking member 814 includes a first end 848, a second end 850, and a central passageway 852 extending from the first end 848 to the second end 850. The central passageway 852 of the locking member 814 is defined by an inner surface 896.

[0200] The second thread 864 is disposed on the inner surface 896 of the locking member 814 and extends radially inwardly, and may extend longitudinally from the first end 848 to the second end 850. In embodiments, the second thread 864 is tapered such that a third inner diameter ID3 of the second thread 864 at the first end 848 of the locking member 814 is greater than a fourth inner diameter ID4 at the second end 850 of the locking member 814. The third inner diameter ID3 of the locking member 814 is slightly larger than a first outer diameter GDI of the second longitudinal section 824 of the body 812 such that the second thread 864 at the first end 848 of the locking member 814 may easily engage and receive the first thread 862 of the second longitudinal section 824 of the body 812 therein. The fourth inner diameter ID4 of the locking member 814 is smaller than the first outer diameter OD1 of the second longitudinal section 824 of the body 812 such that as the first thread 862 engages and is received within the second thread 864 of the locking member 814, the inner surface 896 of the locking member 814 exerts an increasing inward radial force on the outer surface 831 of the second longitudinal section 824 of the body 812 to transition the capsule guide tube 810 from the unlocked configuration to the locked configuration. Stated another way, as the locking member 814 is threaded onto the second longitudinal section 824 of the body 812, the locking member 814 radially compresses the second longitudinal section 824 to engage with a proximal portion of the capsule 206 of the delivery device to releasably couple the capsule guide tube 810 to the capsule 206 of the delivery device 200. In other embodiments, the second thread 864 need not be tapered, and the second longitudinal section 824 of the body 812 may be manually compressed to engage the second thread 864 with the first thread 862 and then the locking member 814 may be advanced as described below.

[0201] The second thread 864 may be any suitable design corresponding to the first thread 862 of the body 812. The second thread 864 is configured to engage the first thread 862 of body 812to releasably couple the capsule guide tube 810 to the proximal portion of the capsule of the delivery device disposed therein. The second thread 864 may be formed for example, and not by way of limitation, as an integral portion of the locking member 814, or as a separate unit coupled to the inner surface 896 of the locking member 814 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While the second thread 148 is shown in FIGS. 29-30B with a specific gender, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0202] The operation and interaction of the various components of the capsule guide tube 810 to releasably couple the capsule guide tube 810 to a proximal portion of the capsule 206 of the delivery device 200 will now be described. As explained above, the capsule 206 and the delivery device 200 are examples only, and the description thereof is not meant to be limiting.

[0203] In a step of the method, the locking member 814 is disposed over a distal end of the delivery device 200, as shown in FIG. 29. More specifically, the distal end of the delivery device 200 is disposed through the central passageway 852 of the locking member 814 and the locking member 814 is moved in a first longitudinal direction LD1 i.e., proximally over a distal portion of the delivery device 200 and positioned proximal of the capsule 206 of the delivery device 200. The delivery device 200 may instead be moved distally through the locking member 814, or both the delivery device 200 and the locking member 814 may be moved in opposite directions relative to each other.

[0204] In another step of the method, the first arm 826A and the second arm 826B of the body 812 are each disposed over opposite sides of a distal end of the delivery device 200 such that a distal portion of the capsule 206 is disposed adjacent to an inner surface 833 of the first longitudinal section 822 and a proximal portion of the capsule 206 is disposed adjacent to an inner surface 832 of the second longitudinal section 824 of the body 812, as shown in FIG. 30A. In embodiments, the distal portion of the capsule 206 may include a coating and the proximal portion of the capsule 206 may not include a coating, but this is not meant to be limiting. With the capsule guide tube 810 in the unlocked configuration, the second longitudinal section 824 of the body 812 may not form a complete circumference around the proximal portion of the capsule 206 of the delivery device 200.

[0205] In another step of the method, the locking member 814 is moved in a second longitudinal direction LD2, i.e., distally, opposite the first longitudinal direction LD1, to engage the secondthread 864 with the inner thread 862. The locking member 814 is rotated in a first direction RD1 such that the second thread 864 moves along the first thread 862 and the locking member 814 moves distally in the direction LD2. As the locking member 814 is rotated and moves distally relative to the body 812, the inner surface 896 of the locking member 814 exerts an increasing radially inward or compressive force on the second longitudinal section 824 of the body 812 of the capsule guide tube 810. The compressive force increases as the first end 848 of the locking member 814 approaches the first end 819 of the second longitudinal section 824 of the body 812 due to the tapered inner diameter of the locking member 814 decreasing in the distal direction. This inward compressive force on the second longitudinal section 824 of the body 812 in turn applies a radially inward force on the proximal portion of the capsule 206 of the delivery device 200, thereby releasably coupling or securing the capsule guide tube 810 to the proximal portion of the capsule 206 of the delivery device 200 via friction.

[0206] With the capsule guide tube 810 secured to the proximal portion of the capsule 206 of the delivery device 200, additional components of a loading system including, but not limited to a loading cone, a loading ring, a valve seat, a tip guide tube, and a loading tray may be utilized to load a heart valve prosthesis into the capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. As explained therein, the capsule guide tube 810 is secured to the delivery device 200 (in this embodiment to the proximal portion of the capsule 206) such that the capsule guide tube 810 moves distally with the capsule 206 to push the capsule 206 over a transcatheter heart valve prosthesis while maintaining the heart valve prosthesis longitudinally stationary to radially compress the heart valve prosthesis and load the heart valve prosthesis into the capsule 206.

[0207] Releasably securing the capsule guide tube 810 to a proximal portion of the capsule 206 of the delivery device 200, proximal of a coating, prevents the capsule guide tube 810 from damaging the coating, such as a hydrophilic coating, on an outer surface of the distal portion of the capsule 206 during loading of a heart valve prosthesis therein. Further, releasably securing the capsule guide tube 810 to the proximal portion of the capsule of the delivery device 200, instead of to the distal portion or the overall outer surface of the capsule 206 permits radial expansion or flaring of the distal portion of the capsule 206 during loading of the heart valve prosthesis therein, easing loading of the heart valve prosthesis into the capsule 206 of the delivery device 200.

[0208] Although embodiments described above describe the locking member 814 applying a radially inward pressure due to the inner surface 896 of the second longitudinal section 824 of the body 812 having an inner diameter that tapers in the proximal direction, this is not meant to be limiting. In another embodiment the inner surface 896 of the locking member 814 may be uniform or not tapered, and the outer surface 831 of the second longitudinal section 824 of the body 812 may be tapered such that the locking member 814 applies radially inward pressure to the second longitudinal section 824 of the body 812 as the second thread 864 of the locking member 814 engages the first thread 862 of the second longitudinal section 824 of the body 812, and the locking member 814 moves in the second longitudinal direction LD2.

[0209] In another embodiment, the inner surface 896 of the locking member 814 may be uniform or not tapered, and the outer surface 831 of the second longitudinal section 824 of the body 812 may be uniform or not tapered. In embodiments, second longitudinal section 824 of the capsule guide tube 810 may be manually compressed over the proximal portion of the capsule 206 of the delivery device 200 and the locking member 814 may engage and receive the second longitudinal section 824 of the body 812 to releasably couple the capsule guide tube 810 to the capsule 206 of the delivery device 200. In greater detail, the second longitudinal section 824 of the body 812 is manually compressed such that the outer diameter of the compressed second longitudinal section 824 is equal to or smaller than the inner diameter of the locking member 814. With the second longitudinal section 824 so compressed, the locking member 814 is rotated in the first direction RD1 to engage the second thread 864 to the first thread 862 and move the locking member 814 in the second longitudinal direction LD2, i.e., distally. When the locking member 814 is disposed over the second longitudinal section 824 of the body 812, the locking member 814 maintains the radially inward or compressive force on the second longitudinal section 824 of the body 812 of the capsule guide tube 810 to releasably couple the second longitudinal section 824 of the body 812 of the capsule guide tube 810 to the proximal portion of the capsule 206 of the delivery device 200, via friction.

[0210] FIGS. 3OC-3OD illustrate another embodiment of a capsule guide tube 1410, in accordance with embodiments hereof. The capsule guide tube 1410 is the same as the capsule guide tube 810 shown in FIGS. 29-30B except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 3OC-3OD and the same reference numerals are used. Thus, generally, as described above, the capsule guide tube 1410 includes thebody 812 and the locking member 814. The capsule guide tube 1410 includes an unlocked configuration and a locked configuration. However, the capsule guide tube 1410 of FIGS. 30C- 30D differs from the capsule guide tube 810 in that the capsule guide tube 1410 is configured to releasably secure to an outer shaft 204 of a delivery device 200, proximal of a capsule 206 of the delivery device 200, when the capsule guide tube 1410 is in the locked configuration.

[0211] In an embodiment, the proximal portion of the body 812 of the capsule guide tube 1410 is configured to be disposed on a distal portion of the delivery device 200. In greater detail, the capsule 206 of the delivery device 200 is disposed within the first longitudinal section 822 of the body 812 and a distal portion of the outer shaft 204 of the delivery device 200 is disposed within the second longitudinal section 824 of the body 812. The locking member 814 is configured to be rotated in the first direction RD1 to engage the second thread 864 to the first thread 862 and move the locking member 814 in the second longitudinal direction LD2, i.e., distally. When the distal end of the delivery device 200 is disposed within the body 812 of the capsule guide tube 810, and the locking member 814 is threaded over the second longitudinal section 824 of the body, the locking member 814 exerts an inward or compressive force on the second longitudinal section 824 of the body 812, which in turn applies a radially inward force to the distal portion of the outer shaft 204 of the delivery device 200, thereby releasably coupling, locking, or securing the capsule guide tube 810 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206, via friction.

[0212] FIGS. 31-32B illustrate another capsule guide tube 910 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, e.g., the delivery device 200, in accordance with embodiments herein. FIG. 31 illustrates various components of the capsule guide tube 910. FIGS. 32A-32B illustrate a method for releasably securing the capsule guide tube 910 to the delivery device 200. The capsule guide tube 910 is configured to be releasably coupled to, secured to, or locked to a proximal portion of the capsule of the delivery device 200. The capsule guide tube 910 includes an unlocked configuration wherein the capsule guide tube 910 is not releasably secured to the capsule 206 of the delivery device 200, and a locked configuration wherein the capsule guide tube 910 is releasably secured to the proximal portion of the capsule 206 of the delivery device 200.

[0213] In embodiments, the capsule guide tube 910 is similar to the capsule guide tube 810 shown in FIGS. 29-30B except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 29-32B. Thus, generally, as described above, thecapsule guide tube 910 includes a body 912 and a locking member 914. The body 912 includes a first (distal) end 916, a second (proximal) end 918, and a central passageway 920 extending between the first end 916 and the second end 918. The body 912 includes a first longitudinal section 922 and a second longitudinal section 924. The locking member 914 includes a first end 948, a second end 950, and a passageway 952 extending from the first end 948 to the second end 950. However, the capsule guide tube 910 of FIGS. 31-32B differs from the capsule guide tube 810 in that a proximal portion of the body 912 of the capsule guide tube 910 is threadable over and exerts an inward or compressive force on the locking member 914, which applies a radially inward force to the proximal portion of the capsule 206 of the delivery device 200, thereby releasably coupling the capsule guide tube 910 to the capsule 206 of the delivery device 200, via friction. Further, in the embodiment of FIGS. 31-32B, the body 912 is not longitudinally split into two parts like the body 812. As noted above, in embodiments, the distal portion of the capsule 206 may include a coating and the proximal portion of the capsule 206 may not include a coating, but this is not meant to be limiting.

[0214] In embodiments herein, the body 912 includes a first thread 962 disposed on an inner surface 932 of the second longitudinal section 924. In an embodiment, the first thread 962 extends radially inwardly and extends longitudinally from the first end 919 of the second longitudinal section 924 to the second end 918 of the body 912. The second longitudinal section 924 of the body 912 has a first inner diameter ID1 including the first thread 962.

[0215] The locking member 914 includes a second thread 964 disposed on an outer surface 954 of the locking member 914. The second thread 964 extends longitudinally from the proximal end 948 to the distal end 950. In embodiments herein, the second thread 964 is tapered such that a first outer diameter OD1 of the second thread 964 at the first end 948 of the locking member 914 is smaller than a second outer diameter OD2 at the second end 950. In embodiments herein, the first outer diameter GDI of the locking member 914 is smaller than the first inner diameter ID1 of the second longitudinal section 924 of the body 912 such that the second thread 964 at the first end 948 of the locking member 914 may easily engage and be received within the first thread 962 of the second longitudinal section 924 of the body 912. The second outer diameter OD2 of the locking member 914 is larger than the first inner diameter ID1 of the second longitudinal section 924 of the body 912. As the second thread 964 engages and is received within the first thread 962 of the second longitudinal section 924 of the body 912, the inner surface 932 of the second longitudinalsection 924 exerts an increasing inward radial force on the outer surface 954 of the locking member 914, and the inner surface 996 of the locking member exerts an increasing inward radial force on a proximal portion of the capsule 206 disposed therein. Thus, the capsule guide tube 910 transitions from the unlocked configuration to the locked configuration. The compressive force of the body 912 on the locking member 914 compresses the locking member 914 onto the proximal portion of the capsule 206 of the device to releasably couple the capsule guide tube 910 to the capsule 206 of the delivery device 200.

