WO2025046447A1

WO2025046447A1 - Prosthetic valve delivery device with a leaflet protection subassembly

Info

Publication number: WO2025046447A1
Application number: PCT/IB2024/058291
Authority: WO
Inventors: Micheal N. FALLON
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2023-09-01
Filing date: 2024-08-26
Publication date: 2025-03-06
Anticipated expiration: 2026-03-01

Abstract

A delivery device for delivering the heart valve prosthesis into a vasculature of a patient. The delivery device includes an outer shaft with a capsule at a distal end thereof, the capsule being configured to retain the heart valve prosthesis in a radially compressed configuration, an inner shaft disposed within the outer shaft, and a leaflet protection subassembly attached to the inner shaft. The leaflet protection subassembly includes a plurality of legs radially extending from the inner shaft. Each leg extends between an interior surface of the frame and an exterior surface of a leaflet of the plurality of leaflets to prevent leaflet protrusion of the leaflet through an opening of a frame of the heart valve prosthesis.

Description

PROSTHETIC VALVE DELIVERY DEVICE WITH A LEAFLET PROTECTION SUBASSEMBLY

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/580,226, filed September 1, 2023, the entire content of which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to a delivery device that minimizes leaflet protrusion and leaflet damage during the loading and/or recapture of a valve prosthesis into the delivery device.

BACKGROUND

[0003] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.

[0004] Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery devices. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0005] In some circumstances, when radially compressing/crimping a heart valve prosthesis into delivery device, recapturing a heart valve prosthesis into a delivery device after at least partial deployment thereof, and/or during deployment of heart valve prosthesis from a delivery device, leaflets of the heart valve prosthesis may get trapped/pinched between struts of the frame as the frame is radially compressed/crimped into the radially compressed configuration or as the frame is radially expanded to the radially expanded configuration. This may cause damage to the leaflets and affect performance and longevity of the heart valve prosthesis in vivo. The present disclosure relates to improvements in delivery devices to minimize or prevent pinching of the leaflets of the heart valve prosthesis during loading, recapture, and/or deployment thereof.

BRIEF SUMMARY OF THE INVENTION

[0006] In accordance with a first example hereof, a system comprising: a heart valve prosthesis including a frame and a prosthetic valve coupled to the frame, the prosthetic valve including a plurality of leaflets; and a delivery device for delivering the heart valve prosthesis into a vasculature of a patient, the delivery device including an outer shaft with a capsule at a distal end thereof, the capsule being configured to retain the heart valve prosthesis in a radially compressed configuration, an inner shaft disposed within the outer shaft, and a leaflet protection subassembly attached to the inner shaft, the leaflet protection subassembly including a plurality of legs radially extending from the inner shaft, wherein when the heart valve prosthesis is coupled to the inner shaft each leg extends between an interior surface of the frame and an exterior surface of a leaflet of the plurality of leaflets to prevent leaflet protrusion of the leaflet through a cell of the frame of the heart valve prosthesis.

[0007] In a second example hereof, the system according to any of the previous or subsequent examples hereof, the frame includes a plurality of first cells and a plurality of second cells larger than the first cells, and each leg is circumferentially aligned with a second cell of the plurality of second cells.

[0008] In a third example hereof, the system according to any of the previous or subsequent examples hereof, the heart valve prosthesis includes exactly three leaflets and the plurality of second cells includes exactly three second cells, and the plurality of legs includes exactly three legs.

[0009] In a fourth example hereof, the system according to any of the previous or subsequent examples hereof, each leg has a planar configuration.

[0010] In a fifth example hereof, the system according to any of the previous or subsequent examples hereof, each leg has a tubular configuration.

[0011] In a sixth example hereof, the system according to any of the previous or subsequent examples hereof, each leg of the plurality of legs has a first end and a second end, the first end being attached to the inner shaft and the second end being radially spaced apart from the inner shaft.

[0012] In a seventh example hereof, the system according to any of the previous or subsequent examples hereof, the second end has an enlarged width relative to the first end. [0013] In an eighth example hereof, the system according to any of the previous or subsequent examples hereof, the second end has a tapered configuration.

[0014] In a nineth example hereof, the system according to any of the previous or subsequent examples hereof, the second end includes a bulbous section.

[0015] In a tenth example hereof, the system according to any of the previous or subsequent examples hereof, at least a portion of each leg is formed from a mesh material.

[0016] In an eleventh example hereof, the system according to any of the previous or subsequent examples hereof, an entire length of each leg is formed from a mesh material.

[0017] In a twelfth example hereof, the system according to any of the previous or subsequent examples hereof, at least a portion of each leg is formed from a self-expanding material.

[0018] In a thirteenth example hereof, a method of delivering and deploying a heart valve prosthesis to a treatment site within a vasculature of a patient, the heart valve prosthesis including a frame and a prosthetic valve coupled to the frame, the prosthetic valve including a plurality of leaflets, the method comprising: advancing a delivery device to the treatment site with the heart valve prosthesis radially compressed within a capsule of the delivery device, the delivery device including an outer shaft with the capsule at a distal portion thereof, an inner shaft disposed within the outer shaft, and a leaflet protection subassembly attached to the inner shaft, the leaflet protection subassembly including a plurality of legs radially extending from the inner shaft, wherein each leg extends between an interior surface of the frame and an exterior surface of a leaflet of the plurality of leaflets; proximally retracting the capsule to partially release the heart valve prosthesis from the capsule, wherein each leg of the leaflet protection subassembly remains disposed between the interior surface of the frame and the exterior surface of the leaflet to prevent leaflet protrusion of the leaflet through a cell of the frame of the heart valve prosthesis; further proximally retracting the capsule to fully deploy the heart valve prosthesis; and proximally retracting the delivery device from the heart valve prosthesis, wherein the leaflet protection subassembly retracts from the heart valve prosthesis.

[0019] In a fourteenth example hereof, the method according to any of the previous or subsequent examples hereof, the frame includes a plurality of first cells and a plurality of second cells larger than the first cells, and each leg is circumferentially aligned with a second cell of the plurality of second cells.

[0020] In a fifteenth example hereof, the method according to any of the previous or subsequent examples hereof, further comprising: distally advancing the capsule to recapture the heart valve prosthesis within the capsule, wherein the step of distally advancing occurs after proximally retracting the capsule to partially release the heart valve prosthesis from the capsule and before further proximally retracting the capsule to fully release the heart valve prosthesis, wherein during the step of distally advancing, each leg of the leaflet protection subassembly remains disposed between the interior surface of the frame and the exterior surface of the leaflet to inhibit the leaflet from being pinched between struts of the frame during recapture of the heart valve prosthesis.

