Method for reducing contour of vascular prosthesis

Abstract

The present disclosure relates generally to methods for reducing a post-curl profile of a medical device, in particular to methods for reducing a post-curl profile of a prosthetic heart valve, and even more particularly to facilitating a desired folding profile of a leaflet of the prosthetic heart valve during curl of a frame of the prosthetic heart valve, methods of reducing the number and volume of void spaces between and around the leaflets, and reducing the post-curl outer diameter profile of the prosthetic heart valve, while reducing the risk of damage to the leaflets and other components of the prosthetic heart valve during the curl process. Methods for reducing the post-curl profile of a prosthetic heart valve may be accomplished by non-simultaneous and / or non-uniform curl of a valve frame during the curl process.

Description

[0001] Application for reference

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 530,610, filed August 3, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to methods for reducing the post-curling profile of a medical device, particularly to methods for reducing the post-curling profile of a prosthetic heart valve, and even more specifically to methods for facilitating a desired folded profile of the leaflets of the prosthetic heart valve during the curling of the valve's frame, to reduce the number and volume of gaps between and around the leaflets, and to reduce the post-curling outer diameter profile of the prosthetic heart valve, while reducing the risk of damage to the leaflets and other components of the prosthetic heart valve during the curling process. The method for reducing the post-curling profile of a prosthetic heart valve can be achieved by non-simultaneous and / or non-uniform curling of the valve frame during the curling process. Background Technology

[0004] Many cardiovascular devices, such as stents and expandable heart valves, are inserted into a patient's body via their vascular system and then expand at the treatment site. These devices are typically coiled onto a catheter before insertion. The minimum diameter at which a cardiovascular device can be coiled onto a catheter sets a limit on the size of the cardiovascular pathway (e.g., blood vessel) into which the device can be inserted. A smaller coil diameter can result in less damage to blood vessels and / or organs (e.g., the heart) when a cardiovascular device is inserted into or placed at the treatment site. A smaller coil diameter also allows the placement of cardiovascular devices in smaller diameter blood vessels (e.g., blood vessels in the brain).

[0005] The coil diameter of an expandable cardiovascular device can be reduced by decreasing the thickness and / or size of its frame, struts, etc. However, such a reduction in size also affects the strength of the cardiovascular device after expansion. After expansion, the cardiovascular device must maintain its expanded shape at the treatment area; otherwise, it may shift out of the treatment area, potentially damage the treatment area, and / or fail to function properly at the treatment area. Therefore, cardiovascular devices made of conventional materials such as stainless steel (e.g., 316L: 17 to 19 wt% chromium, 13 to 15 wt% nickel, 2 to 4 wt% molybdenum, up to 2 wt% manganese, up to 0.75 wt% silicon, up to 0.03 wt% carbon, balance iron) and cobalt-chromium alloys (e.g., MP35N: 19 to 21 wt% chromium, 34 to 36 wt% nickel, 9 to 11 wt% molybdenum, up to 1 wt% iron, up to 1 wt% titanium, up to 0.15 wt% manganese, up to 0.15 wt% silicon, up to 0.025 wt% carbon, balance cobalt) are required to maintain the frame and / or support rod size / thickness, which limits the extent to which the coil diameter can be small by using coiled cardiovascular devices. Other types of CoCr alloys already in use are Phynox and Elgiloy alloys (38 to 42 wt% cobalt, 18 to 22 wt% chromium, 14 to 18 wt% iron, 13 to 17 wt% nickel, 6 to 8 wt% molybdenum) and L605 alloy (18 to 22 wt% chromium, 14 to 16 wt% W, 9 to 11 wt% nickel, balance cobalt).

[0006] Medical devices such as transcatheter aortic valves (TAVs) represent a significant advancement in prosthetic heart valve technology. TAVs bring 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 TAVs are disclosed 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 U.S. Publication No. 2020 / 0405482, all of which are incorporated herein by reference in their entirety.

[0007] 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 original valve. Some TAVs are balloon-expandable, while others are self-expandable. In both cases, the TAV is deployed within a calcified original valve that has been forced open permanently and becomes the surface against which the frame 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 sternotomy, which significantly reduces patient morbidity.

[0008] However, several complications are associated with current TAV devices, such as severe vascular injury or bleeding due to the large delivery profile, misalignment, leaflet damage due to curling, paravalvular leakage, thrombosis, conduction system abnormalities, and prosthesis-patient mismatch.

[0009] TAVR involves the delivery, deployment, and implantation of a coiled, framed valve within a diseased aortic valve or a degenerated bioprosthetic. Current limitations of TAVR procedures include: a) vascular complications such as dissection or severe bleeding due to the large size of the delivery system; b) conduction system damage with a high incidence leading to permanent pacemaker implantation or sudden cardiac death; conduction abnormalities exacerbated by frame rebound forces, requiring the operator to inflate the balloon to a greater diameter to achieve a physiologically effective orifice area after balloon deflation; c) damage to the leaflets and / or frame during the coiling of the prosthetic heart valve frame; and d) device malfunction. TAVR involves the delivery, deployment, and implantation of a coiled valve frame within a diseased aortic valve or a degenerated bioprosthetic. One limitation of these types of procedures is the diameter to which the valve frame can be coiled without damaging the internal leaflet tissue, and the vascular complications, such as dissection, due to the size of the delivery system.

[0010] Therefore, there has been a need for an improved medical device that can a) form a smaller curl diameter, b) achieve a reduction in the diameter after curling, while minimizing damage to the leaflets during the curling process, and / or c) address some of the shortcomings of existing expandable devices (such as, but not limited to, stents, TAVs, etc.). Summary of the Invention

[0011] This disclosure relates to coiling systems, apparatus, and methods for reducing the post-coil profile of medical devices such as, but not limited to, prosthetic heart valves, and more specifically to facilitating a desired folded profile of the leaflets of the prosthetic heart valve during the coiling of the valve frame, thereby reducing the number and volume of void spaces between and around the leaflets and reducing the post-coil outer diameter profile of the prosthetic heart valve, while minimizing the risk of damage to the leaflets and other components of the prosthetic heart valve during the coiling process. Coiler systems, apparatus, and methods for reducing the post-coil profile of a prosthetic heart valve can be achieved through non-simultaneous and / or non-uniform coiling of the valve frame during the coiling process. Although this disclosure will specifically discuss coiler systems, apparatus, and methods for use with prosthetic heart valves, it will be understood that the coiler systems, apparatus, and methods according to this disclosure can be used with other types of medical devices (e.g., stents, etc.) including frames that need to be coiled, plastically deformed, etc., to a smaller profile.

[0012] In a non-limiting aspect of this disclosure, a curler device is provided, configured to reduce the outer diameter of the frame of a prosthetic heart valve along its longitudinal length, wherein the curler device a) gradually (in a continuous manner) or b) stepwise (in a discrete manner) from i) the inflow side to the outflow side or ii) from the outflow side to the inflow side, thereby producing a desired and / or consistent folding shape of the leaflets in the prosthetic heart valve, and this desired and / or consistent leaflet folding shape results in a reduction in the volume profile of the leaflets, which in turn results in a reduction in the outer diameter or profile of the curled prosthetic heart valve. In the continuous or stepwise curling method, the inflow-side portion or the outflow-side portion may be partially or completely curled before other portions of the frame of the curled prosthetic heart valve are curled. In a non-limiting embodiment, the curler device is used to reduce the outer diameter of the frame of the prosthetic heart valve in a gradual or continuous manner along its longitudinal length from the inflow side to the outflow side. In another non-limiting embodiment, the coiler device is used to reduce the outer diameter of the frame of the prosthetic heart valve in a stepwise manner from the inflow side to the outflow side along the longitudinal length of the prosthetic heart valve.

[0013] In another non-limiting aspect of this disclosure, a curler device is provided, configured to provide a linear or non-linear relationship between the amount of handle movement (e.g., the distance the handle moves, etc.) and the diameter or cross-sectional area of ​​the opening. In one non-limiting configuration, the handle is configured to rotate about a handle axis. As the handle rotates from an initial position (0° position) to a final position (e.g., 30 to 360° and all values ​​and ranges therein), the movement of the handle about the handle axis causes the opening of the curler device to decrease in diameter or cross-sectional area. In this arrangement, for each angle of movement of the handle about the handle axis, the diameter or cross-sectional area of ​​the opening of the curler device may decrease proportionally in size (e.g., a linear relationship between the handle rotation position and the size of the opening diameter or cross-sectional area) or decrease at some other rate (e.g., a non-linear relationship between the handle rotation position and the size of the opening diameter or cross-sectional area). In another non-limiting configuration, the coiler device is configured to a) first partially or completely coil the inflow portion of the prosthetic heart valve, and subsequently partially or completely coil the outflow portion of the prosthetic heart valve, or b) gradually and continuously coil the prosthetic heart valve along its longitudinal axis starting from the inflow end, and subsequently advance to and terminate at the outflow end of the prosthetic heart valve.

[0014] In another non-limiting aspect of this disclosure, a curler device is provided, configured to a) progressively curl the frame of a prosthetic heart valve from one end to the other, b) progressively curl the frame of the prosthetic heart valve from one portion of the frame to another, and c) batch-curl different portions of the frame at different times during the curling process (e.g., curling the front portion of the frame before the rear portion). It has been found that this curling process facilitates the organized folding of the leaflets in the prosthetic heart valve, allowing the frame to be curled into a smaller post-curl profile and reducing damage to the leaflets during the curling process.

[0015] In another non-limiting aspect of this disclosure, a coiler device is provided, which is configured to bulk coil the frame of the prosthetic heart valve at different times at different portions of the frame during the coiling process.