[0216] The first thread 962 of the body 912 and the second thread 964 of the locking member may each be any corresponding suitable design such that the first thread 962 is configured to engage the second thread 964 to releasably couple the capsule guide tube 910 to the proximal portion of the capsule of the delivery device disposed therein. The first and second threads 962, 964 may each be formed for example, and not by way of limitation, as an integral portion of the body 912 or locking member 914, respectively, or as a separate unit coupled to the respective components for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While the first and second threads 962, 964 are each shown in FIGS. 31-32B with a specific gender, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0217] The operation and interaction of the various components of the capsule guide tube 910 to releasably couple the capsule guide tube 910 to a proximal portion of capsule 206 of the delivery device 200 will now be described.

[0218] In a step of the method, the locking member 914 is disposed over a distal end of the delivery device 200 and moved in a first longitudinal direction LD1 i.e., proximally, until positioned over a proximal portion of the capsule 206 of the delivery device 200, proximal of a coating on an outer surface of the capsule 206, as shown in FIG. 32A. This movement may also be accomplished by the delivery device 200 being moved distally, or both the locking member 914 and the delivery device 200 being moved relative to each other, as explained above.

[0219] In another step of the method, the body 912 is disposed over a distal end of the delivery device 200. The body 912 is moved in the first longitudinal direction LD1 i.e., proximally, until the second end 918 of the body 912 is adjacent to or abuts the first end 948 of the locking member 914.

[0220] In another step of the method, the body 912 is rotated in a first direction RD1 such that the first thread 962 of the body 912 engages the second thread 964 of the locking member 914 an the body 912 moves in in the first longitudinal direction LD1, i.e., proximally, as the first thread engages the second thread 964 and the locking member 914 is received within the second longitudinal section 924 of the body 912. As the locking member 914 is received within the second longitudinal section 924 of the body 912, the inner surface 932 of the second longitudinal section 924 exerts an increasing radially inward or compressive force on the outer surface 954 of the locking member 914. The compressive force increases as the second end 918 of the body 912 approaches the second end 950 of the locking member 914, thereby compressing the locking member 914 onto the proximal portion of the capsule 206 of the delivery device 200 to releasably couple the capsule guide tube 910 to the proximal portion of the capsule 206 of the delivery device 200 via friction.

[0221] Although the embodiments described the locking member 914 having a tapered outer diameter, this is not meant to be limiting. As described previously with respect to the capsule guide tube 910 and FIGS. 29-30B, the locking member 914 may have a uniform outer surface 954 and the inner surface of the second longitudinal section 924 of the body 912 may be tapered, or neither the locking member 914 nor the second longitudinal section 924 are tapered and the locking member 914 may be manually compressed such that the body 912 may be disposed over the manually compressed locking member 914.

[0222] FIGS. 33-35B show a capsule guide tube 1010 according to another embodiment hereof. In embodiments herein, the capsule guide tube 1010 is similar to the capsule guide tube 910 shown in FIGS. 31-32B except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 33-35B. Thus, the capsule guide tube 1010 includes a body 1012 and a locking member 1014 to releasably couple a proximal portion of the capsule guide tube 1010 to the proximal portion of the capsule 206 of the delivery device 200. The body 1012 includes a first (distal) end 1016, a second (proximal) end 1018, and a central passageway 1020 extending between the first end 1016 and the second end 1018. The locking member 1014 includes a first end 1048, a second end 1050, and a central passageway 1052 extending from the first end 1048 to the second end 1050. However, the capsule guide tube 1010 differs from the capsule guide tube 910 in that a portion of the body 1012 of the capsule guide tube 1010 and a corresponding portion of the locking member 1014 are configured as a circumferential clamp orcollet, to releasably couple the capsule guide tube 1010 to the proximal portion of the capsule 206 of the delivery device 200, via friction.

[0223] Thus, in more detail, the body 1012 includes a first longitudinal section 1022, a second longitudinal section 1024, and a third longitudinal section 1027, as best shown in FIG. 33. The first longitudinal section 1022 extends from the first end 1016 to a second end 1017 of the first longitudinal section 1022. The first longitudinal section 1022 of the body 1012 is a tubular construction and includes an outer surface 1030. The first longitudinal section 1022 includes or defines a first portion 1021 of the central passageway 1020. The first portion 1021 of the central passageway 1020 extends from the first end 1016 of the body 1012 to the second end 1017 of the of the first longitudinal section 1022. In embodiments herein, the first portion 1021 of the central passageway 1020 is shaped and sized to receive the distal portion of the capsule 206 of the delivery device 200. The first portion 1021 of the central passageway 1020 may be configured (e.g., sized) to permit radial expansion of the distal portion of the capsule 206 of the delivery device 200 during loading of a heart valve prosthesis into the capsule 206.

[0224] The second longitudinal section 1024 of the body 1012 extends from a first end 1019 adjacent to the second end 1017 of the first longitudinal section 1022 to a second end 1002 of the second longitudinal section 1024. In embodiments herein, the second longitudinal section 1024 of the body 1012 is a tubular construction and includes a generally circular outer surface 1031. The second longitudinal section 1024 includes a second portion 1023 of the central passageway 1020 extending from the first end 1019 of the second longitudinal section 1024 to a second end 1002 of the second longitudinal section 1024 of the body 1012. In embodiments herein, the second portion 1023 of the central passageway 1020 includes a tapered inner surface 1032. The second portion 1023 is tapered in a direction towards the first end 1018 of the body 1012 such that a first inner diameter ID1 of the second portion 1023 adjacent to the first end 1019 of the second longitudinal section 1024 of the body 1012 is smaller than a second inner diameter ID2 of the second longitudinal section 1024 adjacent to the second end 1002. The second portion 1023 of the central passageway 1020 is configured to receive a portion of the locking member 1014 therein. The inner surface 1032 of the second longitudinal section 1024 is configured to selectively apply radially inward pressure on a portion of the locking member 1014 disposed therein to releasably couple the capsule guide tube 1010 to a proximal portion of the capsule 206 of the delivery device 200, as described below.

[0225] The third longitudinal section 1027 of the body 1012 extends from a first end 1004 adjacent to the second end 1002 of the second longitudinal section 1024 to the second end 1018 of the body 1012. The third longitudinal section 1027 is a tubular construction and includes an outer surface 1037 and an inner surface 1036. The third longitudinal section 1027 includes a third portion 1029 of the central passageway 1020. The third portion 1029 of the central passageway 1020 extends from the first end 1004 of the third longitudinal section 1027 to the second end 1018 of the body 1012. The third portion 1029 of the central passageway 1020 is configured to receive a portion of the locking member 1014. In embodiments herein, the third longitudinal section 1027 of the body 1012 includes a first thread 1062 disposed on the inner surface 1036 and extending radially inward. In embodiments, the first thread 1062 extends longitudinally from the first end 1004 of the third longitudinal section 1027 to the second end 1018 of the body 1012. The third longitudinal section 1027 has a third inner diameter ID3 including the first thread 1062.

[0226] The locking member 1014 of the capsule guide tube 1010 a first longitudinal section 1070, a second longitudinal section 1074, and a third longitudinal section 1078, as shown in FIG. 33. In embodiments herein, the first longitudinal section 1070 (i.e., a distal portion) of the locking member 1014 is configured as a collet. As used herein “collet” is used to describe a segmented tubular component configured to receive a shaft therein and tightened or radially compressed to grip the portion of the shaft. In the present embodiment, the collet of the locking member 1014 is configured to receive a portion of the capsule 206 of the delivery device 200 therein and is configured to be tightened / radially compressed to grip the capsule 206. The first longitudinal section 1070 extends from the first end 1048 to a second end 1071 of the first longitudinal section 1070. The first longitudinal section 1070 of the locking member 1014 is a segmented tubular construction and includes a tapered outer surface 1072. The first longitudinal section 1070 of the locking member 1014 is tapered in a direction towards the first end 1048 of the locking member 1014 such that a first outer diameter GDI of the first longitudinal section 1070 at the first end 1048 of the locking member 1014 is smaller than a second outer diameter OD2 the first longitudinal section 1070 of the locking member 1014 at the second end 1071. The first longitudinal section 1070 includes or defines a first portion 1053 of the central passageway 1052. The first portion 1053 of the central passageway 1052 extends from the first end 1048 of the locking member 1014 to the second end 1071 of the of the first longitudinal section 1070. In embodiments herein, the first longitudinal section 1070 is composed of four segments 1038, as best shown in FIG. 34A.When the capsule guide tube 1010 is in the unlocked configuration, each segment 1038 of the first longitudinal section 1070 of the locking member 1014 is circumferentially separated from an adjacent segment 1038 by a gap 1039. In the unlocked configuration, the first longitudinal section 1070 includes the first outer diameter OD1 and a third inner diameter ID3 at the first end 1048. When the capsule guide tube 1010 is in the locked configuration, each segment 1038 of the first longitudinal section 1070 of the locking member 1014 abuts the adjacent segment 1038 such that the gaps 1039 are closed and the first end 1048 of the first longitudinal section 1070 has a third outer diameter OD3 that is smaller than the first outer diameter OD1, and a fourth inner diameter ID4 that is smaller than the third inner diameter ID3, as shown in FIG. 34B. The first portion 1053 of the central passageway 1052 of the locking member 1014 is shaped and sized to receive the proximal portion of the capsule 206 of the delivery device 200 therein when the capsule guide tube 1010 is in the unlocked configuration. An inner surface 1073 of the first longitudinal section 1070 is configured to be radially compressed onto the proximal portion of the capsule 206 of the delivery device 200 to releasably couple the capsule guide tube 1010 to the capsule 206 of the delivery device 200 when the capsule guide tube 1010 is in the locked configuration. Although the first longitudinal section 1070 of the locking member 1014 is described herein with four segments 1038, this is not meant to be limiting, and more or fewer segments may be utilized.

[0227] The second longitudinal section 1074 of the body 1012 extends from a first end 1075 adjacent to the second end 1071 of the first longitudinal section 1070 to a second end 1076. In embodiments herein, the second longitudinal section 1074 of the locking member 1014 is a tubular construction and includes a generally circular outer surface 1077. The second longitudinal section1074 includes a second portion 1055 of the central passageway 1052 extending from the first end1075 of the second longitudinal section 1074 to the second end 1076. The second portion 1055 of the central passageway 1052 of the locking member 1014 is shaped and sized to receive portion of the capsule 206 of the delivery device 200.

[0228] In embodiments herein, the second longitudinal section 1074 of the locking member 1014 includes a second thread 1064 disposed on the outer surface. The second thread 1064 extends longitudinally from the first end 1075 to the second end 1076. In embodiments herein, the second thread 1064 of the second longitudinal section 1074 of the locking member 1014 is configured to engage and be received within the first thread 1062 of the third longitudinal section 1027 of the body 1012. The first thread 1062 of the body 1012 and the second thread 1064 of the lockingmember 1014 may each be any corresponding suitable design such that the first thread 1062 is configured to engage the second thread 1064 to releasably couple the capsule guide tube 1010 to the proximal portion of the capsule 206 of the delivery device 200 disposed therein, as described below. The first and second threads 1062, 1064 may each be formed for example, and not by way of limitation, as an integral portion of the body 1012 or locking member 1014, respectively, or as a separate unit coupled to the respective components for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While the first and second threads 1062, 1064 are each shown in FIGS. 33-35B with a specific gender, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0229] The third longitudinal section 1078 of the locking member 1014 extends from a first end 1079 adjacent to the second end 1076 of the second longitudinal section 1074 to the second end 1050 of the locking member 1014. The third longitudinal section 1078 is a tubular construction and includes a third portion 1057 of the central passageway 1052. The third portion 1057 of the central passageway 1052 is configured to receive a distal portion of a delivery device.

[0230] With an understanding of the components, the operation and interaction of the capsule guide tube 1010 to releasably couple the capsule guide tube 1010 to the proximal portion of the capsule 206 of the delivery device 200 will now be described. As explained above, the delivery device and capsule 206 are examples only, and the capsule guide tube 1010 may be used with other delivery devices.

[0231] In a step of the method, the locking member 1014 is disposed over a distal end of the delivery device 200 and the locking member 1014 and / or the delivery device 200 is / are moved relative to each other such that the locking member 1014 is positioned over a proximal portion of the capsule 206 and a distal portion of the delivery device 200. In greater detail, the locking member 1014 and / or delivery device 200 is / are moved until the first longitudinal section 1070 of the locking member 1014 is disposed over a proximal portion of the capsule 206 of the delivery device 200 as shown in FIG. 35 A.

[0232] In another step of the method, the body 1012 of the capsule guide tube 1010 is disposed over a distal end of the delivery device 200. The body 1012 and / or the delivery device 200 is / are moved relative to each other until the second end 1018 of the body 1012 is adjacent to or abuts the first end 1075 of the second longitudinal section 1074 of the locking member 1014. Stated anotherway, the body 1012 and / or delivery device 200 is / are moved until the first thread 1062 of the body 1012 abuts the second thread 1064 of the locking member 1014.

