Capsule loading auxiliary equipment and capsule loading auxiliary assembly

Abstract

The utility model relates to capsule loading auxiliary equipment and a capsule loading auxiliary assembly. A capsule loading assist device may include a lead screw, a loading assist nut, and a torque transmitting mechanism. The loading nut includes a capsule engagement surface configured to engage a delivery capsule of a delivery device to apply a loading assist force to the delivery capsule. The capsule loading assist device is configured such that rotation of the lead screw in a first lead screw direction moves the loading assist nut along the lead screw in a distal direction. A capsule loading assist assembly may include a delivery device, a prosthetic heart valve, and a capsule loading assist device. A method may include operatively coupling a delivery device to a capsule loading assist device having a loading assist nut, and rotating a capsule translation knob of the delivery device to translate the loading assist nut in a distal direction.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 376,031, filed on September 16, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to implantable prosthetic heart valves, and to devices that assist in preparing a delivery device that encloses such implantable prosthetic heart valves. Background Art

[0004] The human heart may suffer from various valvular diseases. These valvular diseases may lead to malfunction of the heart and ultimately require repair of the natural valve or replacement of the natural valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as a variety of known methods for implanting these devices and valves in the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver prosthetic medical devices to locations in the body that are not easily accessible by surgery or to locations that are desired to be accessible without surgery.

[0005] In one particular example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches an implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, such as by inflating a balloon on which the prosthetic heart valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery device so that the prosthetic heart valve can expand to its functional size on its own. Utility Model Content

[0006] Delivery devices and methods for implanting a prosthetic heart valve are described herein. The disclosed devices and methods can facilitate loading of a prosthetic heart valve in a delivery device, for example, by applying an axially distally directed force on a delivery capsule of the delivery device relative to a handle of the delivery device as the delivery capsule is advanced in a distal direction to enclose the prosthetic heart valve. Thus, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery devices.

[0007] The capsule loading assist device may include a lead screw and a loading assist nut engaged with the lead screw.In addition to these components, the capsule loading assist device may also include one or more components disclosed herein.

[0008] In some examples, the loading assist nut includes a capsule engaging surface configured to engage a proximal surface of a delivery capsule of a delivery device to apply a distally directed loading assist force to the delivery capsule.

[0009] In some examples, the capsule loading assist device further includes a torque transmission mechanism configured to transmit torque from the handle of the delivery device to the lead screw to rotate the lead screw.

[0010] In some examples, the capsule loading assist device is configured such that rotating the lead screw in a first lead screw direction moves the loading assist nut in a distal direction along the lead screw.

[0011] In some examples, the capsule loading aid includes one or more components recited in Examples 1-67 and 76.

[0012] The capsule loading assistance assembly may include a delivery device, a prosthetic heart valve supported by the delivery device, and a capsule loading assistance device.In addition to these components, the capsule loading assistance assembly may also include one or more components disclosed herein.

[0013] In some examples, a delivery device includes a handle having a capsule translation knob, a delivery capsule, and a capsule shaft extending between the handle and the delivery capsule.

[0014] In some examples, a capsule loading assist device includes a lead screw, a loading assist nut engaged with the lead screw, and a torque transmission mechanism.

[0015] In some examples, the loading assist nut includes a capsule engaging surface configured to engage a proximal surface of the delivery capsule to apply a distally directed loading assist force to the delivery capsule.

[0016] In some examples, the torque transmission mechanism is configured to transmit torque from a handle of the delivery device to the lead screw to rotate the lead screw.

[0017] In some instances, the capsule loading assist device is configured such that rotating the lead screw in a first lead screw direction moves the loading assist nut in a distal direction along the lead screw and applies a loading assist force to the delivery capsule as the delivery capsule moves in the distal direction to at least substantially cover the prosthetic heart valve.

[0018] In some examples, the capsule loading aid assembly includes one or more of the components described in Examples 66-67.

[0019] A method may include operatively coupling a delivery device to a capsule loading aid. In addition to this step, the method may further include one or more steps disclosed herein.

[0020] In some examples, a delivery device includes a handle including a capsule translation knob, a delivery capsule, and a capsule shaft extending between the handle and the delivery capsule.

[0021] In some examples, the capsule loading assist device includes a lead screw and a loading assist nut engaged with the lead screw.

[0022] In some examples, the method further includes rotating the capsule translation knob in a first knob direction to translate the loading assist nut in a distal direction.

[0023] In some examples, the method includes one or more of the steps described in Examples 68-75.

[0024] In a representative example, a capsule loading assist device includes a lead screw, a loading assist nut engaged with the lead screw, and a torque transmission mechanism configured to transmit torque from a handle of a delivery device to the lead screw to rotate the lead screw. The loading nut includes a capsule engagement surface configured to engage a proximal surface of a delivery capsule of the delivery device to apply a distally directed loading assist force to the delivery capsule. The capsule loading assist device is configured such that rotating the lead screw in a first lead screw direction causes the loading assist nut to move along the lead screw in a distal direction.

[0025] In another representative example, a capsule loading assist assembly includes a delivery device, a prosthetic heart valve supported by the delivery device, and a capsule loading assist device. The delivery device includes a handle having a capsule translation knob, a delivery capsule, and a capsule shaft extending between the handle and the delivery capsule. The capsule loading assist device includes a lead screw, a loading assist nut engaged with the lead screw, and a torque transmission mechanism, the torque transmission mechanism being configured to transmit torque from the handle of the delivery device to the lead screw to rotate the lead screw. The loading assist nut is engaged with the lead screw and includes a capsule engagement surface, the capsule engagement surface being configured to engage the proximal surface of the delivery capsule to apply a loading assist force directed distally to the delivery capsule. The capsule loading assist device is configured so that rotating the lead screw in a first lead screw direction causes the loading assist nut to move along the lead screw in a distal direction, and applies a loading assist force to the delivery capsule when the delivery capsule moves in a distal direction to at least substantially cover the prosthetic heart valve.

[0026] In another representative example, a method includes operatively coupling a delivery device to a capsule loading assist device. The delivery device includes: a handle including a capsule translation knob; a delivery capsule; and a capsule shaft extending between the handle and the delivery capsule, and the capsule loading assist device includes a lead screw and a loading assist nut engaged with the lead screw. The method further includes rotating the capsule translation knob in a first knob direction to translate the loading assist nut in a distal direction.

[0027] The above-described devices may be used as part of an implantation procedure performed on a living animal or on a simulator, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0028] The various innovations of the present disclosure may be used in combination or alone. This utility model content is provided to introduce a selection of concepts in simplified form, which are further described below in the detailed description. The utility model content is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a perspective view of a prosthetic heart valve shown in a radially expanded state according to an example.

[0030] Figure 2 For example, Figure 1 Side view of a prosthetic heart valve and delivery assembly of a delivery device.

[0031] Figure 3 is a schematic partial cross-sectional side view of a delivery assembly according to an example, the delivery assembly including a prosthetic heart valve and a delivery device supported by a capsule loading aid.

[0032] Figure 4 is a partial cross-sectional side view of a delivery assembly supported by a capsule loading aid in an initial configuration according to an example.

[0033] Figure 5 For a delivery device according to an example and in an intermediate configuration Figure 4 Partial cross-sectional side view of a capsule loading aid.

[0034] Figure 6 For the delivery device according to the example and in the final configuration Figure 4 Partial cross-sectional side view of a capsule loading aid.

[0035] Figure 7 For example, Figure 4 Line 7-7 in the view Figure 4 A cross-sectional front view of a capsule loading aid device of FIG. 1 with the receiver arms of the loading aid nut in a closed position.

[0036] Figure 8 For example Figure 7 A cross-sectional front view of a capsule loading aid with the hopper arms in an open position.

[0037] Fig. 9 For as along Figure 4 Line 9-9 in the view Figure 4 A cross-sectional front view of a capsule loading aid. DETAILED DESCRIPTION

[0038] General considerations

[0039] It should be understood that the disclosed examples may be suitable for delivery and implantation of prosthetic devices in any native heart annulus (e.g., the pulmonary annulus, mitral annulus, and tricuspid annulus) and may be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0040] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Rather, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to problems.

[0041] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence may be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation, and are easily discernible by those of ordinary skill in the art.

[0042] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "comprising" means "including". Furthermore, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical connection or coupling, and in the absence of specific language to the contrary does not exclude the presence of intervening elements between the coupled or associated items.

[0043] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal movement of a device is the movement of the device away from the implantation site and toward the user (e.g., leaving the patient's body), while the distal movement of the device is the movement of the device away from the user and toward the implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise clearly defined.

[0044] As used herein, the terms "approximately" and "about" mean the listed value and any value within 10% of the listed value. For example, "about 1 mm" means any value between about 0.9 mm and about 1.1 mm, inclusive.

[0045] Direction and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate discussion of the drawings and principles of this document, but are not intended to be limiting. For example, certain terms such as "inside," "outside," "top," "downward," "inside," "outside," etc. may be used. When dealing with relative relationships, particularly with respect to the examples shown, such terms are used to provide some clarity of description, where applicable. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, the "top" portion may become the "bottom" portion simply by flipping the object. Nevertheless, it is still the same portion and the object remains unchanged. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0046] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0047] As used herein, the term "simulation" means performing an action on a cadaver, a cadaver heart, and / or a computer simulated body (eg, a simulated human body part, tissue, etc.).

[0048] Introduction of public technology

[0049] The prosthetic valves disclosed herein can be radially compressed and expanded between a radially compressed state and a radially expanded state. Thus, during delivery, the prosthetic valve can be crimped on or held by an implant delivery device in a radially compressed state, and then once the prosthetic valve reaches the implantation site, the prosthetic valve is expanded to a radially expanded state. It should be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which will be discussed in more detail later.