[0016] In another non-limiting aspect of this disclosure, a leaflet folding device is provided, which may optionally be used in conjunction with a curler device according to this disclosure to facilitate obtaining a leaflet folding configuration during the curling of the frame of a prosthetic heart valve, thereby obtaining the desired folded leaflet configuration after the frame has been fully curled. In one non-limiting embodiment, the leaflet folding device is configured to bend one or more or all of the ends of the leaflets located at or near the outflow end of the prosthetic heart valve toward the central axis of the frame of the prosthetic heart valve. This bending of one or more leaflets by the leaflet folding device occurs a) before the initial curling of the frame of the prosthetic heart valve and / or b) during the curling of the frame of the prosthetic heart valve. In another non-limiting method of use, before and / or during frame curling, a portion or all of the leaflet folding device is rotated (e.g., 2 to 180° and all values ​​and ranges therebetween) about the longitudinal axis of the frame (e.g., the central longitudinal axis of the frame, etc.) to facilitate leaflet folding during frame curling. This rotation is used to facilitate leaflet folding. This rotation of one or more leaflets by the leaflet folding device occurs a) before the initial curling of the frame of the prosthetic heart valve, and / or b) during the curling of the frame of the prosthetic heart valve. One or more portions of the leaflet folding device may include a coating to a) limit or prevent damage to the frame and / or leaflets when one or more portions of the leaflet folding device engage the frame and / or leaflets during the curling process, b) limit or prevent contamination of the frame and / or leaflets when one or more portions of the leaflet folding device engage the frame and / or leaflets during the curling process, c) reduce friction between one or more portions of the leaflet folding device and the frame and / or leaflets during the curling process, and / or d) form a surface color on one or more portions of the leaflet folding device to facilitate visual positioning and use of the leaflet folding device during the curling process. The type and thickness of the coating are not limited when used.

[0017] In another non-limiting aspect of this disclosure, a leaflet folding device is provided, optionally for use with a curler device according to this disclosure, to facilitate obtaining a leaflet folding configuration during the curling of the frame of a prosthetic heart valve, thereby obtaining the desired folded leaflet configuration after the frame has been fully curled, and wherein the leaflet folding device is removed or disengaged from one or more leaflets before the outflow end of the frame of the prosthetic heart valve is fully curled to 5% to 99% (and all values ​​and ranges therebetween). In another non-limiting method, the leaflet folding device is removed or disengaged from one or more leaflets before the outflow end of the frame of the prosthetic heart valve is fully curled to 25% to 99%. In yet another non-limiting method, the leaflet folding device is removed or disengaged from one or more leaflets before the outflow end of the frame of the prosthetic heart valve is fully curled to 30% to 75%. In another non-limiting approach, the leaflet folding device is removed or detached from one or more leaflets after the outflow end of the prosthetic heart valve frame has been fully rolled up.

[0018] According to another non-limiting aspect of this disclosure, another apparatus and method for folding leaflets on a prosthetic heart valve are provided, the method comprising the steps of: inserting a radially collapsible insert into the interior of the prosthetic heart valve before partial curling of the prosthetic heart valve; then, with the radially collapsible insert inside the prosthetic heart valve, the prosthetic heart valve is partially curled (10 to 90% complete curling and all values ​​and ranges therebetween). Typically, the radially collapsible insert is inserted 50 to 100% (and all values ​​and ranges therebetween) along the longitudinal length of the prosthetic heart valve. After the prosthetic heart valve is partially curled, the radially collapsible insert is removed from the prosthetic heart valve, and the prosthetic heart valve is then subjected to further curling by a curling device until the prosthetic heart valve is completely curled. The radially collapsible insert may be designed to be reusable or designed to be single-use. The materials used to form the radially collapsible insert are non-limiting (e.g., metals, plastics, paper, composite materials, etc.). Before the radially collapsible insert is inserted into the prosthetic heart valve, the cross-sectional shape of the radially collapsible insert may be constant or variable along its longitudinal length. The type of curling process used to partially curl the prosthetic heart valve during the curling process involving the radially collapsible insert is not limited. Such curling processes may include a) conventional prior art curling processes, wherein the entire prosthetic heart valve is subjected to curling forces; b) a stepped curling process, wherein a portion of the prosthetic heart valve is subjected to curling forces, and then other portions of the prosthetic heart valve are subjected to curling forces; and / or c) a progressive, continuous curling process, wherein the curling of the prosthetic heart valve begins at the inflow or outflow end and the curling continues continuously along the longitudinal length of the prosthetic heart valve to the opposite ends of the prosthetic heart valve. After the radially collapsible insert is removed from the prosthetic heart valve, the curling process for completing the curling of the prosthetic heart valve may include a) a conventional prior art curling process, wherein the entire prosthetic heart valve is subjected to a curling force; b) a stepped curling process, wherein a portion of the prosthetic heart valve is subjected to a curling force, and then other portions of the prosthetic heart valve are subjected to a curling force; and / or c) a progressive, continuous curling process, wherein the curling of the prosthetic heart valve begins at the inflow or outflow end and the curling continues continuously along the longitudinal length of the prosthetic heart valve to opposite ends of the prosthetic heart valve. In a non-limiting method, during use of the radially collapsible insert, when it is at least partially inserted into the prosthetic heart valve, the radially collapsible insert may be held or mounted so as not to rotate during the partial curling of the prosthetic heart valve.In another non-limiting method, during the use of the radially collapsible insert, when it is at least partially inserted into the prosthetic heart valve, the radially collapsible insert may rotate during the partial curling of the prosthetic heart valve.

[0019] According to another non-limiting aspect of this disclosure, another apparatus and method for folding leaflets on a prosthetic heart valve are provided, the method comprising the step of: inserting a radially collapsible insert into the interior of the prosthetic heart valve before partial curling of the prosthetic heart valve, wherein the cross-sectional shape of the radially collapsible insert is constant along its longitudinal length before insertion. The cross-sectional area of ​​the radially collapsible insert along its longitudinal length may be constant or variable before insertion. In a non-limiting configuration, the cross-sectional area of ​​the radially collapsible insert along its longitudinal length may be constant before insertion.

[0020] According to another non-limiting aspect of this disclosure, another apparatus and method for folding leaflets on a prosthetic heart valve are provided, the method comprising the step of inserting a radially collapsible insert into the interior of the prosthetic heart valve prior to partial curling of the prosthetic heart valve, wherein the radially collapsible insert has a generally circular or elliptical cross-sectional shape along its longitudinal length. The radially collapsible insert may have a generally circular or elliptical cross-sectional shape along a portion (e.g., 10% to 99% and all values ​​and ranges therebetween) or the entire longitudinal length of the radially collapsible insert. In one non-limiting configuration, the generally circular or elliptical cross-sectional shape of the radially collapsible insert has a generally constant cross-sectional dimension of 20% to 100% (and all values ​​and ranges therebetween) along the longitudinal length of the radially collapsible insert. In another non-limiting configuration, the radially collapsible insert has a hollow internal cavity of 20% to 100% (and all values ​​and ranges therebetween) along its longitudinal length. In another non-limiting configuration, the hollow internal cavity has a generally circular or elliptical cross-sectional shape along a portion (e.g., 10% to 99% and all values ​​and ranges therebetween) or the entire longitudinal length of the radially collapsible insert. The shape and / or cross-sectional area of ​​the hollow internal cavity along the longitudinal length of the radially collapsible insert are generally constant; however, this is not required. The thickness and material of the walls used to form the radially collapsible insert are chosen such that the radially collapsible insert at least partially collapses when the prosthetic heart valve is partially rolled up by the rolling device. Typically, the thickness of the walls of the radially collapsible insert is 0.1% to 10% (and all values ​​and ranges therebetween) of the longest cross-sectional length or diameter of the radially collapsible insert. The radially collapsible insert is configured such that when the prosthetic heart valve is rolled up, the leaflets engage in the outer surface of the radially collapsible insert, and the leaflets initially fold in a certain manner based on the engagement with the radially collapsible insert and the radial reduction of the frame of the prosthetic heart valve. During the partial curling of the prosthetic heart valve, the radially collapsible insert also partially collapses due to the inward radial forces exerted on the outer surface of the radially collapsible insert by the leaflets and frame of the prosthetic heart valve. The partial collapse shape of the radially collapsible insert as the prosthetic heart valve is curled also contributes to the desired folding shape of the leaflets. Once the prosthetic heart valve is partially curled, the radially collapsible insert is completely removed from the interior of the prosthetic heart valve, and the prosthetic heart valve is then subjected to a final curling process to fully curl it. During the final curling process, the leaflets continue to fold in the desired manner, thereby reducing or maximizing the reduction of leaflet volume after the prosthetic heart valve is fully curled. This continuous desired leaflet folding is at least partially or completely a result of the initial leaflet folding when using the radially collapsible insert.