[0233] In another step of the method, the body 1012 is rotated in a first direction RD1 such that the first thread 1062 of the body 1012 engages the second thread 1064 of the locking member 1014 such that the body 1012 moves in the first longitudinal direction LD1, i.e., proximally. As the body 1012 moves in the first longitudinal direction LD1 over the locking member 1014, the inner surface 1032 of the second longitudinal section 1024 of the body 1012 exerts an increasing radially inward or compressive force on the outer surface 1072 of the first longitudinal section 1070 of the locking member 1014. The compressive force increases as the body 1012 travels in the first longitudinal direction LD1 to radially compress the segments 1038 (FIG. 34A) of the first longitudinal section 1070 from the third inner diameter ID3 (FIG. 34A) to the smaller fourth inner diameter ID4 (FIG. 34B), thereby transitioning the capsule guide tube 1010 from the unlocked configuration to the locked configuration and radially compressing the capsule guide tube 1010 against the proximal portion of the capsule 206 adjacent the first longitudinal section 1070 of the locking member 1014. When the capsule guide tube 1010 is in the locked configuration with the capsule 206 of the delivery device 200 disposed as shown in FIG. 35B, the capsule guide tube 1010 is releasably coupled to the proximal portion of the capsule 206 of the delivery device 200 via friction. As explained above, in some embodiments, the proximal portion of the capsule 206 may be an uncoated portion. Further, releasably coupling the capsule guide tube 1010 against a proximal portion of the capsule 206 enables radial expansion of the distal portion of the capsule 206 of the delivery device 200 during loading of a heart valve prosthesis into the capsule 206, thereby reducing loading forces.

[0234] FIGS. 36-37C illustrate another capsule guide tube 1110 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. In embodiments herein, the capsule guide tube 1110 is similar to the capsule guide tube 410 shown in FIGS. 11-16C except as described herein. Therefore, all of the details described above with respect to the capsule guide tube 410 are incorporated into the description of FIGS. 36-37C. Generally, as described above, the capsule guide tube 1110 includes a body 1112, a coupling member 1113, and a locking member 1114. Thebody 1112 includes a first (distal) end 1116, a second (proximal) end 1118, and a central passageway 1120 extending between the first end 1116 and the second end 1118. The coupling member 1113 includes a first end 1140, asecond end 1142, and a passageway 1144 extending from the first end 1 140 to the second end 1142. The locking member 1114 includes a first end 1148, a second end (not visible in FIGS. 36- 37C), and a central passageway 1152 extending from the first end 1148 to the second end. However, the capsule guide tube 1110 differs from the capsule guide tube 410 in that the locking member 1114 is a distal portion of an in-line sheath (ILS) (an in-line sheath is described in, for example, U.S. Patent Application Publication No. 2014 / 0364939 and U.S. Patent Application Publication No. 2022 / 0175527, both of which are incorporated by reference herein in their entirety). FIG. 36 illustrates various components of the capsule guide tube 1110 and a delivery device. FIGS. 37A-37C illustrate a method for releasably securing the capsule guide tube 1110 to the delivery device.

[0235] In embodiments hereof, the body 1112 may be divided longitudinally into a first arm 1126A and a second arm 1126B, which come together to form the body 1112. The body 1112 of the capsule guide tube 1110 includes the first longitudinal section 1122, the second longitudinal section 1124, and the third longitudinal section 1127. The first longitudinal section 1122 extends from the first end 1116 to a second end 1117 of the first longitudinal section 1122. The first longitudinal section 1122 of the body 1112 may be a tubular construction having a generally cylindrical outer surface 1130. The first longitudinal section 1122 includes or defines a first portion 1121 of the central passageway 1120. In embodiments herein, the first portion 1121 of the central passageway 1120 is shaped and sized to receive a distal portion of a corresponding capsule 206 of a delivery device 200. The first portion 1121 of the central passageway 1120 may be configured to permit radial expansion of the capsule 206 of the delivery device 200 during loading of a heart valve prosthesis into the capsule 206. Accordingly, an inner diameter of the first portion 1121 of the central passageway 1120 may be larger than an outer diameter of the capsule 206 of the delivery device 200 disposed in the central passageway 1120.

[0236] The second longitudinal section 1124 of the body 1112 extends from a first end 1119 adjacent to the second end 1117 of the first longitudinal section 1122 to a second end 1102. The second longitudinal section 1124 may be a tubular construction with a generally cylindrical outer surface 1131. The second longitudinal section 1124 includes or defines a second portion 1123 of the central passageway 1120. In embodiments herein, the second portion 1123 of the central passageway 1120 is shaped and sized to receive a transition portion of the delivery device 200 where a proximal portion of the capsule 206 of the delivery device transitions to a distal portionof the outer shaft 204 of the delivery device 200. In embodiments herein, the second portion 1123 of the central passageway 1120 may be tapered in a direction towards the second end 1118 of the body 1112 such that a first inner diameter ID1 at the first end 1119 of the second longitudinal section 1124 is larger than a second inner diameter ID2 at the second end 1102 of the second longitudinal section 1124. In the embodiment shown, the tapered second portion 1123 of the central passageway 1120 is configured to match the profile of the transition from the proximal portion of the capsule 206 to the distal portion of the outer shaft 204.

[0237] The third longitudinal section 1127 of the body 1112 includes a first end 1104 adjacent to the second end 1102 of the second longitudinal section 1124, and the second end 1118. The third longitudinal section 1127 includes a third portion 1129 of the central passageway 1120, extending from the first end 1104 to the second end 1118. The third portion 1129 of the central passageway 1120 includes a third inner diameter ID3 that is generally equal to an outer diameter of the outer shaft 204 of the delivery device 200 disposed therein when the capsule guide tube 1110 is in the unlocked configuration. When the capsule guide tube 1110 is in the locked configuration the third portion 1129 has a fourth inner diameter ID4, as described below. In embodiments herein, the fourth inner diameter ID4 is smaller than the third inner diameter ID3. An outer surface of the third longitudinal section 1127 defines a second outer diameter OD2, as shown in FIG. 37A.

[0238] The coupling member 1113 of the capsule guide tube 1110 is a generally tubular structure and is sized to receive the first longitudinal section 1122 of the body 1112 therein. The coupling member 1113 is configured to provide structural rigidity to the body 1112 of the capsule guide tube 1110 such that distal portions of the first and second arms 1126A, 1126B do not separate from each other during loading of a heart valve prosthesis into the capsule 206. In embodiments herein, the passageway 1144 has a fifth inner diameter ID5 that is generally equal to a first outer diameter OD1 of the first longitudinal section 1122 of the body 1112 such that the coupling member 1113 is disposed over the over the first longitudinal section 1122 of the body 1112 without applying a compressive force to the first longitudinal section 1122 of the body 1112.

[0239] In embodiments herein, the locking member 1114 of the capsule guide tube 1110 is the distal portion of an indine sheath ILS. The locking member 1114, i.e., the distal portion of the inline sheath ILS is a generally tubular structure defining a central passageway 1152. In embodiments herein, a distal portion of the central passageway 1152 has a sixth inner diameterID6 that is smaller than the second outer diameter OD2 of the third longitudinal section 1127 of the body 1112. Thus, when the locking member 1114 is disposed over the third longitudinal section 1127, the locking member 1114 applies a radially inward force on the third longitudinal section 1127 of the body 1112, which thereby exerts a radially inward force of the distal portion of the outer shaft 204 of the delivery device 200, thereby securing the body 1112 to the outer shaft 204 of the delivery device 200. Thus, in embodiments herein the locking member 1014 is translatable over the third longitudinal section 1127 of the body 1112 and exerts a radially inward force on the third longitudinal section 1127 to releasably secure the capsule guide tube 1110 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206 of the delivery device 200 when the capsule guide tube 1110 is in the locked configuration. In embodiments herein, the locking member 1114 is secured to the third longitudinal section 1127 of the body 1112 by friction.

[0240] The operation and interaction of the various components of the capsule guide tube 1110 to releasably couple the capsule guide tube 1110 to the outer shaft 204 of a delivery device 200 will now be described.

[0241] In a step of the method, locking member 1114 is disposed proximal of the capsule 206 and a distal end of an outer shaft 204 of the delivery device 200, as shown in FIG. 36. Being that the locking member 1114 may be a distal portion of an in-line sheath ILS, the locking member 1114 may be part of the delivery device 200.

[0242] In another step of the method, the first arm 1126 A and the second arm 1126B of the body 1112 are each placed adjacent to and on opposite sides of the capsule 206 and the distal portion of the outer shaft 204 of the delivery device 200, as shown in FIG. 37A. The body 1112 is positioned with the distal portion of the capsule 206 disposed within the first longitudinal section 1122 of the body 1112, a transition portion of the capsule 206 / outer shaft 204 disposed within the second longitudinal section 1124 of the body 1112, and a distal portion of the outer shaft 204 of the delivery device 200 disposed within the third longitudinal section 1127 of the body 1112 of the capsule guide tube 1110.

[0243] In another step of the method, the coupling member 1113 is moved relative to the body 1112 disposed over the capsule 206, such as in the first longitudinal direction LD1, as shown in FIG. 37B. The coupling member 1113 is moved / located such that the first longitudinal section 1122 of the body 1112 is disposed within the coupling member 1113. The coupling member 1113 disposed over the first longitudinal section 1122 of the body 1112 provides structural rigidity tothe first longitudinal section 1122 of the body 1112 and prevents separation of the first and second arms 1126A, 1116B from each other during loading of a heart valve prosthesis into the capsule 206.

[0244] In another step of the method, the locking member 1114 is moved in a second longitudinal direction LD2, i.e., distally, opposite the first longitudinal direction LD1, as shown in FIG. 37C. The locking member 1114 is moved in the second longitudinal direction LD2 such that the distal portion of the locking member 1114 is disposed over the third longitudinal section 1127 of the body 1112. As noted above, the sixth inner diameter ID6 of the locking member 1114 is smaller than the second outer diameter OD2 of the third longitudinal section 1127 of the body 1112. Thus, the locking member 1114 will not move over the third longitudinal section 1127 without some assistance. Various ways to enable the locking member 1114 to be disposed over the third longitudinal section 1127 may be utilized. For example, and not by way of limitation, the third longitudinal section 1127 may be manually compressed to enable the locking member 1114 to be disposed thereover, and the compression will be maintained by the locking member 1114 upon release of the manual compression. In another non-limiting example, the locking member 1114 may be expanded to be disposed over the third longitudinal section 1127 and may be configured to return to its unexpanded state. In another non-limiting example, the central passageway 1152 of the locking member 1114 and / or the outer diameter of the outer surface of the third longitudinal section 1127 may be tapered to enable the locking member 1114 to initially be disposed over the third longitudinal section 1127, and then the locking member 1114 compresses the third longitudinal section 1127 upon advancement thereover. Other ways to enable the locking member 1114 to be disposed over the third longitudinal section 1127 may also be used. With the locking member 1114 advance over the third longitudinal section 1127, the locking member 1114 applies a radially inward compressive force on the third longitudinal section 1127 of the body 1112, which correspondingly applies a radially inward force on the outer shaft 204 of the delivery device 200, thereby releasably coupling or securing the capsule guide tube 1110 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206, via friction.

[0245] FIGS. 38-40B illustrate a capsule guide tube 1210 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. The capsule guide tube 1210 is configured to be releasably coupled to, secured to, or locked to an outer shaft of a delivery device. The capsule guide tube 1210 includesan unlocked configuration wherein the capsule guide tube 1210 is not secured to the delivery device, and a locked configuration wherein the capsule guide tube 1210 is releasably secured to the delivery device.

[0246] In an embodiment, the capsule guide tube 1210 includes a body 1212 and a locking member 1214, as shown in FIG. 38. The body 1212 of the capsule guide tube 1210 is configured to be disposed on a distal portion of the delivery device. The locking member 1214 is disposed over a proximal portion of the body 1212 and is configured to exert an inward or compressive force on a portion of the outer shaft of the delivery device, thereby releasably coupling, locking, or securing the capsule guide tube 1210 to the outer shaft of the delivery device, proximal of the capsule, via friction. In another embodiment, the locking member 1214 may exert an inward or compressive force on the proximal portion of the capsule of the delivery device to releasably couple, lock, or secure the capsule guide tube 1210 to the capsule of the delivery device via friction.