[0021] In a sixteenth example hereof, a method of loading a heart valve prosthesis into a capsule of a delivery device, the heart valve prosthesis including a frame and a prosthetic valve coupled to the frame, the prosthetic valve including a plurality of leaflets, the method comprising: positioning a plurality of legs of a leaflet protection subassembly such that each leg extends between an interior surface of the frame and an exterior surface of a leaflet of the plurality of leaflets, wherein the leaflet protection subassembly is attached to an inner shaft of a delivery device, the delivery device also including an outer shaft with the capsule at a distal portion thereof; radially compressing the heart valve prosthesis within the capsule of the delivery device.

[0022] In a seventeenth example hereof, the method according to any of the previous or subsequent examples hereof, the leaflet protection subassembly is radially compressed and inserted to a tip guide tube prior to the step of positioning the plurality of legs of the leaflet protection subassembly.

[0023] In an eighteenth example hereof, the method according to any of the previous or subsequent examples hereof, the tip guide tube includes a tube having a plurality of slots formed in a sidewall thereof.

[0024] In a nineteenth example hereof, the method according to any of the previous or subsequent examples hereof, each leg of the plurality of legs of the leaflet protection subassembly extends through a slot of the plurality of slots during the step of positioning the plurality of legs of the leaflet protection subassembly.

[0025] In a twentieth example hereof, the method according to any of the previous or subsequent examples hereof, the frame includes a plurality of first cells and a plurality of second cells larger than the first cells, and each leg is circumferentially aligned with a second cell of the plurality of second cells.

[0026] 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

[0027] 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 may not be to scale. [0028] FIG. 1A shows a side view of an example of a heart valve prosthesis.

[0029] FIG. IB shows an outflow view of the heart valve prosthesis of FIG. 1A.

[0030] FIG. 2A is a schematic perspective view of a delivery device in a delivery configuration according to embodiments hereof.

[0031] FIG. 2B is a schematic perspective view of the delivery device of FIG. 2A in a deployed configuration.

[0032] FIG. 3A is a sectional view of a distal portion of the delivery device of FIG. 2A in the delivery configuration, showing a leaflet protection subassembly according to an embodiment hereof.

[0033] FIG. 3B is a sectional view of the distal portion of the delivery device of FIG. 3A with a capsule of the delivery device partially retracted.

[0034] FIG. 3C is a cross-sectional view taken at line C-C of FIG. 3B.

[0035] FIG. 3D is a flat, as-cut illustration of the heart valve prosthesis partially disposed within the capsule of the delivery device and showing the leaflet protection subassembly.

[0036] FIG. 3E is a sectional view of the distal portion of the delivery device of FIG. 3A with the heart valve prosthesis deployed from the capsule of the delivery device.

[0037] FIG. 3F is a sectional view of the distal portion of the delivery device of FIG. 3A with the heart valve prosthesis fully deployed from the capsule of the delivery device and the delivery device retracted such that the leaflet protection subassembly is removed from the heart valve prosthesis.

[0038] FIG. 4A is a sectional view of a distal portion of the delivery device of FIG. 2A in the delivery configuration, showing a leaflet protection subassembly according to another embodiment hereof, wherein each leg of the leaflet protection subassembly has an enlarged distal end.

[0039] FIG. 4B is a perspective view of an enlarged distal end of a leg of a leaflet protection subassembly according to another embodiment hereof.

[0040] FIG. 4C is a perspective view of an enlarged distal end of a leg of a leaflet protection subassembly according to another embodiment hereof.

[0041] FIG. 4D is a perspective view of an enlarged distal end of a leg of a leaflet protection subassembly according to another embodiment hereof. [0042] FIG. 4E is a perspective view of an enlarged distal end of a leg of a leaflet protection subassembly according to another embodiment hereof.

[0043] FIG. 5 A is a perspective view of a tip guide tube according to an embodiment hereof, the tip guide tube being configured for use in loading a leaflet protection subassembly into a heart valve prosthesis.

[0044] FIG. 5B is a cross-sectional view taken at line B-B of FIG. 5A.

[0045] FIG. 6A is a perspective view of a tip guide tube according to another embodiment hereof, the tip guide tube being configured for use in loading a leaflet protection subassembly into a heart valve prosthesis.

[0046] FIG. 6B is a cross-sectional view taken at line B-B of FIG. 6A.

[0047] FIG. 7A is a schematic view of a step of a method of loading a heart valve prosthesis into a delivery device into a heart valve prosthesis, wherein the method includes the tip guide tube of FIG. 5A being used to load a leaflet protection subassembly of the delivery device into the heart valve prosthesis.

[0048] FIG. 7B is a schematic view of a step of a method of loading a heart valve prosthesis into a delivery device into a heart valve prosthesis, wherein the method includes the tip guide tube of FIG. 5A being used to load a leaflet protection subassembly of the delivery device into the heart valve prosthesis.

[0049] FIG. 7C is a schematic view of a step of a method of loading a heart valve prosthesis into a delivery device into a heart valve prosthesis, wherein the method includes the tip guide tube of FIG. 5A being used to load a leaflet protection subassembly of the delivery device into the heart valve prosthesis.

[0050] FIG. 7D is an enlarged perspective view of a paddle of the heart valve prosthesis being received within a paddle opening of a spindle of the delivery device.

[0051] FIG. 7E is a schematic view of a step of a method of loading a heart valve prosthesis into a delivery device into a heart valve prosthesis, wherein the method includes the tip guide tube of FIG. 5A being used to load a leaflet protection subassembly of the delivery device into the heart valve prosthesis. DETAILED DESCRIPTION

[0052] It should be understood that various embodiments disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single device or subassembly for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or subassemblies associated with, for example, a delivery device. The following detailed description is merely exemplary in nature and is not intended to limit the invention of the application and uses of the invention. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding field of the invention, background, summary or the following detailed description. [0053] As used in this specification, the singular forms “a,” “an” and “the” specifically also encompass the plural forms of the terms to which they refer, unless the content clearly dictates otherwise. The term “about” is used herein to mean approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 20%. It should be understood that use of the term “about” also includes the specifically recited number of value.

[0054] The terms “proximal” and “distal” when used herein with respect to a delivery device are used with reference to the clinician using the devices. Therefore, “proximal” and “proximally” mean in the direction toward the clinician, and “distal” and “distally” mean in the direction away from the clinician. The terms “proximal” and “distal” when used herein with respect to an implanted heart valve prosthesis device are used with reference to the direction of blood flow. Therefore, “proximal” and “proximally” mean upstream with respect to the direction of blood flow, and “distal” and “distally” mean downstream with respect to the direct of blood flow. [0055] Further, numerical terms such as “first,” “second”, “third”, etc. used herein are not meant to be limiting such that use of the term “second” when referring to a part in the specification does not mean that there necessarily is a “first” of part in order to fall within the scope of the invention. Instead, such numbers are merely describing that the particular embodiment being described has a “first” part and a “second” part. The invention is instead defined by the claims, in which one or more of the numbered parts may be claimed.

