Delivery handle device for prosthetic valve delivery system

Abstract

A delivery handle device and system that facilitates the delivery of an expandable medical device to a treatment site, and wherein the delivery handle device comprises: a housing having an inner core that extends linearly between a proximal end and a distal end of the housing, and wherein the inner core receives a flexible catheter and a balloon catheter coaxially disposed within the flexible catheter; an adjustment mechanism configured to control a position of the balloon catheter relative to the flexible catheter, and wherein the adjustment mechanism comprises: a control knob having a plurality of threads; and a threaded shaft configured to linearly translate within the housing; and a switch configured to lock or unlock the adjustment mechanism.

Description

[0001] Application for reference

[0002] This patent application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 541,938, filed October 2, 2023, entitled “Delivery Handle Arrangement for Prosthetic Valve Delivery Systems,” the disclosure of which is hereby incorporated herein by reference in its entirety and is for all purposes a part of this U.S. Utility Patent Application.

[0003] This disclosure is a continuation-in-part of U.S. Application Serial No. 29 / 851,277, filed August 26, 2022, entitled “Delivery Handle Device,” the disclosure of which is hereby incorporated herein by reference in its entirety and is a part of this U.S. utility patent application for all purposes. Technical Field

[0004] This disclosure relates to artificial heart valve replacement systems, particularly to devices, systems, and methods for transcatheter delivery of expandable artificial heart valves, and even more particularly to delivery handle devices for expandable artificial heart valves. Background Technology

[0005] Many cardiovascular devices, such as expandable heart valves, are inserted into a patient's vascular system and then expanded at the treatment site. These devices are typically coiled onto a catheter before insertion. Medical devices such as the transcatheter aortic valve (TAV) represent a significant advancement in artificial heart valve technology. TAV ​​brings the benefits of heart valve replacement to patients who would otherwise not have undergone surgery. Transcatheter aortic valve replacement (TAVR) can be used to treat aortic stenosis in patients classified as high-risk for open-heart surgery aortic valve replacement (SAVR). Non-limiting TAV disclosures are made in U.S. Patent Nos. 5,411,522; 6,730,118; 10,729,543; 10,820,993; 10,856,970; 10,869,761; 10,952,852; 10,980,632; 10,980,633; and 2020 / 0405482, all of which are incorporated herein by reference in their entirety.

[0006] Transcatheter aortic valves (TAVs) are designed to be compressed into a small-diameter catheter and remotely placed within a patient's diseased aortic valve to take over the function of the patient's own valve. Some TAVs are balloon-expandable, while others are self-expandable. In both cases, the TAV is deployed within a calcified autologous valve that has been forced open permanently and becomes the surface against which the stent is secured in place by friction. TAVs can also be used to replace failed bioprosthetic or transcatheter valves, often referred to as valve-in-valve procedures. Key advantages of TAVR compared to traditional surgical methods include avoiding cardiopulmonary bypass, aortic clipping, and / or sternotomy, thus significantly reducing patient morbidity.

[0007] However, several complications are associated with current TAV devices, such as leaflet damage due to misalignment or curling, paravalvular leakage, thrombosis, conduction abnormalities, and prosthesis-patient mismatch. These complications are potentially related to the calcification landscape of the autologous valve, the geometry and mechanical properties of the aortic root, patient-related blood biochemistry and coagulation, and comorbidities such as hypertension, coronary artery disease, and heart failure.

[0008] Currently, some limitations hindering the use of TAV in low-risk patients include: a) vascular complications due to large delivery systems, necessitating smaller profiles; b) paravalvular leak; c) device misalignment; and d) device failure. TAVR involves the delivery, deployment, and implantation of a coiled stent valve within a diseased aortic valve or a degenerated bioprosthetic. Damage to the valve leaflet tissue can lead to increased calcification and premature TAV failure.

[0009] Collapsible artificial heart valves can be delivered to patients via tubular delivery devices (such as catheters, cannulas, laparoscopic instruments, etc.), thus avoiding more invasive surgeries such as open-chest surgery.

[0010] When the collapsed artificial valve reaches the treatment site in the patient's body (e.g., the heart valve of a patient to be replaced by an artificial valve), the artificial valve can be expanded at the treatment site.

[0011] In conventional delivery systems for artificial heart valves, after positioning the valve at the treatment site, it may be necessary to adjust its positioning before it expands at the treatment site. Many delivery devices can adjust the linear position of the valve at the treatment site, but cannot simultaneously adjust it linearly and angularly. Such angular adjustment can facilitate the adjustment of the valve leaflet system at the treatment site to improve the effectiveness of the valve after deployment.

[0012] Therefore, there is a need for further improvements in devices, systems, and methods for transcatheter delivery of collapsible artificial heart valves. Summary of the Invention

[0013] This disclosure relates to artificial heart valve replacement, and more particularly to devices, systems, and methods for transcatheter delivery of expandable artificial heart valves, and even more particularly to delivery handle devices for expandable artificial heart valves. Specifically, this non-limiting disclosure relates to a delivery handle device that facilitates the delivery of expandable medical devices to treatment sites (e.g., stents, TAVs, heart valves, etc.).

[0014] In one non-limiting aspect of this disclosure, the delivery handle device includes: a housing having an inner core extending linearly between a proximal and a distal end of the housing, wherein the inner core receives a flexible catheter and a balloon catheter coaxially disposed within the flexible catheter; an adjustment mechanism configured to control the position of the balloon catheter relative to the flexible catheter, wherein the adjustment mechanism includes: a control knob having a plurality of threads; a threaded shaft configured to translate linearly within the housing; and a switch configured to lock and / or unlock the adjustment mechanism.

[0015] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes a bending mechanism configured to bend the flexible conduit at a predetermined angle. In one non-limiting embodiment, the bending mechanism includes a bending knob coupled to a threaded body, wherein the threaded body is received within a housing; and wherein a threaded insert engages with the threaded body; and wherein an actuating insert has a crimping band; and wherein a wire member is coupled to the flexible conduit and the crimping band. In another non-limiting embodiment, rotation of the bending knob in a first direction causes the threaded insert and the actuating insert to translate linearly along the threaded body from a distal end toward a proximal end, and wherein the wire member pulls the flexible conduit to bend the flexible conduit at a predetermined angle.

[0016] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes a bending mechanism comprising a bending indicator with a needle, wherein the needle is configured to translate along the threaded body to indicate to the user the degree of bending present in the flexible catheter. The bending indicator may optionally include numbers, letters, or other markings to provide the user with additional information about the degree or amount of bending in the flexible catheter.

[0017] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes a rotation mechanism configured to rotate the balloon catheter. In one non-limiting embodiment, the rotation mechanism includes an alignment knob coupled to a threaded shaft of an adjustment mechanism; and a gear, wherein rotation of the alignment knob in a first direction causes the balloon catheter to rotate relative to the flexible catheter.

[0018] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes a control knob having a first portion and a second portion, wherein a switch is optionally positioned between the first and second portions. In one non-limiting embodiment, the switch optionally includes a channel having a first stop and a second stop. The first stop optionally has a different width than the second stop (e.g., the first stop has a larger width than the second stop); and a snap-fit ​​element movable within the channel. In another non-limiting embodiment, the switch optionally has a substantially circular cross-sectional shape; however, other shapes may be used.

[0019] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device is optionally configured such that, when the adjustment mechanism is locked, a latch is optionally positioned at a second stop of the channel; a switch is optionally positioned near a second portion of the control knob; and the latch is optionally engaged with a plurality of threads. In one non-limiting embodiment, rotation of the control knob in a first direction causes the plurality of threads to engage a threaded shaft and cause the threaded shaft to translate linearly within the housing from a proximal end toward a distal end, and wherein rotation of the control knob in a second direction causes the threaded shaft to translate linearly from the distal end toward the proximal end.

[0020] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device is optionally configured such that, when the adjustment mechanism is unlocked, a latch is optionally positioned at a first stop of the channel; a switch is optionally positioned near a first portion of the control knob; and the latch disengages from a plurality of threads. In a non-limiting embodiment, the alignment knob of the rotating mechanism is configured to be pushed to advance the threaded shaft toward the distal end, and wherein the alignment knob is configured to be pulled to retract the threaded shaft toward the proximal end.

[0021] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes a Luer tree coupled to the alignment knob. The Luer tree optionally includes a flushing port; a guidewire lumen configured to receive the guidewire; and a balloon inflation port.

[0022] In another and / or alternative, non-limiting aspect of this disclosure, the delivery handle device optionally includes a thiopancreatography (hs) tube housed within an inner core. The thiopancreatography (hs) tube is optionally configured to allow flushing fluid to flow through the balloon catheter and into the flexible catheter. An O-ring is optionally provided to create a sliding hemostatic seal between the inner surface of the inner core and the outer surface of the thiopancreatography (hs) tube.

[0023] In another and / or alternative non-limiting aspect of this disclosure, the expandable medical device used with the delivery handle device is an artificial heart valve.

[0024] In another and / or alternative non-limiting aspect of this disclosure, a system for delivering an expandable medical device to a treatment site is provided. The system includes a flexible catheter; a balloon catheter coaxially disposed within the flexible catheter; and a delivery handle device. In one non-limiting embodiment, the delivery handle device includes a housing having an inner core extending linearly between a proximal and a distal end of the housing, wherein the inner core receives at least a portion of the flexible catheter and the balloon catheter; and wherein an adjustment mechanism is configured to control the position of the balloon catheter relative to the flexible catheter, and wherein the adjustment mechanism includes: a control knob optionally having a plurality of threads; and an axis (e.g., a threaded shaft, etc.) configured to translate linearly within the housing; and wherein a switch is optionally configured to lock and / or unlock the adjustment mechanism, and wherein the switch optionally includes a channel having a first stop and a second stop, and wherein the first stop optionally has a different width than the second stop (e.g., the first stop has a larger width than the second stop, etc.); and wherein a latching member is optionally movable within the channel.

[0025] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes a bending mechanism configured to bend the flexible catheter at a predetermined angle. In one non-limiting embodiment, the bending mechanism includes a bending knob coupled to a body (e.g., a threaded body), wherein the body is optionally at least partially housed within a housing; and wherein an insert (e.g., a threaded insert) optionally engages with the body; and wherein an actuating insert has a crimping band; and wherein a wire member is coupled to the flexible catheter and the crimping band, and wherein rotation of the bending knob in a first direction causes the insert and the actuating insert to translate linearly along the body from a distal end toward a proximal end, and wherein the wire member pulls the flexible catheter to bend it at a predetermined angle.

[0026] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes a rotation mechanism configured to rotate the balloon catheter. In one non-limiting embodiment, the rotation mechanism includes an alignment knob coupled to a threaded shaft of an adjustment mechanism; and a gear, wherein rotation of the alignment knob in a first direction causes the balloon catheter to rotate relative to the flexible catheter.

[0027] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes an adjustment mechanism, and when the adjustment mechanism is locked, a latch is optionally positioned at a second stop of the channel; and wherein the latch optionally engages with an engagement device (e.g., a plurality of threads), wherein rotation of a control knob in a first direction causes the engagement device to engage a shaft (e.g., a threaded shaft, etc.) and cause the shaft to translate linearly within the housing from the proximal end toward the distal end, and wherein rotation of the control knob in a second direction causes the shaft to translate linearly from the distal end toward the proximal end.