[0021] According to another non-limiting aspect of this disclosure, another apparatus and method for folding leaflets on a prosthetic heart valve are provided, the method comprising the step of: inserting a radially collapsible insert into the interior of the prosthetic heart valve prior to partial curling of the prosthetic heart valve, wherein the radially collapsible insert has a plurality of arms extending outwardly from the outer surface of the radially collapsible insert. Typically, the number of arms on the radially collapsible insert is the same as the number of leaflets in the prosthetic heart valve; however, this is not required. The shape and / or cross-sectional area of ​​the hollow internal cavity along the longitudinal length of the radially collapsible insert is typically constant; however, this is not required. The body and / or arms may optionally include the hollow internal cavity. When the body and / or arms include the hollow internal cavity, the hollow internal cavity extends from 10% to 100% (and all values ​​and ranges therebetween) of the longitudinal length of the radially collapsible insert. The thickness and material of the walls used to form the radially collapsible insert are selected such that the radially collapsible insert at least partially collapses when the prosthetic heart valve is partially rolled up by the coiling device. Typically, the thickness of the walls of the radially collapsible insert is 0.1% to 10% (and all values ​​and ranges therebetween) of the longest cross-sectional length or diameter of the radially collapsible insert. Each arm may have the same or different dimensions, shape, thickness, length, width, and / or construction. Typically, two or more or all adjacently positioned arms may be equidistant from each other around the outer periphery of the body of the radially collapsible insert; however, this is not required. Typically, the arms are formed of the same material as the body of the radially collapsible insert; however, this is not required. The length of each arm is typically 2 to 40 mm (and all values ​​and ranges therebetween; 3 to 30 mm, etc.). Typically, one or more or all of the arms extend 60% to 100% (and all values ​​and ranges therebetween) of the longitudinal length of the radially collapsible insert. Each arm initially extends from the outer surface of the body of the radially collapsible insert at an angle α of 5 to 175° (and all values ​​and ranges therebetween). The angle α of two or more, or all, arms may be the same or different. The shape of the arms extending from the outer surface of the body may be straight, curved, wavy, etc. The number, shape, size, and construction of the arms on the radially collapsible insert are selected to facilitate desired leaflet folding when the prosthetic heart valve is initially rolled up. A radially collapsible insert having one or more arms may be configured such that when the prosthetic heart valve is rolled up, the leaflets engage in the arms and outer surface of the radially collapsible insert, and the leaflets initially fold in a certain manner based on the engagement with the arms and outer surface of the radially collapsible insert and the radial reduction of the frame of the prosthetic heart valve. During partial roll-up of the prosthetic heart valve, the radially collapsible insert also partially collapses due to inward radial forces exerted by the leaflets and frame of the prosthetic heart valve on the arms and / or outer surface of the radially collapsible insert.When the prosthetic heart valve is rolled up, the partially collapsed shape of the radially collapsible insert also contributes to the desired folding shape of the leaflet. Once the prosthetic heart valve is partially rolled up, the radially collapsible insert is completely removed from the interior of the prosthetic heart valve, and the prosthetic heart valve is then subjected to a final roll-up process to fully roll up the prosthetic heart valve. During the final roll-up process, the leaflet continues to fold in the desired manner, thereby reducing or maximizing the reduction of the leaflet volume after the prosthetic heart valve is fully rolled up. This continuous desired leaflet folding is at least partially or completely a result of the initial folding of the leaflet when using the radially collapsible insert. In a non-limiting configuration, the radially collapsible insert comprises three arms. Each of the three arms has a substantially identical shape, thickness, length, width, and construction. The three arms are spaced apart such that adjacently positioned arms are equidistant from each other around the outer periphery of the body of the radially collapsible insert. Each arm extends 80 to 100% (and all values ​​and ranges therebetween) of the longitudinal length of the radially collapsible insert. Each arm has a slightly curved shape, a length of 3 to 10 mm (and all values ​​and ranges therebetween), and an angle α of 15 to 60° (and all values ​​and ranges therebetween).

[0022] According to another non-limiting aspect of this disclosure, another apparatus and method for folding leaflets on a prosthetic heart valve are provided, the method comprising the step of inserting a shaping shaft into the interior of the prosthetic heart valve prior to partial curling of the prosthetic heart valve, wherein the shaping shaft has a plurality of arms extending outward from an outer surface of the shaping shaft. Typically, the number of arms on the shaping shaft is the same as the number of leaflets in the prosthetic heart valve; however, this is not required. In a non-limiting embodiment, a portion of the shaping shaft (e.g., an end, middle, anterior, etc.) includes a plurality of arms. The plurality of arms may extend from 1 to 100% (and all values ​​and ranges therebetween) along the longitudinal length of the shaping shaft. The shaping shaft may have a body of unrestricted shape. Each arm may have the same or different dimensions, shape, thickness, length, width, and / or construction. Typically, two or more or all adjacently positioned arms are equidistant from each other around the outer periphery of the body of the shaping shaft; however, this is not required. Typically, the arms are formed of the same material as the body of the shaping shaft; however, this is not required. The length of each arm is typically 2 to 40 mm (and all values ​​and ranges therebetween; 3 to 30 mm, etc.). Each arm initially extends from the outer surface of the body of the radially retractable insert at an angle of 5 to 175° (and all values ​​and ranges therebetween). The angles of two or more or all arms may be the same or different. The shape of the arms extending from the outer surface of the body may be straight, curved, wavy, etc. The number, shape, size, and construction of the arms on the forming axis are selected to facilitate the desired folding of the leaflets when the prosthetic heart valve is initially rolled up. One or more arms of the forming axis and / or arms may be formed of non-flexible or rigid materials such that during the roll-up of the prosthetic heart valve, one or more arms of the axis and / or arms deflect or bend by 0 to 10% (and all values ​​and ranges therebetween). In a non-limiting configuration, one or more arms of the axis and / or arms are formed of rigid plastic, ceramic, metallic, and / or composite materials. A shaping shaft having one or more arms is configured such that when the prosthetic heart valve is rolled up, the leaflets engage in the arms, and the leaflets are initially folded in a certain manner based on the engagement with the arms and the radial reduction of the frame of the prosthetic heart valve. Once the prosthetic heart valve is partially rolled up, the shaping shaft is completely removed from the interior of the prosthetic heart valve, and the prosthetic heart valve is then subjected to a final roll-up process to fully roll up the prosthetic heart valve. During the final roll-up process, the leaflets continue to be folded in a desired manner, thereby reducing or maximizing the reduction of the leaflet volume after the prosthetic heart valve is fully rolled up. This continuous desired leaflet folding is at least partially or completely a result of the initial folding of the leaflets when using a radially collapsible insert. In a non-limiting configuration, the shaping shaft includes three arms. Each of the three arms has a substantially identical shape, thickness, length, width, and construction. The three arms are spaced apart such that adjacent positioned arms are equidistantly spaced from each other around the outer periphery of the body of the shaping shaft.Each arm extends 5 to 50% (and all values ​​and ranges therebetween) the longitudinal length of the radial forming shaft. Each arm has a slightly curved shape, a length of 3 to 10 mm (and all values ​​and ranges therebetween), and an angle α of 15 to 60° (and all values ​​and ranges therebetween). After the forming shaft is removed from the prosthetic heart valve, the curling process that can be used to complete the curling of the prosthetic heart valve may include a) a conventional prior art curling process in which the entire prosthetic heart valve is subjected to a curling force, b) a stepped curling process in which a portion of the prosthetic heart valve is subjected to a curling force, and then the remaining portion of the prosthetic heart valve is subjected to a curling force, and / or c) a progressive continuous curling process in which the curling of the prosthetic heart valve begins at the inflow or outflow end and the curling continues continuously along the longitudinal length of the prosthetic heart valve to the opposite ends of the prosthetic heart valve. In one non-limiting method, during use of the shaping shaft, when it is at least partially inserted into the prosthetic heart valve, the shaping shaft may be held or mounted so as not to rotate during partial curling of the prosthetic heart valve. In another non-limiting method, during use of the shaping shaft, when it is at least partially inserted into the prosthetic heart valve, the shaping shaft may be allowed to rotate during partial curling of the prosthetic heart valve.

[0023] According to another non-limiting aspect of this disclosure, another apparatus and method for folding leaflets on a prosthetic heart valve are provided, the method comprising the step of: inserting a folding guide device at least partially into the interior of the prosthetic heart valve prior to the curling of the prosthetic heart valve. The folding guide device includes two or more pins configured to engage portions of two or more leaflets when the prosthetic heart valve is partially curled. The pins of the folding guide device may be configured such that one or more of the pins can be inserted 10 to 100% (and all values ​​and ranges therebetween) along the longitudinal length of the prosthetic heart valve. The pins may be configured such that one or more of the pins have the same shape, size, length, width, cross-sectional shape, and / or construction. The pins may be oriented such that two or more of adjacently positioned pins have the same spacing from each other. In one non-limiting arrangement, the width and / or thickness of one or more of the pins is 0.02 to 8 mm (and all values ​​and ranges therebetween; 0.05 to 5 mm, etc.). One or more prongs are typically configured to be flexible, so that when the prosthetic heart valve is partially rolled up, one or more prongs bend. The materials used to form the folding guide device are not limited (e.g., metals, plastics, paper, composites, etc.). During use, before rolling up the prosthetic heart valve, the prongs of the folding guide device are inserted into the interior of the prosthetic heart valve along a portion or the entire longitudinal length of the valve. When the prosthetic heart valve is partially rolled up, the prongs on the folding guide device engage one or more leaflets, causing the leaflets to initially fold in a certain manner based on the engagement of the leaflets with the prongs of the folding guide device. During the partial rolling up of the prosthetic heart valve, the prongs of the folding guide device bend due to inward radial forces exerted on the prongs through the leaflets and / or frame of the prosthetic heart valve. Once the prosthetic heart valve is partially rolled up, the folding guide device is removed from the interior of the prosthetic heart valve, and the prosthetic heart valve is subsequently subjected to a final rolling process to fully roll up the valve. During the final curling process, the leaflets continue to fold in the desired manner, thereby reducing or maximizing the reduction of leaflet volume after the prosthetic heart valve is fully curled. This continuous, desired leaflet folding is at least partially or completely a result of the initial leaflet folding when using a folding guide device. The type of curling process used to partially curl the prosthetic heart valve during the curling process involving the use of a folding guide device is not limited.Such curling processes may include a) conventional prior art curling processes in which the entire prosthetic heart valve is subjected to curling forces, b) step-curling processes in which a portion of the prosthetic heart valve is subjected to curling forces and then other portions of the prosthetic heart valve are subjected to curling forces, and / or c) progressive continuous curling processes in which the curling of the prosthetic heart valve begins at the inflow or outflow end and the curling continues continuously along the longitudinal length of the prosthetic heart valve to the opposite ends of the prosthetic heart valve. After the folded guide device is removed from the prosthetic heart valve, the curling process used to complete the curling of the prosthetic heart valve may include a) a conventional prior art curling process, wherein the entire prosthetic heart valve is subjected to a curling force; b) a stepped curling process, wherein a portion of the prosthetic heart valve is subjected to a curling force, and then other portions of the prosthetic heart valve are subjected to a curling force; and / or c) a progressive continuous curling process, wherein the curling of the prosthetic heart valve begins at the inflow or outflow end and the curling continues continuously along the longitudinal length of the prosthetic heart valve to the opposite ends of the prosthetic heart valve. In a non-limiting method, during use of the folded guide device, when it is at least partially inserted into the prosthetic heart valve, the folded guide device may be held or mounted so as not to rotate during the partial curling of the prosthetic heart valve. In another non-limiting method, during use of the folded guide device, when it is at least partially inserted into the prosthetic heart valve, the folded guide device may be allowed to rotate during partial curling of the prosthetic heart valve. In a non-limiting embodiment, the folded guide device includes three prongs. Each of the three prongs has a substantially identical shape, thickness, length, width, and construction. The three prongs are spaced apart such that adjacently positioned prongs are equidistant from each other. Each of the three prongs is configured to extend 10% to 100% (and all values ​​and ranges therebetween) of the longitudinal length inside the prosthetic heart valve. The thickness and / or width of each of the three prongs is 0.05 to 3 mm (and all values ​​and ranges therebetween).