[0050] Figure 1 An exemplary prosthetic heart valve 100 is shown according to one example. Any of the prosthetic valves disclosed herein are suitable for implantation in the native aortic annulus, but in other examples, they may be suitable for implantation in other native annular regions of the heart (pulmonary, mitral and tricuspid valves). The disclosed prosthetic valves may also be implanted in blood vessels that are connected to the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries and blood vessels of the patient. The disclosed prosthetic valves may also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0051] In some examples, the disclosed prosthetic valve can be implanted in a docking or anchoring device implanted in a natural heart valve or blood vessel. For example, in one example, the disclosed prosthetic valve can be implanted in a docking device implanted in the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in or at a natural mitral valve, such as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in the superior vena cava or the inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Patent Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0052] Delivery Technology

[0053] In order to implant the prosthetic valve in the natural aortic valve via the transfemoral delivery method, the prosthetic valve is installed along the distal portion of the delivery device under radial compression. The distal portion of the prosthetic valve and the delivery device is inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch and through the ascending aorta. The prosthetic valve is positioned in the natural aortic valve and radially expanded (e.g., by inflating the balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from the sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted in the natural aortic valve in a transapical surgery, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through the surgical opening in the chest and the apex, and the prosthetic valve is positioned in the natural aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or a right parasternal mini-thoracotomy, and is then advanced through the ascending aorta toward the native aortic valve.

[0054] To implant a prosthetic valve into the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation made in the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0055] To implant a prosthetic valve into the native tricuspid valve, the prosthetic valve is mounted along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant a prosthetic valve into the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0056] Another delivery method is a transatrial approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the right ventricular wall (usually at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0057] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limited. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0058] Any system, device, equipment, etc. herein can be sterilized (e.g., with heating / heat, pressure, steam, radiation and / or chemicals, etc.) to ensure that they are safe for use by patients, and as one of the steps of the method, any method herein can include the sterilization of associated systems, equipment, devices, etc. The example of heating / thermal sterilization includes steam sterilization and autoclave. The example of radiation for sterilization includes, but is not limited to, gamma radiation, ultraviolet radiation, and electron beam. The example of chemicals for sterilization includes, but is not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide can be accomplished using, for example, hydrogen peroxide plasma.

[0059] The therapeutic techniques, methods, steps, etc. described or suggested herein or in the references incorporated herein can be performed on living animals or on non-living simulators, such as cadavers, cadaver hearts, simulators (e.g., having simulated body parts, tissues, etc.), etc.

[0060] Examples of Public Technology

[0061] Figure 1 One example of a prosthetic heart valve 100 is depicted that is radially compressible for passage through a patient's vasculature and radially expandable to a functional size at a desired implantation location within the patient (eg, a native aortic valve). Prosthetic heart valve 100 includes a frame 102 and a valve structure 104.

[0062] The frame 102 (which may also be referred to as a stent or support structure) may be configured to support a valve structure 104 and to secure the prosthetic heart valve 100 within a native heart valve and / or another support structure (e.g., an anchoring frame such as a coil) and / or within a previously implanted prosthetic heart valve (i.e., in a valve-in-valve procedure). The frame 102 may further include one or more actuators 106 that radially expand or radially compress the frame 102, as described in further detail below.

[0063] Continue to refer Figure 1 , the frame 102 of the prosthetic heart valve 100 has a first end 108 and a second end 110. In the depicted orientation, the first end 108 of the frame 102 is the inlet end, and the second end 110 of the frame 102 is the outlet end. In other examples, the first end 108 of the frame 102 can be the outlet end, and the second end 110 of the frame 102 can be the inlet end. In some examples, the first end 108 can also be referred to as the distal end 108 of the prosthetic heart valve 100, and / or the second end 110 can also be referred to as the proximal end 110 of the prosthetic heart valve 100.

[0064] The frame 102 may include a plurality of interconnected inclined struts 112 and vertical struts 114. In some examples, the inclined struts 112 and vertical struts 114 define a plurality of frame units. Figure 1 As shown in FIG, the vertical struts 114 may terminate axially inward from both the first end 108 and the second end 110 of the frame 102 .

[0065] The frame 102 may be configured to move between a plurality of radial positions, such as Figures 4 to 5 For example, and as discussed in more detail below, Figure 4 The frame 702 of the prosthetic heart valve 700 is shown in a radially expanded state, and Figure 5Frame 702 is shown in a partially radially compressed state. The depicted configurations are exemplary, and frame 102 may be expanded or compressed to a lesser or greater degree than depicted. As frame 102 moves between various configurations, some of struts 112, 114 of frame 102 deflect or pivot relative to one another. For example, angled struts 112 (which may also be referred to as "diagonal struts," i.e., struts that are not vertically and not horizontally oriented) deflect relative to vertically and horizontally oriented struts. In this manner, frame 102 of prosthetic heart valve 100 is axially elongated when the frame is radially compressed, and axially shortened when frame 102 is radially expanded.

[0066] Although the example prosthetic heart valve described above includes a mechanically expandable frame that is expanded by actuator 106, it should be appreciated that in other examples, different frame expansion mechanisms may be used. For example, a self-expanding, partially self-expanding, and balloon-expandable frame 102 may be used instead of a mechanically actuated frame as previously described.

[0067] The frame 102 can be made of any of various suitable plastic expansion materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol) known in the art. When composed of a plastic expansion material, the frame 102 (and therefore the valve 100) can be curled into a radially compressed state on a delivery catheter and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When composed of a self-expanding material, the frame 102 (and therefore 100) can be curled into a radially compressed state and restrained in a compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once in the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0068] Suitable plastic expandable materials that can be used to form the frames disclosed herein (e.g., frame 102) include metal alloys, polymers, or combinations thereof. Example metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, frame 102 may include stainless steel. In some instances, frame 102 may include cobalt-chromium alloys. In some instances, frame 102 may include nickel-cobalt-chromium alloys. In some instances, frame 102 includes nickel-cobalt-chromium-molybdenum alloys, such as MP35N. TM , which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 includes, by weight, 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum. Back to Figure 1, the valve structure 104 of the prosthetic heart valve 100 can be coupled to the frame 102 (e.g., directly and / or indirectly via other components such as a sealing skirt). The valve structure 104 is configured to allow blood to flow through the prosthetic heart valve 100 from a first end 108 (i.e., an inlet end) to a second end 110 (i.e., an outlet end) in an antegrade direction, and to block blood from flowing through the prosthetic heart valve 100 from the second end 110 to the first end 108 in a retrograde direction. The valve structure can include various components, including a leaflet assembly including two or more leaflets 160. For example, the valve structure 104 in the illustrated example includes a leaflet assembly having three leaflets 160. However, it should be understood that in other examples, the valve structure 104 can include a different number of leaflets.

[0069] The leaflets 160 of the prosthetic heart valve 100 can be made of a flexible material. For example, the leaflets 160 can be made in whole or in part of a biomaterial, a biocompatible synthetic material, or other such material. Suitable biomaterials can include, for example, bovine pericardium, equine pericardium, porcine pericardium, and / or pericardium from other sources.

[0070] The leaflets 160 can be arranged to form commissures 162. The commissures 162 can be mounted on a frame at the commissure windows 140, for example. Figure 1 As shown. For example, each leaflet 160 can have two commissure tabs 164 on opposite sides of the leaflet 160. Each commissure tab 164 can be paired with an adjacent commissure tab 164 of an adjacent leaflet to form a corresponding commissure 162. Each pair of commissure tabs 164 can be coupled to a corresponding vertical strut 114 at the commissure window 140, for example, by sutures or other fastening members. Each commissure 162 can include one or more reinforcement members, such as fabric reinforcement members, which are sutured to the commissure tabs 164 and / or the vertical struts 114 to reinforce the connection between the commissure tabs 164 and the vertical struts 114.

[0071] The inlet or cusp edge portion of the leaflet 160 can be coupled to the frame 102 via a variety of techniques and / or mechanisms. For example, the cusp edge portion of the leaflet 160 can be sutured directly to a selected oblique strut 112 or vertical strut 114 located at the first end 108 (e.g., the inlet end) of the prosthetic heart valve. Alternatively, the cusp edge portion of the leaflet 160 can be sutured to an inner skirt (e.g., a fabric skirt, not shown), which in turn can be sutured to a selected oblique strut 112 or vertical strut 114 located at the first end 108 (e.g., the inlet end) of the prosthetic heart valve. In some examples, the inlet portion of the leaflet 160 can also be coupled to one or more axially extending suture posts 142 extending from selected vertical struts 114.

[0072] Continue to refer Figure 1, the valve structure 104 may also include an outer skirt or sealing member 166 disposed around the exterior of the frame 102. The outer skirt may be made of any suitable biocompatible and flexible material, including a material suitable for the leaflets 160, or a synthetic material, such as any suitable biocompatible fabric (e.g., polyethylene terephthalate (PET) fabric). The outer skirt 166 may be attached to the frame 102 by means of sutures, fabrics, adhesives, and / or other means for mounting, and in some instances may be attached to the inclined struts 112 and / or the vertical struts 114 located at the first end 108 (e.g., the inlet end) of the prosthetic heart valve. The outer skirt 166 may be configured to improve the seal between the prosthetic heart valve 100 and the native heart valve in which the prosthetic heart valve has been implanted.

[0073] The skirt may be formed in whole or in part of any suitable biomaterial, synthetic material (e.g., any of a variety of polymers), or a combination thereof. In some examples, the skirt may include a fabric having interwoven yarns or fibers, such as a woven, braided, or knitted fabric. In some examples, the fabric may have a plush pile or suede. Exemplary fabrics having a plush pile or suede include velvet, velvet, velvet, corduroy, terry, fleece, etc. In some examples, the skirt may include a fabric without interwoven yarns or fibers or randomly interwoven yarns or fibers, such as felt or electrospun fabrics. Exemplary materials that can be used to form such fabrics (with or without interwoven yarns or fibers) include, but are not limited to, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide, etc. In some examples, the skirt can include a non-woven or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirt can include a sponge material or foam, such as polyurethane foam. In some examples, the skirt can include natural tissue, such as pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0074] Further details regarding the prosthetic heart valve, including the valve structure 104 and the manner in which the valve structure 104 can be connected to the frame 102 of the prosthetic heart valve 100 can be found in U.S. Patents Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202 and 9,393,110, as well as patent documents with publication number US2018325665A1 and international publication number WO2022046588A1, all of which are incorporated herein by reference.