[0028] In another and / or alternative non-limiting aspect of this disclosure, the delivery handle device optionally includes an adjustment mechanism, and when the adjustment mechanism is locked, a latch is positioned at a first stop of the channel; and the latch disengages from the engagement device (e.g., multiple threads, etc.), wherein an alignment knob of the rotating mechanism is pushed to advance the shaft (e.g., threaded shaft, etc.) toward the distal end, and wherein the alignment knob is pulled to retract the shaft toward the proximal end.

[0029] A non-limiting object of this disclosure is to provide a delivery handle device that facilitates the delivery of an expandable medical device to a treatment site.

[0030] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device comprising: a) a housing having an inner core extending linearly between a proximal end and a distal end of the housing, wherein the inner core at least partially receives a flexible catheter and a balloon catheter, and wherein the flexible catheter and the balloon catheter are at least partially coaxially disposed within the flexible catheter; b) an adjustment mechanism configured to control the position of the balloon catheter relative to the flexible catheter, wherein the adjustment mechanism includes a control knob having a connecting means (e.g., a plurality of threads, etc.), an axis (e.g., a threaded shaft, etc.) configured to translate linearly within the housing, and a switch configured to lock or unlock the adjustment mechanism.

[0031] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a bending mechanism configured to bend a flexible conduit at a predetermined angle.

[0032] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a bending mechanism configured to bend a flexible conduit at a predetermined angle, wherein the bending mechanism includes a) a bending knob coupled to a body (e.g., a threaded body, etc.), wherein the body is at least partially housed within a housing, b) an insert (e.g., a threaded insert, etc.) engaging the body, c) an actuating insert having a crimping band, and d) a wire member coupled to the flexible conduit and the crimping band.

[0033] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a bending mechanism configured to bend a flexible catheter at a predetermined angle, wherein the bending mechanism includes a bending knob coupled to a body (e.g., a threaded body, etc.), and wherein rotation of the bending knob in a first direction causes an insert (e.g., a threaded insert, etc.) and an actuating insert to translate linearly along the body (e.g., a threaded body, etc.) from a distal end or near a distal end toward a proximal end, and wherein the linear member pulls the flexible catheter to bend the flexible catheter at one or more predetermined angles.

[0034] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a bending indicator for indicating the amount and / or degree of bending present in a flexible catheter.

[0035] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a bending indicator, which optionally includes a needle and / or other visual indicator (e.g., meter, digital reader, etc.) for indicating the amount and / or degree of bending present in a flexible catheter.

[0036] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a bend indicator, which optionally includes a needle, and wherein the needle translates along a body (e.g., a threaded body, etc.) to indicate to a user the degree of bend present in a flexible conduit.

[0037] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a rotation mechanism configured to at least partially rotate a balloon catheter.

[0038] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a rotation mechanism configured to at least partially rotate a balloon catheter, and wherein the rotation mechanism includes a) an alignment knob coupled to an axis (e.g., a threaded shaft, etc.) of an adjustment mechanism, and b) a gear, and wherein rotation of the alignment knob causes the balloon catheter to rotate relative to a flexible catheter.

[0039] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes an adjustment mechanism configured to cause linear adjustment of the shaft.

[0040] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes an adjustment mechanism configured to cause linear adjustment of the shaft, wherein the adjustment mechanism includes a control knob having a first portion and a second portion, and wherein a switch is positioned between the first portion and the second portion.

[0041] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes an adjustment mechanism configured to cause linear adjustment of the shaft, wherein the adjustment mechanism includes a control knob having a first portion and a second portion, wherein a switch is positioned between the first portion and the second portion, and wherein the switch includes a) a channel having a first stop and a second stop, wherein the first stop optionally has a different width than the second stop, and b) a latching member movable within the channel.

[0042] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes an adjustment mechanism configured to cause linear adjustment of the shaft, wherein the adjustment mechanism includes a control knob having a first portion and a second portion, wherein a switch is positioned between the first portion and the second portion, and wherein the switch has a substantially circular cross-sectional shape.

[0043] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes an adjustment mechanism configured to cause linear adjustment of the shaft, and when the adjustment mechanism is locked, a) a latching member is positioned at a second stop of the channel, b) a switch is positioned near a second portion of the control knob, and b) the latching member engages with an engagement device (e.g., multiple threads, etc.).

[0044] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes an adjustment mechanism configured to linearly adjust a shaft, wherein the adjustment mechanism includes a control knob, and wherein rotation of the control knob in a first direction causes an engagement device (e.g., a plurality of threads, etc.) to engage the shaft (e.g., a threaded shaft, etc.) and linearly translate the shaft within a housing from a proximal end or near the proximal end toward a distal end, and wherein rotation of the control knob in a second direction causes the shaft to linearly translate from a distal end or near the distal end toward a proximal end.

[0045] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes an adjustment mechanism configured to cause linear adjustment of the shaft, and when the adjustment mechanism is unlocked, a) a latch is positioned at a first stop of the channel, b) a switch is positioned near a first portion of the control knob; and c) the latch disengages from the engagement device (e.g., multiple threads, etc.).

[0046] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a rotation mechanism configured to at least partially rotate a balloon catheter, wherein an alignment knob of the rotation mechanism is configured to be pushed to advance a shaft (e.g., a threaded shaft, etc.) toward the distal end, and wherein the alignment knob is configured to be pulled to retract the shaft toward the proximal end.

[0047] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes a Luer tree coupled to an alignment knob, wherein the Luer tree includes a flushing port, a guidewire lumen configured to receive a guidewire, and / or a balloon inflation port.

[0048] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device that optionally includes: a) a thiopancreatic tube at least partially housed within an inner core, wherein the thiopancreatic tube is configured to allow flushing fluid to flow through the balloon catheter and into a flexible catheter, and b) a sealing device (e.g., an O-ring, etc.) that creates a sliding hemostatic seal between the inner surface of the inner core and the outer surface of the thiopancreatic tube.

[0049] Another and / or alternative non-limiting object of this disclosure is to provide a delivery handle device for use with an artificial heart valve.

[0050] Another and / or alternative non-limiting object of this disclosure is to provide a system for delivering an expandable medical device to a treatment site, wherein the system comprises: a) a flexible catheter, b) a balloon catheter at least partially coaxially disposed within the flexible catheter, c) a delivery handle device, and wherein the delivery handle device comprises i) a housing having an inner core extending linearly between a proximal and a distal end of the housing, wherein the inner core at least partially receives the flexible catheter and the balloon catheter, ii) an adjustment mechanism configured to control the position of the balloon catheter relative to the flexible catheter, and wherein the adjustment mechanism comprises: A) a control knob having a connection means (e.g., a plurality of threads, etc.), and B) an axis (e.g., a threaded shaft, etc.) configured to translate linearly within the housing, and iii) a switch configured to lock or unlock the adjustment mechanism, and wherein the switch comprises: A) a channel having a first stop and a second stop, wherein the first stop has a different width than the second stop, and B) a latching member movable within the channel.

[0051] Another and / or alternative non-limiting object of this disclosure is to provide a system for delivering an expandable medical device to a treatment site, wherein the system includes a bending mechanism configured to bend a flexible catheter at a predetermined angle, and wherein the bending mechanism includes: i) a bending knob coupled to a body (e.g., a threaded body, etc.), wherein the body is at least partially housed within a housing; ii) an insert (e.g., a threaded insert, etc.) engaging the body; c) an actuating insert having a crimping band; and d) a wire member coupled to the flexible catheter and the crimping band, wherein rotation of the bending knob in a first direction causes the insert and the actuating insert to translate linearly along the body from a distal end or near a distal end toward a proximal end, and wherein the wire member pulls the flexible catheter to bend the flexible catheter at one or more predetermined angles.

[0052] Another and / or alternative non-limiting object of this disclosure is to provide a system for delivering an expandable medical device to a treatment site, wherein the system includes a rotation mechanism configured to rotate a balloon catheter, and wherein the rotation mechanism includes: i) an alignment knob coupled to an axis (e.g., a threaded shaft, etc.) of an adjustment mechanism, and ii) a gear, and wherein rotation of the alignment knob in a first direction causes the balloon catheter to rotate relative to a flexible catheter.

[0053] Another and / or alternative non-limiting object of this disclosure is to provide a system for delivering an expandable medical device to a treatment site, wherein the system includes an adjustment mechanism, and wherein when the adjustment mechanism is locked, a) a latch is positioned at a second stop of the channel, and b) the latch engages with a plurality of threads, and wherein rotation of a control knob in a first direction causes an engagement device (e.g., a plurality of threads, etc.) to engage a shaft (e.g., a threaded shaft, etc.) and cause the shaft to linearly translate within the housing from a proximal end or near the proximal end toward a distal end, and wherein rotation of the control knob in a second direction causes the shaft to linearly translate from a distal end or near the distal end toward a proximal end.

[0054] Another and / or alternative non-limiting object of this disclosure is to provide a system for delivering an expandable medical device to a treatment site, wherein the system includes an adjustment mechanism, and wherein when the adjustment mechanism is unlocked, a) a latch is positioned at a first stop of the channel, and b) the latch disengages from an engagement device (e.g., a plurality of threads, etc.), and wherein an alignment knob of a rotating mechanism is pushed to advance a shaft (e.g., a threaded shaft, etc.) toward a distal end, and wherein the alignment knob is pulled to retract the shaft toward a proximal end.

[0055] These and other objects and advantages will become apparent to those skilled in the art upon reading and following the description taken in conjunction with the accompanying drawings. Attached Figure Description

[0056] The accompanying drawings, which are incorporated in and form a part of this specification, schematically illustrate one or more exemplary embodiments of the disclosed technology and, together with the general description given above and the detailed description given below, serve to explain the principles of the disclosed subject matter, wherein: Figure 1 An exemplary non-restricted delivery system including a non-restricted handle device is described.

[0057] Figure 2 yes Figure 1 A cross-sectional side view of the delivery handle device.

[0058] Figure 3 yes Figure 1 A cross-sectional side view of the delivery handle device, wherein the delivery handle device is configured in the locked position.

[0059] Figure 4 yes Figure 1 A cross-sectional side view of the delivery handle device, wherein the delivery handle device is configured in the unlocked position.

[0060] Figure 5 Another exemplary non-restricted delivery system including a non-restricted handle device is described.

[0061] Figure 6 yes Figure 5 A cross-sectional side view of the delivery handle device.

[0062] Figures 7A to 7D An exemplary non-restrictive embolic capture filter sheath configured for use with non-restrictive curved catheters and non-restrictive balloon catheters is depicted. Detailed Implementation

[0063] A more complete understanding of the articles of manufacture / apparatus, processes, and components disclosed herein can be obtained by referring to the accompanying drawings. These drawings are merely schematic representations for the convenience and ease of illustrating this disclosure and are therefore not intended to indicate the relative size and dimensions of the apparatus or its components and / or to define or limit the scope of exemplary embodiments.

[0064] Although specific terms are used in the following description for clarity, these terms refer only to the specific structures of the selected embodiments used for illustration in the drawings and are not intended to limit or restrict the scope of this disclosure. In the drawings and the following description, it should be understood that the same numerical designations refer to components having the same function.

[0065] Unless the context clearly indicates otherwise, the singular forms “a”, “an”, and “the” contain plural indicators.