[0024] In another non-limiting aspect of this disclosure, a leaflet folding device is provided, which may optionally be used in conjunction with a curler device according to this disclosure to facilitate obtaining a leaflet folded configuration during the curling of a prosthetic heart valve frame, wherein the leaflet folding device includes a handle portion and one or more leaflet engagement members attached to and extending from the handle portion. In one non-limiting configuration, the handle portion is sized and shaped such that it can be gripped by a user to enable the user to position one or more leaflet engagement members into a portion of the prosthetic heart valve, thereby bending one or more leaflets. The shape and length of the handle portion, as well as its material and dimensions, are non-limiting. In one non-limiting specific configuration, the handle portion has a cylindrical shape and a length of 1 to 12 inches (and all values ​​and ranges therebetween), and its cross-sectional area is 10 to 95% (and all values ​​and ranges therebetween) of the cross-sectional area of ​​the outflow end of the frame before curling (e.g., the cross-sectional area of ​​the outflow end of the frame in a fully expanded position). In another non-limiting configuration, one or more leaflet engagement members are attached to the distal end or distal end of the handle portion. The type of connection used to attach one or more leaflet engagement members to the handle is non-limiting. In one non-limiting configuration, one or more leaflet engagement members extend radially outward from the central longitudinal axis of the handle portion (e.g., radially outward from 5 to 45° and all values ​​and ranges therebetween). When the leaflet folding device includes two or more leaflet engagement members, two or more or all of the leaflet engagement members may have the same size, shape and / or be formed of the same material; however, this is not required. In another non-limiting configuration, one or more leaflet engagement members are formed of a flexible material that allows one or more leaflet engagement members to flex and / or bend: a) when positioning one or more leaflet engagement members around one or more leaflets, and / or b) during the curling of the frame of the prosthetic heart valve and while one or more leaflet engagement members remain engaged with one or more leaflets during the curling of the frame. In another non-limiting configuration, one or more leaflet engaging members are each formed from a wire loop (e.g., a metal wire loop, a plastic wire loop, etc.). In yet another non-limiting embodiment, the leaflet folding device moves along the longitudinal axis of the frame and toward the frame until one or more leaflet engaging members engage the ends or tips of one or more leaflets. Thereafter, the leaflet folding device continues to move along the longitudinal axis of the frame, such that the ends or tips of one or more leaflet engaging members move between one or more leaflets and the inner surface of the frame. As the leaflet folding device continues to move along the longitudinal axis of the frame, the angular orientation of one or more leaflet engaging members relative to the central axis of the handle portion of the leaflet folding device causes the ends and tips of the leaflets to bend toward the central axis of the frame.Typically, the size and construction of the end regions of one or more leaflet engagement members inhibit or prevent the ends or end regions of one or more leaflet engagement members from passing through lateral openings in the frame of the prosthetic heart valve. Furthermore, one or more leaflet engagement members are typically inserted only a portion of the longitudinal length through the frame (e.g., 1 to 80% of the longitudinal length and all values ​​and ranges therebetween). In a non-limiting method of use, one or more leaflet engagement members are inserted only a portion of the longitudinal length through the frame and spaced apart from the areas of the frame where one or more leaflets connect to the frame.

[0025] In another non-limiting aspect of this disclosure, a leaflet folding device is provided, which may optionally be used in conjunction with a curler device according to this disclosure to facilitate obtaining a leaflet folding configuration during the curling of the frame of a prosthetic heart valve, thereby obtaining the desired folded leaflet configuration after the frame has been fully curled, and wherein the leaflet folding device includes a cylindrical body portion configured to be partially or completely inserted into the prosthetic device: a) before the initial curling of the prosthetic heart valve frame, and / or b) during the curling of the prosthetic heart valve frame. The cylindrical body portion may be a) a solid structure, b) a hollow structure including cavities extending partially or completely along the longitudinal length of the cylindrical body, or c) a cylindrical body including one or more internal void spaces and / or surface cavities. The diameter and / or cross-sectional area of ​​the cylindrical body portion configured to insert into the prosthetic heart valve may be a) constant for 50 to 100% (and all values ​​and ranges therebetween) along the longitudinal length of such cylindrical body portion, or b) vary along the longitudinal length of such cylindrical body portion. The cylindrical body portion may optionally be formed of a flexible material (e.g., plastic, foam, etc.). In one non-limiting configuration, the outer diameter of the cylindrical body portion of the leaflet folding device configured to partially or completely insert into the prosthetic device is approximately 5 to 90% (and all values ​​and ranges therebetween) of the inner diameter of the frame of the prosthetic heart valve before it is rolled up. In another non-limiting method, the cylindrical body portion of the leaflet folding device is removed from the frame of the prosthetic heart valve before the inner diameter of the frame of the prosthetic heart is reduced during the rolling process to a diameter 0 to 20% (and all values ​​and ranges therebetween) larger than the outer diameter of the cylindrical body portion of the leaflet folding device. In one non-limiting method of use, the cylindrical body portion of the leaflet folding device is positioned within the region of the leaflet, such that the leaflet is located between the cylindrical body portion of the leaflet folding device and the frame. During the curling of the frame of the prosthetic heart valve, the cylindrical body portion of the leaflet folding device can a) move along the longitudinal axis of the frame and / or b) rotate about the longitudinal axis of the frame.

[0026] In another non-limiting aspect of this disclosure, the medical device is a valve (e.g., a heart valve, a TAVR valve, aortic valve, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement, etc.). In one non-limiting embodiment, the medical device includes an expandable frame; more specifically, the medical device is in the form of a cardiovascular implant for treating structural heart disease, wherein the cardiovascular implant includes an expandable frame; and more specifically, the medical device is in the form of a prosthetic heart valve for treating structural heart disease, wherein the prosthetic heart valve includes an expandable frame optionally formed of a rhenium-containing metal alloy.

[0027] In another non-limiting aspect of this disclosure, the medical device is a valve comprising a frame formed of a rhenium-containing metal alloy, which allows for novel geometries of structural prosthetic heart valve frames. The combination of the rhenium-containing metal alloy and the novel geometry of the prosthetic heart valve frame addresses the current deficiencies of prosthetic heart valves discussed above. The novel geometry of the prosthetic heart valve frame, combined with a frame formed partially (e.g., 10 to 99.99% by weight and all values ​​and ranges therein) or entirely of a rhenium-containing alloy, enables the formation of a frame that a) has an open geometries that can be used to reduce the size of the delivery system, thereby reducing vascular and neurological complications; b) has an open structure that has high radial strength due to the high yield strength and ultimate tensile strength of the rhenium-containing metal alloy; and c) improves the recovery of physiological EOA in challenging, severely calcified valves, which are superior to bioprosthetic valves. Increased force while allowing for a smaller vascular access coil diameter; d) Improved recovery of physiological EOA, thus extending the lifespan of the bioprosthetic valve; e) Lower rebound than conventional materials used for frame formation, such as stainless steel, chromium-cobalt, or titanium alloys, resulting in less frame rebound during expansion, leading to a reduced risk of valvular embolism; reduced paravalvular leakage due to improved fit to the native anatomy; more precise recovery of physiological EOA; and reduced conduction system damage due to the smaller balloon inflation diameter required to achieve physiological EOA after balloon inflation; f) Features an openwork geometry. The valve is configured to have very little (e.g., 0 to 20% longitudinal fluoroscopic shortening along the longitudinal axis of the expandable frame and all values ​​and ranges therebetween) or no fluoroscopic shortening upon expansion. This allows for more precise placement of the valve within the native annulus, and the frame with little or no longitudinal fluoroscopic shortening upon expansion can be expanded with a shorter balloon. Using a shorter balloon for frame expansion reduces conduction system damage. g) It has occlusion margin alignment marks and openings between the occlusion margins, which allows for proper placement of the bioprosthetic valve relative to the valve's native occlusion margins to achieve the desired effect regarding the valve. The proper hemodynamic function of the valve, including flushing and blood flow to the coronary arteries, results in better valve durability and lifespan, as well as accessibility and re-intervention in the coronary arteries, thus preventing future adverse events; h) it has an openwork geometry with radial and longitudinal symmetry and little or no longitudinal fluoroscopic shortening, which allows for symmetrical and cylindrical expansion of the prosthetic valve, resulting in a lower rate of leaflet thrombosis and structural valve degeneration; and i) it is formed of a rhenium-containing metal alloy without nickel content, which prevents allergic reactions due to the presence of nickel and restenosis associated with nickel content.