[0075] Described herein are examples of steerable delivery devices (sometimes referred to as steerable catheters) that can be used to guide the vasculature of a subject to deliver an implantable, expandable medical device (e.g., a prosthetic heart valve), tool, agent, or other therapy to a location in the subject's body. Examples of procedures for which steerable catheters are applicable include neurological, urological, gynecological, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures that include access to any body duct or cavity. Specific examples include placement of implants, including stents, grafts, embolization coils, etc.; positioning of imaging devices and / or components thereof, including ultrasonic transducers; and positioning of energy sources, RF sources, ultrasonic transmitters, electromagnetic sources, laser sources, heat sources, etc., such as for performing lithotripsy.

[0076] Suitable delivery devices for implanting a prosthetic heart valve disclosed herein may include: an elongated shaft configured to pass through a patient's vasculature; one or more delivery actuators for manipulating the prosthetic heart valve within the patient's body; and a control mechanism that a physician can use to control the actuators. Some examples of the delivery device may further include a restriction mechanism configured to maintain the prosthetic heart valve in a compressed configuration.

[0077] Figure 2 A delivery device 200 is shown according to one example, which is designed to advance a prosthetic heart valve 100 through a patient's vasculature and / or deliver the prosthetic heart valve 100 to an implantation site (e.g., a native heart valve) within a patient's body. The prosthetic heart valve 100 can be mounted on, retained within, and / or removably coupled to a distal portion of the delivery device 200.

[0078] The delivery device 200 in the illustrated example generally includes: a handle 208; a first shaft 212 (an outer shaft in the illustrated example) extending distally from the handle 208; a second shaft 214 (an inner shaft in the illustrated example) extending distally from the handle 208 through the first shaft 212; one or more delivery system actuators 216 extending distally through the outer shaft 212; and one or more support tubes (sometimes referred to as support members) 218, which may extend distally through the outer shaft 212 and may abut the proximal end 110 of the prosthetic heart valve 100. The delivery device 200 may also include a nose cone 220 connected to the distal portion of the second shaft 214.

[0079] Each delivery system actuator 216 can have a distal end connected to the actuator 106 of the prosthetic heart valve 100. Each delivery system actuator 216 can extend through a respective support tube 218, and together can define a respective actuator assembly that can extend through the outer shaft 212 to the handle 208. In an alternative example, the delivery system actuator 216 and the support tube 218 need not be coaxial with each other, but can extend side by side through the shaft.

[0080] When the prosthetic heart valve 100 includes a linear actuator 106, the delivery system actuator 216 and / or the support tube 218 can be configured to radially expand the prosthetic heart valve 100 by bringing the ends 108, 110 of the prosthetic heart valve 100 closer together (i.e., axially compressing the prosthetic heart valve 100), thereby axially shortening and radially expanding the prosthetic heart valve 100. As an example, the delivery system actuator 216 can be configured to be actuated to provide a proximally directed (e.g., pulling) force to the actuator 106 of the prosthetic heart valve 100, while the one or more support tubes 218 can be configured to provide a counteracting distally directed (e.g., pushing) force to the proximal end 110 of the prosthetic heart valve 100. The actuator 106 can then transmit the force to the distal end 108 of the prosthetic heart valve 100. In one such instance, the physician may pull the delivery system actuator 216 to provide a proximally directed force to the distal end 108 of the prosthetic heart valve 100 while simultaneously gripping, holding and / or pushing the handle 208 to provide a counteracting distally directed force to the proximal end 110 of the prosthetic heart valve 100 .

[0081] When the prosthetic heart valve includes an actuator 106 that is driven in a rotational manner, the delivery system actuator 216 can be configured to apply a rotational force to the actuator 106. In such an example, the actuator 106 can have a first threaded end that is configured to connect with a corresponding threaded end of the delivery system actuator 216. When the delivery system actuator 216 is rotated in a first rotational direction, the actuator 106 can apply an axial force to the distal end 108 of the prosthetic heart valve 100 in a proximal direction, thereby axially shortening and radially expanding the prosthetic heart valve 100. When the delivery system actuator 216 is rotated in a second rotational direction opposite to the first rotational direction, the actuator 106 can apply an axial force to the distal end 108 of the prosthetic heart valve 100 in a distal direction, thereby axially expanding and radially contracting the prosthetic heart valve 100. In this example, the physician can rotationally manipulate the actuator 106 of the prosthetic heart valve 100 to radially expand or contract the prosthetic heart valve 100 to a desired diameter.

[0082] although Figure 2218, it should be understood that the delivery device 200 may include more or less than three delivery system actuators 216 and / or three support tubes 218 in other examples. As just one example, the delivery device 200 may include six delivery system actuators 216 and / or six support tubes 218. In other examples, there may be a greater or lesser number of delivery system actuators 216 and / or support tubes 218, such as four, five, seven, and / or eight delivery system actuators 216 and / or four, five, seven, and / or eight support tubes 218. In some examples, the delivery device 200 may include an equal number of delivery system actuators 216 and support tubes 218. However, in other examples, the delivery device 200 may include a different number of delivery system actuators 216 and support tubes 218.

[0083] like Figure 2 As shown, the handle 208 may include one or more knobs that may be configured to perform various functions of the delivery device 200 to deliver the prosthetic heart valve 100 to an implantation location in a patient. In one example, the handle 208 may include a first knob 222, a second knob 224, and a third knob 226. In one example, the knobs 222, 224, 226 may be knobs that can rotate about the longitudinal axis L1 of the handle 208 and relative to the main body portion 228 of the handle.

[0084] In this example, a first knob 222 is located at the proximal end of the handle 208 and can be used to operate the delivery system actuator 216 of the delivery device 200 and the actuator 106 of the prosthetic heart valve 100. The first knob 222 can be configured to operate a gear box disposed within the handle 208. The delivery system actuator 216 can be coupled to the gear box so as to be rotated by the gear box. The rotation of the delivery system actuator 216 can be converted into a rotational movement of the actuator 106 of the prosthetic heart valve 100. The second knob 224 can be configured to release the delivery system actuator 216 from the prosthetic heart valve 100 (e.g., after positioning the prosthetic heart valve 100 at a desired implantation location and expanding the prosthetic heart valve 100 to a working diameter).

[0085] exist Figure 2 In the example of the third knob 226 is located at the distal end of the handle 208. The third knob 226 can be configured such that rotation of the knob relative to the handle body causes the first shaft 212 to move axially relative to the handle 208, the delivery system actuator 216, the prosthetic heart valve 100, and / or the second shaft 214.

[0086] As shown in FIG. 2 , a delivery capsule 230 may be attached to the distal end of the first shaft 212. Axial movement of the first shaft 212 in a distal direction relative to the other shafts and the prosthetic valve may move the delivery capsule 230 on the distal portion of the delivery system actuator 216 and the prosthetic heart valve 100 (i.e., when the prosthetic heart valve 100 is in a radially compressed state), so that the prosthetic heart valve 100 is enclosed in the delivery capsule. Axial movement of the first shaft 212 in a proximal direction relative to the other shafts and the prosthetic valve may retract the delivery capsule 230 from the prosthetic heart valve 100, thereby exposing the prosthetic heart valve, for example, for deployment at an implantation location. In some instances, the third knob 226 may be operably coupled to a rack within a distal portion of the cavity of the handle 208. The first shaft 212 may be coupled to the rack so that rack movement caused by rotation of the third knob 226 causes axial displacement of the first shaft 212.

[0087] To prepare the delivery device 200 and the prosthetic heart valve 100 for delivery to a desired implantation site, the delivery capsule 230 may be advanced in a distal direction relative to the prosthetic heart valve 100 to enclose the prosthetic heart valve 100 within the delivery capsule 230. In instances where the delivery capsule 230 is coupled to and / or integral with the external shaft 212, the delivery capsule 230 may be selectively advanced in a distal direction or retracted in a proximal direction by rotating the third knob 226 relative to the handle body 228. Specifically, in order to advance the delivery capsule 230 in a distal direction toward the prosthetic heart valve 100 and / or to advance the delivery capsule over the prosthetic heart valve, the third knob 226 may be rotated relative to the handle body 228 in a first direction.

[0088] In some examples, as delivery capsule 230 is advanced in a distal direction, delivery system actuator 216 and / or prosthetic heart valve 100 may frictionally and / or mechanically resist the movement of delivery capsule 230, thereby necessitating that a substantial force must be applied in a distal direction to delivery capsule 230. In particular, advancing delivery capsule 230 toward and / or over prosthetic heart valve 100 may also serve to exert radially inwardly directed forces on delivery system actuator 216 and / or components of prosthetic heart valve 100, such as frame 102. Thus, such forces may serve to radially contract delivery system actuator 216 and / or frame 102 because such components are mechanically constrained by the fixed inner diameter of delivery capsule 230. The delivery system actuator 216 and / or components of the prosthetic heart valve 100 may accordingly apply a proximally directed force to the delivery capsule 230 and / or the first shaft 212, which proximally directed force must be overcome by a corresponding distally directed force in order to propel the delivery capsule 230 in the distal direction above the prosthetic heart valve 100.

[0089] In some examples, this distally directed force may be provided primarily or exclusively by the first shaft 212 to which the delivery capsule 230 is connected. In such cases, this force must be transmitted along the entire length of the outer shaft extending between the handle 208 and the delivery capsule 230. To facilitate this process, the user may manually maintain the outer shaft 212 in a generally straight orientation and / or manually apply tension between the handle 208 and the delivery capsule 230.

[0090] In some examples, a capsule loading assist device according to the present disclosure may be used to assist in the process of advancing a delivery capsule 230 over a prosthetic heart valve 100. The capsule loading assist device may, for example, facilitate maintaining the outer shaft 212 in a substantially straight orientation without manually grasping and / or supporting the handle 208 and / or the delivery capsule 230. As another example, the capsule loading assist device may facilitate creating tension between the handle 208 and the delivery capsule 230 in a consistent and / or easily reproducible manner.

[0091] Figure 3 An example of a capsule loading assist device 300 is shown coupled to (eg, supporting) an example of a delivery device 400. Additionally, and as described in more detail below, Figures 4 to 9 Aspects of an example of a capsule loading assistance device 800 that may be coupled to an example of a delivery device 600 are shown.