[0066] As used in the specification and claims, the term "comprising" may include embodiments of "consisting of" and "substantially consisting of". The terms "comprise(s)", "include(s)", "having", "has", "can", "contain(s)", and variations thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of a specified ingredient / step and permit the presence of other ingredients / steps. However, such descriptions should be interpreted as also describing the composition or process as "consisting of the listed ingredients / steps" and "substantially consisting of the listed ingredients / steps", which allows for the presence of only the specified ingredient / step, and any unavoidable impurities that may result therefrom, and excludes other ingredients / steps.

[0067] The numerical values ​​in the specification and claims of this application should be understood to include the same numerical values ​​as when reduced to the same number of significant figures, and the differences from said values ​​are less than the experimental errors of conventional measurement techniques belonging to the type described in this application for determining values.

[0068] All ranges disclosed herein include the listed endpoints and can be combined independently (e.g., the range “2 g to 10 g” includes the endpoints 2 g and 10 g as well as all intermediate values).

[0069] The terms “about” and “approximately” can be used to encompass any numerical value that can vary without altering its fundamental function. When used with a range, “about” and “approximately” also disclose a range defined by the absolute values ​​of its two endpoints; for example, “about 2 to about 4” also discloses a range of “2 to 4”. Typically, the terms “about” and “approximately” can refer to plus or minus 10% of the number being referred to.

[0070] Unless otherwise expressly stated, the percentage of an element shall be assumed to be the weight percentage of the element.

[0071] While exemplary embodiments of the disclosed methods may be described in a specific order for ease of presentation, it should be understood that the disclosed embodiments may include an order of operations other than the specific order disclosed. For example, in some cases, the operations described in order may be rearranged or performed simultaneously. Furthermore, the descriptions and disclosures provided in association with a particular embodiment are not limited to that embodiment and may be applied to any of the disclosed embodiments.

[0072] For simplicity, the accompanying drawings may not show the various ways in which the systems, methods, and apparatuses disclosed herein can be used in conjunction with other systems, methods, and apparatuses (which can be readily discerned by those skilled in the art based on this disclosure). Additionally, the description sometimes uses terms such as “produce” and “provide” to describe the disclosed methods. These terms are abstract concepts of actual operations that can be performed. The actual operations corresponding to these terms may vary from specific implementation to specific methods and can be readily discerned by those skilled in the art based on this disclosure.

[0073] The exemplary embodiments of the disclosed technology generally provide a medical device that may include valves (e.g., heart valves, TAVR valves, mitral valve replacements, tricuspid valve replacements, pulmonary valve replacements, etc.) and a delivery system for delivering the valves to a treatment site (e.g., in a patient's heart valves, etc.). More specifically, the exemplary embodiments of the disclosed technology provide a delivery handle device configured to more accurately deliver such valves to the treatment site. The delivery handle device includes: (i) a bending mechanism configured to facilitate the passage of a bending catheter around various bends or arches (e.g., aortic arch bends) and to adjust the coaxial alignment of the coiled valve with the aortic rings before unfolding; (ii) an adjustment mechanism configured to advance or retract the balloon catheter relative to the axial position of the bending catheter; and (iii) an engagement alignment mechanism configured to rotate the coiled valve and control the direction of rotation of the implant leaflet attachment point (engagement) relative to the natural anatomy. The adjustment mechanism can be advantageously switched between a locked and unlocked position via a switch, depending on the amount or precision of control required to advance or retract the balloon catheter.

[0074] According to one non-limiting aspect of this disclosure, the artificial heart valve is not limited to TAV, but may be a mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement, or other valve replacement. The artificial heart valve includes a radially collapsible and expandable frame and a leaflet structure comprising multiple leaflets. The artificial heart valve may optionally include an annular skirt or covering member disposed over and covering holes in at least a portion of the frame. The frame may include a plurality of interconnected struts and strut connectors defining multiple openings within the frame. The frame is partially (e.g., from 1 wt% to 99.999 wt% and all values ​​and ranges therebetween) or entirely made of metallic material.

[0075] In some non-limiting aspects of this disclosure, the artificial heart valve includes a frame, a leaflet structure supported by the frame, and optional inner skirts fixed to the surfaces of the frame and / or leaflet structure, as well as optional outer skirts fixed to the frame. The artificial heart valve can be implanted into a natural aortic valve annulus; however, the artificial heart valve can also be configured for implantation into other valves of the heart (e.g., tricuspid valve, pulmonary valve, mitral valve). The artificial heart valve has a “lower” end and an “upper” end, wherein the lower end of the artificial heart valve is an inflow end, and the upper end of the artificial heart valve is an outflow end. The metal alloy used for the frame that partially or completely forms the artificial heart valve is configured to be radially collapsed to a collapsed or coiled state for introduction into the body (e.g., on a delivery catheter, etc.), and radially expanded to an expanded state to implant the artificial heart valve at a desired location in the body (e.g., aortic valve, tricuspid valve, pulmonary valve, mitral valve, etc.). The frame of the artificial heart valve can be formed from a plastic expandable material that allows the frame to be rolled into a smaller profile for delivery and expansion. Expansion of the rolled-up frame of the artificial heart valve can be achieved via an expansion device (such as, but not limited to, a balloon in a balloon catheter); however, the frame can optionally be formed partially (e.g., 1 wt% to 99.999 wt% and all values ​​and ranges therebetween) or entirely from a self-expanding material (e.g., nitinol, etc.). The frame is at least partially (e.g., 1 wt% to 99.999 wt% and all values ​​and ranges therebetween) formed by a plurality of angled, vertically extending posts or struts. The posts or struts can optionally be interconnected via strut connectors through a lower row of circumferentially extending struts and an upper row of circumferentially extending struts. The struts can be arranged in various patterns (e.g., zigzag, sawtooth, triangular, polygonal, elliptical, etc.). One or more of the posts and / or struts can have the same or different thicknesses and / or cross-sectional shapes and / or cross-sectional areas.

[0076] In other non-limiting aspects of this disclosure, the artificial heart valve may include an inner skirt that can be formed from a variety of flexible materials, such as polymers [e.g., polyethylene terephthalate (PET), polyester, nylon, Kevlar®, silicone, etc.], composite materials, metals, fabric materials, etc. In one non-limiting embodiment, the material used to partially (e.g., from 1 wt% to 99.999 wt% and all values ​​and ranges therebetween) or completely form the inner skirt may optionally be substantially inelastic (i.e., substantially non-stretchable and non-compressible). In another non-limiting embodiment, the material used to partially or completely form the inner skirt may optionally be a stretchable and / or compressible material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biomaterials [e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives], etc.). The inner skirt may optionally be formed from a combination of fabric or woven materials coated with a flexible material or a stretchable and / or compressible material to provide additional structural integrity to the inner skirt. The dimensions, construction, and thickness of the inner skirt are not limited (e.g., thicknesses from 0.1 to 20 mils and all values ​​and ranges therebetween). The inner skirt can be secured to the inside and / or outside of the frame in various ways (e.g., stitching, clamping devices, etc.).

[0077] In other non-limiting aspects of this disclosure, the artificial heart valve may optionally include an inner skirt that can be used to 1) at least partially seal and / or prevent paravalvular leakage, 2) at least partially secure the leaflet structure to the frame, 3) at least partially protect the leaflets from damage during the curling and / or expansion process, and / or 4) at least partially protect the leaflets from damage during operation of the artificial heart valve in the heart.

[0078] In other non-limiting aspects of this disclosure, the artificial heart valve may optionally include an outer skirt or sleeve positioned at least partially (e.g., from 1% to 99.999% by weight and all values ​​and ranges therebetween) around an outer region of a frame. The outer skirt or sleeve is typically positioned completely around a portion of the exterior of the frame. Typically, the outer skirt is positioned around the lower portion of the frame but does not completely cover the upper portion of the frame; however, this is not required. The outer skirt can be attached to the frame by various methods (e.g., sutures, adhesives, fusion bonding, clamping devices, etc.). At least a portion of the outer skirt may optionally be located on an inner surface of the frame. Typically, the outer skirt is formed of a more flexible and / or compressible material than the inner skirt; however, this is not required. The outer skirt may be formed of a variety of stretchable and / or compressible materials (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefins, hydrogels, biomaterials [e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives], etc.). The outer skirt may optionally be formed from a combination of fabric or woven materials coated with a stretchable and / or compressible material to provide additional structural integrity. The dimensions, construction, and thickness of the outer skirt are not limiting. The thickness of the outer skirt is typically from 0.1 to 20 mils (and all values ​​and ranges therebetween).

[0079] In other non-limiting aspects of this disclosure, the artificial heart valve may include a leaflet structure that can be attached to a frame and / or skirt. Connection methods for securing the leaflet structure to the frame and / or skirt are non-limiting (e.g., sutures, U-shaped staples, fusion bonding, adhesives, clamping devices, etc.). Materials used to form the leaflet structure include bovine pericardial tissue, biocompatible synthetic materials, or various other suitable natural or synthetic materials.

[0080] In other non-limiting aspects of this disclosure, the artificial heart valve may comprise a leaflet structure consisting of two or more leaflets (e.g., 2, 3, 4, 5, 6, etc.). In one non-limiting arrangement, the leaflet structure comprises three leaflets arranged to collapse in a tricuspid valve configuration. The construction of the leaflet structure is non-limiting.

[0081] In other non-limiting aspects of this disclosure, the artificial heart valve may include a leaflet structure, wherein the leaflets of the leaflet structure may optionally be fixed to each other on adjacent sides to form a junction (edge ​​of leaflet confluence) of the leaflet structure. The leaflet structures may be fixed together by a variety of connection methods (e.g., sutures, adhesives, fusion bonding, clamping devices, etc.).

[0082] In other non-limiting aspects of this disclosure, an artificial heart valve may include a leaflet structure, wherein one or more leaflets may optionally include reinforcing structures or strips to 1) facilitate securing the leaflets together, 2) facilitate securing the leaflets to a skirt and / or frame, and / or 3) inhibit or prevent tearing or other types of damage to the leaflets.