[0028] In one non-limiting aspect of this disclosure, a prosthetic heart valve (e.g., a heart valve, a TAVR valve, a mitral valve replacement, a tricuspid valve replacement, a pulmonary valve replacement, etc.) includes a radially collapsible and expandable frame and a leaflet structure comprising multiple leaflets. In another non-limiting embodiment, the prosthetic heart valve optionally includes an annular skirt or covering member disposed over and partially or completely covering or covering at least a portion of the openings in the frame. In yet another non-limiting embodiment, the frame of the prosthetic heart valve includes a plurality of interconnected axial longitudinal members, angled hinge members, and strut connectors defining a plurality of openings in the frame.

[0029] In another and / or alternative non-limiting aspect of this disclosure, the framework of the prosthetic heart valve is optionally formed, in part or entirely, of a) a refractory metal alloy and / or b) a metal alloy comprising at least 15 atomic weight percent (AJ%) or atomic percentage percent (AJ%) of rhenium, in order to produce a “rhenium effect” in the metal alloy. As used herein, atomic weight percent (AJ%) or atomic percentage (AJ%) or atomic percentage (AJ%) are used interchangeably. As defined herein, a weight percent (wt%) of an element is the weight of that element measured in a sample divided by the weight of all elements in the sample multiplied by 100. An atomic percentage or atomic weight percent (AJ%) is the number of atoms of that element at that weight percent divided by the total number of atoms in the sample multiplied by 100. The use of the terms weight percent (wt%) and atomic percentage or atomic weight percent (AJ%) refers to two ways of referring to metal alloys and their composition. It has been found that for several metal alloys, the presence 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 presence 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. As defined herein, a refractory metal alloy is a metal alloy containing 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. In one non-limiting arrangement, 50 to 100% by weight (and all values ​​and ranges therebetween) of the expandable frame of the prosthetic heart valve is made of a refractory metal alloy or a metal alloy containing at least 15 atomic weights of rhenium. In another non-limiting arrangement, the metal alloy used to partially or completely form the expandable frame of the prosthetic heart valve contains at least 30% by weight (e.g., 30 to 99% by weight and all values ​​and ranges therebetween) of one or more of molybdenum, rhenium, niobium, tantalum, or tungsten.In another non-limiting embodiment, a refractory metal alloy or a metal alloy containing at least 15 atomic weight % rhenium can be used to 1) improve the radiation impermeability of the prosthetic heart valve frame, 2) improve the radial strength of the prosthetic heart valve frame, 3) improve the yield strength and / or ultimate tensile strength of the prosthetic heart valve frame, 4) improve the stress-strain characteristics of the prosthetic heart valve frame, 5) improve the curling and / or expansion characteristics of the prosthetic heart valve frame, and 6) improve the frame of the prosthetic heart valve. 7) Improve the flexibility and / or suppleness of the prosthetic heart valve frame; 8) Improve the rigidity of the prosthetic heart valve frame; 9) Improve the biocompatibility and / or biostability of the prosthetic heart valve frame; 10) Improve the fatigue resistance of the prosthetic heart valve frame; 11) Resist cracking in the prosthetic heart valve frame; 12) Resist crack propagation in the prosthetic heart valve frame; 13) Enable the manufacture of smaller, thinner, and / or lighter-weight valves. The framework of the prosthetic heart valve, 14) promotes the reduction of the outer diameter of the coiled prosthetic heart valve, 15) improves the fit of the framework of the prosthetic heart valve to the shape of the treatment area when the prosthetic heart valve expands in the treatment area, 16) reduces the rebound of the framework after the prosthetic heart valve expands in the treatment area, 17) reduces adverse tissue reactions caused by the framework of the prosthetic heart valve, 18) reduces the release of metal ions from the framework after the prosthetic heart valve is implanted, 19) reduces the... 20) Reduce corrosion of the prosthetic heart valve frame, 21) Reduce allergic reactions caused by the prosthetic heart valve frame after implantation (e.g., reduce the nickel content of the metal alloy), 22) Increase the hydrophilicity of the prosthetic heart valve frame, 23) Reduce the magnetization of the prosthetic heart valve stent, 24) Reduce the longitudinal fluoroscopic shortening of the prosthetic heart valve frame when the frame expands, and / or 25) Reduce the toxicity of the prosthetic heart valve frame after implantation.

[0030] In another and / or alternative non-limiting aspect of this disclosure, the framework of the prosthetic heart valve is optionally partially (e.g., 1 to 99.999% by weight and all values ​​and ranges therein) or entirely formed of a metallic material including a) stainless steel, b) CoCr alloy, c) TiAlV alloy, d) aluminum alloy, e) nickel alloy, f) titanium alloy, g) tungsten alloy, h) molybdenum alloy, i) copper alloy, j) beryllium-copper alloy, k) titanium-nickel alloy, l) refractory metal alloy or m) a metallic alloy containing at least 5 atomic weight percent (atomic weight%) or atomic weight percent (atomic weight%) rhenium (e.g., 5 to 99 atomic weight percent rhenium and all values ​​and ranges therein) (e.g. stainless steel, CoCr alloy, TiAlV alloy, aluminum alloy, nickel alloy, titanium alloy, tungsten alloy, molybdenum alloy, copper alloy, beryllium-copper alloy, titanium-nickel alloy, refractory metal alloy, etc.). As defined herein, stainless steel alloys (SS alloys) comprise at least 50 wt% iron, 10 to 28 wt% chromium, 0 to 35 wt% nickel, and optionally 0 to 4 wt% molybdenum, 0 to 2 wt% manganese, 0 to 0.75 wt% silicon, 0 to 0.3 wt% carbon, 0 to 5 wt% titanium, 0 to 10 wt% niobium, 0 to 5 wt% copper, 0 to 4 wt% aluminum, 0 to 10 wt% tantalum, 0 to 1 wt% selenium, 0 to 2 wt% vanadium, and 0 to 2 wt% tungsten. 316L alloys, which are stainless steel alloys, comprise 17 to 19 wt% chromium, 13 to 15 wt% nickel, 2 to 4 wt% molybdenum, up to 2 wt% manganese, up to 0.75 wt% silicon, up to 0.03 wt% carbon, and the balance iron. As defined herein, a cobalt-chromium alloy (CoCr alloy) comprises 30 to 68 wt% cobalt, 15 to 32 wt% chromium, and optionally 1 to 38 wt% nickel, 2 to 18 wt% molybdenum, 0 to 18 wt% iron, 0 to 1 wt% titanium, 0 to 0.15 wt% manganese, 0 to 0.15 wt% silver, 0 to 0.25 wt% carbon, 0 to 16 wt% tungsten, 0 to 2 wt% silicon, 0 to 2 wt% aluminum, 0 to 1 wt% iron, 0 to 0.1 wt% boron, 0 to 0.15 wt% silver, and 0 to 2 wt% titanium. For example, the MP35N alloy, which belongs to the CoCr alloy category, 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% boron, 0 to 0.15 wt% silver, and the balance cobalt. As defined herein, the Phynox and Elgiloy alloys, which belong to the CoCr alloy category, 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 L605 alloy, belonging to the CoCr alloy category, comprises 18 to 22 wt% chromium, 14 to 16 wt% tungsten, 9 to 11 wt% nickel, and the balance cobalt. As defined herein, the titanium-aluminum-vanadium alloy (TiAlV alloy) comprises 4 to 8 wt% aluminum, 3 to 6 wt% vanadium, 80 to 93 wt% titanium, and optionally 0 to 0.4 wt% iron, 0 to 0.2 wt% carbon, and 0 to 0.5 wt% yttrium, or more. The Ti-6Al-4V alloy, belonging to the TiAlV alloy category, comprises 3.5 to 4.5 wt% vanadium, 5.5 to 6.75 wt% aluminum, up to 0.3 wt% iron, up to 0.08 wt% carbon, up to 0.05 wt% yttrium, and the balance titanium. As defined herein, the aluminum alloy comprises 80 to 99 wt% aluminum and optionally 0 to 12 wt% silicon, 0 to 5 wt% magnesium, 0 to 1 wt% manganese, 0 to 0.5 wt% scandium, 0 to 0.5 wt% beryllium, 0 to 0.5 wt% yttrium, 0 to 0.5 wt% cerium, 0 to 0.5 wt% chromium, 0 to 3 wt% iron, 0 to 0.5, 0 to 9 wt% zinc, 0 to 0.5 wt% titanium, 0 to 3 wt% lithium, 0 to 0.5 wt% silver, 0 to 0.5 wt% calcium, 0 to 0.5 wt% zirconium, 0 to 1 wt% lead, 0 to 0.5 wt% cadmium, 0 to 0.05 wt% bismuth, 0 to 1 wt% nickel, 0 to 0.2 wt% vanadium, 0 to 0.1 wt% gallium, and 0 to 7 wt% copper, or more of these. As defined herein, the nickel alloy comprises 30 to 98 wt% nickel and optionally 5 to 25 wt% chromium, 0 to 65 wt% iron, 0 to 30 wt% molybdenum, 0 to 32 wt% copper, 0 to 32 wt% cobalt, 2 to 2 wt% aluminum, 0 to 6 wt% tantalum, 0 to 15 wt% tungsten, 0 to 5 wt% titanium, 0 to 6 wt% niobium, and 0 to 3 wt% silicon. As defined herein, the titanium alloy comprises 80 to 99 wt% titanium and optionally 0 to 6 wt% aluminum, 0 to 3 wt% tin, 0 to 1 wt% palladium, 0 to 8 wt% vanadium, 0 to 15 wt% molybdenum, 0 to 1 wt% nickel, 0 to 0.3 wt% ruthenium, 0 to 6 wt% chromium, 0 to 4 wt% zirconium, 0 to 4 wt% niobium, 0 to 1 wt% silicon, 0.05 wt% cobalt, and 0 to 2 wt% iron. As defined herein, the tungsten alloy comprises 85 to 98 wt% tungsten and optionally 0 to 8 wt% nickel, 0 to 5 wt% copper, 0 to 5 wt% molybdenum, and 0 to 4 wt% iron. As defined herein, the molybdenum alloy comprises 90 to 99.5 wt% molybdenum and optionally 0 to 1 wt% nickel, 0 to 1 wt% titanium, 0 to 1 wt% zirconium, 0 to 30 wt% tungsten, 0 to 2 wt% hafnium, and 0 to 2 wt% lanthanum.As defined herein, copper alloys comprise 55 to 95 wt% copper and optionally 0 to 40 wt% zinc, 0 to 10 wt% tin, 0 to 10 wt% lead, 0 to 1 wt% iron, 0 to 5 wt% silicon, 0 to 12 wt% manganese, 0 to 12 wt% aluminum, 0 to 3 wt% beryllium, 0 to 1 wt% cobalt, and 0 to 20 wt% nickel. As defined herein, beryllium-copper alloys comprise 95 to 98.5 wt% copper, 1 to 4 wt% beryllium, and optionally 0 to 1 wt% cobalt and 0 to 0.5 wt% silicon. As defined herein, titanium-nickel alloys (e.g., nickel-titanium alloys) comprise 42 to 58 wt% nickel and 42 to 58 wt% titanium.