[0092] Delivery device 400 and / or delivery device 600 may be used with Figure 2 The delivery device 200 shares any suitable components, features, attributes, etc. Additionally or alternatively, Figure 2 The delivery device 200 and / or Figures 4 to 7 The delivery device 600 of 9 can be described as representing Figure 3 400. Thus, in the present disclosure, a component having a reference numeral beginning with a first digit 2, 4, or 6 may share any suitable features, attributes, etc. with a corresponding component having a reference numeral beginning with another first digit 2, 4, or 6 (i.e., a component having a reference numeral whose second and third digits are the same), even when no specific reference is made herein to such reference numerals. For example, any two or more of handle 208 of delivery device 200, handle 408 of delivery device 400, and / or handle 608 of delivery device 600 may be similar and / or analogous to each other. As another example, any two or more of delivery capsule 230, delivery capsule 430, and / or delivery capsule 630 may be similar and / or analogous to each other.

[0093] Similarly, Figures 4 to 9 The capsule loading aid 800 can be used with Figure 3 The capsule loading aid 300 of the present invention shares any suitable components, features, attributes, etc. Additionally or alternatively, Figures 4 to 9 The capsule loading auxiliary device 800 can be described as representing Figure 3 800. Thus, in the present disclosure, components having reference numerals beginning with a first digit 3 or 8 may share any suitable features, attributes, etc. with corresponding components having reference numerals beginning with other first digits 3 or 8 (i.e., components having reference numerals whose second and third digits are the same), even when no specific reference is made herein to such reference numerals. For example, lead screw 310 of capsule loading aid 300 may be similar and / or analogous to lead screw 810 of capsule loading aid 800.

[0094] exist Figure 3 In the example of , the delivery device 400 is coupled to a prosthetic heart valve 500 including a frame 502. For simplicity, Figure 3 Only the frame 502 of the prosthetic heart valve 500 is shown; however, it should be understood that the prosthetic heart valve 500 can be used with any other prosthetic heart valve disclosed herein, such as Figures 1 to 2 The prosthetic heart valves 100 share any suitable components, features, attributes, etc. Figure 3 Prosthetic heart valve 500 is shown in a radially expanded state.

[0095] Similar to Figure 2 The delivery device 200, Figure 3 The delivery device 400 includes a handle 408 that is selectively manipulated to selectively translate a delivery capsule 430 of the delivery device relative to the prosthetic heart valve 500. Figure 3 In the example of FIG. 4 , the handle 408 includes a capsule translation knob 426 that can be rotated relative to a handle body 428 of the handle 408 to translate the delivery capsule 430 in the proximal direction 302 or in the distal direction 304. In this way, the capsule translation knob 426 can be similar to Figure 2 The third knob 226 of the delivery device 200. Figure 3 As shown in FIG. 4 , the handle 408 may also include a first knob 422 and a second knob 424 , which may be similar to the first knob 222 and the second knob 224 , respectively, of the delivery device 200 as described above.

[0096] like Figure 3As shown in , the capsule loading assist device 300 includes a lead screw 310 and a loading assist nut 350 engaged with the lead screw 310. The loading assist nut 350 includes a capsule engagement surface 370, which is configured to engage the proximal surface 434 of the delivery capsule 430 of the delivery device 400 to apply a distally directed force to the delivery capsule 430. In the present disclosure, the distally directed force applied by the loading assist nut 350 on the proximal surface 434 of the delivery capsule 430 may also be referred to as a loading force and / or as a loading assist force. Because the loading assist nut 350 applies the loading assist force on the delivery capsule 430, the loading assist nut 350 may also be described as applying tension on the outer shaft 412 of the delivery device 400 between the delivery capsule 430 and the handle 408.

[0097] The capsule loading assist apparatus 300 is configured such that rotating the lead screw 310 in the first lead screw direction 311 moves the loading assist nut 350 in the distal direction 304 along the lead screw 310 while the capsule engagement surface 370 remains engaged with the delivery capsule 430. Specifically, when the handle 408 is used to advance the delivery capsule 430 in the distal direction 304, rotating the lead screw 310 may provide a supplemental force (e.g., a distally directed force and / or a loading assist force) to assist in moving the delivery capsule 430 over the prosthetic heart valve 500. For example, to move the delivery capsule 430 over the prosthetic heart valve 500, it may be beneficial to apply a distally directed force between the delivery capsule 430 and the handle 408 sufficient to overcome a proximally directed force applied to the delivery capsule 430 by components of the delivery apparatus 400 and / or the prosthetic heart valve 500 enclosed by the delivery capsule 430. In this manner, the loading assist nut 350 can support the distal end of the outer shaft 412 to help maintain the outer shaft 412 in a substantially straight configuration, thereby preventing and / or reducing the likelihood of buckling and / or kinking of the outer shaft 412 when the delivery capsule 430 is advanced over the prosthetic heart valve 500. Thus, providing a loading assist force with the loading assist nut 350 of the capsule loading assist device 300 as described herein can help advance the delivery capsule 430 over the prosthetic heart valve 500 in a stable and consistent manner.

[0098] like Figure 3As shown, and as described in more detail below, the capsule loading assistance device 300 additionally includes a torque transmission mechanism 330 configured to transmit torque from the handle 408 to the lead screw 310 to rotate the lead screw 310. Thus, actuating the handle 408 to advance the delivery capsule 430 in the distal direction 304 (e.g., by rotating the capsule translation knob 426 relative to the handle body 428) may in some cases additionally serve to rotate the lead screw 310 via the torque transmission mechanism 330 to move the loading assistance nut 350 along the lead screw 310 in the distal direction 304. In this way, the capsule loading assistance device 300 may be described as automatically advancing the loading assistance nut 350 in the distal direction 304 when the handle 408 is actuated (e.g., via the knob 426) to move the delivery capsule 430 in the distal direction 304.

[0099] The loading assistance nut 350 can have any of a variety of features and / or configurations for moving along the lead screw 410 and / or for engaging the delivery capsule 430 as described herein. In various examples, the loading assistance nut 350 is configured to translate relative to the handle 408 as the lead screw 410 rotates, without rotating relative to the handle 408. Specifically, the lead screw 310 can have a lead screw thread 316 that threadingly engages the loading assistance nut 350, such that rotation of the lead screw 310 relative to the loading assistance nut 350 causes the loading assistance nut 350 to move along the lead screw 310.

[0100] like Figure 3 As shown in , the loading assist nut 350 may include: a body 352, which defines a lead screw receiver 354 for receiving the lead screw 310; and a capsule shaft receiver 362, which is configured to receive the capsule shaft of the delivery device 400 extending between the handle 408 and the delivery capsule 430. Specifically, in Figure 3 In the example of FIG. 4 , the capsule shaft is the outer shaft 412 of the delivery device 400. Figure 3 As shown, at least a portion of the body 352 can extend between the lead screw receiver 354 and the capsule shaft receiver 362. The interior of the capsule shaft receiver 362 can be threaded to threadably engage the lead screw threads 316 of the lead screw 310.

[0101] In some examples, the capsule loading aid device 300 includes one or more features to stabilize the loading aid nut 350 during its operational use. Figure 3As shown in , the capsule loading assistance device 300 may include a support shaft 320 extending parallel to the lead screw 310 and engaging a loading assistance nut 350 to limit the loading assistance nut 350 from rotating relative to the lead screw 310 and / or relative to the support shaft 320. In such an example, the loading assistance nut 350 may include a support shaft receiver 360 that receives and engages the support shaft 320. Thus, when the lead screw 310 rotates, the engagement between the loading assistance nut 350 and the support shaft 320 may limit the loading assistance nut 350 from rotating with the lead screw 310, thereby forcing the loading assistance nut 350 to translate along the axial direction of the lead screw 310 (i.e., left or right in the depicted orientation) due to the threaded connection therebetween. The increased stability provided by the support shaft 320 may also be used to prevent the loading assistance nut 350 from rotating (e.g., twisting) out of a plane extending perpendicular to the lead screw 310.

[0102] In some examples, support shaft receiver 360 is configured to slidingly engage support shaft 320 when loading assist nut 350 translates along lead screw 310. For example, support shaft receiver 360 and support shaft 320 can each be unthreaded such that support shaft receiver 360 acts as a flat bearing.

[0103] In some examples, the support shaft receiver 360 can be threadedly engaged with the support shaft 320. For example, each of the support shaft receiver 360 and the support shaft 320 can be threaded so that rotating the support shaft 320 while rotating the lead screw 310 translates the loading assist nut 350 along each of the lead screw 310 and the support shaft 320.

[0104] In some instances, such as in Figure 3 In an example of the present invention, during the operational use of the capsule loading assist device 300, the lead screw 310 extends between the support shaft 320 and the delivery device 400. In other words, in such an example, during the operational use of the capsule loading assist device 300, the lead screw 310 and the support shaft 320 are positioned on opposite sides of the delivery device 400. However, not all examples require this. For example, it is also within the scope of the present disclosure that the support shaft 320 can extend between the lead screw 310 and the delivery device 400. For example, the capsule loading assist device 300 can be configured such that the lead screw 310 and the delivery device 400 are positioned on opposite sides of the support shaft 320 during its operational use. As another example, the capsule loading assist device 300 can be configured such that the support shaft 320 and the lead screw 310 are positioned on opposite sides of the delivery device 400 during its operational use.

[0105] In some instances, such as in Figure 3In an example of the present invention, the lead screw 310 and the support shaft 320 can be at least substantially coplanar with the delivery device 400 (e.g., with the outer shaft 412) during operational use of the capsule loading assist device 300. However, not all examples require this. For example, the capsule loading assist device 300 can be configured such that the lead screw 310, the support shaft 320, and the outer shaft 412 of the delivery device 400 are non-coplanar during its operational use. As a more specific example, the capsule loading assist device 300 can be configured such that the lead screw 310, the support shaft 320, and the outer shaft 412 of the delivery device 400 extend along substantially parallel respective axes during its operational use and are arranged in a triangular configuration.