[0056] Embodiments hereof relate to a delivery device including a leaflet protection subassembly configured to prevent leaflet protrusion through the frame of a heart valve prosthesis during loading or recapture of the heart valve prosthesis into a capsule of the delivery device. The leaflet protection subassembly is mounted or attached to an inner shaft of the delivery device and includes a plurality legs that circumferentially align with enlarged cells or openings of a frame of the heart valve prosthesis. The plurality of legs is configured to prevent, or block, leaflets of the heart valve prosthesis from protruding through the enlarged cells or openings in the frame of the heart valve prosthesis during loading of and deployment of the heart valve prosthesis that may cause leaflet pinching and damage. When the heart valve prosthesis is being loaded into the capsule of the delivery device, and/or is being deployed from the capsule, and/or is being recaptured into the capsule, the plurality of legs prevents the leaflets from protruding through enlarged cells or openings of the frame of the heart valve prosthesis, thereby protecting the leaflets by minimizing potential damage thereto during loading, deployment and/or recapture.

[0057] FIGS. 1A and IB illustrate a side view and an outflow view, respectively, of a heart valve prosthesis 100. The heart valve prosthesis 100 includes a radially-expandable frame or stent 108 and a prosthetic valve 118. The frame 108 of the heart valve prosthesis 100 supports the prosthetic valve 118 within the interior of the frame 108. In the example heart valve prosthesis 100 shown in FIGS. 1A-1B, the frame 108 is self-expandable. However, this is not meant to be limiting, and the frame 108 can be balloon-expandable or mechanically expandable.

[0058] The prosthetic valve 118 includes at least one leaflet 119 disposed within and secured to the frame 108. In the embodiment shown in FIGS. 1A-1B, the prosthetic valve 118 includes exactly three leaflets 119, as shown in FIG. IB. However, this is not meant to be limiting, as the prosthetic valve 118 may include more or fewer leaflets 119. The leaflets 119 open and close to regulate flow through the heart valve prosthesis 100.

[0059] As shown in FIG. 1A, the heart valve prosthesis 100 includes an inflow end 102 and an outflow end 104. The leaflets 119 are attached to the frame 108 such that when pressure at the inflow end 102 exceeds pressure at the outflow end 104, the leaflets 119 open to allow blood flow through the heart valve prosthesis 100 from the inflow end 102 to the outflow end 104. When the pressure at the outflow end 104 exceeds pressure at the inflow end 102, the leaflets 119 close to prevent blood flow from the outflow end 104 to the inflow end 102.

[0060] The frame 108 of the heart valve prosthesis 100 further includes a plurality of struts 112 that are arranged to form a plurality of side openings or cells 110 arranged circumferentially around a longitudinal axis LA of the heart valve prosthesis 100 and longitudinally to form a tubular structure defining a central lumen 106 of the heart valve prosthesis 100. The struts 112 are defined herein as the elongated wire segments of the frame 108. The struts 112 come together to form crowns 114 or nodes 116, as can be seen in FIG. 1 A. The frame 108 is configured to secure the prosthetic valve 118 within the central lumen 106 of the frame 108 and to secure the heart valve prosthesis 100 in place in the vasculature of the patient.

[0061] As noted above, the struts 112, crowns 114, and nodes 116 define the plurality of cells 110. In the example shown in FIG. 1A, the plurality of cells 110 may be diamondshaped. In the example shown, the plurality of cells 110 includes a plurality of first cells 110A and a plurality of second cells HOB. Stated another way, the plurality of first cells 110A and the plurality of second cells 110B are collectively referred to herein as the plurality of cells 110. The second cells HOB are larger than the first cells 110A. The second cells 110B may be disposed at an axial and circumferential location configured to be aligned with the coronary ostia upon deployment. In the embodiment shown, there are exactly three second cells 110B. However, this is not meant to be limiting, as the frame 108 of the heart valve prosthesis 100 can include more or fewer second cells 110B. The second cells 110B each have an enlarged area relative or compared to the first cells 110A, as can be seen in FIG. 1A. Further, the second cells 110B may be located in other locations than the locations shown in FIG. 1A. In some embodiments, the plurality of cells 110 may have the same size (e.g., no larger and smaller cells 110A and HOB). In other embodiments, the first cells 110A may be arranged at or adjacent to the inflow end of the prosthesis and the second cells HOB may be adjacent to the first cells 110A closer to the outflow end. In other embodiments, the second cells 11 OB may extend around an entire circumference of the prosthesis or may be spaced apart with smaller cells 110A therebetween. In some embodiments, the second cells 110B may extend to the outflow end of the prosthesis. In further embodiments, the prosthesis may include a plurality of third cells (not shown) which may be arranged at the outflow end of the prosthesis (e.g., opposite the first cells 110A, with second cells 110B between). The third cells may be smaller than the second cells 11 OB, but may be smaller, larger, or equal to the first cells 110A.

[0062] The frame 108 may further include a plurality of tabs or paddles 103 for coupling the heart valve prosthesis 100 to a delivery device. In the embodiment shown, there are three paddles 103, with each aligned with a corresponding commissure of the prosthetic valve 118 (only two are shown in FIG. 1A due to the view). Further, although shown as symmetrically disposed around the circumference of the frame 108, the tabs need not be symmetrically disposed, as described, for example, in U.S. Pat. Pub. No. 2022/0175524 to Harewood et al., assigned to the same assignee as the present application, which is herein incorporated by reference in its entirety. Further, in other embodiments, more or fewer paddles 103 may be utilized.

[0063] As explained above, a delivery device is used to deliver the heart valve prosthesis 100 in a radially compressed or crimped configuration and to deploy the heart valve prosthesis 100 in a radially expanded configuration at the treatment site within the vasculature. When the heart valve prosthesis 100 is loaded into the delivery device or recaptured into the delivery device, the frame 108 is radially compressed or crimped to the crimped configuration. As the frame 108 is compressed, the cells 110 reduce in size, potentially trapping or pinching the one or more of the leaflets 119 between the struts 112 defining the cells 110. Further, during the deployment process, expansion of the frame 108 from the crimped configuration to the expanded configuration causes the area of the cells 110 to increase in size. In some instances, one or more of the leaflets 119 of the prosthetic valve 118 may protrude through one of the cells 110 during the expansion process, which may cause the leaflets 119 to get pinched, or stuck between the struts 112 of the frame 108 and sustain damage such as tearing. Leaflet protrusion becomes increasingly likely as the area of the cells increases. Therefore, it is more likely to occur at the second cells HOB than the first cells 110A of the frame 108. However, regardless of the relative size of the cell 110, leaflet protrusion is a possible concern. Accordingly, embodiments of a delivery device of the present invention include a leaflet protection subassembly configured to minimize the risk of leaflet protrusion, as described in further detail below.