[0247] As shown in FIGS. 39, the body 1212 of the capsule guide tube 1210 includes a first (distal) end 1216 and a second (proximal) end 1218. The body 1212 defines a central passageway 1220 extending between the first end 1216 and the second end 1218. The body 1212 includes a first longitudinal section 1222 and a second longitudinal section 1224. The first longitudinal section 1222 extends from the first end 1216 to a second end 1217 of the first longitudinal section 1222. The first longitudinal section 1222 of the body 1212 is a tubular construction and may include a tapered outer surface 1230. In embodiments herein, the outer surface 1230 of the first longitudinal section 1222 is tapered in a direction towards the first end 1216 of the body 1212. The outer surface 1230 is tapered such that a second outer diameter OD2 of the outer surface 1230 adjacent to the first end 1216 of the body 1212 is smaller than a first outer diameter OD1 of the outer surface 1230 adjacent to the second end 1217 of the first longitudinal section 1222 of the body 1212. The first longitudinal section 1222 includes or defines a first portion 1221 of the central passageway 1220. The first portion 1221 of the central passageway 1220 extends from the first end 1216 of the body 1212 to the second end 1217 of the of the first longitudinal section 1222. In embodiments herein, the first portion 1221 of the central passageway 1220 may include a first or tapered section 1221A and a second or cylindrical section 1221B. The first section 1221A is tapered in a direction towards the second section 1221B of the first portion 1221 of the central passageway 1220 such that a first inner diameter ID1 of the first section 1221 A adjacent to thefirst end 1216 of the body 1212 is larger than a second inner diameter ID2 of the first section 1221A adjacent to the second section 1221B of the first portion 1221 of the central passageway 1220. In embodiments, the second section 1221B of the first portion 1221 of the central passageway 1220 is cylindrical with a third inner diameter ID3. In an embodiment, the third inner diameter ID3 is equal to the second inner diameter ID2 of the first section 1221 A adjacent the second section 122 IB.

[0248] The second longitudinal section 1224 of the body 1212 extends from a first end 1219 adjacent to the second end 1217 of the first longitudinal section 1222 to the second end 1218 of the body 1212. In embodiments herein, the second longitudinal section 1224 of the body 1212 is a tubular construction and includes a generally circular outer surface 1231 with an outer diameter OD3. The second longitudinal section 1224 includes a second portion 1223 of the central passageway 1220 extending from the first end 1219 to the second end 1218 of the body 1212. In embodiments herein, the second portion 1223 of the central passageway 1220 is shaped and sized to receive a corresponding capsule of a delivery device. The second portion 1223 of the central passageway 1220 may be configured to permit radial expansion of the capsule of the delivery device disposed therein during loading of a heart valve prosthesis into the capsule. Accordingly, a fourth inner diameter ID4 of the second portion 1223 of the central passageway 1220 may be larger than an outer diameter of the capsule of the delivery device disposed therein. Further, in embodiments, the fourth inner diameter ID4 of the second portion 1223 of the central passageway 1220 may be larger than the third inner diameter ID3 of the second section 1221B of the first portion 1221 of the central passageway 1220, thereby forming a shoulder 1238 at the junction of the second section 1221B of the first portion 1221 and the second portion 1223.

[0249] The body 1212 of the capsule guide tube 1210 may be formed of a first arm 1226A and a second arm 1226B, as shown in FIG. 39. In embodiments herein, the first arm 1226A and the second arm 1226B are each approximately one-half of the body 1212, divided generally longitudinally. In embodiments, the first arm 1226A and the second arm 1226B may be formed with sufficient rigidity or stiffness to prevent separation of the distal portion of the first arm 1226A from the second arm 1226B during loading of a heart valve prosthesis therein.

[0250] In embodiments the body 1212 may include one or more recesses 1290 extending radially inward from the outer surface 1231 of the second longitudinal section 1224 of the body 1212. Each recess 1290 is configured to engage a corresponding tab 1292 of the locking member1214 to releasably couple the locking member 1214 to the body 1212, as described below. In the embodiment of FIG. 39, the body 1212 includes two recesses 1290 disposed opposite each other around the circumference of the body 1212 (z.e., 180 degrees apart), with a first recess 1290A on the first arm 1226A and a second recess 1290B on the second arm 1226B. However, this is not meant to be limiting, and there may be more or fewer recesses 1290. It shall be understood that FIG. 39 illustrates the locking member 1214 rotated approximately 90° relative to the body 1212 for illustrative purposes only. In other words, the locking member 1214 is rotated approximately one-quarter turn from the orientation when the tabs 1292 of the locking member 1214 and the recesses 1290 of the body 1212 are rotationally aligned such that one of the tabs 1292 and both recesses 1290 are shown. Further, in the embodiment shown, the recesses 1290 are rectangular in shape, but this is not meant to be limiting, and the recesses 1290 may be other shapes to correspond with shapes of the corresponding tabs 1292 of the locking member 1214. Each recess 1290 may be formed, for example, and not by way of limitation, as an integral portion of corresponding first or second arm 1226 A, 1226B of the body 1212 or of the body 1212 may be removed, such as by cutting or etching or other methods, to form the recesses 1290.

[0251] In embodiments, the locking member 1214 of the capsule guide tube 1210 is a generally tubular structure. The locking member 1214 includes a first or unlocked state shown in FIG. 40 A and a second or locked state shown in FIG. 40B. The locking member 1214 is configured to exert an inward or compressive force on a portion of an outer shaft of the delivery device disposed therein when the locking member 1214 is in the locked state, as described below. As shown in FIG. 39, the locking member 1214 includes a first end 1248, a second end 1250, and a passageway 1252 extending from the first end 1248 to the second end 1250. In the embodiment shown in FIGS. 39-40B the locking member 1214 includes a distal or first longitudinal section 1254, a middle or second longitudinal section 1255, and a proximal or third longitudinal section 1256.

[0252] The first longitudinal section 1254 extends from the first end 1248 of the locking member 1214 to a second end 1257 of the first longitudinal section 1254. The first longitudinal section 1254 of the locking member 1214 is a tubular construction and may include a tapered outer surface 1258. In embodiments herein, the outer surface 1258 of the first longitudinal section 1254 is tapered in a direction towards the first end 1248 of the locking member 1214 such that a fourth outer diameter OD4 of the outer surface 1258 adjacent to the first end 1248 of the locking member 1214 is smaller than a fifth outer diameter OD5 of the outer surface 1258 adjacent to the secondend 1257 of the first longitudinal section 1254 of the locking member 1214. However, this is not meant to be limiting, and the first longitudinal section 1254 outer surface may be cylindrical or other shapes. The first longitudinal section 1254 includes or defines a first portion 1252A of the central passageway 1252. The first portion 1252A of the central passageway 1252 extends from the first end 1248 of the locking member 1214 to the second end 1257 of the first longitudinal section 1254. In embodiments herein, the first portion 1252A of the central passageway 1252 is configured to receive a proximal portion of the second longitudinal section 1224 of the body 1212 of capsule guide tube 1210. Accordingly, a fifth inner diameter ID5 of the first portion 1252A of the central passageway 1252 of the locking member 1214 is larger than the third outer diameter OD3 of the second longitudinal section 1224 of the body 1212.

[0253] A first actuator channel 1260 is formed in a proximally facing surface at the second end 1257 of the first longitudinal section 1254, as shown in FIG. 40A. The first actuator channel 1260 is a circumferential channel or recess disposed at a first radius R1 from a central longitudinal axis LA of the locking member 1214. The first actuator channel 1260 is configured to slidingly receive a first actuator rail 1274 of an actuator 1269 of the second longitudinal section 1255, as described below. In embodiments, the first actuator channel 1260 is configured to retain the first actuator rail 1274 of the actuator 1269 while permitting the first actuator rail 1274 to move or slide circumferentially within the first actuator channel 1260 around the central longitudinal axis LA of the locking member 1214. While the first actuator channel 1260 is shown in FIGS. 39-40B with an L-shaped profile, this is not meant to be limiting, and the first actuator channel 1260 may be of any shape suitable for retaining the first actuator rail 1274 while permitting rotational movement of the actuator 1269 described herein.

[0254] A first grip channel 1261 is formed in the proximally facing surface at the second end 1257 of the first longitudinal section 1254 of the locking member 1214. The first grip channel 1261 is a circumferential channel or recess in the proximally facing surface at the second end 1257 and is disposed at a second radius R2 from the central longitudinal axis LA of the locking member 1214. In the embodiment of FIGS. 39-40B, the second radius R2 to the first grip channel 1261 is smaller than the first radius R1 to the first actuator channel 1260. The first grip channel 1261 is configured to retain a first grip rail 1285 of an adjustable grip 1271 within the second longitudinal section 1255 of the locking member 1214. The first grip channel 1261 is configured to slidingly receive the first grip rail 1285 of the grip 1271 as described below. In embodiments, the first gripchannel 1261 is configured to permit the first grip rail 1285 of the grip 1271 to selectively move or slide radially inward or radially outward relative to the central longitudinal axis LA of the locking member 1214, as described below. While the first grip channel 1261 is shown in FIGS. 39-40B with an L-shaped profile, this is not meant to be limiting, and the first grip channel 1261 may be of any shape suitable for retaining the first grip rail 1285 while permitting radial movement of the grip 1271 described herein.

[0255] The first longitudinal section 1254 includes a plurality of tabs 1292, as best shown in FIG. 40A. Each tab 1292 extends radially inward from an arm 1293 coupled to an interior surface of the first longitudinal section 1254. A backing plate 1295 may also be provided radially outwardly of the tab 1292 and the arm 1293. The arm 1293 enables the tab 1292 to move radially inwardly towards the central longitudinal axis LA or radially outwardly away from the central longitudinal axis LA. In embodiments, the arm 1293 may act as a biasing element to bias the tab 1292 radially inwardly. Thus, when the locking member 1214 is disposed over the body 1212 of the capsule guide tube 1210, the arm 1293 and the tab 1292 move radially outwardly until the tab 1292 aligns with one of the recesses 1290 of the body 1212. When the tab 1292 aligns with one of the recesses 1290, the arm 1293 causes the tab 1292 to move radially inwardly into the recess 1290, thereby coupling the locking member 1214 to the body 1212. In embodiments of FIGS. 38- 40B, the first longitudinal section 1254 includes two tabs 1292 disposed opposite each other around the circumference of the first longitudinal section 1254, but this is not meant to be limiting, and there may be more of fewer tabs 1292. Further, in the embodiment shown, the tabs 1292 are rectangular in shape to correspond to the recesses 1290 of the body 1212, but this is not meant to be limiting, and the tabs 1292 may be other shapes corresponding to the recesses 1290 of the body 1212. Although the embodiment shown shows tabs extending from the locking member and recesses in the body of the capsule guide tube, this is not meant to be limiting. In other embodiments, the body may include tabs and the locking member may include recesses. In other embodiments, other ways to couple the locking member to the body may be utilized such that the first longitudinal section 1254 of the locking member 1214 does not rotate when the second longitudinal section 1255 is rotated, as described below. In other embodiments, such a coupling mechanism is not needed provided that the second longitudinal section 1255 may be rotated relative to the first longitudinal section 1254, as described below.

[0256] The third longitudinal section 1256, also referred to as an end cap, extends from a first end 1262 thereof to the second end 1250 of the locking member 1214, as shown in FIG. 39. The third longitudinal section 1256 of the locking member 1214 is a tubular construction and includes an outer surface 1265. The third longitudinal section 1256 includes or defines a third portion 1252C of the central passageway 1252 and extends from the first end 1262 of the third longitudinal section 1256 to the second end 1250 of the locking member 1214. In embodiments herein, the third portion 1252C of the central passageway 1252 is configured to receive a distal portion of an outer shaft of the delivery device disposed therein. The third portion 1252C of the central passageway 1252 has a sixth inner diameter ID6 that is larger than an outer diameter of an outer shaft of the delivery device disposed therein.

[0257] A second actuator channel 1263 is formed in a distally facing surface at the first end1262 of the third longitudinal section 1256 of the locking member 1214, as shown in FIGS. 40A. The second actuator channel 1263 is a circumferential channel or recess disposed at the first radius R1 from the central longitudinal axis LA of the locking member 1214. The second actuator channel1263 is configured to slidingly receive a second rail or guide 1275 of the actuator 1269 of the second longitudinal section 1255 as described below. In embodiments, the second actuator channel 1263 is configured to retain the second actuator rail 1275 of the actuator 1269, therein. The second actuator channel 1263 is configured to permit the second actuator rail 1275 of the actuator 1269 to selectively move or slide circumferentially around the central longitudinal axis LA of the locking member 1214. While the second actuator channel 1263 is shown in FIGS. 39-40B with a specific shape, this is not meant to be limiting, and the second actuator channel 1263 may be of any shape suitable for the purposes described herein.

[0258] A second grip channel 1264 is formed in the distally facing surface at the first end 1262 of the third longitudinal section 1256 of the locking member 1214. The second grip channel 1264 is a circumferential channel or recess in the distally facing surface third longitudinal section 1256 and is disposed at the second radius R2 from the central longitudinal axis LA of the locking member 1214. The second grip channel 1264 is configured to retain a second grip rail or guide 1286, therein. In embodiments, the second grip channel 1264 is configured to permit the second grip rail 1286 of the grip 1271 to selectively move or slide radially inward or outward relative to the central longitudinal axis LA of the locking member 1214. While the second grip channel 1264is shown in FIGS. 39-40B with a specific shape, this is not meant to be limiting, and the second grip channel 1264 may include and shape suitable for the purposes described herein.

[0259] The second longitudinal section 1255 of the locking member 1214 is disposed between the first longitudinal section 1254 and the third longitudinal section 1256 of the locking member 1214. As shown in FIG. 39, the second longitudinal section 1255 includes a first end 1267 disposed adjacent to the second end 1257 of the first section and a second end 1268 disposed adjacent to the first end 1262 of the third longitudinal section 1256.