[0106] In some examples, the capsule loading aid 300 may include a plurality of support shafts. Figure 3 As shown in dashed lines in , the capsule loading assistance device 300 may further include a second support shaft 322 engaged with the loading assistance nut 350. In such examples, the second support shaft 322 may engage the loading assistance nut 350 in any manner disclosed herein regarding the engagement between the support shaft 320 (which may also be referred to as the first support shaft 320) and the loading assistance nut 350. In some such examples, and as Figure 3 , during operational use of the capsule loading assist device 300, the delivery device 400 extends between the first support shaft 320 and the second support shaft 322. Specifically, supporting the loading assist nut 350 with support shafts positioned on either side of the delivery device 400 can enhance the torsional stability of the loading assist nut 350 by reducing the torque exerted by the loading assist nut 350 on the lead screw 310 and / or the first support shaft 320 when the loading assist nut 350 is pushed to engage with the delivery capsule 230.

[0107] In some instances, such as in Figure 3 In some examples, the body 352 may define a capsule engagement surface 370 and / or at least a portion of the capsule shaft receiver 362. In the present disclosure, the capsule shaft receiver 362 generally refers to an opening (e.g., a hole, an orifice, a recess, etc.) through which the capsule shaft extends during operational use of the capsule loading assist device 300. Additionally, in the present disclosure, the capsule engagement surface 370 generally refers to a surface of the loading assist nut 350 that directly engages the delivery capsule 430 during operational use of the capsule loading assist device 300. In some examples, the capsule engagement surface 370 at least substantially surrounds the capsule shaft receiver 362. Additionally or alternatively, the capsule engagement surface 370 may at least partially define the capsule shaft receiver 362.

[0108] The capsule shaft receiver 362 and / or the capsule engagement surface 370 can be configured to receive and / or interface with the delivery capsule 430 and / or the capsule shaft in any suitable manner. Figure 3 As shown in FIG, the delivery capsule 430 has a delivery capsule diameter 432, and the capsule shaft receiver diameter 364 of the capsule shaft receiver 362 is smaller than the delivery capsule diameter 432. Therefore, when the capsule shaft receiver 362 receives the capsule shaft, translating the loading assist nut 350 in the distal direction 304 can push the capsule engagement surface 370 against the proximal surface 434 of the delivery capsule 430.

[0109] The capsule engagement surface 370 may also have any suitable configuration for engaging the proximal surface 434 of the delivery capsule 430. For example, the capsule engagement surface 370 may include an inclined surface, a concave surface, and / or a surface shaped to match the shape of the delivery capsule 430 (e.g., the convex shape of the proximal surface 434). Thus, in some such examples, the capsule engagement surface 370 may be configured to contact the delivery capsule 430 and / or the proximal surface 434 across a two-dimensional contact area (e.g., rather than at a single contact point and / or a one-dimensional contact line).

[0110] The capsule loading aid device 300 may further include an additional stabilizing structure spaced apart from the loading aid nut 350. For example, in some examples, and as Figure 3 As shown, the capsule loading assist device 300 may include a proximal bearing 340 supporting the proximal portion 312 of the lead screw 310 and / or a distal bearing 380 supporting the distal portion 314 of the lead screw 310. In this way, the proximal bearing 340 and / or the distal bearing 380 may support the lead screw 310 and / or the loading assist nut 350 relative to the delivery device 400 (e.g., via the lead screw 310).

[0111] The proximal bearing 340 can be configured to engage the lead screw 310 so that the lead screw 310 can rotate relative to the proximal bearing 340. For example, and as Figure 3 As shown in , the proximal bearing 340 may include a proximal bearing lead screw receiver 346 that receives the lead screw 310 and / or engages the lead screw 310 when the lead screw 310 rotates relative to the proximal bearing 340. The proximal bearing 340 may engage the lead screw 310 via any suitable bearing surface. As an example, the proximal bearing lead screw receiver 346 may include a plane bearing, a ball bearing, a roller bearing, etc.

[0112] Similarly, the distal bearing 380 can be configured to engage the lead screw 310 so that the lead screw 310 can rotate relative to the distal bearing 380. For example, and as Figure 3As shown in , the distal bearing 380 may include a distal bearing lead screw receiver 386 that receives and / or engages the lead screw 310 when the lead screw 310 rotates relative to the distal bearing 380. The distal bearing 380 may engage the lead screw 310 via any suitable bearing surface. As an example, the distal bearing lead screw receiver 386 may include a plane bearing, a ball bearing, a roller bearing, etc.

[0113] In some instances, and as Figure 3 As shown in , the proximal bearing 340 and / or the distal bearing 380 additionally engage the (first) support shaft 320 and / or the second support shaft 322. Specifically, in the instance where the capsule loading assisting device 300 includes the (first) support shaft 320, the proximal bearing 340 may include a proximal bearing (first) support shaft receiver 342 that receives the proximal portion of the (first) support shaft 320. Additionally or alternatively, in such an instance, the distal bearing 380 may include a distal bearing (first) support shaft receiver 382 that receives the distal portion of the (first) support shaft 320. In some instances, the proximal bearing (first) support shaft receiver 342 and / or the distal bearing (first) support shaft receiver 382 are fixedly coupled to the (first) support shaft 320.

[0114] Additionally or alternatively, in instances where the capsule loading aid 300 includes a second support shaft 322, the proximal bearing 340 may include a proximal bearing second support shaft receiver 344 that receives a proximal portion of the second support shaft 322. Additionally or alternatively, in such instances, the distal bearing 380 may include a distal bearing second support shaft receiver 384 that receives a distal portion of the second support shaft 322. In some instances, the proximal bearing second support shaft receiver 344 and / or the distal bearing second support shaft receiver 384 are fixedly coupled to the second support shaft 322.

[0115] In some examples, the proximal bearing 340 is further configured to engage and / or support the handle 408 of the delivery device 400 relative to the lead screw 310. For example, and as Figure 3 As shown, the proximal bearing 340 may include a proximal bearing handle receiver 348 configured to receive the handle 408 to support the handle 408 relative to the lead screw 310. In some examples, the proximal bearing handle receiver 348 is configured to fixedly engage the handle 408, such as to limit rotation and / or translation of the handle 408 relative to the proximal bearing 340.

[0116] In some examples, the lead screw 310 and / or the support shaft 320 may include one or more retaining features (integrally formed or coupled thereto) to retain the components between the proximal bearing 340 and the distal bearing 380. For example, the lead screw 310 and / or the support shaft 320 may each include one or more flanges that are larger than the openings in the bearings. The flanges may thereby limit the axial movement of the lead screw 310 and / or the support shaft 320 relative to the bearings 340, 380. In some cases, the flanges may be washers coupled to the lead screw 310 and / or the support shaft 320 by fasteners (and / or other coupling members).

[0117] The torque transmission mechanism 330 may have any suitable components and / or functionality for rotating the lead screw 310 in response to rotation of a portion of the handle 408. Figure 3 As shown in , the handle 408 may include a handle body 428 and a capsule translation knob (e.g., a third knob 426). That is, as used herein, the third knob 426 may also be referred to as a capsule translation knob 426. The capsule translation knob 426 is configured to be selectively rotated relative to the handle body 428 in a first knob direction 427 to translate the delivery capsule 430 in the distal direction 304 relative to the handle body 428. In some examples, the torque transmission mechanism 330 is configured to be selectively coupled to the capsule translation knob 426 so that rotation of the capsule translation knob 426 rotates the lead screw 310.

[0118] In some examples, the torque transmission mechanism 330 is configured to rotate the lead screw 310 such that when the capsule translation knob 426 is rotated, the lead screw 310 translates the loading assist nut 350 at a rate that is equal to or approximately equal to the rate at which the capsule translation knob 426 advances the delivery capsule 430. Specifically, the delivery device 400 can be configured such that rotating the capsule translation knob 426 in the first knob direction 427 translates the delivery capsule 430 in the distal direction 304 at a capsule advancement rate. Similarly, the torque transmission mechanism 330 can be configured such that rotation of the capsule translation knob 426 in the first knob direction 427 rotates the lead screw 310 at a rotation rate such that the loading assist nut 350 translates in the distal direction 304 at a nut advancement rate that is equal to or approximately equal to the capsule advancement rate. The capsule advancement rate and the nut advancement rate can be measured and / or quantified in any suitable manner, such as based on the translation distance achieved along the distal direction 304 for each full rotation of the capsule translation knob 426.

[0119] The torque transfer mechanism 330 can transfer torque from the capsule translation knob 426 to the lead screw 310 in any of a variety of ways. As discussed above, the capsule loading assistance device 300 is configured such that rotating the lead screw 310 in the first lead screw direction 311 moves the loading assistance nut 350 along the lead screw 310 in the distal direction 304. In some examples, the first knob direction can be the same as the first lead screw direction. In other examples, such as in Figure 3 In an example, the first knob direction 627 can be opposite to the first lead screw direction 311.

[0120] In some examples, the torque transmission mechanism 330 is configured such that rotation of the capsule translation knob 326 at a knob rotation rate causes the lead screw 310 to rotate at a lead screw rotation rate that is equal to or approximately equal to the knob rotation rate. In such examples, the torque transmission mechanism 330 may be described as operatively interconnecting the capsule translation knob 326 and the lead screw 310 at a gear ratio (or effective gear ratio) of 1:1. For example, the capsule translation knob 326 may be operatively coupled to a capsule shaft (e.g., outer shaft 412) of the delivery device 400 via a screw mechanism having a capsule shaft pitch, the capsule shaft extending between the handle 408 and the delivery capsule 430, and the lead screw pitch of the lead screw thread 316 may be equal to or approximately equal to the capsule shaft pitch. However, not all examples require this, and it is also within the scope of the present disclosure that rotation of the capsule translation knob 326 at the knob rotation rate causes the lead screw to rotate at a lead screw rotation rate that is less than or greater than the knob rotation rate.

[0121] The torque transfer mechanism 330 may include any suitable mechanism for rotating the lead screw 310 in response to rotation of the capsule translation knob 426, examples of which include one or more gears, belts, chains, and / or any other suitable mechanism for rotationally coupling the capsule translation knob 426 and the lead screw 310.