[0064] FIGS. 2A-2B show schematic side view of a delivery device 220 for percutaneously delivering and deploying a heart valve prosthesis (such as but not limited to the heart valve prosthesis 100) according to embodiments hereof. One skilled in the art will realize that FIGS. 2A-2B illustrate one example of a delivery device and that subassemblies illustrated in FIGS. 2A-2B may be removed and/or additional subassemblies may be added. For illustrative purposes only, the delivery device 220 will be described for use with the heart valve prosthesis 100 since the structure thereof has been described herein.

[0065] The delivery device 220 extends from a proximal end 222 to a distal end 224. The delivery device 220 includes, inter alia, a handle 226 at the proximal end 222, an outer shaft 230 extending distally from the handle 226, an inner shaft 250 disposed within the outer shaft 230, and a middle member 240 disposed between the inner shaft 250 and the outer shaft 230. The handle 226 enables a clinician to manipulate a distal portion of the delivery device 220 and includes actuators for moving parts of the delivery device relative to other parts. In the delivery device 220, the outer shaft 230 is coupled to an actuator 228 of the handle 226 for moving the outer shaft 230 (and the capsule noted below) relative to the inner shaft 250, as shown in FIG. 2B. A distal portion of the outer shaft 230, referred to herein as a capsule 232, is configured to surround a heart valve prosthesis during delivery to the treatment site, e.g. , a native heart valve, and the capsule 232 is retracted from the heart valve prosthesis to expose the heart valve prosthesis such that it self-expands. As known to those skilled in the art, when the delivery device 220 is in position such that the heart valve prosthesis 100 is at the desired position at the treatment site in the patient’s vasculature, the actuator 228 is actuated to move the capsule 232 relative to the inner shaft 250 and the heart valve prosthesis 100 disposed between the inner shaft 250 and the capsule 232, thereby enabling the heart valve prosthesis 100 to deploy via self-expansion at the treatment site, as shown in FIG. 2B (without showing the heart valve prosthesis 100). [0066] FIGS. 3A-3C include sectional views of the distal portion of the delivery device 220. FIG. 3A shows a cross-sectional view of the capsule 232 with the heart valve prosthesis 100 loaded therein, and FIG. 3B shows a cross-section view of the capsule 232 partially retracted therefrom, either during loading of the heart valve prosthesis 100 into the capsule 232 or deployment of the heart valve prosthesis 100 from the capsule 232. FIG. 3C is a cross-sectional view taken along line C-C of FIG. 3B.

[0067] As shown in FIGS. 3 A and 3B, the capsule 232 of the delivery device 220 is a longitudinal tube having an open distal end 234, a proximal end 236, and a central lumen 238 extending from the proximal end 236 to the distal end 234. The proximal end 236 of the capsule 232 is coupled to or integrally formed with the outer shaft 230. The inner shaft 250 extends through the central lumen 238 of the capsule 232, as shown in FIG. 3A. The central lumen 238 of the capsule 232 is sized and shaped to contain the heart valve prosthesis 100 therein in a crimped or radially compressed configuration suitable for delivery within a vasculature. During delivery, the heart valve prosthesis 100 is disposed over a distal portion of the inner shaft 250, within the capsule 232.

[0068] In the embodiment shown, the middle member 240 is disposed over the inner shaft 250 between the inner shaft 250 and the outer shaft 230. A retainer or spindle 242 is attached to a distal end of the middle member 240 for receiving the paddles 103 of the heart valve prosthesis 100. More particularly, the spindle 242 is attached to a distal end of the middle member 240 and the inner shaft 250 extends through a central opening or passageway (not shown) of the spindle 242. The spindle 242 includes a plurality of paddle pockets (not shown on FIGS. 3A and 3B; shown in FIG. 7D) configured to receive the paddles 103 of the heart valve prosthesis 100. In the embodiment shown, the spindle 242 includes three paddle pockets, with each paddle pocket sized and shaped to receive a corresponding one of the three paddles 103 of the heart valve prosthesis 100. In another embodiment hereof (not shown), the spindle 242 may be attached to or formed on other components of the delivery device 220, such as the inner shaft 250.

[0069] The inner shaft 250 extends through the middle member 240. The inner shaft 250 is coupled to the handle 226 and movement of the handle 226 translates to movement of the inner shaft 250. As shown on FIGS. 2A and 2B, a distal tip 252 is attached to or integrally formed with a distal end of the inner shaft 250. The inner shaft 250 and the distal tip 252 may also be translated relative to the outer shaft 230 and the handle 226 via an actuator on the handle 226.

[0070] The delivery device 220 includes a leaflet protection subassembly 260 including a plurality of legs 262. The leaflet protection subassembly 260 is disposed on the inner shaft 250 proximal to the distal tip 252 and distal to the spindle 242 of the middle member 240. In the embodiment shown, the plurality of legs 262 includes exactly three legs, which corresponds to the three leaflets 119 and the three second cells 110B of the frame 108 of the heart valve prosthesis 100. However, this is not meant to be limiting, and more or fewer legs 262 may be used depending on the number of enlarged openings of the frame of the heart valve prosthesis and/or depending on the desired ratio of legs per enlarged opening.

[0071] In an embodiment, the legs 262 of the leaflet protection subassembly 260 may be formed from a shape memory material such as a nickel titanium alloy (e.g., Nitinol). With this material, the legs 262 are self-expandable from a radially-compressed configuration to a radially-expanded configuration, such as by the removal of external forces (e.g., compressive forces), such as forces imparted by a shaft of a delivery device and/or a shaft of a loading device. The legs 262 can be formed in or biased to the radially-expanded configuration and may be compressed and re-expanded multiple times without significantly damaging the structure thereof. In an embodiment, the legs 262 are formed in or biased to the radially-expanded configuration at an angle between 30 and 45 degrees relative to the inner shaft 250. In an embodiment, the legs 262 are formed in or biased to the radially- expanded configuration at approximately 35 degrees relative to the inner shaft 250, with approximately being defined as a tolerance of 2 degrees.

[0072] Each leg 262 of the leaflet protection subassembly 260 includes a first or proximal end 264 and a second or distal end 266. A body 265 of each leg 262 defined between the first end 264 and the second end 266 of each leg 262 may have a flat or planar configuration or may have a tubular or cylindrical configuration. The first end 264 of each leg 262 is attached to the inner shaft, and the body 265 and the second end 266 of each leg 262 are not attached to the inner shaft 20. In the radially-expanded configuration, each leg 262 extends distally and radially from the inner shaft 250, as shown in FIGS. 3A and 3B, and the second end 266 thereof is radially spaced apart from the inner shaft 250. [0073] In the embodiment of FIGS. 3A-3F, the first ends 264 of the legs 262 of the leaflet protection subassembly 260 are attached to an annular coupler 261 that is disposed over and attached to the inner shaft 250. In such an embodiment, the legs 262 and the annular coupler may be laser-cut from a single piece of material or may be assembled from a number of different components or manufactured from various other methods known in the art. In an embodiment, the coupler 261 is overmolded to attach to the inner shaft 250. In another embodiment, the first ends 264 of the legs 262 of the leaflet protection subassembly 260 may be directly attached to the inner shaft 250 at circumferentially spaced apart locations on the inner shaft without an annular coupler.