[0083] In other non-limiting aspects of this disclosure, the framework of the artificial heart valve is partially (e.g., from 1 wt% to 99.999 wt% and all values ​​and ranges therein) or entirely formed of a metallic material, including a) standard stainless steel, b) standard CoCr alloy or standard MP35N alloy or standard Phynox alloy or standard Elgiloy alloy or standard L605 alloy, c) standard TiAlV alloy, d) standard aluminum alloy, e) standard nickel alloy, f) standard titanium alloy, g) standard tungsten alloy, h) standard molybdenum alloy, i) standard copper alloy, j) standard beryllium-copper alloy, k) standard nickel-titanium alloy, l) refractory metal alloy or m) a metal alloy containing at least 15 atomic weight percent (atomic weight%) rhenium. As defined herein, standard stainless steel alloys contain 10 wt% to 28 wt% chromium, 0 wt% to 35 wt% nickel, 0 wt% to 4 wt% molybdenum, 0 wt% to 2 wt% manganese, 0 wt% to 0.75 wt% silicon, 0 wt% to 0.3 wt% carbon, 0 wt% to 5 wt% titanium, 0 wt% to 10 wt% niobium, 0 wt% to 5 wt% copper, 0 wt% to 4 wt% aluminum, 0 wt% to 10 wt% tantalum, 0 wt% to 1 wt% selenium, 0 wt% to 2 wt% vanadium, 0 wt% to 2 wt% tungsten, and at least 50 wt% iron. Standard 316L alloys contain 17 wt% to 19 wt% chromium, 13 wt% to 15 wt% nickel, 2 wt% to 4 wt% molybdenum, up to 2 wt% manganese, up to 0.75 wt% silicon, up to 0.03 wt% carbon, and the remainder iron. As defined herein, a standard CoCr alloy contains 15 wt% to 32 wt% chromium, 1 wt% to 36 wt% nickel, 2 wt% to 18 wt% molybdenum, 0 wt% to 18 wt% iron, 0 wt% to 1 wt% titanium, 0 wt% to 0.15 wt% manganese, 0 wt% to 0.15 wt% silver, 0 wt% to 0.025 wt% carbon, 0 wt% to 16 wt% tungsten, 0 wt% to 2 wt% Si, 0 wt% to 2 wt% aluminum, 0 wt% to 1 wt% iron, and 30 wt% to 68 wt% cobalt. As defined herein, the standard MP35N alloy contains 18 to 22 wt% chromium, 32 to 38 wt% nickel, 8 to 12 wt% molybdenum, 0 to 2 wt% iron, 0 to 0.5 wt% silicon, 0 to 0.5 wt% manganese, 0 to 0.2 wt% carbon, 0 to 2 wt% titanium, 0 to 0.1 wt% phosphorus, 0 to 0.1 wt% boron, 0 to 0.1 wt% sulfur, 0 to 0.15 wt% silver, and the remainder cobalt. As defined herein, the standard Phynox and standard Elgiloy alloys contain 38 to 42 wt% cobalt, 18 to 22 wt% chromium, 14 to 18 wt% iron, 13 to 17 wt% nickel, and 6 to 8 wt% molybdenum.As defined herein, the standard L605 alloy comprises 18 wt% to 22 wt% chromium, 14 wt% to 16 wt% tungsten, 9 wt% to 11 wt% nickel, and the remainder cobalt. As defined herein, the standard TiAlV alloy comprises 5.5 wt% to 6.75 wt% aluminum, 3.5 wt% to 4.5 wt% vanadium, 85 wt% to 93 wt% titanium, 0 wt% to 0.4 wt% iron, and 0 wt% to 0.2 wt% carbon. The standard Ti-6Al-4V alloy comprises 3.5 wt% to 4.5 wt% vanadium, 5.5 wt% to 6.75 wt% aluminum, up to 0.3 wt% iron, up to 0.2 wt% oxygen, up to 0.08 wt% carbon, up to 0.05 wt% nitrogen, up to 0.015 wt% hydrogen (H), up to 0.05 wt% yttrium, and the remainder titanium. As defined herein, a standard aluminum alloy comprises 80 wt% to 99 wt% aluminum, 0 wt% to 12 wt% silicon, 0 wt% to 5 wt% magnesium, 0 wt% to 1 wt% manganese, 0 wt% to 0.5 wt% scandium, 0 wt% to 0.5 wt% beryllium, 0 wt% to 0.5 wt% yttrium, 0 wt% to 0.5 wt% cerium, 0 wt% to 0.5 wt% chromium, 0 wt% to 3 wt% iron, and 0 to 0.5 wt% to 9 wt% chromium. Zinc, 0 wt% to 0.5 wt% titanium, 0 wt% to 3 wt% lithium, 0 wt% to 0.5 wt% silver, 0 wt% to 0.5 wt% calcium, 0 wt% to 0.5 wt% zirconium, 0 wt% to 1 wt% lead, 0 wt% to 0.5 wt% cadmium, 0 wt% to 0.05 wt% bismuth, 0 wt% to 1 wt% nickel, 0 wt% to 0.2 wt% vanadium, 0 wt% to 0.1 wt% gallium, and 0 wt% to 7 wt% copper. As defined herein, a standard nickel alloy comprises 30 wt% to 98 wt% nickel, 5 wt% to 25 wt% chromium, 0 wt% to 65 wt% iron, 0 wt% to 30 wt% molybdenum, 0 wt% to 32 wt% copper, 0 wt% to 32 wt% cobalt, 2 wt% to 2 wt% aluminum, 0 wt% to 6 wt% tantalum, 0 wt% to 15 wt% tungsten, 0 wt% to 5 wt% titanium, 0 wt% to 6 wt% niobium, and 0 wt% to 3 wt% silicon. As defined herein, a standard titanium alloy comprises 80 wt% to 99 wt% titanium, 0 wt% to 6 wt% aluminum, 0 wt% to 3 wt% tin, 0 wt% to 1 wt% palladium, 0 wt% to 8 wt% vanadium, 0 wt% to 15 wt% molybdenum, 0 wt% to 1 wt% nickel, 0 wt% to 0.3 wt% ruthenium, 0 wt% to 6 wt% chromium, 0 wt% to 4 wt% zirconium, 0 wt% to 4 wt% niobium, 0 wt% to 1 wt% silicon, 0.05 wt% cobalt, and 0 wt% to 2 wt% iron. As defined herein, a standard tungsten alloy comprises 85 wt% to 98 wt% tungsten, 0 wt% to 8 wt% nickel, 0 wt% to 5 wt% copper, 0 wt% to 5 wt% molybdenum, and 0 wt% to 4 wt% iron.As defined herein, a standard molybdenum alloy comprises 90 wt% to 99.5 wt% molybdenum, 0 wt% to 1 wt% nickel, 0 wt% to 1 wt% titanium, 0 wt% to 1 wt% zirconium, 0 wt% to 30 wt% tungsten, 0 wt% to 2 wt% hafnium, and 0 wt% to 2 wt% lanthanum. As defined herein, a standard copper alloy comprises 55 wt% to 95 wt% copper, 0 wt% to 40 wt% zinc, 0 wt% to 10 wt% tin, 0 wt% to 10 wt% lead, 0 wt% to 1 wt% iron, 0 wt% to 5 wt% silicon, 0 wt% to 12 wt% manganese, 0 wt% to 12 wt% aluminum, 0 wt% to 3 wt% beryllium, 0 wt% to 1 wt% cobalt, and 0 wt% to 20 wt% nickel. As defined herein, a standard beryllium-copper alloy comprises 95 wt% to 98.5 wt% copper, 1 wt% to 4 wt% beryllium, 0 wt% to 1 wt% cobalt, and 0 wt% to 0.5 wt% silicon. As defined herein, a standard nickel-titanium alloy comprises 42 wt% to 58 wt% nickel and 42 wt% to 58 wt% titanium. As defined herein, a refractory metal alloy is a metal alloy comprising at least 20 wt% of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten. Non-limiting refractory metal alloys include MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr, molybdenum alloys, rhenium alloys, tungsten alloys, tantalum alloys, niobium alloys, etc.

[0084] In other non-limiting aspects of this disclosure, the framework of the artificial heart valve is formed of a metallic material comprising a metal alloy containing at least 15 atomic weight percent rhenium. It has been found that, for several metal alloys, the inclusion of at least 15 atomic weight percent rhenium improves both the ductility and / or tensile strength of these alloys compared to rhenium-free alloys. The improvement in ductility and / or tensile strength resulting from the inclusion of at least 15 atomic weight percent rhenium in a metal alloy is referred to as the "rhenium effect." As defined herein, the "rhenium effect" is a) an increase of at least 10% in the ductility of a metal alloy due to the addition of rhenium and / or b) an increase of at least 10% in the tensile strength of a metal alloy due to the addition of rhenium. It has been found that for some metal alloys (e.g., standard stainless steel, standard CoCr alloys, standard TiAlV alloys, standard aluminum alloys, standard nickel alloys, standard titanium alloys, standard tungsten alloys, standard molybdenum alloys, standard copper alloys, standard MP35N alloys, standard beryllium-copper alloys, etc.), the presence of at least 15 atomic weight percent rhenium results in increased ductility and / or tensile strength. It has been found that adding rhenium to metal alloys can lead to the formation of twinned alloys, which cause an increase in the overall ductility of the metal alloy with increasing yield strength and tensile strength, due to reduction and / or work hardening of the metal alloy containing rhenium. The rhenium effect has been observed when the atomic weight of rhenium in the metal alloy is at least 15% (e.g., 15 atomic weight percent to 99 atomic weight percent rhenium in the metal alloy and all values ​​and ranges therebetween). For example, for standard stainless steel alloys, the rhenium effect can begin to appear when the stainless steel alloy is modified to include at least 5% to 10% (and all values ​​and ranges therebetween) rhenium of the stainless steel alloy. For standard CoCr alloys, the rhenium effect can begin to appear when the CoCr alloy is modified to include at least 4.8% to 9.5% (and all values ​​and ranges therebetween) rhenium of the CoCr alloy. For standard TiAlV alloys, the rhenium effect can begin to appear when the TiAlV alloy is modified to include at least 4.5% to 9% (and all values ​​and ranges therebetween) rhenium of the TiAlV alloy. It is understood that the rhenium content in the above non-limiting examples can be greater than the minimum amount required to produce the rhenium effect in the metal alloy.

[0085] In other non-limiting aspects of this disclosure, the metal alloy comprises at least 15 atomic weight percent rhenium and at least 0.1 wt percent (e.g., from 0.1 wt percent to 96 wt percent and all values ​​and ranges therebetween) one or more of the following: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, cerium oxide, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium and / or zirconium oxide, and optionally comprises 0 wt percent to 2 wt percent (and all values ​​and ranges therebetween) of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen, and the metal alloy exhibits the rhenium effect. In another non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a refractory metal alloy. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard stainless steel alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard cobalt-chromium alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard TiAlV alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard aluminum alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard nickel alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard titanium alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard tungsten alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard molybdenum alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard copper alloy modified to contain at least 15 atomic weight percent rhenium. In one non-limiting embodiment, the metal alloy used to partially or completely form the framework of the artificial heart valve is a standard beryllium-copper alloy modified to contain at least 15 atomic weight percent rhenium.

[0086] In other non-limiting aspects of this disclosure, the metal alloy used to partially or completely form the framework of the artificial heart valve comprises rhenium and molybdenum, and the weight percentage of rhenium in the metal alloy is greater than the weight percentage of molybdenum in the metal alloy. In one non-limiting embodiment, the metal alloy comprises rhenium and molybdenum, and the weight percentage of rhenium in the metal alloy is greater than the weight percentage of molybdenum in the metal alloy, and the weight percentage of one or more of bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium in the metal alloy is greater than the weight percentage of molybdenum in the metal alloy, and the metal alloy may optionally contain 0% to 2% by weight of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen, and / or nitrogen combinations.

[0087] In other non-limiting aspects of this disclosure, the metal alloy used to partially or completely form the framework of the artificial heart valve comprises rhenium and molybdenum, and the atomic weight percentage of rhenium is in the ratio of the atomic weight percentage of one or more of bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper and iridium to 0.4:1 to 2.5:1 (and all values ​​and ranges therebetween).