[0122] As discussed above, Figures 4 to 9 Aspects of a capsule loading aid 800 that may be coupled to a delivery device 600 are shown. Specifically, Figures 4 to 6 800 when the lead screw 810 is advanced in the distal direction 804 to engage the delivery capsule 630. Figures 4 to 6 In the example of the delivery device 600, a frame 702 (in Figures 4 to 5 For simplicity, Figures 4 to 5 Only the frame 702 of the prosthetic heart valve 700 is shown; however, it should be understood that the prosthetic heart valve 700 can be used with any other prosthetic heart valve disclosed herein, such as Figures 1 to 2 The prosthetic heart valve 100 and / or Figure 3 The prosthetic heart valve 500 shares any suitable components, features, attributes, etc.

[0123] like Figures 4 to 6 , the capsule translation knob 626 is rotated in a first knob direction 627 relative to the handle body 628 to move the loading assist nut 850 in a distal direction 804 along the lead screw 810 to apply a distally directed loading assist force to the delivery capsule 630 as the delivery capsule 630 also moves in the distal direction 804. When the delivery capsule 630 moves in the distal direction 804, the prosthetic heart valve 700 is moved from the radially expanded state ( Figure 4 ) radially contracted to the intermediate state ( Figure 5 ) and shrink to a radially compressed state ( Figure 6 ), in the radially compressed state, the delivery capsule 630 can completely encapsulate the prosthetic heart valve 700.

[0124] Figures 7 to 8 Aspects of the loading aid nut 850 of the capsule loading aid device 800 are shown. Figure 3 , the size of the loading assist nut 350 (e.g., the capsule shaft receiver diameter 364 of the capsule shaft receiver 362) can be configured such that the loading assist nut cannot slide longitudinally onto or off the outer shaft 412 of the delivery device 400 when the delivery capsule 430 and the handle 408 are attached to the outer shaft 412. Thus, the loading assist nut 350 can be configured to selectively transition between different configurations to permit the outer shaft 412 to be inserted into or removed from the capsule shaft receiver 362. For example, referring to Figures 7 to 8 The loading assist nut 850 may include a movable receiver arm 856 connected to the body 852 and defining at least a portion of the capsule shaft receiver 862.

[0125] like Figures 7 to 8 As shown in FIG. , the receiver arm 856 is configured to be in the open position ( Figure 8 ) and closed position ( Figure 7 ) are selectively transitioned between the main body 852 and the main body 852. When the receiver arm 856 is in the open position, at least a portion of the receiver arm 856 is spaced apart from the main body 852 (e.g., bent and / or pivoted away from the main body) to allow the capsule shaft to be inserted into or removed from the loading assistance nut 850. When the receiver arm 856 is in the closed position, the loading assistance nut 850 can be used to apply a loading assistance force to the delivery capsule when the capsule shaft is received in the capsule shaft receiver 862.

[0126] In some examples, the capsule shaft receiver 862 can be constructed and / or oriented to substantially surround the capsule shaft only when the receiver arms 856 are in the closed position. Figures 7 to 8 As shown in , the receiver arm 856 defines at least a portion of the capsule engagement surface 870.

[0127] The receiver arm 856 can be configured to transition between the open position and the closed position in any suitable manner. Figures 7 to 8 In the example of the embodiment, the receiver arm 856 is hingedly coupled to the body 852. Additionally or alternatively, the receiver arm 856 can be configured to bend elastically relative to the body 852 to transition between the open position and the closed position.

[0128] In some instances, and as Figures 7 to 8 As shown in , the loading assist nut 850 includes a locking mechanism 858 configured to selectively retain the receiver arm 856 in the closed position. Specifically, in such examples, it may be necessary to selectively unlock, disable, release, and / or otherwise overcome the locking mechanism 858 before transitioning the receiver arm 856 from the closed position to the open position. When present, the locking mechanism 858 may include and / or be any suitable mechanism, examples of which include a latch, a snap, a snap-fit ​​mechanism, and / or a magnetic fastening mechanism.

[0129] Although Figures 7 to 8 An example is shown where the receiver arm 856 remains attached to the rest of the loading assist nut 850 when the receiver arm 856 is in the open position, but this is not required in all examples. For example, the receiver arm can be a separate component that can be completely removed from the body to transition the receiver arm from the closed position to the open position, and it is also within the scope of the present disclosure.

[0130] Figures 4 to 6 9 also illustrate aspects of the torque transmission mechanism 830 of the capsule loading assist device 800. Specifically, in Figures 4 to 6 In the examples of and 9, the torque transmission mechanism 830 includes: a handle gear 832 configured to rotate in unison with the capsule translation knob 626; and a lead screw gear 834 operatively coupled to the lead screw 810 such that rotation of the handle gear 832 rotates the lead screw 810. In some examples, the lead screw gear 834 can be fixedly coupled to the lead screw 810.

[0131] The handle gear 832 can be connected to the capsule translation knob 626 in any suitable manner. Figures 4 to 6In the examples of and 9, the handle gear 832 can be configured to be selectively coupled to the capsule translation knob 626, such as by sliding the handle gear 832 onto the capsule translation knob 626, by assembling the handle gear 832 around the capsule translation knob 626, etc. In other examples, the capsule translation knob can include and / or be the handle gear. For example, the capsule translation knob itself can include an outer surface that is ridged, textured, and / or otherwise shaped to rotationally engage another component of the torque transfer mechanism, such as a lead screw gear.

[0132] In some instances, such as in Figures 4 to 6 In the examples of and 9, the handle gear 832 directly engages the lead screw gear 834. Therefore, in such examples, the first knob direction 627 is opposite to the first lead screw direction 811. However, not all examples require this, and in addition, within the scope of the present disclosure, the torque transmission mechanism may further include one or more intermediate gears that operatively couple the handle gear and the lead screw gear to each other. In some such examples, the intermediate gears may be configured so that the first knob direction is the same as the first lead screw direction or opposite to the first lead screw direction.

[0133] Additional Examples of Disclosed Technology

[0134] Considering the above implementation of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of the examples adopted in combination, and optionally combined with one or more features of one or more other examples, are other examples that also fall within the disclosure of the present application.

[0135] Example 1. A capsule loading assist device, comprising: a lead screw; a loading assist nut engaged with the lead screw and including a capsule engaging surface, wherein the capsule engaging surface is configured to engage a proximal surface of a delivery capsule of a delivery device to apply a distally directed loading assist force to the delivery capsule; and a torque transfer mechanism configured to transmit torque from a handle of the delivery device to the lead screw to rotate the lead screw; wherein the capsule loading assist device is configured so that rotating the lead screw in a first lead screw direction causes the loading assist nut to move along the lead screw in a distal direction.

[0136] Example 2. According to any example herein, in particular the capsule loading assist device described in Example 1, wherein the loading assist nut comprises: a main body defining a lead screw receiver for receiving a lead screw; and a capsule shaft receiver configured to receive a capsule shaft of a delivery device extending between a handle and a delivery capsule; and wherein at least a portion of the main body extends between the lead screw receiver and the capsule shaft receiver.

[0137] Example 3. The capsule loading aid according to any example herein, particularly example 2, wherein the body defines at least a portion of the capsule engagement surface.

[0138] Example 4. According to any example herein, in particular the capsule loading aid according to any one of examples 2 to 3, the body defines at least a portion of the capsule shaft receiver.

[0139] Example 5. The capsule loading aid according to any example herein, particularly any one of examples 2 to 4, wherein the capsule engagement surface at least substantially surrounds the capsule shaft receiver.

[0140] Example 6. The capsule loading aid according to any example herein, particularly any one of examples 2 to 5, wherein the capsule engagement surface at least partially defines a capsule shaft receiver.

[0141] Example 7. The capsule loading aid device according to any example herein, particularly any one of examples 1 to 6, wherein the loading aid nut is configured to translate relative to the handle as the lead screw rotates, but not to rotate relative to the handle.

[0142] Example 8. A capsule loading assist device according to any example herein, particularly any one of Examples 2 to 7, wherein the loading assist nut further includes a receiver arm connected to the body, wherein the receiver arm defines at least a portion of a capsule shaft receiver, and wherein the receiver arm is configured to selectively transition between an open position and a closed position, wherein in the open position, at least a portion of the receiver arm is spaced apart from the body to allow the capsule shaft to be inserted into or removed from the loading assist nut, and in the closed position, when the capsule shaft is received in the capsule shaft receiver, the loading assist nut is used to apply a loading assist force to the delivery capsule.

[0143] Example 9. The capsule loading aid according to any example herein, particularly example 8, wherein the receiver arm defines at least a portion of the capsule engagement surface.

[0144] Example 10. The capsule loading aid according to any example herein, particularly any one of examples 8 to 9, wherein the receiver arm is hingedly coupled to the body.

[0145] Example 11. The capsule loading aid according to any example herein, particularly any one of examples 8 to 10, wherein the receiver arm is configured to be resiliently bent relative to the body to transition between an open position and a closed position.

[0146] Example 12. The capsule loading aid device according to any example herein, particularly any one of examples 8 to 11, wherein the loading aid nut further comprises a locking mechanism configured to selectively hold the receiver arm in the closed position.

[0147] Example 13. The capsule loading aid according to any example herein, particularly example 12, wherein the locking mechanism comprises one or more of a latch, a snap-fit ​​mechanism, and a magnetic fastening mechanism.

[0148] Example 14. The capsule loading aid according to any example herein, particularly any one of examples 1 to 13, wherein the capsule engagement surface comprises an inclined surface.

[0149] Example 15. The capsule loading aid according to any example herein, particularly any one of examples 1 to 14, wherein the capsule engagement surface comprises a concave surface.

[0150] Example 16. The capsule loading aid according to any example herein, particularly any one of examples 1 to 15, wherein the capsule engaging surface is shaped to match the shape of the delivery capsule.

[0151] Example 17. The capsule loading aid according to any example herein, particularly any one of examples 1 to 16, wherein the capsule engagement surface is configured to engage the delivery capsule across a two-dimensional contact area.

[0152] Example 18. According to any example herein, specifically the capsule loading assistance device described in any one of Examples 1 to 17, wherein the handle comprises: a handle body; and a capsule translation knob configured to selectively rotate relative to the handle body in a first knob direction to translate the delivery capsule in a distal direction relative to the handle body; and wherein the torque transfer mechanism is configured to selectively connect to the capsule translation knob so that rotation of the capsule translation knob causes the lead screw to rotate.