[0074] The leaflet protection subassembly 260 of the delivery device 220 is configured to prevent leaflets 119 of the prosthetic valve 118 from protruding through the cells 110 of the frame 108 during loading, recapture and/or deployment of the heart valve prosthesis 100. In an embodiment, the legs 262 of the leaflet protection subassembly 260 are particularly configured to prevent the leaflets 119 from protruding through the enlarged second cells HOB of the frame 108 of the heart valve prosthesis 100. However, regardless of the relative size of the cell 110, the legs 262 of the leaflet protection subassembly 260 are particularly configured to prevent or block the leaflets 119 from protruding through any cell 110 they extend across. Accordingly, as shown in FIGS. 3A and 3B, the heart valve prosthesis 100 is loaded into the capsule 232 of the delivery device 220 such that the legs 262 of the leaflet protection subassembly 242 extend between the frame 108 and the prosthetic valve 118 of the heart valve prosthesis 100. Stated another way, when the heart valve prosthesis 100 is loaded into the delivery device 220, each leg 262 extends between an interior surface of the frame 108 and an exterior surface of a leaflet 119 and each leg 262 is circumferentially aligned with a second cell HOB of the frame 108. Since the legs 262 are formed from a self-expanding material, the legs 262 are biased towards the radially expanded configuration and will radially expand until a portion thereof comes into contact with the interior surface of the frame 108. Since the legs 262 are disposed radially outward relative to the leaflets 119 and circumferentially aligned with the second cells 110B of the frame 108, the legs 262 function to block, or prevent, the material of the leaflets 119 from protruding through the second cells 110B of the frame 108 to prevent pinching and potential damage to the leaflets 119. [0075] As best shown on FIG. 3B, each leg 262 of the leaflet protection subassembly 260 extends from the inner shaft 250, into the outflow end 104 the frame 108, and between a corresponding one of the leaflets 119 and the frame 108. In other words, the legs 262 are disposed radially inward from the frame 108 of the heart valve prosthesis 100 and are disposed radially outward from the leaflets 119 of the heart valve prosthesis 100. Due to the location of the leaflets 119 and the second cells HOB, the distal end 266 of each leg 262 of the leaflet protection subassembly 260 approximately longitudinally bisects the corresponding second cell HOB, as best shown in FIG. 3D. FIG. 3D is a flat, as-cut illustration of the heart valve prosthesis 100 partially disposed within the capsule 232 of the delivery device 220. Each leg 262 of the leaflet protection subassembly 260 presses radially inwardly on the corresponding leaflet 119, thereby preventing or minimizing the likelihood that the leaflets 119 protrude through the second cells 110B during loading, recapture, and/or deployment of the heart valve prosthesis 100 into/from the capsule 232.

[0076] As stated previously, FIG. 3 A shows the heart valve prosthesis 100 loaded within the capsule 232 of the delivery device 220 in the crimped or compressed configuration, with the first ends 264 of the legs 262 of the leaflet protection subassembly 260 attached to the inner shaft 250 and the second ends 266 of the legs 262 of the leaflet protection subassembly 260 disposed between the leaflets 119 and the frame 108 of the heart valve prosthesis 100. Upon delivery of the delivery device 220 to a treatment site within the vasculature of a patient, such as a native aortic valve, the heart valve prosthesis 100 is deployed from the delivery device 220 and self-expands within the native valve of the patient.

[0077] To transition deploy the heart valve prosthesis 100, the capsule 232 is retracted proximally in order to release, or uncover, the heart valve prosthesis 100. In other words, as the open distal end 234 of the capsule 232 is retracted proximally, the inner shaft 250 including the leaflet protection subassembly 260, the middle member 240 having the spindle 242, and the heart valve prosthesis 100 remain in place such that they exit the central lumen 238 of the capsule 232 through the distal end 234. As the capsule 232 is retracted proximally, the inflow end 102 of the heart valve prosthesis 100 may begin to self-expand in the vasculature, as it is no longer enclosed by the capsule 232. As the capsule 232 translates proximally and uncovers or releases the heart valve prosthesis 100, the legs 262 of the leaflet protection subassembly 260 remain disposed between the interior surface of the frame 108 and the leaflets 119 of the heart valve prosthesis 100 to prevent leaflet pinching and/or damage while the frame 108 expands. More particularly, each second end 266 of each leg 262 of the leaflet protection subassembly 260 remains radially aligned with each second cell HOB of the frame 108 and prevents or inhibits each leaflet 119 from moving radially outward such that the leaflets 119 are prevented or inhibited from extending or protruding through the second cells HOB, as shown in FIG. 3B. With the leaflet protection subassembly 260 in place during retraction of the capsule 232, if recapture of the heart valve prosthesis 100 is needed after partial expansion of the heart valve prosthesis 100 (as shown in FIG. 3B), such as for repositioning of the heart valve prosthesis 100, the legs 262 of the leaflet protection subassembly 260 prevent or inhibit leaflet pinching while the frame 108 is recompressed into the capsule 232.

[0078] When it is desired to fully deploy or release the heart valve prosthesis 100, the capsule 232 is fully retracted proximal of the heart valve prosthesis 100 such that the entire heart valve prosthesis 100 is released from the capsule 232 and is fully expanded at the treatment site within the vasculature, as shown in the sectional view of FIG. 3E. The delivery device 220 can then be retracted by moving the handle 226 proximally such that the inner shaft 250 including the distal tip 252 and the leaflet protection subassembly 260, the middle member 240 including the spindle 242, and the outer shaft 230 including the capsule 232 are retracted proximally with the handle 226 to remove the legs 262 of the leaflet protection subassembly 260 from within the heart valve prosthesis 100, as shown in FIG. 3F. The delivery device 220 can then be removed from the vasculature of the patient.

[0079] The legs 262 of the leaflet protection subassembly 260 may have alternative configurations or geometries beyond the configuration illustrated in the embodiments of FIGS. 3A-3F. Mor particularly, FIG. 4A illustrates an alternative configuration of a leaflet protection subassembly 460 having a plurality of legs 462. Aside from the configuration of the leaflet protection subassembly 460, the delivery device is the same as the delivery device 220 described above with respect to FIGS. 2A-2B and FIGS. 3A-3F. Therefore, the details of the delivery device 220 are not repeated with respect to FIG. 4A.

[0080] The leaflet protection subassembly 460 is disposed on the inner shaft 250 proximal to the distal tip 252 and distal to the spindle 242 of the middle member 240. In the embodiment shown, the plurality of legs 462 includes exactly three legs, which corresponds to the three leaflets 119 and the three second cells 110B of the frame 108 of the heart valve prosthesis 100. However, this is not meant to be limiting, and more or fewer legs 462 may be used depending on the situation. Similar to the leaflet protection subassembly 260, each leg 462 of the leaflet protection subassembly 460 includes a first or proximal end 464 attached to the inner shaft 250 and a second or distal end 466 that is not attached to the inner shaft 20. In the radially-expanded configuration, each leg 462 extends distally and radially from the inner shaft 250, as shown in FIG. 4A, and the second end 466 thereof is radially spaced apart from the inner shaft 250.