[0260] The second longitudinal section 1255 includes or defines a second portion 1252B of the central passageway 1252 and extends from the first end 1267 of the second longitudinal section 1255 to the second end 1268 of the second longitudinal section 1255. The second longitudinal section 1255 is configured to selectively exert an inward or compressive force on a portion of the outer shaft of the delivery device disposed therein. In embodiments herein, the second portion 1252B of the central passageway 1252 is configured to receive a distal portion of the outer shaft of the delivery device disposed therein. The second portion 1252B of the central passageway 1252 includes a seventh inner diameter ID7 when the locking member 1214 is in the unlocked state as shown in FIG. 40A and an eighth inner diameter ID8 when the locking member 1214 is in the locked state as shown in FIG. 40B. In embodiments, the seventh inner diameter ID7 is larger than the eighth inner diameter ID8. The seventh inner diameter ID7 of the second portion 1252B of the central passageway 1252 is larger than an outer diameter of the outer shaft of the delivery device disposed therein and the eighth inner diameter ID8 of the second portion 1252B of the central passageway 1252 is approximately equal to or smaller than the outer diameter of the outer shaft of the delivery device disposed therein to apply a radially inward or compressive force on the outer shaft to secure the locking member 1214, and thus the capsule guide tube 1210, to the outer shaft of the delivery device, as described below.

[0261] The second longitudinal section 1255 of the locking member 1214 includes the actuator 1269, a wedge 1270, and the grip 1271, as best shown in FIGS. 40 A and 40B. The actuator 1269, the wedge 1270, and the grip 1271 are each generally tubular structures and are concentrically disposed about the central longitudinal axis LA of the locking member 1214. The grip 1271 is disposed within the wedge 1270, and the wedge 1270 and the grip 1271 are disposed within the actuator 1269.

[0262] The actuator 1269 of the second longitudinal section 1255 of the locking member 1214 is a tubular construction and includes an outer surface 1272 and an inner surface 1273, as shown in FIG. 40A. In embodiments, the actuator 1269 is disposed such that the outer surface 1272 generally radially aligns with the outer surface 1258 of the first longitudinal section 1254 at the second end 1257. The actuator 1269 includes the first actuator rail 1274 extending in a distal direction from a distally facing surface at the first end 1267 of the actuator 1269 and a second actuator rail 1275 extending in a proximal direction from a proximally facing surface at the second end 1268 of the actuator 1269. The first actuator rail 1274 is configured to be slidingly received within the first actuator channel 1260 of the first longitudinal section 1254 of the locking member 1214 and the second actuator rail 1275 is configured to be slidingly received within the second actuator channel 1263 of the third longitudinal section 1256 of the locking member 1214. The actuator 1269 is configured to be rotatable in a first or clockwise direction or in a second or counter clockwise direction around the longitudinal axis LA of the locking member 1214. Thus, the actuator 1269 is rotatable and is longitudinally and radially retained between the first and third longitudinal sections 1254, 1256.

[0263] The actuator 1269 of the second longitudinal section 1255 includes a first thread 1276 along the inner surface 1273. The first thread 1276 extends radially inward between the first end 1267 and the second end 1268 of the actuator 1269 and is configured to engage a second thread 1282 of the wedge 1270. The first thread 1276 may be formed for example, and not by way of limitation, as an integral portion of the inner surface 1273 of the actuator 1269, or as a separate unit coupled to the inner surface 1273 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While the first thread 1276 is shown in FIGS. 40A and 40B with a specific gender, hardness, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0264] The wedge 1270 is slidingly disposed in an annular void or space 1277 concentrically located between the actuator 1269 and the grip 1271. The wedge 1270 is configured to move longitudinally between the first end 1267 and the second end 1268 of the second longitudinal section 1255 as described below. Accordingly, the wedge 1270 includes a first longitudinal length LI that is shorter than a second longitudinal length L2 of the actuator 1269. In the embodiment of FIGS. 39- 40B, the wedge 1270 is a tubular structure with a first end 1278, a second end 1279, an outer surface 1280, and an inner surface 1281 . The outer surface 1280 is disposed adjacent to andis generally parallel to the inner surface 1273 of the actuator 1269. The inner surface 1281 is tapered in a direction towards the first end 1278 such that a ninth inner diameter ID9 of the inner surface 1281 of the wedge 1270 adjacent to the first end 1278 is larger than a tenth inner diameter ID10 of the inner surface 1281 adjacent to the second end 1279.

[0265] The wedge 1270 of the second longitudinal section 1255 includes the second thread 1282 extending radially outward along a portion of the outer surface 1280 thereof. The second thread 1282 may be any suitable design corresponding to the first thread 1276 of the actuator 1269. The second thread 1282 is configured to engage the corresponding first thread 1276 of the actuator 1269 as described below. The second thread 1282 may be formed for example, and not by way of limitation, as an integral portion of the outer surface 1280 of the wedge 1270, or as a separate unit coupled to the outer surface 1280 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While the second thread 1282 is shown in FIGS. 39-40B with a specific gender, hardness, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0266] The grip 1271 includes the first end 1267 of the second longitudinal section 1255 and the second end 1268 of the second longitudinal section 1255. The grip 1271 of the second longitudinal section 1255 of the locking member 1214 is a tubular construction and includes a tapered outer surface 1283 and a generally cylindrical inner surface 1284. The grip 1271 of the second longitudinal section 1255 of the locking member 1214 is configured to selectively move radially inward or radially outward, as described below. The outer surface 1283 of the grip 1271 is tapered in a direction towards the second end 1268 such that a seventh outer diameter OD7 of the outer surface 1283 of the grip 1271 adjacent to the first end 1267 of the second longitudinal section 1255 is larger than an eighth outer diameter OD8 of the outer surface 1283 adjacent to the second end 1268. The outer surface 1283 is disposed adjacent to the inner surface 1281 of the wedge 1270. The inner surface 1284 of the grip 1271 is disposed generally parallel to the central longitudinal axis LA of the locking member 1214. The inner surface 1281 of the grip 1271 defines the second portion 1252B of the central passageway 1252 and extends from the first end 1267 to the second end 1268 of the second longitudinal section 1255 of the locking member 1214. The second portion 1252B of the central passageway 1252 is configured to receive a distal portion of an outer shaft of a delivery device disposed therein. The second portion 1252B includes the seventh inner diameter ID7 when the locking member 1214 is in the unlocked state, as shown in FIG. 40A,and the eighth inner diameter ID8 when the locking member is in the locked state, as shown in FIG. 40B, wherein the seventh inner diameter ID7 is larger than the eighth inner diameter ID8. Stated another way, the inner surface 1284 of the adjustable grip 1271 is selectable between the seventh inner diameter ID7 and the eighth inner diameter ID8, and any diameter therebetween, to selectively transition the locking member 1214 between the unlocked state and the locked state. Thus, when the locking member 1214 is in the locked state and the capsule guide tube 1210 is in the locked configuration with the delivery device disposed therein, the inner surface 1284 of the grip 1271 of the second longitudinal section 1255 contacts or engages the outer surface of the outer shaft of the delivery device to releasably secure the capsule guide tube 1210 to the delivery device, via friction.

[0267] The grip 1271 includes the first grip rail 1285 extending in the first or distal direction from a distally facing surface at the first end 1267 of the grip 1271 and the second grip rail 1286 extending in the second or proximal direction from a proximally facing surface at the second end 1268 of the grip 1271. The first grip rail 1285 is configured to be slidingly received within the first grip channel 1261 of the first longitudinal section 1254 of the locking member 1214 and the second grip rail 1286 is configured to be slidingly received within the second channel 1264 of the third longitudinal section 1256 of the locking member 1214. When the first and second grip rails 1285, 1286 are each disposed in the corresponding second channels 1261, 1263, the grip 1271 is longitudinally constrained between the first longitudinal section 1254 and the third longitudinal section 1256. Thus, the grip 1271 is radially retained and permitted to move radially inward or radially outward within the limits of the second grip channels 1261, 1264 of the first and third section 1254, 1256, respectively. In embodiments, the grip 1271 may be configured to return to the seventh inner diameter ID7 when the grip 1271 is not radially compressed by the wedge 1270 by any method suitable for the purposes described herein. The grip 1271 may be formed of any suitable material, as will be understood by persons skilled in the art including, but not limited to medical grade silicone rubbers, thermoplastic elastomers (TPE), polyurethane elastomers (PU), ethylene vinyl acetate (EVA), and styrene-ethylene-buylene-styrene (SEBS). Such materials are easy to process, biocompatible, relatively soft, and sterilization resistant. Thus, other materials with similar properties may also be used.

[0268] The operation and interaction of the various components of the capsule guide tube 1210 to releasably couple the capsule guide tube 1210 to an outer shaft of a delivery device, for example,to the outer shaft 204 of the delivery device 200, will now be described with reference to FIGS. 40A-40B.

[0269] In a step in the method, the locking member 1214 is disposed over a distal end of the delivery device 200. More specifically, the distal end of the delivery device 200 is disposed through the central passageway 1252 of the locking member 1214 and the locking member 1214 is moved in a first longitudinal direction LD1 i.e., proximally over a distal portion of the delivery device 200 and positioned proximal of the capsule 206 of the delivery device 200. The delivery device 200 may instead be moved distally through the locking member 1214, or both the delivery device 200 and the locking member 1214 may be moved in opposite directions relative to each other.

[0270] In another step of the method, the first arm 1226 A and the second arm 1226B of the body 1212 are each disposed over opposite sides of a distal end of the delivery device 200 such that the capsule 206 is disposed within the central passageway 1220 of the body 1212.

[0271] In another step of the method, the locking member 1214 is moved in a second longitudinal direction LD2, i.e., distally, opposite the first longitudinal direction LD1. The plurality of tabs 1292 of the locking member 1214 are rotationally aligned with the plurality of recesses 1290 of the body 1212 such that each tab 1292 engages the corresponding recess 1290 to releasably couple the locking member 1214 to the body 1212, as shown in FIG. 40 A. In greater detail, as each tab 1292 travels in the second longitudinal direction LD2, each tab 1292 moves or flexes radially outward via the arm 1293 as the tab 1292 encounters and passes over the outer surface 1231 of the second longitudinal section 1224 of the body 1212. When each tab 1292 is longitudinally and rotationally aligned with the corresponding recess 1290 of the body 1212, each tab 1292 moves radially inward to engage the corresponding recess 1290.

[0272] As shown in FIG. 40B, in a step of the method the actuator 1269 is actuated such that the locking member 1214 transitions from the unlocked state to the locked state and the capsule guide tube 1210 transitions from the unlocked configuration to the locked configuration with the capsule guide tube 1210 releasably coupled to the outer shaft 204 of the delivery device 200. More particularly, with the locking member 1214 in the unlocked state, the actuator 1269 is rotated in a first (i.e., clockwise) direction indicated by an arrow RD1. When the actuator 1269 is rotated in the first direction RD1, the first thread 1276 of the actuator 1269 engages the corresponding second thread 1282 of the wedge 1270 such that the wedge 1270 is translated in the first or distallongitudinal direction of the arrow LD1. As the wedge 1270 travels in the first longitudinal direction of the arrow LD1, the inner surface 1281 of the wedge 1270 exerts a radially inward pressure on the outer surface 1283 of the grip 1271. The inward radial force on the grip 1271 causes the grip 1271 to move radially inward such that the inner surface 1284 of the grip 1271 engages and exerts a radially inward force on the distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, to secure the capsule guide tube 1210 to the delivery device 200.

[0273] With the capsule guide tube 1210 secured to the distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, additional components of a loading system including, but not limited to a loading cone, a loading ring, a valve seat, a tip guide tube, and a loading tray may be utilized to load a heart valve prosthesis into the capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety. As explained therein, the capsule guide tube 1210 is secured to the delivery device 200 (in this embodiment to the outer shaft 204) such that the capsule guide tube 1210 moves distally with the outer shaft 204 and the capsule 206 to push the loading cone over the transcatheter heart valve prosthesis while maintaining the heart valve prosthesis longitudinally stationary to radially compress the heart valve prosthesis and load the heart valve prosthesis into the capsule 206.

[0274] FIGS. 41-44B show a capsule guide tube 1310 in accordance with embodiments herein. FIGS. 41-43B show an embodiment of the capsule guide tube 1310, and FIGS. 44A and 44B illustrate alternative embodiments. The capsule guide tube 1310 is configured to be releasably coupled to, secured to, or locked to an outer shaft of a delivery device. The capsule guide tube 1310 includes an unlocked configuration wherein the capsule guide tube 1310 is not releasably secured to the delivery device, and a locked configuration wherein the capsule guide tube 1310 is releasably secured to the delivery device. A proximal portion of the capsule guide tube 1310 exerts an inward or compressive force on the outer shaft of the delivery device, thereby releasably coupling, locking, or securing the capsule guide tube 410 to the outer shaft of the delivery device, proximal of the capsule, via friction.

[0275] In embodiments herein, the capsule guide tube 1310 includes a body 1312. The body 1312 of the capsule guide tube 1310 is configured to be disposed on a distal portion of a deliverydevice. The body 1312 is similar to the body 412 shown in FIG. 11 -13 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 41-44B.