[0153] Example 19. According to any example herein, in particular the capsule loading assist device described in Example 18, wherein the delivery device is configured such that rotating the capsule translation knob in a first knob direction causes the delivery capsule to translate in a distal direction at a capsule advancement rate, and wherein the torque transmission mechanism is configured such that rotation of the capsule translation knob in the first knob direction causes the lead screw to rotate such that the loading assist nut translates in a distal direction at a nut advancement rate approximately equal to the capsule advancement rate.

[0154] Example 20. The capsule loading assistance device according to any example herein, particularly any one of examples 18 to 19, wherein the first knob direction is the same as the first lead screw direction.

[0155] Example 21. The capsule loading assistance device according to any example herein, particularly any one of Examples 18 to 19, wherein the direction of the first knob is opposite to the direction of the first lead screw.

[0156] Example 22. According to any example herein, in particular the capsule loading assistance device of any one of Examples 18 to 21, wherein the torque transmission mechanism is configured such that rotation of the capsule translation knob at a knob rotation rate causes the lead screw to rotate at a lead screw rotation rate approximately equal to the knob rotation rate.

[0157] Example 23. According to any example herein, in particular the capsule loading assistance device of any one of Examples 18 to 21, wherein the torque transmission mechanism is configured such that rotation of the capsule translation knob at a knob rotation rate causes the lead screw to rotate at a lead screw rotation rate less than the knob rotation rate.

[0158] Example 24. A capsule loading assistance device according to any example herein, particularly any one of Examples 18 to 21, wherein the torque transmission mechanism is configured such that rotation of the capsule translation knob at a knob rotation rate causes the lead screw to rotate at a lead screw rotation rate greater than the knob rotation rate.

[0159] Example 25. A capsule loading assist device according to any example herein, particularly any one of Examples 18 to 24, wherein the capsule translation knob is operably connected to the capsule shaft of the delivery device via a screw mechanism having a capsule shaft pitch, the capsule shaft extending between the handle and the delivery capsule, and wherein the lead screw has a lead screw thread having a lead screw pitch approximately equal to the capsule shaft pitch.

[0160] Example 26. A capsule loading assistance device according to any example herein, particularly any one of Examples 18 to 25, wherein the torque transfer mechanism comprises: a handle gear configured to rotate in unison with a capsule translation knob; and a lead screw gear operatively connected to the lead screw; and wherein rotation of the handle gear causes the lead screw to rotate.

[0161] Example 27. The capsule loading aid according to any example herein, particularly Example 26, wherein the lead screw gear is fixedly coupled to the lead screw.

[0162] Example 28. The capsule loading assistance device according to any example herein, particularly any one of examples 26 to 27, wherein the handle gear is configured to be selectively coupled to the capsule translation knob.

[0163] Example 29. The capsule loading assistance device according to any example herein, particularly any one of examples 26 to 28, wherein the capsule translation knob comprises a handle gear.

[0164] Example 30. The capsule loading aid according to any example herein, particularly any one of examples 26 to 29, wherein the handle gear directly engages the lead screw gear.

[0165] Example 31. The capsule loading assistance device according to any example herein, particularly any one of examples 26 to 29, wherein the torque transmission mechanism further comprises one or more intermediate gears operatively coupling the handle gear and the lead screw gear.

[0166] Example 32. According to any example herein, in particular the capsule loading assistance device of Example 31, wherein the one or more intermediate gears are configured such that the first knob direction is the same as the first lead screw direction.

[0167] Example 33. According to any example herein, in particular the capsule loading assistance device of Example 31, wherein the one or more intermediate gears are configured such that the first knob direction is opposite to the first lead screw direction.

[0168] Example 34. The capsule loading aid according to any example herein, particularly any one of examples 1 to 33, wherein the torque transmission mechanism comprises one or both of a belt and a chain.

[0169] Example 35. According to any example herein, in particular the capsule loading assist device of any one of Examples 1 to 34, further comprising a support shaft extending parallel to the lead screw, wherein the support shaft engages the loading assist nut to limit rotation of the loading assist nut relative to the lead screw.

[0170] Example 36. The capsule loading assistance device according to any example herein, particularly Example 35, wherein the loading assistance nut includes a support shaft receiver for receiving the support shaft.

[0171] Example 37. The capsule loading assist device according to any example herein, particularly Example 36, wherein the support shaft receiver is configured to slidingly engage the support shaft when the loading assist nut translates along the lead screw.

[0172] Example 38. The capsule loading aid according to any example herein, particularly any one of examples 36 to 37, wherein the support shaft receiver is non-threaded.

[0173] Example 39. The capsule loading aid according to any example herein, particularly any one of examples 36 to 37, wherein the support shaft receiver engages the support shaft in a threaded engagement.

[0174] Example 40. The capsule loading aid according to any example herein, particularly any one of examples 35 to 39, wherein during operational use of the capsule loading aid, the lead screw extends between the support shaft and the delivery device.

[0175] Example 41. The capsule loading aid according to any example herein, particularly any one of examples 35 to 39, wherein during operational use of the capsule loading aid, a support shaft extends between the lead screw and the delivery device.

[0176] Example 42. The capsule loading aid according to any example herein, particularly any one of examples 35 to 41, wherein the support shaft is a first support shaft, and wherein the capsule loading aid further comprises a second support shaft engaging a loading aid nut.

[0177] Example 43. The capsule loading aid according to any example herein, particularly Example 42, wherein during operational use of the capsule loading aid, the delivery device extends between the first support shaft and the second support shaft.

[0178] Example 44. The capsule loading assistance device according to any example herein, particularly any one of examples 1 to 43, further comprising a proximal bearing supporting a proximal portion of the lead screw.

[0179] Example 45. According to any example herein, in particular the capsule loading assist device described in Example 44, further comprising a support shaft extending parallel to the lead screw, wherein the support shaft engages a loading assist nut to limit rotation of the loading assist nut relative to the lead screw, and wherein the proximal bearing comprises a proximal bearing support shaft receiver for receiving the support shaft.

[0180] Example 46. The capsule loading aid according to any example herein, particularly Example 45, wherein the proximal bearing support shaft receiver is fixedly coupled to the support shaft.

[0181] Example 47. According to any example herein, specifically the capsule loading assist device described in any one of Examples 44 to 46, wherein the support shaft is a first support shaft, wherein the capsule loading assist device further includes a second support shaft, wherein the second support shaft is engaged with a loading assist nut, and wherein the proximal bearing includes a proximal bearing second support shaft receiver for receiving the second support shaft.

[0182] Example 48. The capsule loading assist device according to any example herein, particularly Example 47, wherein the proximal bearing second support shaft receiver is fixedly coupled to the second support shaft.

[0183] Example 49. The capsule loading assistance device according to any example herein, particularly any one of examples 44 to 48, wherein the proximal bearing is configured to engage the lead screw so that the lead screw can rotate relative to the proximal bearing.

[0184] Example 50. The capsule loading assistance device according to any example herein, particularly any one of examples 44 to 49, wherein the proximal bearing comprises a proximal bearing lead screw receiver that receives the lead screw.

[0185] Example 51. The capsule loading assist device of any example herein, particularly Example 50, wherein the proximal bearing lead screw receiver engages the lead screw when the lead screw rotates relative to the proximal bearing.

[0186] Example 52. According to any example herein, in particular the capsule loading aid according to any one of examples 44 to 51, the proximal bearing comprises one or more of a plane bearing, a ball bearing, and a roller bearing.

[0187] Example 53. The capsule loading assistance device according to any example herein, particularly any one of examples 44 to 52, wherein the proximal bearing is further configured to support the handle relative to the lead screw.

[0188] Example 54. The capsule loading aid according to any example herein, particularly Example 53, wherein the proximal bearing is configured to be fixedly coupled to the handle.

[0189] Example 55. The capsule loading aid according to any example herein, particularly any one of examples 53 to 54, wherein the proximal bearing comprises a proximal bearing handle receiver configured to receive the handle.

[0190] Example 56. The capsule loading aid according to any example herein, particularly Example 55, wherein the proximal bearing handle receiver is configured to fixedly engage the handle.

[0191] Example 57. The capsule loading assistance device according to any example herein, particularly any one of Examples 1 to 56, further comprising a distal bearing supporting a distal portion of the lead screw.

[0192] Example 58. According to any example herein, in particular the capsule loading assist device described in Example 57, further comprising a support shaft extending parallel to the lead screw, wherein the support shaft engages a loading assist nut to limit rotation of the loading assist nut relative to the lead screw, and wherein the distal bearing comprises a distal bearing support shaft receiver for receiving the support shaft.

[0193] Example 59. The capsule loading assist device according to any example herein, particularly Example 58, wherein the distal bearing support shaft receiver is fixedly coupled to the support shaft.

[0194] Example 60. According to any example herein, specifically the capsule loading assist device described in any one of Examples 57 to 59, wherein the support shaft is a first support shaft, wherein the capsule loading assist device further includes a second support shaft, wherein the second support shaft is engaged with a loading assist nut, and wherein the distal bearing includes a distal bearing second support shaft receiver for receiving the second support shaft.

[0195] Example 61. The capsule loading assistance device of any example herein, particularly Example 60, wherein the distal bearing second support shaft receiver is fixedly coupled to the second support shaft.

[0196] Example 62. The capsule loading assistance device according to any example herein, particularly any one of Examples 57 to 61, wherein the distal bearing is configured to engage the lead screw so that the lead screw can rotate relative to the distal bearing.

[0197] Example 63. The capsule loading assistance device according to any example herein, particularly any one of Examples 57 to 62, wherein the distal bearing comprises a distal bearing lead screw receiver that receives the lead screw.

[0198] Example 64. The capsule loading assist device of any example herein, particularly Example 63, wherein the distal bearing lead screw receiver engages the lead screw when the lead screw rotates relative to the distal bearing.

[0199] Example 65. The capsule loading assist device according to any example herein, particularly any one of Examples 63 to 64, wherein the distal bearing comprises one or more of a plane bearing, a ball bearing, and a roller bearing.