[0081] Similar to legs 262, a body 465 defined between the first end 464 and the second end 466 of each leg 462 may have a planar configuration or may have a tubular configuration. However, in this embodiment, the second end 466 of each leg 462 has an enlarged width relative to the body 465 and the first end 464. The enlarged second end 466 provides a larger surface area for each leaflet protection subassembly 260 to prevent or inhibit the leaflets 119 of the heart valve prosthesis 100 from protruding through the cells 110 of the frame 108 during loading, recapture and/or deployment of the heart valve prosthesis 100. In addition, while the first end 464 and the body 465 of each leg are formed from a first material which is a shape memory material such as a nickel titanium alloy (e.g., Nitinol), the enlarged second end 466 is formed from a second softer material to avoid damaging the leaflets 119 of the prosthetic valve 118. The second material of the second end 466 is an atraumatic soft polymer, such as, but not limited to, polytetrafluoroethylene (PTFE), ePTFE, polyurethane, silicone, Acetal, Delrin, or nylon. In an embodiment, the second material of the second end 466 is a low friction material to avoid damaging the leaflets 119 of the prosthetic valve 118.

[0082] Since the first end 464 and the body 465 of each leg are formed from first material which is a shape memory material, the legs 462 are self-expandable from a radially- compressed configuration to a radially-expanded configuration, such as by the removal of external forces (e.g., compressive forces), such as forces imparted by a shaft of a delivery device and/or a shaft of a loading device. The legs 462 can be formed in or biased to the radially-expanded configuration and may be compressed and re-expanded multiple times without significantly damaging the structure thereof. [0083] In the embodiment of FIG. 4A, the second end 466 is bulbous and has an enlarged width relative to the body 465 and the first end 464. FIGS. 4B-4E are perspective views of alternative configurations of the second end 466. In the embodiment of FIG. 4B, a second end 466B is substantially cylindrical and has an enlarged width relative to the body 465 and the first end 464. In the embodiment of FIG. 4C, a second end 466C includes a bulbous portion 468 and a substantially cylindrical portion 470 distal to the bulbous portion 468. At least the bulbous portion 468 has an enlarged width relative to the body 465 and the first end 464, and in an embodiment, the substantially cylindrical portion 470 also has an enlarged width relative to the body 465 and the first end 464. In the embodiment of FIG. 4D, a second end 466D has a tapered profile in which the diameter or width tapers in a distal direction. At least a proximal end of the tapered profile has an enlarged width relative to the body 465 and the first end 464, and in an embodiment, the distal end of the tapered profile also has an enlarged width relative to the body 465 and the first end 464. In the embodiment of FIG. 4E, a second end 466E has a tapered profile in which the diameter or width tapers in a proximal direction. At least a distal end of the tapered profile has an enlarged width relative to the body 465 and the first end 464, and in an embodiment, the proximal end of the tapered profile also has an enlarged width relative to the body 465 and the first end 464. [0084] In an embodiment, the enlarged second end 466 may be formed from a mesh to enable compression thereof when crimped inside the capsule 232. Further, when the second end 466 is formed of mesh, blood may flow through the openings in the mesh when positioned in vivo. In another embodiment hereof, the entire length of each leg 462 (i.e., the first end 464, the body 465, and the enlarged second end 466) is formed from a mesh material.

[0085] In embodiments hereof, the heart valve prosthesis 100 is crimped and loaded into the capsule 232 using a funnel (not shown) at the geographic location where the heart valve prosthesis 100 is going to be implanted into a patient (e.g., a hospital). Inserting the legs 262/462 of the leaflet protection device 260/460 into the heart valve prosthesis 100 as the heart valve prosthesis is being loaded into the delivery device 220 may be difficult and may cause damage to the leaflets 119. When loading the heart valve prosthesis 100 into the delivery device 220, the second ends 266/466 of the legs 262/462 of the leaflet protection device 260/460 would be advanced through the outflow end 104 of the heart valve prosthesis 100 and between the leaflets 119 and the frame 108.

[0086] FIGS. 5A and 5B depict a tip guide tube 580 that may be utilized during the loading/crimping procedure to enable positioning of the leaflet protection device 260/460 into the heart valve prosthesis 100. FIG. 5B is a cross-sectional view taken along line B-B of FIG. 5A. The tip guide tube 580 includes atube 582 having a plurality of longitudinally- extending slots 583 formed in a sidewall thereof and a grip 584. The plurality of longitudinally-extending slots 583 includes exactly three slots 583, circumferential placement of which correspond with the three legs 262/462 of the leaflet protection subassembly 260/460. In the embodiment of FIGS. 5A and 5B, the tube 582 and the grip 584 are a single piece, however, this is not meant to be limiting. The tip guide tube 580 includes a first end 586 at the grip end of the tip guide tube 580 and a second end 588 opposite the first end 586. Each slot 583 extends from a location adjacent to the first end 586 to the second end 588.

[0087] FIGS. 6A and 6B depict an alternative configuration of a tip guide tube 680 that may be utilized during the loading/crimping procedure to enable positioning of the leaflet protection device 260/460 into the heart valve prosthesis 100. FIG. 6B is a cross-sectional view taken along line B-B of FIG. 6A. The tip guide tube 680 includes a tube 682 having a plurality of longitudinally-extending slots 683 formed in a sidewall thereof and a grip 684. The plurality of longitudinally-extending slots 683 includes exactly three slots 683, which correspond with the three legs 262/462 of the leaflet protection subassembly 260/460. In the embodiment of FIGS. 6A and 6B, the tube 682 and the grip 684 are a single piece, however, this is not meant to be limiting. The tip guide tube 680 includes a first end 686 at the grip end of the tip guide tube 680 and a second end 688 opposite the first end 686. Each slot 683 extends from a location adjacent to the first end 686 to the second end 688.