[0088] In other non-limiting aspects of this disclosure, the metal alloy used to partially or completely form the framework of an artificial heart valve comprises at least 15 atomic weight percent rhenium plus at least two metals selected from the group consisting of molybdenum, bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium, and the metal alloy comprises other elements and compounds in an amount of 0 to 0.1 wt%. In another non-limiting embodiment, the metal alloy comprises rhenium, molybdenum, and chromium. In yet another non-limiting embodiment, the metal alloy comprises at least 35 wt percent (e.g., 35 wt percent to 75 wt percent and all values ​​and ranges therebetween) rhenium, and the metal alloy also comprises chromium. In a non-limiting embodiment, the metal alloy comprises at least 35% by weight rhenium, and at least 25% by weight (e.g., 25% to 49.9% by weight and all values ​​and ranges therebetween) of the metal alloy comprises chromium, and optionally 0.1% to 40% by weight (and all values ​​and ranges therebetween) of the metal alloy comprises one or more of the following: aluminum, bismuth, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, lanthanum oxide, lead, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium and / or zirconium oxide, and optionally 0% to 2% by weight of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen combinations. In another non-limiting embodiment, the metal alloy comprises 15 atomic weight percent to 50 atomic weight percent rhenium (and all values ​​and ranges therebetween) and 0.5 atomic weight percent to 70 atomic weight percent chromium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 atomic weight percent to 50 atomic weight percent rhenium (and all values ​​and ranges therebetween) and 0.5 atomic weight percent to 70 atomic weight percent tantalum (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 atomic weight percent to 50 atomic weight percent rhenium (and all values ​​and ranges therebetween) and 0.5 atomic weight percent to 70 atomic weight percent niobium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 atomic weight percent to 50 atomic weight percent rhenium (and all values ​​and ranges therebetween) and 0.5 atomic weight percent to 70 atomic weight percent titanium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 atomic weight percent to 50 atomic weight percent rhenium (and all values ​​and ranges therebetween) and 0.5 atomic weight percent to 70 atomic weight percent zirconium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 atomic weight percent to 50 atomic weight percent rhenium (and all values ​​and ranges therebetween) and 0.5 atomic weight percent to 70 atomic weight percent molybdenum (and all values ​​and ranges therebetween).In another non-limiting embodiment, the metal alloy comprises at least 15 atomic weight percent rhenium, greater than 50 wt percent titanium (e.g., 51 wt percent to 80 wt percent and all values ​​and ranges therebetween), 15 wt percent to 45 wt percent niobium (and all values ​​and ranges therebetween), 0 wt percent to 10 wt percent zirconium (and all values ​​and ranges therebetween), 0 wt percent to 15 wt percent tantalum (and all values ​​and ranges therebetween), and 0 wt percent to 8 wt percent molybdenum (and all values ​​and ranges therebetween).

[0089] In other non-limiting aspects of this disclosure, the artificial heart valve may comprise, contain, and / or coat with one or more formulations that are beneficial to the success of the artificial heart valve and / or the treatment area. The term "formulation" includes, but is not limited to, substances, pharmaceuticals, biological products, veterinary products, medicines, and analogues or derivatives otherwise formulated and / or designed to prevent, inhibit, and / or treat one or more clinical and / or biological events and / or to promote healing. When a formulation is used, the amount of the formulation contained on, in, and / or in combination with the artificial heart valve is about 0.01 μg / mm. 2 -100ug / mm 2 (and all values ​​and ranges therein) and / or at least about 0.00001% by weight of the device; however, other amounts may be used. The amounts of two or more formulations used on, in, and / or in combination with an artificial heart valve may be the same or different. One or more formulations may be coated on and / or impregnated in an artificial heart valve by a variety of mechanisms, such as, but not limited to, spraying (e.g., atomized spraying techniques, etc.), flame spraying, powder deposition, dip coating, flow coating, dip spin coating, roll coating (direct and reverse), ultrasonic treatment, brush coating, plasma deposition, deposition by vapor deposition, MEMS technology, and rotary die deposition. When two or more formulations are used, the amounts of the two or more formulations used on, in, and / or in combination with an artificial heart valve may be the same or different.

[0090] In other non-limiting aspects of this disclosure, one or more formulations on and / or in the artificial heart valve (when used on the artificial heart valve) may optionally be released in a controlled manner to deliver a desired dose of the formulation to the area to be treated over a sustained period of time. It should be understood that controlled release of one or more formulations on the artificial heart valve is not always necessary and / or desirable.

[0091] In other non-limiting aspects of this disclosure, one or more polymers used to at least partially control the release of one or more agents from an artificial heart valve may be porous or non-porous.

[0092] In other non-limiting aspects of this disclosure, different formulations may optionally be located within and / or between and / or on the structure of the artificial heart valve in different polymer coatings. It should also be understood that many other and / or additional coating combinations and / or configurations may be used. The concentration of one or more formulations, the type of polymer, the type and / or shape of the internal structure in the artificial heart valve, and / or the coating thickness of one or more formulations may be used to control the release time, release rate, and / or dosage of one or more formulations; however, other or additional combinations may be used. One or more formulations and / or polymers may be coated onto the artificial heart valve by a variety of mechanisms, such as, but not limited to, spraying (e.g., atomized spraying technology), dip coating, roll coating, ultrasonic treatment, brush coating, plasma deposition, and / or deposition via vapor deposition.

[0093] In other non-limiting aspects of this disclosure, the thickness of each polymer layer and / or formulation layer is typically at least about 0.01 µm and typically less than about 150 µm (e.g., 0.01 µm to 149.9999 µm and all values ​​and ranges therebetween). In one non-limiting embodiment, the thickness of the polymer layer and / or formulation layer is about 0.02 µm to 75 µm, more particularly about 0.05 µm to 50 µm, and even more particularly about 1 µm to 30 µm. As should be understood, other thicknesses may be used.

[0094] In other non-limiting aspects of this disclosure, various polymers can be coated onto and / or used to form at least a portion of an artificial heart valve. When one or more polymer layers are coated onto at least a portion of an artificial heart valve, one or more coatings can be applied by a variety of techniques, such as, but not limited to, vapor deposition and / or plasma deposition, spraying, dip coating, roll coating, ultrasonic treatment, atomization, brushing, etc.; however, other or additional coating techniques may be used.

[0095] In other non-limiting aspects of this disclosure, one or more portions of the artificial heart valve may optionally 1) comprise the same or different formulations, 2) comprise one or more formulations in the same or different amounts, 3) comprise the same or different polymer coatings, 4) comprise one or more polymer coatings with the same or different coating thicknesses, 5) allow one or more portions of the artificial heart valve to controllably release and / or uncontrollably release one or more formulations, and / or 6) allow one or more portions of the artificial heart valve to controllably release one or more formulations and uncontrollably release one or more formulations.

[0096] In other non-limiting aspects of this disclosure, the artificial heart valve may optionally include a marking material that facilitates proper positioning of the artificial heart valve at the treatment site. The marking material is generally designed to be visible to: electromagnetic waves (e.g., X-rays, microwaves, visible light, infrared waves, ultraviolet waves, etc.); acoustic waves (e.g., ultrasound waves, etc.); magnetic waves (e.g., MRI waves, etc.); and / or other types of electromagnetic waves (e.g., microwaves, visible light, infrared waves, ultraviolet waves, etc.). In one non-limiting embodiment, the marking material is visible to X-rays (i.e., radiopaque). The marking material may form all or part of the artificial heart valve and / or be coated on one or more portions of the artificial heart valve (on the flared portion and / or body portion, at the end of the artificial heart valve, at or near the transition between the body portion and the flared portion, etc.). The marking material may be located at one or more locations on the artificial heart valve. The size of the one or more areas including the marking material may be the same or different. The marker materials can be spaced apart at defined intervals to form ruler-like marks on the artificial heart valve to facilitate its positioning within the body's channels. The marker materials can be rigid or flexible.

[0097] In other non-limiting aspects of this disclosure, the artificial heart valve may optionally include one or more microstructures (e.g., microneedles, micropores, microcolumns, microcones, micropyramids, microtubes, microparallelograms, microprisms, microhemispheres, teeth, ribs, spines, ratchet wheels, hinges, zippers, zipper-like structures, etc.) located on the surface of the artificial heart valve. As defined herein, a “microstructure” is a structure having at least one dimension (e.g., average width, average diameter, average height, average length, average depth, etc.) not exceeding about 2 mm and generally not exceeding about 1 mm.

[0098] In other non-limiting aspects of this disclosure, the medical device, handle, and / or artificial heart valve can be formed by one or more manufacturing processes. These manufacturing processes may include, but are not limited to, laser cutting, etching, annealing, drawing, Pilger rolling, electroplating, electropolishing, machining, plasma coating, 3D printing of coatings, 3D printing, chemical vapor deposition, chemical polishing, cleaning, pickling, ion beam deposition or implantation, sputtering coating, vacuum deposition, etc. In one non-limiting embodiment, at least part or all of the medical device, handle, and / or artificial heart valve is formed by a 3D printing process.

[0099] In other non-limiting aspects of this disclosure, one or more components of the artificial heart valve (e.g., frame, inner skirt, outer skirt, leaflet, material for securing the leaflet to the frame, etc.) may be partially (e.g., from 1% to 99.99% and all values ​​and ranges therein) or completely coated with a reinforcing coating to improve one or more properties of the artificial heart valve (e.g., changing the external color of the material having the coated surface, increasing surface hardness by using the coated surface, increasing the surface toughness of the material having the coated surface, reducing friction by using the coated surface, improving the surface properties of the material having the coated surface). The coating enhances the material's scratch resistance, improves impact abrasion resistance of the coated surface, improves the corrosion and oxidation resistance of the coated material, forms a non-stick coated surface, improves the biocompatibility of the material with the coated surface, reduces the toxicity of the material with the coated surface, reduces ion release from the material with the coated surface, reinforces the coating to form a surface that causes less irritation to cells around the coated surface after implantation of the artificial heart valve, reduces the rate of cell growth on the coated surface after implantation of the artificial heart valve, reduces the rate at which the leaflets fail to function properly after implantation of the artificial heart valve, and promotes the production and / or release of NO, etc. In one non-limiting embodiment, only the frame of the artificial heart valve includes the reinforcing coating, and the frame is partially (e.g., 1% to 99.99% and all values ​​and ranges therebetween) or completely coated with the reinforcing coating. In another non-limiting embodiment, only one or more leaflets of all leaflets of the artificial heart valve include the reinforcing coating, and one or more or all leaflets are partially (e.g., 1% to 99.99% and all values ​​and ranges therebetween) or completely coated with the reinforcing coating. In another non-limiting embodiment, only the inner skirt of the artificial heart valve includes a reinforcing coating, and wherein the inner skirt is partially (e.g., 1% to 99.99% and all values ​​and ranges therebetween) or completely coated with the reinforcing coating. In another non-limiting embodiment, only the outer skirt of the artificial heart valve includes a reinforcing coating, and wherein the outer skirt is partially (e.g., 1% to 99.99% and all values ​​and ranges therebetween) or completely coated with the reinforcing coating. In another non-limiting embodiment, two or more of the following of the artificial heart valve: a) the frame, b) one or more or all of the leaflets, c) the inner skirt, and d) the outer skirt, or all of them, are partially (e.g., 1% to 99.99% and all values ​​and ranges therebetween) or completely coated with the reinforcing coating.Non-limiting reinforcing coatings that can be applied to a portion or all of the outer surface of one or more components of an artificial heart valve include chromium nitride (CrN), diamond-like carbon (DLC), titanium nitride (TiN), titanium oxynitride or titanium oxynitride (TiNOx), zirconium nitride (ZrN), zirconium oxide (ZrO2), zirconium oxynitride (ZnNxOy) [e.g., cubic ZrN:O, cubic ZrO2:N, tetragonal ZrO2:N, and monoclinic ZrO2:N phase coatings], zirconium oxynitride-nitrogen-carbon (ZrNC), zirconium oxycarbide (ZrOC), and combinations of such coatings. In one non-limiting embodiment, one or more reinforcing coatings are optionally applied to a portion or all of the outer surface of one or more components of the artificial heart valve via a vacuum process that uses energy to evaporate the material and deposit a thin layer of reinforcing coating material. When used, such vacuum coating processes may include physical vapor deposition (PVD) processes (e.g., sputtering deposition, cathodic arc deposition, or electron beam heating), chemical vapor deposition (CVD) processes, atomic layer deposition (ALD) processes, or plasma-enhanced chemical vapor deposition (PE-CVD) processes. In another non-limiting embodiment, the thickness of the enhanced coating is greater than 1 nanometer (e.g., 2 nanometers to 100 micrometers and all values ​​and ranges therein), and is typically 0.1-25 micrometers, more typically 0.2-10 micrometers.