[0031] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the framework of a prosthetic heart valve comprises at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) rhenium and at least 0.1 to 96 wt percent (and all values ​​and ranges therebetween) one or more additives selected from the group consisting of: aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium, and the metal alloy optionally comprises 0 to 2 wt percent (and all values ​​and ranges therebetween) of other components (e.g., carbon, oxygen, phosphorus, sulfur, hydrogen, lead, nitrogen, etc.) and the metal alloy exhibits a rhenium effect. In one non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a stainless steel alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a cobalt-chromium alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a TiAlV alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is an aluminum alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a nickel alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a titanium alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a tungsten alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a molybdenum alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a copper alloy modified to contain at least 15 atomic weight percent rhenium. In another non-limiting embodiment, the frame for partially or completely forming the prosthetic heart valve is a beryllium-copper alloy modified to contain at least 15 atomic weight percent rhenium.

[0032] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the framework of the prosthetic heart valve comprises rhenium and molybdenum, and the weight percentage of rhenium in the metal alloy is optionally greater than the weight percentage of molybdenum in the metal alloy, and the weight percentage of one or more additives in the metal alloy (e.g., aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium) is optionally greater than the weight percentage of molybdenum in the metal alloy, and the metal alloy optionally comprises 0 to 2% by weight of a combination of other components (e.g., carbon, oxygen, phosphorus, sulfur, hydrogen, lead, nitrogen, etc.) excluding additives. In a non-limiting embodiment, the metal alloy used to partially or completely form the prosthetic heart valve framework comprises rhenium and molybdenum, and the weight percentage of rhenium plus the combined weight percentage of additives is greater than the weight percentage of molybdenum, and the metal alloy optionally comprises 0 to 2% by weight of a combination of other components (e.g., carbon, oxygen, phosphorus, sulfur, hydrogen, lead, nitrogen, etc.) other than additives.

[0033] According to another and / or alternative aspect of the invention, the metal alloy used to partially or completely form the framework of the prosthetic 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).

[0034] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the framework of a prosthetic heart valve comprises at least 5 atomic weight percent (e.g., 5 to 99 atomic weight percent and all values ​​and ranges therebetween) of 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 comprising other elements and compounds is present in a content of 0 to 0.1 wt%. In another non-limiting embodiment, the metal alloy comprises rhenium, molybdenum, and chromium. In another non-limiting embodiment, the metal alloy comprises at least 35 wt percent (e.g., 35 to 75 wt percent and all values ​​and ranges therebetween) of 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, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc and / or zirconium, and the metal alloy optionally comprises 0 to 2% by weight (and all values ​​and ranges therebetween) of other metals, carbon, oxygen, phosphorus, sulfur, hydrogen and / or nitrogen combinations. In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % chromium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % tantalum (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % niobium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % titanium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % zirconium (and all values ​​and ranges therebetween). In another non-limiting embodiment, the metal alloy comprises 15 to 50 atomic weight % rhenium (and all values ​​and ranges therebetween) and 0.5 to 70 atomic weight % 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 to 80 wt percent and all values ​​and ranges therein), 15 to 45 wt percent niobium (and all values ​​and ranges therein), 0 to 10 wt percent zirconium (and all values ​​or ranges therein), 0 to 15 wt percent tantalum (and all values ​​and ranges therein), and 0 to 8 wt percent molybdenum (and all values ​​or ranges therein).

[0035] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is partially or completely formed of a refractory metal alloy, wherein the refractory metal alloy contains at least 20% by weight of one or more of niobium, tantalum or tungsten, and wherein the refractory metal alloy contains 0 to 30% by weight of molybdenum (and all values ​​and ranges therebetween), and wherein the refractory metal alloy contains at least 5% by weight of rhenium (e.g., 5 to 80% by weight of rhenium and all values ​​and ranges therebetween).

[0036] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is partially or completely formed of a metal alloy comprising at least 5 atomic weight % rhenium (e.g., 5 to 99 atomic weight % rhenium and all values ​​and ranges therebetween) and at least 0.1 weight % of one or more of the following: aluminum, bismuth, chromium, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, nickel, niobium, osmium, rhodium, ruthenium, silicon, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, and zirconium, and wherein the metal alloy comprises 0 to 30 weight % molybdenum (and all values ​​and ranges therebetween), and wherein the combined weight percentage of rhenium and added metals is 70 to 100 weight % (and all values ​​and ranges therebetween).

[0037] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is formed partially or completely from a metal alloy of stainless steel that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of iron, chromium, nickel, tantalum, niobium, copper, manganese, aluminum, titanium, selenium, vanadium, tungsten and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0038] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is formed partially or completely from a cobalt-chromium alloy that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of cobalt, chromium, nickel, iron, titanium, manganese, silver, tungsten, silicon, aluminum, iron, boron, silver, titanium and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0039] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is partially or completely formed from a titanium-aluminum-vanadium alloy that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of aluminum, vanadium, titanium, iron, yttrium and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0040] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is formed from a metal alloy of aluminum alloy that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of aluminum, silicon, magnesium, manganese, scandium, beryllium, yttrium, cerium, chromium, iron, zinc, titanium, lithium, silver, calcium, zirconium, cadmium, bismuth, nickel, vanadium, gallium, copper and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0041] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is formed from a metal alloy of nickel alloy that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of nickel, chromium, iron, copper, cobalt, aluminum, tantalum, tungsten, titanium, niobium, silicon and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0042] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is formed from a metal alloy of titanium alloy that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of titanium, aluminum, tin, palladium, vanadium, nickel, ruthenium, chromium, zirconium, niobium, silicon, cobalt, iron and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0043] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is formed from a metal alloy of a tungsten alloy that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of tungsten, nickel, copper, iron and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0044] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is formed from a copper alloy that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of copper, zinc, tin, iron, silicon, manganese, aluminum, beryllium, cobalt, nickel and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0045] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form the medical device is formed partially or completely from a beryllium-copper alloy that has been modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of copper, beryllium, cobalt, silicon and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0046] According to another and / or alternative aspect of this disclosure, the metal alloy used to partially or completely form a medical device is formed from a titanium-nickel alloy that has been partially or completely modified with at least 5 atomic weight % rhenium (e.g., 5 to 50 atomic weight % rhenium and all values ​​and ranges therebetween), and wherein the combined weight percentage of nickel, titanium and rhenium is 70 to 100 wt% (and all values ​​and ranges therebetween).

[0047] According to a non-limiting aspect of this disclosure, a medical device of a non-limiting form of a prosthetic heart valve (e.g., a TAV valve, a mitral valve replacement, a tricuspid valve replacement, or a pulmonary valve replacement) is provided, the prosthetic heart valve comprising a radially collapsible and expandable frame and a leaflet structure including a plurality of leaflets. The prosthetic heart valve may optionally include an annular skirt or covering member disposed over and covering an opening in at least a portion of the frame. The frame may include a plurality of interconnected struts defining a plurality of openings within the frame.

[0048] According to another and / or alternative non-limiting aspect of this disclosure, a prosthetic heart valve is provided, comprising a frame, leaflet structures supported by the frame, and optional inner skirts fixed to the surfaces of the frame and / or leaflet structures. The prosthetic heart valve may be implanted in the annulus of an autologous aortic valve; however, the prosthetic heart valve may also be configured for implantation in other valves of the heart (e.g., tricuspid valve, pulmonary valve, mitral valve). The prosthetic heart valve has a “lower” end and an “upper” end, wherein the lower end of the prosthetic heart valve is the inflow end, and the upper end of the prosthetic heart valve is the outflow end.

[0049] According to another and / or alternative non-limiting aspect of this disclosure, at least a portion of the medical device is configured to be radially collapseable to a collapsed or coiled state for introduction into the body (e.g., on a delivery catheter, etc.) and radially expandable to an expanded state for implantation of the medical device at a desired location within the body. The frame of the medical device may be formed of a plastic expandable material that allows the frame to be coiled into a smaller profile for delivery and expansion. Expansion of the coiled frame of the medical device may be achieved by an expansion device, such as, but not limited to, a balloon on a balloon catheter.