[0276] Thus, generally, as described above, the body 1312 includes a first (distal) end 1316, a second (proximal) end 1318, and a central passageway 1320 extending between the first end 1316 and the second end 1318. The body 1312 includes a first longitudinal section 1322, a second longitudinal section 1324, and a third longitudinal section 1327. However, the body 1312 of FIGS. 41-44B differs from the body 412 of FIGS. 11-13 in that an inner surface 1336 of the third longitudinal section 1327 is tapered such that when the capsule guide tube 1310 is in the locked configuration, a portion of the inner surface 1336 contacts or engages an outer surface of the outer shaft of the delivery device to releasably secure the capsule guide tube 1310 to the delivery device, via friction. In embodiments, the body 1312 further differs from the body 412 of FIGS. 11-13 in that the body 1312 may include one or more hinges and / or one or more releasable locks, as described below.

[0277] The first longitudinal section 1322 is similar to the first longitudinal section 422 of FIGS. 11-13 and the second longitudinal section 1324 is similar to the second longitudinal section 424 of FIGS. 11-13. Therefore, a detailed description of the first longitudinal section 1322 and the second longitudinal section 1324 will not be repeated here.

[0278] The third longitudinal section 1327 of the body 1312 extends from a first end 1304 adjacent to a second end 1302 of the second longitudinal section 1324 to the second end 1318 of the body 1312. The third longitudinal section 1327 is a tubular construction and includes a generally cylindrical outer surface 1337. The third longitudinal section 1327 includes a third portion 1329 of the central passageway 1320. The third portion 1329 of the central passageway 1320 extends from the first end 1304 of the third longitudinal section 1327 to the second end 1318 of the body 1312. The third portion 1329 of the central passageway 1320 may be tapered in a direction towards the second end 1318 of the body 1312 such that a fifth inner diameter ID5 at the first end 1304 of the third longitudinal section 1327 of the body 1312 is larger than a sixth inner diameter ID6 at the second end 1318 of the body 1312. The sixth inner diameter ID6 of the third portion 1329 of the central passageway 1320 is generally equal to or slightly smaller than an outer diameter of the outer shaft of the delivery device disposed therein. Thus, when the capsule guide tube 1310 is in the locked configuration with the delivery device disposed therein, a proximal portion of an inner surface 1336 of the third longitudinal section 1327 contacts or engages theouter surface of the outer shaft of the delivery device to releasably secure the capsule guide tube 1310 to the delivery device, proximal of the capsule, via friction.

[0279] The body 1312 of the capsule guide tube 1310 may be formed of a first arm 1326A and a second arm 1326B. In embodiments herein, the first arm 1326A and the second arm 1326B are each approximately one-half of the body 1312, divided generally longitudinally. The first arm 1326A and the second arm 1326B are similar to the first arm 426A and the second arm 426B of FIGS. 11-13 and therefore will not be described in detail with respect to FIGS. 41-44B. In general, the first arm 1326A of the body 1312 includes a first circumferential edge 1334A and a second circumferential edge 1335A, as shown in FIG. 41. The second arm 1326B of the body includes a first circumferential edge 1334B and a second circumferential edge 1335B. When the capsule guide tube 1310 is in the unlocked configuration of FIG. 41, the first circumferential edges 1334A, 1334B of the first and second arms 1326A, 1326B do not abut each other. Stated another way, the first and second circumferential edges 1334A, 1335A of the first arm 1326A are separated or spaced from the corresponding first and second circumferential edges 1334B, 1335B of the second arm 1326B when the capsule guide tube 1310 is in the unlocked configuration. When the capsule guide tube 1310 is in the locked configuration of FIG. 42, the first circumferential edge 1334A of the first arm 1326A is adjacent to and abuts the first circumferential edge 1334B of the second arm 1326B and the second circumferential edge 1335A of the first arm 1326A is adjacent to and abuts the second circumferential edge 1335B of the second arm 1326B.

[0280] In the embodiment of FIGS. 41-44B, the first arm 1326A and the second arm 1326B of the body 1312 may be pivotably coupled by a one or more hinges 1386 or similar mechanism, as shown in FIG. 41. The one or more hinges 1386 are configured to permit the first arm 1326A and the second arm 1326B of the body 1312 to pivot around the one or more hinges 1386 to transition the capsule guide tube 1310 between the unlocked configuration of FIG. 41 and the locked configuration of FIG. 42. The embodiment of FIGS 41-44B, each hinge 1386 is disposed adjacent to the first circumferential edges 1334A, 1334B of the first and second arms 1326A, 1326B, respectively, of the body 1312. When the capsule guide tube 1310 is in the locked configuration, the first and second arms 1326A, 1326B may be releasably coupled or locked to each other, such as by a releasable lock 1388, as shown in FIG. 43 A. In embodiments, the releasable lock 1388 may be a catch / latch lock, as shown in FIG. 43A and 43B, but this is not meant to be limiting. As would be understood by skilled in the art, other releasable locks may be utilized. While two hinges1386 and the releasable lock 1388 are each shown in specific locations in FIGS. 41-44B, this is not meant to be limiting, and any number of hinges 1386 and any number of releasable locks 1388 may be utilized at any suitable position.

[0281] The operation and interaction of the various components of the capsule guide tube 1310 to releasably couple the capsule guide tube 1310 to an outer shaft of a delivery device, for example, to the outer shaft 204 of the delivery device 200, will now be described.

[0282] In a step of a method, the distal end of the delivery device 200 is disposed within the second arm 1326B of the body 1312. More particularly, the distal portion of the delivery device 200 is disposed within a portion of the second arm 1326B of the body 1312 of the capsule guide tube 1310 such that the capsule 206 of the delivery device 200 is disposed within the second longitudinal section 1324B of the second arm 1326B of the body 1312 and a distal portion of the outer shaft 204 of the delivery device 200 is disposed within the third longitudinal section 1327B of the second arm 1326B.

[0283] In a next step, the first arm 1326A is pivoted in the direction of an arrow Pl such that such that first and the second circumferential edges 1334A, 1335A of the first arm 1326A abut the corresponding first and second circumferential edges 1334B, 1335B of the second arm 1326B, as shown in FIG. 42. As the first arm 1326A abuts the second arm 1326B, as described above, a proximal portion of the tapered inner surface 1336 of the third longitudinal section 1327 applies a radially inward force on the outer shaft 204 of the delivery device 200, thereby releasably coupling or securing the capsule guide tube 1310 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206, via friction.

[0284] In a step of the method, with the capsule guide tube 1310 releasably coupled to the outer shaft 204 of the delivery device 200, the lock 1388 may be engaged to releasably couple or lock the first arm 1326A to the second arm 1326B of the body 1312, and to transition the capsule guide tube 1310 to the locked configuration, as shown in FIG. 43 A.

[0285] Although the embodiments of FIGS. 41-43B describe the body 1312 applying radially inward pressure due to the third longitudinal section 1327 of the body 1312 having an inner diameter that tapers in the proximal direction, this is not meant to be limiting. In another embodiment shown in FIG. 44A, an inner surface 1336’ of a third longitudinal section 1327’ of the body 1312 may not be tapered and may include a split washer 1390 extending radially inward from the inner surface 1336’ . The split washer 1390 is configured to apply radially inward pressureon the outer shaft 204 of the delivery device 200, as shown in FIG. 44A to releasably couple the capsule guide tube 1310 to the outer shaft 204 of the delivery device 200. FIG. 44B illustrates another embodiment of the capsule guide tube 1310, wherein a third longitudinal section 1327” of the body 1312 may include a one or more protrusions 1392 configured to apply radially inward pressure on the outer shaft 204 of the delivery device 200 to releasably couple the capsule guide tube 1310 to the outer shaft 204 of the delivery device 200, as shown in FIG. 44B. The one or more protrusions 1392 may be coupled to and extend radially inward from the inner surface 1336” of the third longitudinal section 1327”. In embodiments herein, the one or more split washers 1390 and the one or more protrusions 1392 may be of any shape, size, material, and location suitable for the purposes described herein.

[0286] With the capsule guide tube 1310 releasably coupled to the distal portion of the outer shaft 204 of the delivery device 200, proximal of the capsule 206, additional components of a loading system including, but not limited to a loading cone, a loading ring, a valve seat, a tip guide tube, and a loading tray may be utilized to load a heart valve prosthesis into the capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, previously incorporated by reference herein in its entirety.

[0287] In embodiments, the second longitudinal section 1322 may include a non-slip coating on an inner surface thereof. The non-slip coating grips the capsule 206 of the delivery device 200 to limit relative longitudinal movement between the body 1312 and the capsule 1306 when the capsule guide tube 1310 is in the locked configuration. In embodiments herein, the non-slip coating does not affect the assembly process or damage coatings on the outer surface of the capsule 206 of the delivery device 200 as the capsule 206 is disposed within the body 1312 when the capsule guide tube is in the unlocked configuration and the first arm 1326A and the second arm 1326B of the body are separated from each other. Stated another way, the body 1312 of the capsule guide tube 1310 does not slide over the capsule 206 of the delivery device 200.

[0288] FIGS. 45-46C illustrate a capsule guide tube 1510 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. The capsule guide tube 1510 is configured to be releasably coupled to, secured to, or locked to an outer shaft of a delivery device. The capsule guide tube 1510 includes an unlocked configuration wherein the capsule guide tube 1510 is not secured to the delivery device, and a locked configuration wherein the capsule guide tube 1510 is releasably secured tothe delivery device. The capsule guide tube 1510 is similarto the capsule guide tube 1210 ofFIGS. 38-41 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 45-46C. Thus, generally, as described above, the capsule guide tube 1510 includes a body 1512 and a locking member 1514. However, the capsule guide tube 1510 of FIGS. 45-46C differs from the capsule guide tube 1210 in that the locking member 1514 is configured with radially compressible locking arms configured to releasably secure the capsule guide tube 1510 to an outer shaft of a delivery device when the capsule guide tube 1510 is in the locked configuration.

[0289] The body 1512 of the capsule guide tube 1510 is similar to the body 1212 shown in FIGS. 38-41 except as described herein. Therefore, details of the construction and alternatives of the body 1512 will not be repeated. In general, the body 1512 includes a first (distal) end 1516, a second (proximal) end 1518, a central passageway 1520, a first longitudinal section 1522 and a second longitudinal section 1524 as shown in FIG. 45.

[0290] In embodiments herein, the locking member 1514 of the capsule guide tube 1510 is a generally tubular structure as shown in FIG. 45. The locking member 1514 includes a first or unlocked state and a second or locked state. The locking member 1514 is configured to exert an inward or compressive force on a portion of an outer shaft of a delivery device disposed therein when the locking member 1514 is in the locked state, as described below. The locking member 1514 includes a first end 1548, a second end 1550, and a central passageway 1552 extending from the first end 1548 to the second end 1550. In the embodiment shown in FIGS. 45-46C the locking member 1514 includes a distal or first longitudinal section 1554 and a second or proximal longitudinal section 1555.

[0291] The first longitudinal section 1554 extends from the first end 1548 of the locking member 1514 to a second end 1557 of the first longitudinal section 1554. The first longitudinal section 1554 of the locking member 1514 is a tubular construction including an outer surface 1558. The first longitudinal section 1554 includes or defines a first portion 1552A of the central passageway 1552. The first portion 1552A of the central passageway 1552 extends from the first end 1548 of the locking member 1514 to the second end 1557 of the of the first longitudinal section 1554. In embodiments herein, the first portion 1552A of the central passageway 1552 is configured to receive a proximal portion of the second section 1524 of the body 1512. A fifth inner diameter ID5 of the first portion 1552A of the central passageway 1552 of the locking member 1514 islarger than or equal to a third outer diameter OD3 of the second longitudinal section 1 24 of the body 1512.

[0292] The first longitudinal section 1554 of the locking member 1514 includes a first thread 1560. The first thread 1560 extends radially outward on a proximal portion of the first longitudinal section 1554. The first thread 1560 is configured to engage a second thread 1582 of the second longitudinal section 1555 of the locking member 1514 as described below. The first thread 1560 may be formed for example, and not by way of limitation, as an integral portion of the outer surface 1558 of the first longitudinal section 1554, or as a separate unit coupled to the outer surface 1558 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While the first thread 1560 is shown in FIGS. 45-46C with a specific gender, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized.

[0293] The locking member 1514 includes a plurality of locking arms 1562 extending proximally and radially inward from the second end 1557 of the first longitudinal section 1554. Each locking arm 1562 includes a first end 1564 coupled to the second end 1557 of the first longitudinal section 1554 and a second end 1566. The plurality of locking arms 1562 are configured to releasably lock, secure, or couple the capsule guide tube 1510 to the distal end of the delivery device disposed therein. Accordingly, when the locking member 1514 is in the unlocked state, i.e., when the second longitudinal section 1555 is not coupled to the first longitudinal section 1554, the second ends 1566 of the plurality of locking arms 1562 define a sixth inner diameter ID6, as shown in FIGS. 45and 46B. In embodiment, the sixth inner diameter ID6 may be larger than an outer surface of an outer shaft of a delivery device disposed therein. In an embodiment, the sixth inner diameter ID6 may be larger than an outer surface of a capsule of the delivery device disposed therein. When the locking member 1514 is in the locked state, i.e., when the second longitudinal section 1555 is releasably coupled to the first longitudinal section 1554, the second ends 1566 of the plurality of locking arms 1562 define a seventh inner diameter ID7 that is equal to or smaller than the outer surface of the outer shaft or the delivery device disposed therein, as shown in FIG. 46C. Stated another way, when the locking member 1514 is in the locked state, the locking member is configured such that the second end 1566 of each of the plurality of locking arms 1562 engage the outer surface of the outer shaft of the delivery device disposed therein.