[0100] Now refer to the attached document. Figures 1 to 4 One or more embodiments of this application are described, wherein the same reference numerals are used to refer to the same elements throughout.

[0101] Figure 1 An exemplary non-restricted delivery system 50a including a non-restricted handle device 100 is depicted. Figure 2 yes Figure 1 A cross-sectional side view of the delivery handle device 100. Figure 3 yes Figure 1 A cross-sectional side view of the delivery handle device 100, wherein the delivery handle device 100 is configured in the locked position. Figure 4 yes Figure 1 A cross-sectional side view of the delivery handle device 100, wherein the delivery handle device 100 is configured in the unlocked position.

[0102] refer to Figures 1 to 4A delivery system 50a configured for use with an artificial heart valve is provided. The delivery system 50a includes a delivery handle device 100, a curved catheter or similar flexible guiding catheter 200 having a shaft 210, and a balloon catheter 300 coaxially disposed within the curved catheter 200. The balloon catheter 300 includes a shaft 310 and an inflatable balloon 320. The delivery handle device 100 includes an elongated housing 110 having a proximal end 120a and a distal end 120b. The housing 110 has a generally circular cross-sectional shape along its longitudinal axis; however, other shapes may be used. The cross-sectional area of ​​the housing 110 may optionally vary along its longitudinal length. For example, in this non-limiting embodiment, the housing 110 includes a smaller cross-sectional area in the central region of the housing 110 compared to the regions located at and / or near the proximal end 120a and the distal end 120b. In this non-limiting embodiment, the housing 110 has a length sufficient to allow a user to easily grip the housing 110 with their hands (e.g., 4 inches to 12 inches and all values ​​and ranges therein). The housing 110 further includes an outer handle 135 having an outer surface 130, wherein the outer surface 130 includes one or more ribs 140 formed thereon, the one or more ribs being configured to facilitate gripping the outer handle 135.

[0103] For details, please refer to the following: Figures 2 to 4 The delivery handle device 100 includes a hollow inner body core 150, which forms the center of the delivery handle device 100 and is located between a proximal end 120a and a distal end 120b along the central longitudinal axis of the delivery handle device 100. The outer surface of a curved catheter shaft 210 is fixed to the inner surface of the body core 150. In a non-limiting aspect of this disclosure, the curved catheter shaft 210 is fixed to the body core 150 by an adhesive; however, other connection arrangements (e.g., fusion connection, mechanical connection, etc.) may be used. A balloon catheter 300 and a shaft 310 extend coaxially through the curved catheter shaft 210. The curved catheter 200 and the balloon catheter 300 exit the distal end 120b of the housing 110.

[0104] Return to reference Figures 1 to 4The delivery handle device 100 further includes a bending mechanism 400, an adjusting mechanism 500, and / or an engagement alignment (CA) mechanism or a similar rotating mechanism 600. The bending mechanism 400 is located near the distal end 120b of the housing 110, and the adjusting mechanism 500 and the CA mechanism 600 are located near the proximal end 120a of the housing 110. The bending mechanism 400 includes a rotatable knob 410 connected to a knob body 420 housed within the housing 110. The knob body 420 includes a plurality of internal threads 422 that receive and engage a threaded insert 430. The bending mechanism 400 further includes a bending actuation insert 440, a pull wire 450 passing through an opening or lumen on one side of the bending conduit shaft 210, and a crimping band 460 fixed within the bending actuation insert 440. The pull wire 450 is coupled to the crimping band 460. When the knob 410 is rotated in the first direction (clockwise or counterclockwise), the threaded insert 430 and the bending actuation insert 440 translate axially along the knob body 420, thereby pulling the line 450 and causing the bending guide shaft 210 to bend or shift by one or more predetermined angles.

[0105] In a non-limiting example of this disclosure, rotating the knob 410 in a first direction (clockwise or counterclockwise) causes the threaded insert 430 and the bending actuation insert 440 to translate along the knob body 420 from the distal end 120b toward the proximal end 120a, thereby pulling the line 450 and causing the bending conduit shaft 210 to bend or shift by a predetermined angle.

[0106] Still referencing Figures 1 to 4 The adjustment mechanism 500 includes a control knob 510 having a first portion 512, a second portion 514, and a plurality of locking threads 540. The adjustment mechanism 500 further includes an axially locating threaded shaft 520 housed within the housing 110. The adjustment mechanism 500 is configured to advance or retract the balloon catheter shaft 310 relative to the curved catheter 200. The adjustment mechanism 500 can be locked in a position via a switch 550. Figure 3 ) and unlock location ( Figure 4 Switch 550 is positioned between a first portion 512 and a second portion 514 of a control knob 510. Switch 550 includes a channel 560 formed therein and a latching member 570, wherein the latching member 570 is movable within the channel 560. Channel 560 includes a first stop 562 and a second stop 564, wherein the width of the first stop 562 is greater than the width of the second stop 564. In this non-limiting embodiment, switch 550 and latching member 570 have a substantially circular cross-sectional shape.

[0107] Still referencing Figures 1 to 4When the adjusting mechanism 500 is in the locked position: (i) the latch 570 is positioned at the second stop 564 of the channel 560; (ii) the switch 550 is positioned closer to the second portion 514 of the control knob 510; and (iii) the latch 570 engages with the locking thread 540. In this locked position, the relative axial position between the balloon catheter shaft 310 and the curved catheter 200 is fixed, and the axial position of the balloon catheter shaft 310 can be adjusted in a controlled manner by rotating (clockwise or counterclockwise) the control knob 510. Rotating the control knob 510 causes the locking thread 540 to engage the axial positioning thread shaft 520, thereby causing the axial positioning thread shaft 520 to translate linearly along the longitudinal axis of the delivery handle device 100.

[0108] In one non-limiting example of this disclosure, when in the locked position, rotating the control knob 510 in a first direction (clockwise or counterclockwise) causes the axially locating threaded shaft 520 to translate linearly from the proximal end 120a toward the distal end 120b, thereby advancing the balloon catheter shaft 310 relative to the curved catheter 200. In another non-limiting example of this disclosure, when in the locked position, rotating the control knob in a second direction (clockwise or counterclockwise) causes the axially locating threaded shaft 520 to translate linearly from the distal end 120b toward the proximal end 120a, thereby retracting the balloon catheter shaft 310 relative to the curved catheter 200.

[0109] Still referencing Figures 1 to 4 When the adjustment mechanism 500 is in the unlocked position: (i) the latch 570 is positioned at the first stop 562 of the channel 560; (ii) the switch 550 is positioned closer to the first portion 512 of the control knob 510; and (iii) the latch 570 disengages from the locking thread 540. In this unlocked position, the user can freely advance and retract the balloon catheter shaft 310 within the curved catheter 200 by manually pushing (e.g., forward) or pulling (e.g., retracting) the knob 610 and / or the Luer tree 190 (discussed in more detail below).

[0110] In one non-limiting example of this disclosure, when in the unlocked position, pushing the alignment knob 610 and / or the Luer tree 190 causes the axially oriented threaded shaft 520 to translate linearly from the proximal end 120a toward the distal end 120b, thereby advancing the balloon catheter shaft 310 relative to the curved catheter 200. In another non-limiting example of this disclosure, when in the unlocked position, pulling the alignment knob 610 and / or the Luer tree 190 causes the axially oriented threaded shaft 520 to translate linearly from the distal end 120b toward the proximal end 120a, thereby retracting the balloon catheter shaft 310 relative to the curved catheter 200.

[0111] Still referencing Figures 1 to 4The CA mechanism 600 includes an alignment knob 610 with an inner cover 620 and a gear 630. The alignment knob 610 is coupled to an axially oriented threaded shaft 520. The alignment knob 610 is rotatable (clockwise or counterclockwise) about the gear 630 to control the rotational movement of the balloon catheter shaft 310 relative to the curved catheter 200. Rotation of the alignment knob 610 correspondingly rotates the axially oriented threaded shaft 520. Rotation of the balloon catheter shaft 310 correspondingly rotates the coiled valve on it, thereby controlling the rotational orientation of the implant leaflet attachment point (junction) relative to natural anatomical features. The alignment knob 610 is rotatable to control the rotational movement of the balloon catheter shaft 310 regardless of the locked or unlocked position of the adjustment mechanism 500.

[0112] Still referencing Figures 1 to 4 The Luer tree 190 is coupled to the alignment knob 610. The Luer tree 190 includes a curved catheter flushing port 192, a guidewire lumen 194 configured to receive a guidewire, and a balloon inflation port 196.

[0113] Still referencing Figures 1 to 4 The housing 110 further includes a central ring 170, a hemostatic O-ring 175, and a hypotube 180. The central ring 170 is housed within the housing 110 and configured to hold the outer handle 135 in a fixed, non-rotatable position relative to rotatable components of the delivery handle assembly 100 (e.g., knob 410, control knob 510, alignment knob 610, etc.). The hypotube 180 is housed within the body core 150 and configured to allow flushing fluid to flow through the balloon catheter shaft 310 and into the curved catheter shaft 210 when the artificial heart valve moves and / or dilates at the treatment site. The hypotube 180 is freely linearly and rotationally translated relative to the body core 150 when the axially locating threaded shaft 520 is correspondingly linearly translated (via the adjustment mechanism 500) and / or rotationally translated (via the CA mechanism 600). The hemostatic O-ring 175 creates a sliding hemostatic seal between the inner surface of the body core 150 and the outer surface of the hypotube 180.

[0114] Still referencing Figures 1 to 4 The housing 110 further includes a nose cone 160 attached to the body core 150 around the distal end 120b. The nose cone 160 is configured to hold the knob 410 and the knob body 420 in place relative to the delivery handle device 100.

[0115] Now refer to the attached document. Figures 5 to 6 One or more embodiments of this application are described, wherein the same reference numerals are used to refer to the same elements throughout. Figure 5 Another exemplary non-restricted delivery system 50b, including a non-restricted handle device 1000, is depicted. Figure 6 yes Figure 5 A cross-sectional side view of the delivery handle device 1000.