[0088] A method of loading the heart valve prosthesis 100 into the capsule 232 of the delivery device 220 having a leaflet protection subassembly as described herein is shown in FIGS. 7A-7E. The method depicted in FIGS. 7A-7E utilizes the tip guide tube 580 but it will be apparent to one of ordinary skill in the art that tip guide tube 680 has a similar structure and may alternatively be used in the method described herein. [0089] The tip guide tube 580 may be a device of a loading system as described in copending U.S. Pat. Appl. No. 63/511,924 to Nolan et al., assigned to the same assignee as the present application and fried on July 5, 2023, herein incorporated by reference in its entirety, which in addition to a tip guide tube also includes a loading cone 590, a loading ring 592, a valve seat (not shown in FIGS. 7A-7E), and a capsule guide tube 594. As initial steps in a loading method/procedure, as described in U.S. Pat. Appl. No. 63/511,924 to Nolan et al. which was previously incorporated by reference, the heart valve prosthesis 100 is disposed within the loading cone 590 and the loading ring 592 as shown in FIG. 7A, with the valve seat disposed within the heart valve prosthesis 100. Further, the actuator 228 of the delivery device 220 is retracted such that the capsule 232 of the delivery device 220 is retracted from the distal tip 252, thereby exposing the spindle 242. The capsule guide tube 594 is slid over the distal tip 252 of the delivery device 220 and moved proximally until the distal end of the capsule guide tube 594 is adjacent the distal end of the capsule 232. With the capsule guide tube 594 in place, a locking member of the capsule guide tube 594 is moved distally to apply an inward force to the tube of the capsule guide tube 594, which in turn applies a radially inward force to the capsule 232 of the delivery device 220, thereby securing the capsule guide tube 594 to the capsule 232 via friction.

[0090] With further reference to FIG. 7A, the tip guide tube 580 is inserted through the loading ring 592, the heart valve prosthesis 100 (via the inflow end 102), and the loading cone 590. In particular, with the loading cone 590 and the loading ring 592 secured to each other, the second end 588 of the tip guide tube 580 is inserted into a central passageway of a valve seat (not visible in FIG. 7A), which is disposed within the loading ring 592. The second end 588 of the tip guide tube 580 continues to be advanced through the valve seat, through the heart valve prosthesis 100 which is disposed within the loading cone 590, until the second end 588 of the tip guide tube 580 protrudes past the loading cone 590, as shown in FIG. 7B. As shown in FIG. 7B, the second end 588 of the tip guide tube 580 prevents the outflow end 104 of the heart valve prosthesis 100 from collapsing radially inward. In other words, the second end 588 of the tip guide tube 580 maintains the outflow end 104 of the heart valve prosthesis 100 at an inner diameter substantially equal to the outer diameter of the tube 582 of the tip guide tube 580 at the second end 588. This eases coupling of the paddles 103 to the paddle pockets of the spindle 242 of the delivery device 220. [0091] In a next step of the method, as shown in FIG. 7C, the combination of the loading cone 590 coupled to the loading ring 592 with the heart valve prosthesis 100 disposed therein on the valve seat, with the tip guide tube 580 disposed therethrough, is loaded onto the delivery device 220. In particular, the distal tip 252 of the delivery device 220 is inserted into the second end 588 of the tip guide tube 580. The combination of the loading cone 590 coupled to the loading ring 592 with the heart valve prosthesis 100 disposed therein on the valve seat, with the tip guide tube 580 disposed therethrough, is advanced towards the capsule 232 of the delivery device 220 until the second end 588 of the tip guide tube 580 is adjacent the spindle 242, as shown in FIG. 7C. During this step of the method, the legs 262/462 of the leaflet protection subassembly are radially compressed and inserted into the second end 588 of the tip guide tube 580. The tip guide tube 580, having the legs 262/462 of the leaflet protection subassembly 260/460 radially compressed therein, is thus advanced through the heart valve prosthesis 100 (which is in its radially expanded configuration within the loading cone 590 and loading ring 592). As the tip guide tube 580 is advanced towards the capsule 232 of the delivery device 220, the legs 262/462 will radially expand and extend through the slots 583 of the tip guide tube 580 as the slots 583 are circumferentially aligned with the legs 262/462. In particular, the loading cone 590 may be rotated as necessary to rotate the heart valve prosthesis 100 as necessary to align the paddles 103 with the paddle pockets of the spindle 242 and/or the tip guide tube 580 may be rotated as necessary to align the slots 583 with legs 262/462 and the paddle pockets of the spindle 242. When the paddles 103 of the heart valve prosthesis 100 are aligned with the paddle pockets of the spindle 242, the second cells 110B of the frame 108 are aligned with leaflets 119 and the legs 262/462 of the leaflet protection subassembly 260/460 are aligned with the leaflets 119. Thus, the circumferential alignment of the paddles 103 with the paddle pockets of the spindle 242 ensures that the legs 262/462 of the leaflet protection subassembly 260/460 are in the correct circumferential position to protect the leaflets 119.

[0092] Since the legs 262 are formed from a self-expanding material, the legs 262 are biased towards the radially expanded configuration and each leg 262/462 will radially expand through a slot 583 of the tip guide tube 580 until a portion thereof comes into contact with the interior surface of the frame 108. As the tip guide tube 580 is further advanced towards the capsule 232 of the delivery device 220, each leg 262/462 is positioned to extend between an interior surface of the frame 108 and an exterior surface of a leaflet 119 and each leg 262/462 is circumferentially aligned with a second cell 11 OB of the frame 108.

[0093] In a next step of the method, as depicted in FIG. 7D, the paddles 103 are placed in paddle pockets 243 of the spindle 242. As previously described, the loading cone 590 has been rotated as necessary to rotate the heart valve prosthesis 100 as necessary to align the paddles 103 with the paddle pockets 243. The tip guide tube 580 may be withdrawn slightly as the loading cone 590/loading ring 592 is slightly advanced, and the paddles 103 are placed in the paddle pockets of the spindle 242 as shown in FIG. 7D.

[0094] In a next step of the method, as depicted in FIG. 7E, the tip guide tube 580 is completely removed from the loading cone 590/loading ring 592. Notably, as the slots 583 extend to the second end 588 of the tip guide tube 580, the tip guide tube 580 may be withdrawn without disturbing the legs 262/462 of the leaflet protection subassembly 260/460 that are radially extending through the slots 583. Stated another way, the tip guide tube 580 is withdrawn and the leaflet protection subassembly 260/460 remains properly disposed within the heart valve prosthesis 100 with each leg 262/462 extending between an interior surface of the frame 108 and an exterior surface of a leaflet 119. The heart valve prosthesis 100 is checked to ensure that the paddles 103 are in the paddle pockets 243 of the spindle 242 and the crowns at the outflow end 104 are properly situated at the spindle 242. FIG. 7E shows the heart valve prosthesis 100 with the paddles 103 in the paddle pockets of the spindle 242, with the capsule 232 proximal of the spindle 242 and the loading cone 590, the loading ring 592, and the remainder of the inflow end 102 of the heart valve prosthesis 100 distal of the spindle 242.