[0050] According to another and / or alternative non-limiting aspect of this disclosure, a medical device is provided comprising a frame at least partially formed by a plurality of angled, vertically extending posts or supports. The posts or supports may optionally be interconnected via a lower row of circumferentially extending supports and an upper row of circumferentially extending supports. The supports may be arranged in various patterns (e.g., zigzag, sawtooth, triangular, polygonal, elliptical, etc.). One or more of the posts and / or supports may have the same or different thicknesses and / or cross-sectional shapes and / or cross-sectional areas.

[0051] According to another and / or alternative non-limiting aspect of this disclosure, a medical device is provided comprising a frame optionally coated with a polymeric material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biomaterial (e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives)). The coating may be used to partially or completely encapsulate struts on the frame and / or to fill openings between struts on the frame.

[0052] According to another and / or alternative non-limiting aspect of this disclosure, a medical device in the form of a prosthetic heart valve is provided, the prosthetic heart valve including 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 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.).

[0053] According to another and / or alternative non-limiting aspect of this disclosure, a medical device in the form of a prosthetic heart valve is provided, the prosthetic heart valve optionally including an inner skirt which is used to 1) at least partially seal and / or prevent paravalvular leakage, 2) at least partially secure the leaflet structure to a frame, 3) at least partially protect the leaflets from damage during curling and / or dilation processes, and / or 4) at least partially protect the leaflets from damage during operation of the prosthetic heart valve in the heart.

[0054] According to another and / or alternative non-limiting aspect of this disclosure, a medical device in the form of a prosthetic heart valve is provided, which optionally includes an outer skirt or sleeve positioned at least partially around an outer region of a frame. The outer skirt or sleeve is typically positioned completely around a portion of the outer side of the frame. Typically, the outer skirt is positioned around the lower part of the frame but does not completely cover the upper half of the frame; however, this is not required. The outer skirt can be attached to the frame by various methods, such as 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 can be formed of a variety of stretchable and / or compressible materials, such as 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).

[0055] According to another and / or alternative non-limiting aspect of this disclosure, a medical device in the form of a prosthetic heart valve is provided, the prosthetic heart valve comprising a leaflet structure capable of attaching 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, 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.

[0056] According to another and / or alternative non-limiting aspect of this disclosure, a medical device in the form of a prosthetic heart valve is provided, the prosthetic heart valve comprising a leaflet structure consisting of two or more leaflets (e.g., 2, 3, 4, 5, 6, etc.). In a 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.

[0057] According to another and / or alternative non-limiting aspect of this disclosure, a medical device in the form of a prosthetic heart valve is provided, the prosthetic heart valve including a leaflet structure wherein the leaflets of the leaflet structure are optionally fixed to each other on adjacent sides to form a mating edge (the edge where the leaflets meet) of the leaflet structure. The leaflet structures can be fixed together by a variety of connection methods (e.g., sutures, adhesives, fusion bonding, clamping devices, etc.).

[0058] According to another and / or alternative non-limiting aspect of this disclosure, a medical device in the form of a prosthetic heart valve is provided, the prosthetic heart valve including 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.

[0059] According to another and / or alternative non-limiting aspect of this disclosure, at least a portion of the metal alloy used to form the medical device optionally has one or more enhanced properties (e.g., strength, durability, hardness, biocompatibility, flexural properties, coefficient of friction, radial strength, flexibility, tensile strength, elongation at break, longitudinal elongation, stress-strain characteristics, reduced springback, radiation impermeability, thermal sensitivity, biocompatibility, extended fatigue life, crack resistance, crack propagation resistance, reduced magnetization, etc.), enhanced conformability upon bending, less springback, increased yield strength, enhanced fatigue ductility, enhanced durability, extended fatigue life, reduced adverse tissue reactions, reduced metal ion release, reduced corrosion, reduced allergic reactions, enhanced hydrophilicity, reduced toxicity, reduced metal component thickness, enhanced bone fusion, and / or lower ion release into tissue. These improved physical properties of the metal alloy can be achieved in the medical device or its parts (e.g., the frame of the medical device) without increasing the volume, size, and / or weight of the medical device or its parts (e.g., the frame of the medical device), and in some cases, even when the volume, size, and / or weight of the medical device or its parts (e.g., the frame of the medical device) is reduced compared to a medical device or its frame that is at least partially made of conventional stainless steel, titanium alloy, or cobalt and chromium alloy materials.

[0060] According to another and / or alternative non-limiting aspect of this disclosure, the metallic alloy used to at least partially form a medical device or a portion thereof (e.g., a frame of a medical device, etc.) may optionally: 1) increase the radiopaqueness of the medical device or a portion thereof (e.g., a frame of a medical device, etc.), 2) increase the radial strength of the medical device or a portion thereof (e.g., a frame of a medical device, etc.), 3) increase the yield strength and / or ultimate tensile strength of the medical device or a portion thereof (e.g., a frame of a medical device, etc.), 4) improve the stress-strain characteristics of the medical device or a portion thereof (e.g., a frame of a medical device, etc.), 5) improve the performance of the medical device or a portion thereof (e.g., a frame of a medical device, etc.). 6) Improve the bending and / or expansion properties of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 7) Improve the strength and / or durability of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 8) Increase the stiffness of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 9) Improve the resilience of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 10) Improve the biostability and / or biocompatibility of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 11) Increase the fatigue resistance of the medical device or a part of the medical device (e.g., the frame of the medical device, etc.), 12) Resist the 13) Enables the manufacture of smaller, thinner, and / or lighter medical devices or parts of medical devices (e.g., frames of medical devices), 14) Reduces the outer diameter of curled medical devices or parts of medical devices (e.g., frames of medical devices), 15) Improves the fit of the medical device or parts of medical devices (e.g., frames of medical devices) to the shape of the treatment area when used and / or expanded in the treatment area, and 16) Reduces the impact of cracking when the medical device or parts of medical devices (e.g., frames of medical devices) expand in the treatment area. 17) The amount by which a medical device or a portion thereof (e.g., the frame of a medical device) springs back to the shape of the treatment area; 18) Increasing the yield strength of a medical device or a portion thereof (e.g., the frame of a medical device); 19) Improving the fatigue ductility of a medical device or a portion thereof (e.g., the frame of a medical device); 20) Reducing adverse tissue reactions after implantation of a medical device or a portion thereof (e.g., the frame of a medical device); 21) Reducing adverse tissue reactions after implantation of a medical device or a portion thereof (e.g., the frame of a medical device);22) Reduce the release of metal ions after implantation of the medical device or its components (e.g., the frame of the medical device), 23) Reduce allergic reactions after implantation of the medical device or its components (e.g., the frame of the medical device), 24) Increase the hydrophilicity of the medical device or its components (e.g., the frame of the medical device), 25) Reduce the thickness of the metal parts of the medical device or its components (e.g., the frame of the medical device), 26) Improve bone fusion with the medical device or its components (e.g., the frame of the medical device), and / or 27) Reduce the release of ions from the medical device or its components (e.g., the frame of the medical device) into the tissue, 28) Reduce the magnetic susceptibility of the medical device or its components (e.g., the frame of the medical device) when implanted in a patient, and / or 29) Reduce the toxicity of the medical device or its components (e.g., the frame of the medical device) after implantation of the prosthetic medical device.

[0061] According to another and / or alternative non-limiting aspect of this disclosure, the use of a metal alloy to partially or completely form the frame of a prosthetic heart valve, compared to stainless steel, chromium-cobalt alloys, or titanium alloys, can optionally increase the strength, stiffness, and / or durability of the medical device or a portion thereof (e.g., the frame of the medical device, etc.); thus, a smaller amount of metal alloy can be used in the medical device or a portion thereof (e.g., the frame of the medical device, etc.) to achieve similar strength compared to a medical device or a frame thereof formed of a different metal. Therefore, by using a metal alloy, the resulting medical device can be made smaller and more voluminous without sacrificing strength and durability. Such medical devices can have smaller profiles, thus allowing insertion into smaller areas, openings, and / or channels. The metal alloy can also increase the radial strength of the medical device. For example, the walls of the medical device or a portion thereof (e.g., the frame of the medical device, etc.) and / or the thickness of the wires used to at least partially form the medical device or a portion thereof can be made thinner and achieve similar or improved radial strength compared to a thicker-walled medical device formed of stainless steel, titanium alloys, or cobalt and chromium alloys. Metal alloys can also improve the stress-strain characteristics, bending properties, and flexibility of medical devices, thereby extending their lifespan. For example, medical devices can be used in areas where they are subjected to bending. Because metal alloys improve the physical properties of the medical device, it exhibits enhanced fracturing resistance in such frequent bending environments. Alternatively, the improved bending and flexibility of the medical device due to the use of metal alloys makes it easier to insert the device into various areas of the body. Metal alloys can also reduce the degree of springback during the curling and / or expansion of the medical device. For example, due to the use of metal alloys, the medical device better maintains its curled form and / or better maintains its expanded form after expansion. Therefore, when the medical device is mounted onto a delivery device while curled, it better maintains its smaller profile during insertion into various areas of the body. Furthermore, the medical device better maintains its expanded profile after expansion, promoting successful placement in the treatment area. In addition to the improved physical properties of medical devices achieved through the use of metallic alloys, they also offer enhanced radiopaque properties compared to standard materials such as stainless steel or cobalt-chromium alloys, thereby reducing or eliminating the need for marking materials on medical devices. For example, metallic alloys are believed to have at least 10 to 20% higher radiopaqueness than stainless steel or cobalt-chromium alloys.