[0116] refer to Figures 5 to 6 A delivery system 50b is provided, including a delivery handle device 1000. The delivery system 50b and handle 1000 function similarly to the delivery system 50a and handle 100 and include similar components, except that the delivery system 50b includes: (i) a bending indicator 7000 configured to provide the user with information about the degree or amount of bending present in the bending guide shaft 2100; and (ii) a cover 6400, a spring 6500, and a tooth 6600 included in the engagement alignment (CA) mechanism 6000.

[0117] It should be understood that any of the disclosed components incorporated into delivery system 50a may be used in combination with the disclosed components of delivery system 50b. It should also be understood that any of the disclosed components incorporated into delivery system 50b may be used in combination with the disclosed components of delivery system 50a.

[0118] Still referencing Figures 5 to 6 A delivery system 50b configured for use with an artificial heart valve is provided. The delivery system 50b has a delivery handle assembly 1000 and a curved catheter or similar flexible guiding catheter 2000 having a shaft 2100. The balloon catheter shaft 3100 is coaxially arranged within the curved catheter 2000. The delivery handle assembly 1000 includes an elongated housing 1100 having a proximal end 1200a and a distal end 1200b. The housing 1100 has a generally circular cross-sectional shape along its longitudinal axis. The cross-sectional area of ​​the housing 1100 may optionally vary along its longitudinal length. For example, in this non-limiting embodiment, the housing 1100 includes a smaller cross-sectional area in the central region of the housing 1100 compared to the regions located at and / or near the proximal end 1200a and the distal end 1200b. In this non-limiting embodiment, the housing 1100 has a length sufficient to allow a user to easily grip the housing 1100 with their hands (e.g., 4 inches to 12 inches and all values ​​and ranges therein). The housing 1100 further includes an outer handle 1350 having an outer surface 1300, wherein the outer surface 1300 includes one or more ribs 1400 formed thereon, the one or more ribs being configured to facilitate gripping the outer handle 1350.

[0119] The delivery handle device 1000 includes a hollow inner body core 1500, which forms the center of the delivery handle device 1000 and is located between a proximal end 1200a and a distal end 1200b along the central longitudinal axis of the delivery handle device 1000. The outer surface of a curved catheter shaft 2100 is fixed to the inner surface of the body core 1500. In a non-limiting aspect of this disclosure, the curved catheter shaft 2100 is fixed to the body core 1500 by an adhesive. A balloon catheter shaft 3100 extends coaxially through the curved catheter shaft 2100. The curved catheter 2000 and the balloon catheter shaft 3100 exit the distal end 1200b of the housing 1100.

[0120] Still referencing Figures 5 to 6 The delivery handle device 1000 further includes a bending mechanism 4000, an adjusting mechanism 5000, and an engagement alignment (CA) mechanism or similar rotating mechanism 6000. The bending mechanism 4000 is located near the distal end 1200b of the housing 1100, and the adjusting mechanism 5000 and the CA mechanism 6000 are located near the proximal end 1200a of the housing 1100. The bending mechanism 4000 includes a rotatable knob 4100 connected to a knob body 4200 housed within the housing 1100. The knob body 4200 includes a plurality of internal threads 4220 that receive and engage a threaded insert 4300. The bending mechanism 4000 further includes a bending actuation insert 4400, a pull wire 4500 passing through an opening or lumen on one side of the bending conduit shaft 2100, and a crimping band 4600 fixed within the bending actuation insert 4400. The pull wire 4500 is coupled to the crimping band 4600. When the knob 4100 is rotated in the first direction (clockwise or counterclockwise), the threaded insert 4300 and the bending actuation insert 4400 translate axially along the knob body 4200, thereby pulling the line 4500 and causing the bending guide shaft 2100 to bend or shift by a predetermined angle.

[0121] In a non-limiting example of this disclosure, rotating the knob 4100 in a first direction (clockwise or counterclockwise) causes the threaded insert 4300 and the bending actuation insert 4400 to translate along the knob body 4200 from the distal end 120b toward the proximal end 120a, thereby pulling the line 4500 and causing the bending conduit shaft 2100 to bend or shift by a predetermined angle.

[0122] In this non-limiting embodiment, the delivery handle device 1000 includes a bending indicator 7000. The bending indicator 7000 includes a needle 7100 and a protector 7200. The bending indicator 7000 is configured to provide a user with information about the degree or amount of bending present in the bending conduit shaft 2100. The needle 7100 includes one or more threads 7110 configured to engage a knob body 4200. As the knob 4100 is rotated (clockwise or counterclockwise), the needle 7100 translates along the knob body 4200, indicating to the user the degree or amount of bending present in the bending conduit shaft 2100.

[0123] Still referencing Figures 5 to 6 The adjustment mechanism 5000 includes a control knob 5100 having a first portion 5120, a second portion 5140, and a plurality of locking threads 5400. The adjustment mechanism 5000 further includes an axially locating threaded shaft 5200 received within a housing 1100. The adjustment mechanism 5000 is configured to advance or retract the balloon catheter shaft 3100 relative to the curved catheter 2000. The adjustment mechanism 5000 can be switched between a locked position and an unlocked position by a switch 5500. The switch 5500 is positioned between the first portion 5120 and the second portion 5140 of the control knob 5100. The switch 5500 includes a channel 5600 formed therein and a latching member 5700, wherein the latching member 5700 is movable within the channel 5600. The channel 5600 includes a first stop 5620 and a second stop 5640, wherein the width of the first stop 5620 is greater than the width of the second stop 5640. In this non-limiting embodiment, the switch 5500 and the latch 5700 have a substantially circular cross-sectional shape.

[0124] When the regulating mechanism 5000 is in the locked position (see...) Figure 6 (i) The latch 5700 is positioned at the second stop 5640 of the channel 5600; (ii) the switch 5500 is positioned closer to the second portion 5140 of the control knob 5100; and (iii) the latch 5700 engages with the locking thread 5400. In this locked position, the relative axial position between the balloon catheter shaft 3100 and the curved catheter 2000 is fixed, and the axial position of the balloon catheter shaft 3100 can be adjusted in a controlled manner by rotating (clockwise or counterclockwise) the control knob 5100. Rotating the control knob 5100 causes the locking thread 5400 to engage the axial positioning thread shaft 5200, thereby causing the axial positioning thread shaft 5200 to translate linearly along the longitudinal axis of the delivery handle device 1000.

[0125] When the adjustment mechanism 5000 is in the unlocked position: (i) the latch 5700 is positioned at the first stop 5620 of the channel 5600; (ii) the switch 5500 is positioned closer to the first portion 5120 of the control knob 5100; and (iii) the latch 5700 disengages from the locking thread 5400. In this unlocked position, the user can freely advance and retract the balloon catheter shaft 3100 within the curved catheter 2000 by manually pushing (e.g., forward) or pulling (e.g., retracting) the knob 6100 and / or the Luer tree 1900 (discussed in more detail below).

[0126] Still referencing Figures 5 to 6 The CA mechanism 6000 includes an alignment knob 6100 with an inner cover 6200 and a gear 6300. The alignment knob 6100 is coupled to an axially oriented threaded shaft 5200. The alignment knob 6100 is rotatable (clockwise or counterclockwise) about the gear 6300 to control the rotational movement of the balloon catheter shaft 3100 relative to the curved catheter 2000. Rotation of the alignment knob 6100 correspondingly rotates the axially oriented threaded shaft 5200. Rotation of the balloon catheter shaft 3100 correspondingly rotates the coiled valve on it, thereby controlling the rotational orientation of the implant leaflet attachment point (junction) relative to natural anatomical features. The alignment knob 6100 is rotatable to control the rotational movement of the balloon catheter shaft 3100 regardless of the locked or unlocked position of the adjustment mechanism 5000.

[0127] The alignment knob 6100 further includes a cap 6400, a spring 6500, and a tooth 6600. The cap 6400 holds the spring 6500 in place against the tooth 6600. As the tooth 660 rotates about the gear 6300, the tooth 660 moves up and down or slides.

[0128] Still referencing Figures 5 to 6 The Luer tree 1900 is coupled to the alignment knob 6100. The Luer tree 1900 includes a curved catheter flushing port 1920, a guidewire lumen 1940 configured to receive a guidewire, and a balloon inflation port 1960.

[0129] The housing 1100 further includes a central ring 1700 and a hypotube 1800. The central ring 1700 is housed within the housing 1100 and configured to hold the outer handle 1350 in a fixed, non-rotatable position relative to rotatable components of the delivery handle assembly 1000 (e.g., knob 4100, control knob 5100, alignment knob 6100, etc.). The hypotube 1800 is housed within the body core 1500 and configured to allow flushing fluid to flow through the balloon catheter shaft 3100 and into the curved catheter shaft 2100 when the artificial heart valve moves and / or dilates at the treatment site. The hypotube 1800 is freely linearly and rotationally translated relative to the body core 1500 when the axially locating threaded shaft 5200 is correspondingly linearly translated (via the adjustment mechanism 5000) and / or rotationally translated (via the CA mechanism 6000).

[0130] Still referencing Figures 5 to 6 The housing 1100 further includes a nose cone 1600 attached to the body core 1500 around the distal end 1200b. The nose cone 1600 is configured to hold the knob 4100 and the knob body 4200 in place relative to the delivery handle device 1000.

[0131] Now refer to the attached document. Figures 7A to 7D One or more embodiments of this application are described, wherein the same reference numerals are used to refer to the same elements throughout. Figures 7A to 7D An exemplary non-restrictive embolic capture filter sheath or similar filter 700 is depicted, configured for use with a non-restrictive curved catheter 740 and a non-restrictive balloon catheter 720.

[0132] refer to Figures 7A to 7D An embolic capture filter sheath or similar filter 700 is provided and mounted on the exterior of the balloon catheter shaft 710. A balloon catheter 720 is housed within the balloon catheter shaft 710 and includes an inflatable balloon 730. The balloon catheter shaft 710 extends coaxially within a curved catheter 740 and a curved catheter shaft 750. The balloon catheter 720 further includes a nose portion 760 configured to facilitate movement through an artery or similar catheter.

[0133] Still referencing Figures 7A to 7DThe embolism capture filter sheath 700 includes a porous membrane having one or more pores sized to effectively block the passage of embolic particles (e.g., 50 μm) and including sufficient pore density to provide minimal flow resistance (e.g., 20% to 60% of the open area relative to the remaining material) when deployed in the aorta. The embolism capture filter sheath 700 expands and contacts the inner lumen of the aorta proximal to the balloon 730 as the curved catheter shaft 750 retracts before the balloon 730 inflates to deploy the artificial heart valve. The embolism capture filter sheath 700 closes as the curved catheter shaft 750 advances again, thereby accommodating any trapped embolus. The embolism capture filter sheath 700 opens only for a short period before the balloon 730 inflates and closes shortly after the balloon 730 deflates. It should be understood that the disclosed embolism capture filter sheath 700 can be used with the delivery systems 50a and / or 50b discussed herein.

[0134] However, it should be understood that all these terms and similar terms should be associated with appropriate physical quantities and are merely convenient notations for applying to those quantities.