[0200] Example 66. A capsule loading assist assembly comprising: a delivery device comprising a handle having a capsule translation knob, a delivery capsule, and a capsule shaft extending between the handle and the delivery capsule; a prosthetic heart valve supported by the delivery device; and a capsule loading assist device comprising: a lead screw; a loading assist nut engaged with the lead screw and comprising a capsule engagement surface, the capsule engagement surface being configured to engage a proximal surface of the delivery capsule to apply a distally directed loading assist force to the delivery capsule; and a torque transfer mechanism configured to transmit torque from the handle of the delivery device to the lead screw to rotate the lead screw; wherein the capsule loading assist device is configured such that rotating the lead screw in a first lead screw direction causes the loading assist nut to move along the lead screw in a distal direction, and applies a loading assist force to the delivery capsule when the delivery capsule moves in the distal direction to at least substantially cover the prosthetic heart valve.

[0201] Example 67. According to any example herein, in particular the capsule loading assist assembly of Example 66, wherein the loading assist nut includes a capsule shaft receiver, wherein the capsule shaft receiver is configured to receive a capsule shaft of a delivery device extending between a handle and a delivery capsule, wherein the delivery capsule has a delivery capsule diameter, and wherein the capsule shaft receiver diameter of the capsule shaft receiver is smaller than the delivery capsule diameter.

[0202] Example 68. A method comprising: operatively connecting a delivery device to a capsule loading assist device, wherein the delivery device comprises: a handle comprising a capsule translation knob; a delivery capsule; and a capsule shaft extending between the handle and the delivery capsule, and wherein the capsule loading assist device comprises a lead screw and a loading assist nut engaged with the lead screw; and rotating the capsule translation knob in a first knob direction to translate the loading assist nut in a distal direction.

[0203] Example 69. The method of any example herein, particularly Example 68, wherein operatively coupling the delivery device to the capsule loading assist device comprises inserting a capsule shaft into a capsule shaft receiver of the loading assist nut.

[0204] Example 70. A method according to any example herein, particularly Example 69, wherein the loading assist nut includes a body and a receiver arm connected to the body, wherein the receiver arm is configured to selectively transition between an open position and a closed position, and wherein inserting the capsule shaft into the capsule shaft receiver includes: positioning the capsule shaft between the body and the receiver arm when the receiver arm is in an open position; and transitioning the receiver arm from the open position to the closed position.

[0205] Example 71. A method according to any example herein, particularly Example 70, wherein the loading assist nut further includes a locking mechanism configured to selectively maintain the receiver arm in a closed position, and wherein inserting the capsule shaft into the capsule shaft receiver further includes locking the receiver arm in the closed position with the locking mechanism.

[0206] Example 72. The method of any example herein, particularly any one of Examples 68 to 71, wherein rotating the capsule translation knob comprises rotating a handle gear operatively coupled to the lead screw via a lead screw gear.

[0207] Example 73. A method comprising sterilizing any of the capsule loading aid assembly, delivery device, prosthetic heart valve, or capsule loading aid device of any of Examples 1-67.

[0208] Example 74. A method of implanting a prosthetic device, the prosthetic device comprising any one of the devices disclosed herein, and specifically any one of the devices described in any one of Examples 1 to 67.

[0209] Example 75. A method of simulating an implantation surgery for a prosthetic device, the prosthetic device comprising any one of the devices disclosed herein, and specifically any one of the devices described in any one of Examples 1 to 67.

[0210] Example 76. The device according to any example herein, particularly any one of examples 1 to 67, wherein the device is sterilized.

[0211] Example 77. A method comprising: operatively connecting a delivery device to a capsule loading assist device, wherein the delivery device comprises: a handle comprising a capsule translation knob; a delivery capsule; and a capsule shaft extending between the handle and the delivery capsule, and wherein the capsule loading assist device comprises a lead screw and a loading assist nut engaged with the lead screw; and rotating the capsule translation knob in a first knob direction to translate the loading assist nut in a distal direction.

[0212] Example 78. The method of any example herein, particularly Example 77, wherein operatively coupling the delivery device to the capsule loading assist device comprises inserting the capsule shaft into a capsule shaft receiver of the loading assist nut.

[0213] Example 79. A method according to any example herein, particularly Example 78, wherein the loading assist nut includes a body and a receiver arm connected to the body, wherein the receiver arm is configured to selectively transition between an open position and a closed position, and wherein inserting the capsule shaft into the capsule shaft receiver includes: positioning the capsule shaft between the body and the receiver arm when the receiver arm is in the open position; and transitioning the receiver arm from the open position to the closed position.

[0214] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more of the other examples. For example, any one or more features of one capsule loading aid may be combined with any one or more features of another capsule loading aid. As another example, any one or more features of one delivery device may be combined with any one or more features of another delivery device.

[0215] In view of the fact that the principles of the disclosed utility model can be applied to many possible embodiments, it should be recognized that the embodiments shown are only preferred embodiments of the utility model and should not be considered as limiting the scope of the utility model. In fact, the scope of the utility model is defined by the following claims and their equivalents. Therefore, we claim all content within the scope and spirit of these claims as our utility model.

Claims

1. A capsule loading auxiliary device, characterized in that include: Lead screw; a loading assist nut engaged with the lead screw and including a capsule engaging surface configured to engage a proximal surface of a delivery capsule of a delivery device to apply a distally directed loading assist force to the delivery capsule; as well as a torque transmission mechanism configured to transmit torque from a handle of the delivery device to the lead screw to rotate the lead screw; The capsule loading aid device is configured such that rotating the lead screw in a first lead screw direction moves the loading aid nut in a distal direction along the lead screw.

2. The capsule loading assisting device according to claim 1, wherein the loading assisting nut comprises: a main body defining a lead screw receiver for receiving the lead screw; as well as a capsule shaft receiver configured to receive a capsule shaft of the delivery device extending between the handle and the delivery capsule; and Wherein at least a portion of the body extends between the lead screw receiver and the capsule shaft receiver. 3 . The capsule loading aid of claim 2 , wherein the body defines at least a portion of the capsule engagement surface.

4. The capsule loading aid according to any one of claims 2 to 3, wherein the body defines at least a portion of the capsule shaft receiver.

5. A capsule loading assist device according to any one of claims 2 to 3, wherein the loading assist nut includes a receiver arm connected to the body, wherein the receiver arm defines at least a portion of the capsule shaft receiver, and wherein the receiver arm is configured to selectively transition between an open position and a closed position, wherein in the open position, at least a portion of the receiver arm is spaced apart from the body to allow the capsule shaft to be inserted into or removed from the loading assist nut, and in the closed position, when the capsule shaft is received in the capsule shaft receiver, the loading assist nut is used to apply the loading assist force to the delivery capsule. 6 . The capsule loading aid device according to claim 1 , wherein the loading aid nut is configured to translate relative to the handle as the lead screw rotates, but not to rotate relative to the handle.

7. The capsule loading aid according to any one of claims 1 to 3, wherein the handle comprises: handle body; as well as a capsule translation knob configured to be selectively rotated relative to the handle body in a first knob direction to translate the delivery capsule in the distal direction relative to the handle body; and Wherein the torque transfer mechanism is configured to be selectively coupled to the capsule translation knob such that rotation of the capsule translation knob rotates the lead screw.

8. The capsule loading assisting device according to claim 7, wherein the torque transmission mechanism comprises: a handle gear configured to rotate in unison with the capsule translation knob; as well as a lead screw gear operatively coupled to the lead screw; and Rotation of the handle gear causes the lead screw to rotate.

9. The capsule loading aid according to any one of claims 1 to 3 and 8, characterized in that Further included is a support shaft extending parallel to the lead screw, wherein the support shaft engages the loading assist nut to limit rotation of the loading assist nut relative to the lead screw. 10 . The capsule loading assisting apparatus according to claim 9 , wherein the loading assisting nut comprises a support shaft receiver that receives the support shaft.

11. The capsule loading aid according to any one of claims 1 to 3, 8 and 10, characterized in that Further included is a proximal bearing supporting a proximal portion of the lead screw.

12. The capsule loading auxiliary device according to claim 11, characterized in that Further comprising a support shaft extending parallel to the lead screw, wherein the support shaft engages the loading assist nut to limit rotation of the loading assist nut relative to the lead screw, and wherein the proximal bearing comprises a proximal bearing support shaft receiver that receives the support shaft.

13. The capsule loading assistance device of claim 11, wherein the proximal bearing is configured to support the handle relative to the lead screw.

14. The capsule loading aid according to any one of claims 1 to 3, 8, 10 and 12-13, characterized in that Further included is a distal bearing supporting a distal portion of the lead screw.

15. The capsule loading auxiliary device according to claim 14, characterized in that Further comprising a support shaft extending parallel to the lead screw, wherein the support shaft engages the loading assist nut to limit rotation of the loading assist nut relative to the lead screw, and wherein the distal bearing comprises a distal bearing support shaft receiver that receives the support shaft.

16. A capsule loading auxiliary component, characterized in that include: a delivery device comprising a handle having a capsule translation knob, a delivery capsule, and a capsule shaft extending between the handle and the delivery capsule; a prosthetic heart valve supported by the delivery device; as well as Capsule loading auxiliary equipment, comprising: Lead screw; a loading assist nut engaged with the lead screw and including a capsule engaging surface configured to engage a proximal surface of the delivery capsule to apply a distally directed loading assist force to the delivery capsule; and a torque transfer mechanism configured to transfer torque from the handle of the delivery device to the lead screw to rotate the lead screw; The capsule loading assist device is configured such that rotating the lead screw in a first lead screw direction causes the loading assist nut to move along the lead screw in a distal direction, and applies the loading assist force to the delivery capsule when the delivery capsule moves in the distal direction to at least cover the prosthetic heart valve.

17. The capsule loading assist assembly of claim 16, wherein the loading assist nut comprises a capsule shaft receiver configured to receive a capsule shaft of the delivery device extending between the handle and the delivery capsule, wherein the delivery capsule has a delivery capsule diameter, and wherein the capsule shaft receiver diameter of the capsule shaft receiver is smaller than the delivery capsule diameter.

Images