[0294] While FIGS. 45-46C show three locking arms 1562 of a specific shape and disposed at specific locations around the circumference of the second end 1557 or the first longitudinal section 1554, this is not meant to be limiting, and any number of locking arms 1562 of any suitable shape disposed at any suitable location may be utilized.

[0295] The second longitudinal section 1555 extends from a first end 1567 to a second end 1568 of the second longitudinal section 1555. The second longitudinal section 1555 of the locking member 1514 is a tubular construction including a generally cylindrical outer surface 1572. The second longitudinal section 1555 includes or defines a second portion 1552B of the central passageway 1552. The second portion 1552B of the central passageway 1552 extends from the first end 1567 of the second longitudinal section 1555 to the second end 1568. In embodiments herein, the second portion 1552B of the central passageway 1552 may include a first or cylindrical section 1552B1, a second or tapered section 1552B2, and a third or cylindrical section 1552B3, as best shown in FIG. 45. The first section 1552B1 of the second portion 1552B of the central passageway 1552 is cylindrical with an eighth inner diameter ID8. The third section 1552B3 of the second portion 1552B of the central passageway 1552 is cylindrical with a ninth inner diameter ID9. In embodiments herein, the eighth inner diameter ID8 is larger than the ninth inner diameter ID9. The second section 1552B2 of the second portion 1552B of the central passageway 1552 is tapered in a direction towards the second end 1568 of the second longitudinal section 1555 between the first section 1552B1 and the third section 1552B3. In embodiments herein, the eighth and ninth inner diameters ID8, ID9 are each larger than the outer diameter of the outer shaft of the delivery device disposed therein.

[0296] The second longitudinal section 1555 of the locking member 1514 includes a second thread 1582. The second thread 1582 extends radially inward on a distal portion of the second longitudinal section 1555. In an embodiment, the second thread 1582 extends radially inward into the first section 1552B1 of the second portion 1552B of the central passageway 1552 of the locking member 1514. The second thread 1582 is configured to engage the first thread 1576 of the first longitudinal section 1554 to releasably couple the second longitudinal section 1555 to the first longitudinal section 1554 and to transition the locking member 1514 from the unlocked state to the locked state as described below. The second thread 1582 may be formed for example, and not by way of limitation, as an integral portion of an inner surface 1573 of the second longitudinal section 1555, or as a separate unit coupled to the inner surface 1573 by methods including, but notlimited to adhesives, welding, or other methods as appropriate. While the second thread 1582 is shown in FIGS. 45-46C with a specific gender, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations corresponding to the first thread 1576 may be utilized.

[0297] The operation and interaction of the various components of the capsule guide tube 1510 to releasably couple the capsule guide tube 1510 to a proximal portion of the capsule 206 of the delivery device 200 will now be described. As explained above, the capsule 206 and the delivery device 200 are examples only, and the description thereof is not meant to be limiting.

[0298] In a step of the method, the second longitudinal section 1555 of the locking member 1514 is disposed over a distal end of the delivery device 200, as shown in FIG. 46A. More specifically, the distal end of the delivery device 200 is disposed through the second portion 1552B of the second longitudinal section 1555 of the locking member 1514. The second longitudinal section 1555 of the locking member 1514 is moved in a first longitudinal direction LD1 i.e., proximally over a distal portion of the delivery device 200 and positioned proximal of the capsule 206 of the delivery device 200. The delivery device 200 may instead be moved distally through the second longitudinal section 1555 of the locking member 1514, or both the delivery device 200 and the second longitudinal section 1555 of the locking member 1514 may be moved in opposite directions relative to each other.

[0299] In another step of the method, the first longitudinal section 1554 of the locking member 1514 is disposed over the distal end of the delivery device 200 and the distal end of the delivery device 200 is disposed through the first portion 1552A of the first longitudinal section 1554 of the locking member 1514. The first longitudinal section 1554 of the locking member 1514 is moved in the first longitudinal direction LD1 i.e., proximally over the distal portion of the delivery device 200 and positioned proximal of the capsule 206 of the delivery device 200 and distal of the second longitudinal section 1555 of the locking member 1514.

[0300] In a step of the method, the first arm 1526 A and the second arm 1526B of the body 1512 are each disposed over opposite sides of the distal end of the delivery device 200 such that the capsule 206 is disposed within a second portion 1523 of the central passageway 1520, within the second longitudinal section 1524, as shown in FIG. 46B.

[0301] In another step of the method, the first longitudinal section 1554 of the locking member 1514 is moved in a second longitudinal direction LD2, i.e., distally, opposite the first longitudinaldirection LD1 , over a proximal portion of the body 1512 of the capsule guide tube 1510 such that the second end 1557 of the first longitudinal section 1554 of the locking member 1514 is adjacent to the second end 1518 of the body 1512 and the plurality of locking arms 1562 are each disposed radially outward of the outer shaft 204 of the delivery device 200.

[0302] In a step of the method, the second longitudinal section 1555 of the locking member 1514 is moved in the second longitudinal direction LD2, i.e., distally, opposite the first longitudinal direction LD1 to engage the second thread 1582 with the first thread 1560 of the first longitudinal section 1554, as shown in FIG. 46C. The second longitudinal section 1555 of the locking member 1514 is rotated in a first direction RD1 such that the second thread 1582 moves along the first thread 1560 and the second longitudinal section 1555 of the locking member 1514 moves distally in the direction LD2. As the second longitudinal section 1555 of the locking member 1514 is rotated and moves distally relative to the body 1512, a tapered inner surface 1584 of the second longitudinal section 1555 defining the second section 1552B2 of the second portion 1552B of the central passageway 1252 of the locking member 1514 exerts an increasing radially inward or compressive force on the plurality of arms 1562 of the first longitudinal section 1554 of the locking member 1514. The compressive force increases as the second longitudinal section 1555 approaches the first longitudinal section 1554 due to the tapered inner surface 1584 of the second longitudinal section 1555 locking member 1514. This inward compressive force on the plurality of locking arms 1562 in turn applies a radially inward force on the distal portion of the outer shaft 204 of the delivery device 200 by the locking arms 1562, thereby releasably coupling or securing the capsule guide tube 1510 to the outer shaft 204 of the delivery device 200, proximal of the capsule 206, via friction.

[0303] With the capsule guide tube 1510 secured to the distal portion of the outer shaft 204 of the delivery device 200, proximal the capsule 206, additional components of a loading system including, but not limited to a loading cone, a loading ring, a valve seat, a tip guide tube, and a loading tray may be utilized to load a heart valve prosthesis into the capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety.

[0304] FIGS. 47-49D illustrate a capsule guide tube 1610 for use with a loading system for loading a transcatheter heart valve prosthesis into a delivery device, in accordance with embodiments herein. FIG. 47 illustrates the components of the capsule guide tube 1610. FIGS.48A and 48B illustrate a cross-sectional view of the capsule guide tube in an unlocked configuration and a locked configuration, respectively. FIGS. 49A-49D illustrate the operation and interaction of the capsule guide tube 1610 with a capsule of a delivery device. The capsule guide tube 1610 is configured to be releasably coupled to, secured to, or locked to a proximal portion of a capsule of a delivery device. The capsule guide tube 1610 includes an unlocked configuration wherein the capsule guide tube 1610 is not secured to the delivery device, and the locked configuration wherein the capsule guide tube 1610 is releasably secured to the delivery device. The capsule guide tube 1610 is similar to the capsule guide tube 1210 of FIGS. 38-41 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 47-49C. Thus, generally, as described above, the capsule guide tube 1610 includes a body 1612 and a locking member 1614. However, the capsule guide tube 1610 of FIGS. 47-49D differs from the capsule guide tube 1210 in that the body 1612 includes a plurality of inclined rails and the locking member 1614 is configured with a radially compressible twist lock configured to releasably secure the capsule guide tube 1610 to the proximal portion of the capsule of the delivery device.

[0305] The body 1612 of the capsule guide tube 1610 is similar to the body 1212 shown in FIGS. 38-41 except as described herein. Therefore, details of the construction and alternatives of the body 1612 are not repeated. In general, the body 1612 includes a first (distal) end 1616, a second (proximal) end 1618, a central passageway 1620, a first longitudinal section 1622 and a second longitudinal section 1624 as shown in FIG. 47. The second longitudinal section 1624 of the body 1612 includes an inner surface 1637. In embodiments, a portion of the inner surface 1637 is configured to engage a proximal portion of a capsule of a delivery device when the capsule guide tube 1610 is in the locked configuration.

[0306] In embodiments, the body 1612 includes a plurality of inclined rails 1640, as shown in FIG. 47. The plurality of inclined rails 1640 are configured to engage the locking member 1614 to center the locking member 1614 over the body 1612 of the capsule guide tube 1610, as described below. Each inclined rail 1640 includes a first end 1642 and a second end 1644 and extends radially outward from an outer surface 1631 of the second longitudinal section 1624 of the body 1612. An outer surface 1646 of each rail 1640 is tapered in a direction towards the second end 1644 such that a fourth outer diameter OD4 at or near the first end 1642 of each inclined rail 1640 is larger than a fifth outer diameter OD5 at or near the second end 1642 of the respective inclined rail 1640.Each inclined rail 1640 is disposed along the second longitudinal section 1624 of the body 1612, generally parallel to a longitudinal axis LA of the body 1612 and generally on an opposite side of the body from a corresponding inclined rail 1640. While FIG. 47 shows four inclined rails 1640 on the body 1612, this is not meant to be limiting, and a fewer or more inclined rails 1640 may be utilized. Each inclined rail 1640 of the plurality of inclined rails 1640 may be formed for example, and not by way of limitation, as an integral portion of the outer surface 1631 of the second longitudinal section 1624, or as a separate unit coupled to the outer surface 1631 for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate.

[0307] In embodiments herein, the locking member 1614 of the capsule guide tube 1610 is a generally tubular structure as shown in FIG. 47 including a first section or slider 1613 and a butterfly or twist lock 1615. The locking member 1614 includes a first or unlocked state and a second or locked state. The locking member 1614 is configured to exert an inward or compressive force on a proximal portion of the second longitudinal section 1624 of the body 1612 of the capsule guide tube 1610 when the locking member 1614 is in the locked state, as described below. The slider 1613 of the locking member 1614 includes a first end 1648, a second end 1650, and a central passageway 1652 extending from the first end 1648 to the second end 1650. The slider 1613 includes an outer surface 1654 and an inner surface 1656.

[0308] In an embodiment, the central passageway 1652 is tapered in a direction towards a second end 1650 of the slider 1613 such that the central passageway 1652 adjacent to a first end 1648 is larger than the central passageway 1652 adj acent to the second end 1650. Accordingly, the slider 1613 has a fifth inner diameter ID5 adjacent to the first end 1648 and a sixth inner diameter ID6 adjacent to the second end 1650. In embodiments, the fifth inner diameter ID5 is larger than the fourth outer diameter OD4 of the one or more tapered rails 1640 of the body 1612 of the capsule guide tube 1610. The sixth inner diameter ID6 is larger than the fifth outer diameter OD5 and smaller than the fourth outer diameter of the one or more tapered rails 1640 of the body 1612. Thus, the central passageway 1652 of the locking member 1614 is configured to receive a portion of the second longitudinal section 1624 of the body 1612. While described herein with the central passageway 1652 being tapered from the first end 1648 to the second end 1650, this is not meant to be limiting, and in an embodiment only a portion of the central passageway 1652 may be tapered.

[0309] In the embodiment of FIGS. 47-49D, the slider 1613 of the locking member 1614 includes two locking arms 1658. In the embodiment shown, each locking arm 1658 is a cut-out in a proximal portion of the slider 1613. In particular, each locking arm 1658 includes first and second circumferential cuts 1660, 1662 defining first and second longitudinal ends / first and second longitudinal edges thereof, and a longitudinal cut 1667 extending between the first and second circumferential cuts 1660, 1162 at first circumferential ends of the first and second circumferential cuts 1660, 1662, defining a first longitudinal edge 1666 of each locking arm 1658. At second circumferential ends of the first and second circumferential cuts 1660, 1662 (shown at 1664 of the drawings), each locking arm 1658 is coupled to the rest of the slider 1613. Thus, each locking arm 1658 is a circumferential cantilever and each locking arm 1658 can flex radially inwardly and outwardly. When the lock 1615 is engaged as described in more detail below, the locking arms 1658 are flexed radially inwardly to apply a radially inward force to the proximal portion of the body 1612 of the capsule guide tube 1610, thereby releasably securing the body 1612 to a proximal portion of the capsule of the delivery device. In embodiments, an outer surface of the locking arm 1658 adjacent to the second longitudinal cut 1666 extends radially outward forming a ridge or protrusion 1665. While FIGS. 48A and 48B show two locking arms 1658, this is not meant to be limiting, and a larger or smaller number of locking arms 1658 may be utilized. It shall be understood that in embodiments, the outer surface 1654 of the slider 1613 may include various texturing and / or one or more first wing grips 1668 for ease of handling and manipulation, as illustrated in FIG. 47.