[0135] Therefore, it will be found that the purposes set forth above and those that become clear from the foregoing description are effectively achieved, and since certain changes can be made to the described construction without departing from the spirit and scope of this disclosure, it is intended that all subject matter contained in the foregoing description and shown in the accompanying drawings should be interpreted as illustrative and not restrictive. This disclosure has been described with reference to preferred and alternative embodiments. Modifications and variations will become apparent to those skilled in the art upon reading and understanding the detailed discussion of this disclosure provided herein. This disclosure is intended to include all such modifications and variations, provided they fall within the scope of this disclosure. It should also be understood that the following claims are intended to cover all general and specific features of this disclosure described herein and all statements of scope of this disclosure, which may fall within the scope according to the language. These and other modifications to the preferred embodiments and other embodiments of this disclosure will be apparent from the disclosure herein, and thus the foregoing description is to be interpreted merely as illustrative and not limiting. This disclosure is intended to include all such modifications and variations, provided they fall within the scope of the appended claims.

[0136] For purposes of illustration and description, embodiments and examples have been presented. This disclosure is not intended to be exhaustive or limited to the forms described. Many modifications are possible in accordance with the teachings herein. Some of these modifications have been discussed, and others will be understood by those skilled in the art. The embodiments were chosen and described to illustrate the principles of various embodiments suitable for the particular purpose contemplated. Of course, the scope is not limited to the examples set forth herein, but can be used by those skilled in the art for any number of applications and equivalent devices.

[0137] In order to assist the Patent Office and any reader of this application and any resulting patent in interpreting the appended claims, the applicant does not intend for any appended claim or claim element to invoke 35 USC 112(f) unless the words “means for…” or “steps for…” are expressly used in a particular claim.

Claims

1. A delivery handle device that facilitates the delivery of an expandable medical device to a treatment site; The delivery handle device includes: A housing having an inner core that extends linearly at least partially between a proximal end and a distal end of the housing; and wherein the inner core at least partially receives a flexible catheter and a balloon catheter at least partially coaxially disposed within the flexible catheter; An adjustment mechanism configured to control the position of the balloon catheter relative to the flexible catheter; the adjustment mechanism includes: - A control knob with a connecting device; and - An axis configured to translate linearly within the housing; and A switch configured to lock or unlock the regulating mechanism.

2. The delivery handle device of claim 1, further comprising a bending mechanism configured to bend the flexible catheter at one or more predetermined angles; the bending mechanism comprising: A curved knob coupled to the body, wherein the body is at least partially housed within the housing; An insert that engages with the body; An actuating insert with a crimping band; and Linear components coupled to the flexible conduit and the crimping tape.

3. The delivery handle device of claim 1, wherein rotation of the bending knob in a first direction causes the insert and the actuating insert to translate linearly along the body from the distal end toward the proximal end, and wherein the line member pulls the flexible conduit to bend the flexible conduit to the one or more predetermined angles.

4. The delivery handle device of claim 2, wherein rotation of the bending knob in a first direction causes the insert and the actuating insert to translate linearly along the body from the distal end toward the proximal end, and wherein the line member pulls the flexible conduit to bend the flexible conduit to one or more predetermined angles.

5. The delivery handle device of claim 1, further comprising a bending indicator having a needle, wherein the needle translates along the body to indicate to the user the degree of bending present in the flexible catheter.

6. The delivery handle device according to any one of claims 2 to 4, further comprising a bending indicator having a needle, wherein the needle translates along the body to indicate to the user the degree of bending present in the flexible catheter.

7. The delivery handle device of claim 1, further comprising a rotation mechanism configured to rotate the balloon catheter; the rotation mechanism comprising: An alignment knob coupled to the shaft of the adjustment mechanism; and gear; and The rotation of the alignment knob in the first direction causes the balloon catheter to rotate relative to the flexible catheter.

8. The delivery handle device according to any one of claims 2 to 6, further comprising a rotation mechanism configured to rotate the balloon catheter; the rotation mechanism comprising: An alignment knob coupled to the shaft of the adjustment mechanism; and gear; and The rotation of the alignment knob in the first direction causes the balloon catheter to rotate relative to the flexible catheter.

9. The delivery handle device of claim 1, wherein the control knob comprises a first portion and a second portion, and wherein the switch is positioned between the first portion and the second portion.

10. The delivery handle device according to any one of claims 2 to 8, wherein the control knob comprises a first portion and a second portion, and wherein the switch is positioned between the first portion and the second portion.

11. The delivery handle device according to claim 1, wherein the switch comprises: A channel having a first stop and a second stop, wherein the first stop has a different width than the second stop; and A snap-fit ​​element that can move within the channel.

12. The delivery handle device according to any one of claims 2 to 10, wherein the switch comprises: A channel having a first stop and a second stop, wherein the first stop has a different width than the second stop; and A snap-fit ​​element that can move within the channel.

13. The delivery handle device according to claim 1, wherein the switch has a substantially circular cross-sectional shape.

14. The delivery handle device according to any one of claims 2 to 12, wherein the switch has a substantially circular cross-sectional shape.

15. The delivery handle device of claim 1, wherein when the adjustment mechanism is locked, a) the latch is positioned at the second stop of the channel, b) the switch is positioned near the second portion of the control knob, and c) the latch engages with the engagement device.

16. The delivery handle device according to any one of claims 2 to 14, wherein when the adjustment mechanism is locked, a) the latch is positioned at the second stop of the channel, b) the switch is positioned near the second portion of the control knob, and c) the latch engages with the engagement device.

17. The delivery handle device of claim 1, wherein rotation of the control knob in a first direction causes the engagement device to engage the shaft and linearly translate the shaft within the housing from the proximal end or near the proximal end toward the distal end, and wherein rotation of the control knob in a second direction causes the shaft to linearly translate from the distal end or near the distal end toward the proximal end.

18. The delivery handle device according to any one of claims 2 to 16, wherein rotation of the control knob in a first direction causes the engagement device to engage the shaft and linearly translate the shaft within the housing from the proximal end or near the proximal end toward the distal end, and wherein rotation of the control knob in a second direction causes the shaft to linearly translate from the distal end or near the distal end toward the proximal end.

19. The delivery handle device of claim 1, wherein when the adjustment mechanism is unlocked, a) the latch is positioned at the first stop of the channel, b) the switch is positioned near the first portion of the control knob, and c) the latch disengages from the engagement device.

20. The delivery handle device according to any one of claims 2 to 18, wherein when the adjustment mechanism is unlocked, a) the latch is positioned at the first stop of the channel, b) the switch is positioned near the first portion of the control knob, and c) the latch disengages from the engagement device.

21. The delivery handle device of claim 7, wherein the alignment knob of the rotating mechanism is pushed to advance the shaft toward the distal end, and wherein the alignment knob is pulled to retract the shaft toward the proximal end.

22. The delivery handle device according to any one of claims 8 to 20, wherein the alignment knob of the rotating mechanism is pushed to advance the shaft toward the distal end, and wherein the alignment knob is pulled to retract the shaft toward the proximal end.

23. The delivery handle device of claim 1, further comprising a Luer tree coupled to the alignment knob; the Luer tree comprising one or more of a flushing port, a guidewire lumen configured to receive a guidewire, and / or a balloon inflation port.

24. The delivery handle device according to any one of claims 2 to 22, further comprising a Luer tree coupled to the alignment knob; the Luer tree comprising one or more of a flushing port, a guidewire lumen configured to receive a guidewire, and / or a balloon inflation port.

25. The delivery handle device according to claim 1, further comprising: A hypotube housed within the inner core, wherein the hypotube is configured to allow flushing fluid to flow at least partially through the balloon catheter and at least partially into the flexible catheter; and A sealing device that creates a sliding hemostatic seal between the inner surface of the inner core and the outer surface of the hyaluronic acid tube.

26. The delivery handle device according to any one of claims 2 to 24, further comprising a Luer tree coupled to the alignment knob; the Luer tree comprising one or more of a flushing port, a guidewire lumen configured to receive a guidewire, and / or a balloon inflation port.

27. The delivery handle device of claim 1, wherein the expandable medical device is an artificial heart valve.

28. The delivery handle device according to any one of claims 2 to 26, wherein the expandable medical device is an artificial heart valve.

29. A system for delivering an expandable medical device to a treatment site, the system comprising: Flexible catheter; A balloon catheter coaxially disposed within the flexible catheter; and Delivery handle device; The delivery handle device includes: - A housing having an inner core extending linearly between the proximal and distal ends of the housing, wherein the inner core at least partially receives the flexible catheter and the balloon catheter; - An adjustment mechanism configured to control the position of the balloon catheter relative to the flexible catheter, wherein the adjustment mechanism includes: -- A control knob with a coupling device; and -- An axis configured to translate linearly within the housing; and A switch configured to lock or unlock the regulating mechanism, wherein the switch includes: -- A channel having a first stop and a second stop, wherein the first stop has a different width than the second stop; and -- A snap fastener that can move within the channel.

30. The system of claim 29, wherein the delivery handle device further comprises a bending mechanism configured to bend the flexible catheter at one or more predetermined angles; the bending mechanism comprising: A curved knob coupled to the body, wherein the body is at least partially housed within the housing; An insert that engages with the body; An actuating insert with a crimping band; and A wire component coupled to the flexible conduit and the crimping tape; and The rotation of the bending knob in the first direction causes the insert and the actuating insert to translate linearly along the body from the distal end or near the distal end toward the proximal end, and the line member pulls the flexible catheter to bend the flexible catheter at one or more predetermined angles.

31. The system of claim 29, wherein the delivery handle device further comprises a rotation mechanism configured to rotate the balloon catheter; the rotation mechanism comprising: An alignment knob coupled to the shaft of the adjustment mechanism; and gear; and The rotation of the alignment knob in the first direction causes the balloon catheter to rotate relative to the flexible catheter.

32. The system of claim 30, wherein the delivery handle device further comprises a rotation mechanism configured to rotate the balloon catheter; the rotation mechanism comprising: An alignment knob coupled to the shaft of the adjustment mechanism; and gear; and The rotation of the alignment knob in the first direction causes the balloon catheter to rotate relative to the flexible catheter.

33. The system of claim 29, wherein when the adjusting mechanism is locked, a) the latching member is positioned at the second stop of the channel, and b) the latching member engages with the engaging device; and wherein rotation of the control knob in the first direction causes the engaging device to engage the shaft and linearly translate the shaft within the housing from the proximal end or near the proximal end toward the distal end, and wherein rotation of the control knob in the second direction causes the shaft to linearly translate from the distal end or near the distal end toward the proximal end.

34. The system according to any one of claims 30 to 32, wherein when the adjusting mechanism is locked, a) the latching member is positioned at the second stop of the channel, and b) the latching member engages with the engaging device; and wherein rotation of the control knob in the first direction causes the engaging device to engage the shaft and linearly translate the shaft within the housing from the proximal end or near the proximal end toward the distal end, and wherein rotation of the control knob in the second direction causes the shaft to linearly translate from the distal end or near the distal end toward the proximal end.

35. The system of claim 29, wherein when the adjustment mechanism is unlocked, a) the latch is positioned at the first stop of the channel; and b) the latch disengages from the engagement device; and wherein the alignment knob of the rotation mechanism is pushed to advance the shaft toward the distal end, and wherein the alignment knob is pulled to retract the shaft toward the proximal end.

36. The system according to any one of claims 30 to 34, wherein when the adjusting mechanism is unlocked, a) the latch is positioned at the first stop of the channel; and b) the latch disengages from the engaging device; and wherein the alignment knob of the rotating mechanism is pushed to advance the shaft toward the distal end, and wherein the alignment knob is pulled to retract the shaft toward the proximal end.

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