[0095] At this stage of the method, with the leaflet protection subassembly 260/460 still properly disposed within the heart valve prosthesis 100 with each leg 262/462 extending between an interior surface of the frame 108 and an exterior surface of a leaflet 119, the heart valve prosthesis 100 is radially compressed within the capsule 232 of the delivery device 220. More particularly, the actuator 228 is rotated to advance the capsule distally, i.e., towards the distal tip 252 ofthe delivery system. As the capsule 232 is advanced distally, the capsule 232 first covers the paddles 103 of the heart valve prosthesis 100 in the paddle pockets 243 of the spindle 242. As the capsule 232 continues to be advanced, the capsule 232 and the capsule guide tube 594 push the loading cone 590, loading ring 592, and valve seat distally. Because the heart valve prosthesis 100 is prevented from translating distally by the paddles 103 disposed in the paddle pockets 243 of the spindle 242, the loading cone 590 moves relative to the heart valve prosthesis 100 such that the loading cone 590 radially compresses the heart valve prosthesis 100. Further, as the loading cone 590 moves relative to the heart valve prosthesis 100, the heart valve prosthesis 100 exits the loading cone 590 and enters the open distal end of the capsule 232. This actuation of the actuator 228, distal advancement of the capsule 232, distal translation of the loading cone 590, radial compression of the heart valve prosthesis 100, and capture of the heart valve prosthesis 100 within the capsule 232 continues until the heart valve prosthesis 100 is fully captured within the capsule 232. The combination of the loading cone 590, the loading ring 592, and the valve seat can then be removed from the distal tip 252 of the delivery device 220. The capsule guide tube 594 can be unlocked and removed from the capsule 232 and distally over the distal tip 252 of the delivery device 220. The actuator 228 is further rotated, causing the capsule 232 to translate distally until the distal end of the capsule 232 abuts a proximal portion of the distal tip 252. The delivery device 220 with the heart valve prosthesis 100 loaded into the capsule 232 is ready to be used to transluminally deliver the heart valve prosthesis 100 to the site of a native heart valve and deploy the heart valve prosthesis 100 from the delivery device 220.

[0096] It should be understood that various embodiments disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single device or subassembly for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or subassemblies.

Claims

WHAT IS CLAIMED IS:

1. A system comprising: a heart valve prosthesis including a frame and a prosthetic valve coupled to the frame, the prosthetic valve including a plurality of leaflets; and a delivery device for delivering the heart valve prosthesis into a vasculature of a patient, the delivery device including an outer shaft with a capsule at a distal end thereof, the capsule being configured to retain the heart valve prosthesis in a radially compressed configuration, an inner shaft disposed within the outer shaft, and a leaflet protection subassembly attached to the inner shaft, the leaflet protection subassembly including a plurality of legs radially extending from the inner shaft, wherein when the heart valve prosthesis is coupled to the inner shaft each leg extends between an interior surface of the frame and an exterior surface of a leaflet of the plurality of leaflets to prevent leaflet protrusion of the leaflet through a cell of the frame of the heart valve prosthesis.

2. The system of claim 1, wherein the frame includes a plurality of first cells and a plurality of second cells larger than the first cells, and wherein each leg is circumferentially aligned with a second cell of the plurality of second cells.

3. The system of claim 2, wherein the heart valve prosthesis includes exactly three leaflets and the plurality of second cells includes exactly three second cells, and the plurality of legs includes exactly three legs.

4. The system of any one of claims 1 through 3, wherein each leg has a planar configuration.

5. The system of any one of claims 1 through 3, wherein each leg has a tubular configuration.

6. The system of any one of claims 1 through 5, wherein each leg of the plurality of legs has a first end and a second end, the first end being attached to the inner shaft and the second end being radially spaced apart from the inner shaft.

7. The system of any one of claims 1 through 6, wherein the second end has an enlarged width relative to the first end.

8. The system of claim 7, wherein the second end has a tapered configuration.

9. The system of claim 7, wherein the second end includes a bulbous section.

10. The system of any one of claims 1 through 9, wherein at least a portion of each leg is formed from a mesh material.

11. The system of any one of claims 1 through 10, wherein an entire length of each leg is formed from a mesh material.

12. The system of any one of claims 1 through 11, wherein at least a portion of each leg is formed from a self-expanding material.

13. A method of delivering and deploying a heart valve prosthesis to a treatment site within a vasculature of a patient, the heart valve prosthesis including a frame and a prosthetic valve coupled to the frame, the prosthetic valve including a plurality of leaflets, the method comprising: advancing a delivery device to the treatment site with the heart valve prosthesis radially compressed within a capsule of the delivery device, the delivery device including an outer shaft with the capsule at a distal portion thereof, an inner shaft disposed within the outer shaft, and a leaflet protection subassembly attached to the inner shaft, the leaflet protection subassembly including a plurality of legs radially extending from the inner shaft, wherein each leg extends between an interior surface of the frame and an exterior surface of a leaflet of the plurality of leaflets; proximally retracting the capsule to partially release the heart valve prosthesis from the capsule, wherein each leg of the leaflet protection subassembly remains disposed between the interior surface of the frame and the exterior surface of the leaflet to prevent leaflet protrusion of the leaflet through a cell of the frame of the heart valve prosthesis; further proximally retracting the capsule to fully deploy the heart valve prosthesis; and proximally retracting the delivery device from the heart valve prosthesis, wherein the leaflet protection subassembly retracts from the heart valve prosthesis.

14. The method of claim 13, wherein the frame includes a plurality of first cells and a plurality of second cells larger than the first cells, and wherein each leg is circumferentially aligned with a second cell of the plurality of second cells.

15. The method of claim 13 or claim 14, further comprising: distally advancing the capsule to recapture the heart valve prosthesis within the capsule, wherein the step of distally advancing occurs after proximally retracting the capsule to partially release the heart valve prosthesis from the capsule and before further proximally retracting the capsule to fully release the heart valve prosthesis, wherein during the step of distally advancing, each leg of the leaflet protection subassembly remains disposed between the interior surface of the frame and the exterior surface of the leaflet to inhibit the leaflet from being pinched between struts of the frame during recapture of the heart valve prosthesis.

16. A method of loading a heart valve prosthesis into a capsule of a delivery device, the heart valve prosthesis including a frame and a prosthetic valve coupled to the frame, the prosthetic valve including a plurality of leaflets, the method comprising: positioning a plurality of legs of a leaflet protection subassembly such that each leg extends between an interior surface of the frame and an exterior surface of a leaflet of the plurality of leaflets, wherein the leaflet protection subassembly is attached to an inner shaft of a delivery device, the delivery device also including an outer shaft with the capsule at a distal portion thereof; radially compressing the heart valve prosthesis within the capsule of the delivery device.

17. The method of claim 16, wherein the leaflet protection subassembly is radially compressed and inserted to a tip guide tube prior to the step of positioning the plurality of legs of the leaflet protection subassembly.

18. The method of claim 17, wherein the tip guide tube includes a tube having a plurality of slots formed in a sidewall thereof.

19. The method of claim 18, wherein each leg of the plurality of legs of the leaflet protection subassembly radially extends through a slot of the plurality of slots during the step of positioning the plurality of legs of the leaflet protection subassembly.

20. The method of claim 18 or claim 19, wherein the frame includes a plurality of first cells and a plurality of second cells larger than the first cells, and wherein each leg is circumferentially aligned with a second cell of the plurality of second cells.