[0310] In embodiments herein, the twist lock 1615 of the locking member 1614 of the capsule guide tube 1610 is a generally tubular structure as shown in FIG. 47. The twist lock 1615 includes a body 1670 including a first end 1672, a second end 1674, and a central passageway 1676 extending between the first end 1672 and the second end 1674. The central passageway 1676 is configured to slidingly and rotatably receive a proximal portion of the slider 1613 of the locking member 1614, as described below. The twist lock 1615 is configured to exert an inward or compressive force on the one or more locking arms 1658 of the slider 1613 of the locking member 1614 when the locking member 1614 is in the locked state. The central passageway 1676 is defined by an inner surface 1680 extending from the first end 1672 to the second end 1674 of the body 1670. In the embodiment of FIGS. 47-49D the twist lock 1615 includes two wing grips 1678A, 1678B extending radially outward from and on opposite sides of an outer surface of the body 1670.The wing grips 1678 A, 1678B are each configured for ease in handling and manipulation of the twist lock 1615. While described with two wing grips 1678, this is not meant to be limiting and embodiments of the twist lock 1615 may include more or fewer wing grips 1678, or may include different features to enable twisting or rotation of the twist lock 1615.

[0311] In embodiments, the capsule guide tube 1610 may include a grip 1690 coupled to the outer surface 1631 of a proximal portion of the body 1612. The grip 1690 is configured to provide convenient gripping of the capsule guide tube 1610 by a user.

[0312] In the embodiment shown in FIGS. 48A and 48B, the inner surface 1680 of the twist lock 1615 includes a first circumferential portion 1681 A and a second circumferential portion 168 IB. Each circumferential portion 1681 is configured to exert a radially inward force on a portion of the slider 1613 of the locking member 1614 when the locking member 1614 is in the locked state. More precisely, when the locking member 1614 is in the locked state, each circumferential portion 1681 of the twist lock 1615 is configured to exert a radially inward force on a corresponding locking arm 1658 of the slider 1613 of the locking member 1614, as described below. In embodiments herein, the first circumferential portion 1681 A and the second circumferential portion 168 IB are each approximately one-half of the inner surface 1680. Each circumferential portion 1681 includes a first circumferential end 1682 and a second circumferential end 1684. Each circumferential portion 1681 has a first radius R1 at the first circumferential end 1682 and a second radius R2 at the second circumferential end 1684, wherein the first radius R1 is larger than the second radius R2. Thus, each circumferential portion 1681 of the inner surface 1680 is tapered from the first circumferential end 1682 to the second circumferential end 1684. As shown in FIG. 48A, the first circumferential end 1682A of the first circumferential portion 1681 A is adjacent the second circumferential end 1682B of the second circumferential portion 168 IB, and the second circumferential end 1682B of the first circumferential portion 1681A is adjacent the second circumferential end 1682A of the second circumferential portion 1681B. Thus, shoulders 1688 are formed between the adjacent ends of the first and second circumferential portions 1681A, 1681B.

[0313] When the locking member 1614 is in the unlocked state, the first longitudinal edge 1666 of each locking arm 1658 of the slider 1613 is disposed adjacent to the first end 1682 (larger radius) of the corresponding circumferential portion 1681 of the inner surface 1680 of the twist lock 1615 of the locking member 1614. When the twist lock 1615 is rotated such that the locking member1614 is in the locked state, as shown in FIG. 48B, the first longitudinal edge 1666 of each locking arm 1658 of the slider 1613 is disposed between the first end 1682 and the second end 1684 of the corresponding circumferential portion 1681 of the inner surface 1680 of the twist lock 1615 of the locking member 1614. Since the inner surface 1681 is tapered between the first end 1682 and the second end 1684, the inner surface 1680 of the corresponding circumferential portion 1681 exerts an increased radially inward force on the corresponding arm 1658 within the circumferential portion 1681, thereby causing the corresponding arm 1658 to flex radially inwardly. The amount of rotation of the twist lock 1615 determines the amount of radially inward movement of the arms 1658.

[0314] In embodiments, the number of circumferential portions 1681 is equal to the number of locking arms 1658 of the slider 1613. For example, if the slider 1613 of the locking member 1614 includes two locking arms 1658, then the inner surface 1680 of the twist lock 1615 will include two circumferential portions 1681. If the slider 1613 includes three or four locking arms 1658, then the twist lock 1615 will include three or four circumferential portions 1681 of the inner surface 1680, respectively.

[0315] With an understanding of the components, the operation of the capsule guide tube 1610 to releasably couple the capsule guide tube 1610 to a proximal portion of a capsule of a delivery device, for example the capsule 206 of the delivery device 200, will now be described. The capsule 206 and the delivery device 200 are examples only, and the description thereof is not meant to be limiting.

[0316] In a step of a method, the capsule guide tube 1610 with the locking member 1614 in the unlocked state is disposed over a distal end of the delivery device 200, as shown in FIG. 49A. The distal end of the delivery device 200 is received within the central passageway 1620 of the body 1612 and the capsule guide tube 1610 is moved in a first longitudinal direction LD1 (z.e., proximally) over a distal portion of the delivery device 200 and / or the delivery device 200 is moved in a second longitudinal direction LD2 ( .e., distally) Isuch that the capsule 206 of the delivery device 200 is disposed within the central passageway 1620 of the body 1612 of the capsule guide tube 1610.

[0317] In another step of the method, the locking member 1614 is moved in the second longitudinal direction LD2, i.e., distally, opposite the first longitudinal direction LD1, over a portion of the body 1612 of the capsule guide tube 1610, as shown in FIGS. 49B and 49C. Inparticular, the slider 1613 with the twist lock 1615 in the unlocked state slides over the proximal the body 1612. As the locking member 1614 moves in the second longitudinal direction LD2 over the proximal portion of the body 1612 of the capsule guide tube 1610, the inner surface 1656 of the slider 1613 engages the tapered rails 1640, the slider 1613 exerts a radially inward force on the body 1612, which in turn exerts a radially inward force on the proximal portion of the capsule 206 of the delivery system 200. In a nonlimiting example, the inner surface 1637 (visible in FIG. 47) of the second longitudinal section 1624 of the body 1612 may engage the capsule 206 in a range between 6mm to 20mm from a proximal end of the capsule 206.

[0318] In another step of the method, the twist lock 1615 is rotated in a first rotational direction RD1 to secure the locking member 1614 to the body 1612 of the capsule guide tube 1610, as shown in FIG. 49D. In greater detail, the twist lock 1615 is rotated in the first rotational direction RD 1 to transition the locking member 1614 from the unlocked state in FIGS. 48A and 49B to the locked state in FIGS. 48B and 49D. As best illustrated in FIGS. 48A and 48B, as the twist lock 1615 rotates in the first rotational direction RD 1, the tapered inner surface 1680 of each circumferential portion 1681 of the twist lock 1615 exerts an increasing radially inward or compressive force on the locking arms 1658 of the slider 1613. The compressive force increases as the second end 1684 of each circumferential portion 1681 of the twist lock 1615 approaches the second longitudinal edge 1666 of the corresponding locking arm 1658 due to the tapered inner surface 1680 of each circumferential portion 1681 to transition the locking member 1614 from the unlocked state to the locked state. This inward compressive force on the plurality of locking arms 1658 bends, deflects, or radially compresses a portion of each locking arm 1658 such that a portion of an inner surface of each locking arm 1658 engages the outer surface 1631 of the second longitudinal section 1624 of the body 1612 to lock the locking member 1614 relative to the body 1612 of the capsule guide tube 1610, and complete the transition of the capsule guide tube 1610 from the unlocked configuration to the locked configuration of FIG. 49D.

[0319] With the capsule guide tube 1610 secured to the capsule 206 of the delivery device 200, additional components of a loading system including, but not limited to a loading cone, a loading ring, a valve seat, a tip guide tube, and a loading tray may be utilized to load a heart valve prosthesis into the capsule 206 of the delivery device 200, as explained in more detail in International Publication No. WO 2024 / 044597, incorporated by reference herein in its entirety.

[0320] While various embodiments have been described above, it should be understood that they have been presented only as illustrations and examples of the present technology, and not by way of limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail may be made therein without departing from the spirit and scope of the present technology. Thus, the breadth and scope of the present technology should not be limited by any of the above-described embodiments but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, may be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.

Claims

CLAIMSWhat is claimed is:

1. A system comprising: a delivery device for delivering a heart valve prosthesis to a treatment site, the delivery device including an outer shaft and a capsule coupled to a distal portion of the outer shaft and extending distally therefrom, wherein the capsule has a larger diameter than the outer shaft proximal of the capsule; and a capsule guide tube configured to be releasably coupled to the delivery device during loading of the heart valve prosthesis into the capsule, the capsule including an unlocked configuration and a locked configuration, the capsule guide tube comprising: a body disposed around the capsule of the delivery device; and a locking member configured to releasably secure the body to the delivery device.

2. The system of claim 1, wherein in the locked configuration the locking member includes a lock central passageway including a distal portion having a first diameter and disposed around a proximal portion of the body, and a proximal portion having a second diameter smaller than the first diameter and disposed around the outer shaft of the delivery device proximal of the capsule of the delivery device.

3. The system of claim 2, wherein in the locked configuration the locking member exerts a radially inward force on the outer shaft proximal of the capsule to secure the capsule guide tube to the delivery device.

4. The system of claim 2 or claim 3, wherein the locking member comprises a first section and a second section divided longitudinally, wherein the locking member includes a first state wherein the first section and the second section are separated such that the lock central passageway is not complete and a second state wherein the first section and the second section are releasably secured to each other such that the lock central passageway is complete, wherein the first state corresponds to the unlocked configuration and the second state corresponds to the locked configuration.

5. The system of claim 4, wherein the first section includes a first circumferential half of the lock central passageway and the second section includes a second circumferential half of the lock central passageway such that the lock central passageway is completed with the locking member in the second state.

6. The system of claim 4 or claim 5, wherein the first section includes first and second circumferential edges surfaces and the second section includes third and fourth circumferential edge surfaces, wherein in the first state the first and second circumferential edges surfaces do not abut the third and fourth circumferential edges surfaces, and in the second state the first circumferential edge surface abuts the third circumferential edge surface and the second circumferential edge surface abuts the fourth circumferential edge surface.

7. The system of claim 6, wherein the first circumferential edge surface includes a protrusion, the third circumferential edge surface includes a recess, and in the second state the protrusion is disposed within the recess.

8. The system of any one of claims 4 through 7, wherein the first section of the locking member includes a tab extending radially inward from an inner surface of the distal portion of the locking member, and wherein the proximal portion of the body includes a body recess, and wherein in the locked configuration the tab of the locking member is disposed in the body recess.

9. The system of any one of claims 4 through 8, wherein the locking member further comprises a hinge coupling together the first section and the second section of the locking member, wherein the first section and the second section are configured to be rotated away from each other in the first state and are configured to be rotated towards each other in the second state.

10. The system of any one of claims 4 through 9, wherein the locking member further comprises a releasable lock configured to lock the first section to the second section in the second state.

11. The system of claim 10, wherein the releasable lock is a latch / catch lock.

12. The system of claim 2 or claim 3, wherein the locking member comprises a first longitudinal section and a second longitudinal section divided radially, wherein the locking member includes a first state wherein the first longitudinal section and the second longitudinal section are separated such that the lock central passageway is not complete and a second state wherein the first longitudinal section and the second longitudinal section are releasably secured to each other such that the lock central passageway is complete, wherein the first state corresponds to the unlocked configuration and the second state corresponds to the locked configuration.

13. The system of claim 12, wherein the first longitudinal section includes a plurality of locking arms extending proximally therefrom, wherein each locking arm of the plurality of locking arms includes a first end and a second end.

14. The system of claim 13, wherein with the capsule guide tube in the unlocked configuration, the lock central passageway adjacent to the second ends of the plurality of locking arms includes a first diameter that is larger than an outer diameter of the outer shaft of the delivery device and in the locked configuration the lock central passageway adjacent to the second ends of the plurality of locking arms includes a second diameter that is smaller than the outer diameter of the outer shaft of the delivery device.

15. The system of any one of claims 12 through 14, wherein the first longitudinal section of the locking member includes a first thread and the second longitudinal section of the locking member includes a second thread, wherein the first thread is configured to engage the second thread to transition the capsule guide tube to the locked configuration.

16. The system of claim 1, wherein the capsule guide tube is configured to be releasably coupled to a proximal portion of the capsule of the delivery device during loading of the heart valve prosthesis into the capsule.

17. The system of claim 16, wherein the locking member includes a butterfly compression lock configured to selectively lock the capsule guide tube in the locked configuration.

Images