[0062] According to another and / or alternative non-limiting aspect of this disclosure, a medical device may comprise, contain, and / or coat with one or more formulations that promote the success of the medical device and / or 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. Non-limiting examples of clinical events that can be addressed by one or more formulations include, but are not limited to, viral, fungal, and / or bacterial infections; vascular diseases and / or conditions; digestive system diseases and / or conditions; reproductive system diseases and / or conditions; lymphatic system diseases and / or conditions; cancer; implant rejection; pain; nausea; swelling; arthritis; bone diseases and / or conditions; organ failure; immune diseases and / or conditions; cholesterol problems; blood diseases and / or conditions; lung diseases and / or conditions; heart diseases and / or conditions; brain diseases and / or conditions; neuralgia diseases and / or conditions; kidney diseases and / or conditions. / or conditions; ulcers; liver diseases and / or conditions; intestinal diseases and / or conditions; gallbladder diseases and / or conditions; pancreatic diseases and / or conditions; mental disorders; respiratory diseases and / or conditions; glandular diseases and / or conditions; skin diseases and / or conditions; hearing diseases and / or conditions; oral diseases and / or conditions; nasal diseases and / or conditions; eye diseases and / or conditions; fatigue; hereditary diseases and / or conditions; burns; scars and / or scabs; trauma; weight disorders and / or conditions; addictive diseases and / or conditions; hair loss; cramps; muscle spasms; tissue repair; nerve repair; nerve regeneration, etc. The type and / or amount of the preparations included in and / or applied to the medical device may vary. When two or more preparations are included in and / or applied to the medical device, the amounts of the two or more preparations may be the same or different. The type and / or amount of the preparations included in, in, and / or combined with the medical device are generally selected to address one or more clinical events.

[0063] According to another and / or alternative non-limiting aspect of this disclosure, when a formulation is used, the amount of the formulation contained on, in, and / or in combination with the medical device is about 0.01 to 100 μg / mm² (and all values ​​and ranges therebetween) and / or at least about 0.00001 wt% of the device; however, other amounts may be used. The amounts of two or more formulations used on, in, and / or in combination with the medical device may be the same or different. One or more formulations can be coated on and / or impregnated in the medical device by a variety of mechanisms, such as, but not limited to, spraying (e.g., atomization spraying technology, 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 the medical device may be the same or different.

[0064] According to another and / or alternative non-limiting aspect of this disclosure, when used on a medical device, one or more formulations on and / or in the medical device can 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 medical device is not always necessary and / or desirable. Therefore, during and / or after insertion of the medical device into the treatment area, one or more formulations on and / or in the medical device can be released uncontrollably from the medical device. It should also be understood that one or more formulations on and / or in the medical device can be released controllably from the medical device, and one or more formulations on and / or in the medical device can be released uncontrollably from the medical device. It should also be understood that one or more formulations on and / or in one area of ​​the medical device can be released controllably from the medical device, and one or more formulations on and / or in the medical device can be released uncontrollably from another area of ​​the medical device. Therefore, a medical device can be designed such that 1) all formulations on and / or in the medical device are controllably released, 2) some formulations on and / or in the medical device are controllably released and some formulations are uncontrollably released, or 3) all formulations on and / or in the medical device are uncontrollably released. A medical device can also be designed such that one or more formulations are released from the medical device at the same or different rates. A medical device can also be designed such that one or more formulations are released from one or more regions of the medical device at the same or different rates. Non-limiting arrangements that can be used to control the release of one or more formulations from a medical device include: 1) coating one or more formulations at least partially with one or more polymers, 2) incorporating one or more formulations at least partially into and / or encapsulating one or more formulations at least partially incorporating and / or at least partially encapsulating one or more formulations with one or more polymers, and / or 3) inserting one or more formulations into holes, channels, cavities, etc., in the medical device and coating or covering such holes, channels, cavities, etc., at least partially with one or more polymers. As should be understood, other or additional arrangements may be used to control the release of one or more agents from the medical device.

[0065] According to another and / or alternative non-limiting aspect of this disclosure, one or more polymers used for at least partially controlling the release of one or more agents from the medical device may be porous or non-porous. One or more agents may be inserted into and / or applied to one or more surface structures and / or microstructures on the medical device and / or used to at least partially form one or more surface structures and / or microstructures on the medical device. Thus, one or more agents on the medical device may: 1) be coated on one or more surface regions of the medical device, 2) be inserted into and / or impregnated in one or more surface structures and / or microstructures of the medical device, and / or 3) form at least a portion of the structure of the medical device or be included in at least a portion of the structure of the medical device. When one or more formulations are applied to a medical device, the formulations may be: 1) applied directly to one or more surfaces of the medical device; 2) mixed with one or more coating polymers or other coating materials and then at least partially applied to one or more surfaces of the medical device; 3) at least partially applied to the surface of another coating material already at least partially applied to the medical device; and / or 4) at least partially encapsulated between: a) a surface or area of ​​the medical device and one or more other coating materials and / or b) two or more other coating materials. It should be understood that many other coating arrangements may be used alternatively or in addition to these. When one or more formulations are inserted into and / or impregnated into one or more internal structures, surface structures, and / or microstructures of the medical device, 1) one or more other coating materials may be at least partially applied to one or more internal structures, surface structures, and / or microstructures of the medical device and / or 2) one or more polymers may be combined with one or more formulations. Therefore, one or more formulations may 1) be embedded in the structure of a medical device; 2) be positioned in one or more internal structures of a medical device; 3) be encapsulated between two polymer coatings; 4) be encapsulated between a substrate structure and a polymer coating; and / or 5) be mixed in the substrate structure of a medical device including at least one polymer coating. Alternatively or additionally, one or more coatings of one or more polymers on a medical device may include 1) one or more coatings of a nonporous polymer; 2) one or more coatings of a combination of one or more porous polymers and one or more nonporous polymers; and / or 3) one or more coatings of a porous polymer.

[0066] According to another and / or alternative non-limiting aspect of this disclosure, different formulations may optionally be located within and / or between different polymer coatings and / or on the structure of the medical device. 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 medical device, 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. Therefore, the combination of formulations and polymer systems, and their location on the medical device, can be numerous. It should also be understood that one or more formulations may be deposited on the top surface of the medical device to provide an initial uncontrolled burst effect of one or more formulations prior to: 1) controlled release of one or more formulations through one or more layers of a polymer system comprising one or more nonporous polymers and / or 2) uncontrolled release of one or more formulations through one or more layers of the polymer system. One or more formulations and / or polymers may be coated onto the medical device by a variety of mechanisms, such as, but not limited to, spraying (e.g., atomized spraying technology, etc.), dip coating, roll coating, ultrasonic treatment, brush coating, plasma deposition, and / or deposition via vapor deposition.

[0067] According to another and / or alternative non-limiting aspect 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 to 75 µm, more particularly about 0.05 to 50 µm, and even more particularly about 1 to 30 µm. As should be understood, other thicknesses may be used.

[0068] According to another and / or alternative non-limiting aspect of this disclosure, a variety of polymers can be coated onto and / or used to form at least a portion of a medical device. When one or more polymer layers are coated onto at least a portion of a medical device, one or more coatings can be applied using 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. One or more polymers that can be coated onto and / or used to at least partially form a medical device can be polymers considered to be biodegradable, bioabsorbable, or bioerectable; polymers considered to be biostable; and / or polymers that can be modified to be biodegradable and / or bioresorbable. One or more polymers can be coated onto a medical device via a variety of mechanisms, such as, but not limited to, spraying (e.g., atomized spraying technology, etc.), dip coating, roll coating, ultrasonic treatment, brushing, plasma deposition, and / or deposition via vapor deposition.

[0069] According to another and / or alternative non-limiting aspect of this disclosure, a medical device, when comprising and / or coated with one or more agents, may include and / or may be coated with one or more agents that are the same or different in different regions of the medical device and / or have different amounts and / or concentrations in different regions of the medical device. For example, the medical device may 1) be coated with and / or comprise one or more biological agents on at least a portion of the medical device, and at least another portion of the medical device is not coated with and / or comprises any agents; 2) be coated with and / or comprise one or more biological agents that are different from those on at least another portion of the medical device; and / or 3) be coated with and / or comprise one or more biological agents at a different concentration than those on at least another portion of the medical device; etc.

[0070] According to another and / or alternative non-limiting aspect of this disclosure, one or more portions of the medical device may optionally: 1) include the same or different formulations, 2) include one or more formulations in the same or different amounts, 3) include the same or different polymer coatings, 4) include one or more polymer coatings with the same or different coating thicknesses, 5) allow one or more portions of the medical device to controllably release and / or uncontrollably release one or more formulations, and / or 6) allow one or more portions of the medical device to controllably release one or more formulations and allow one or more portions of the medical device to uncontrollably release one or more formulations.

[0071] According to another and / or alternative non-limiting aspect of this disclosure, one or more surfaces of a medical device may optionally be treated to achieve desired coating properties of one or more formulations and one or more polymers coated on the medical device. Such surface treatment techniques include, but are not limited to, cleaning, polishing, smoothing, nitriding, annealing, forging, cold working, etching (chemical etching, plasma etching, etc.), etc. It should be understood that other or additional surface treatment processes may be used prior to coating one or more agents and / or polymers onto the surface of the medical device. Once one or more surface areas of the medical device have been treated, one or more coatings of polymers and / or formulations can be applied to one or more areas of the medical device. One or more layers of formulation can be applied to the medical device using a variety of techniques, such as dipping, roller coating, brush coating, spraying, particle atomization, etc. One non-limiting coating technique is an ultrasonic atomization process, in which ultrasonic waves are used to break up droplets of the formulation and form a mist of very fine droplets. The average droplet diameter of these fine droplets is approximately 0.1 to 3 micrometers. The fine droplet mist promotes the formation of a uniform coating thickness and can increase the coverage area on the medical device.

[0072] According to another and / or alternative non-limiting aspect of this disclosure, the medical device may optionally include a marking material that facilitates proper positioning of the medical device within a body passage (e.g., a blood vessel, a heart valve). The marking material is typically designed to be visible to electromagnetic waves (e.g., X-rays, microwaves, visible light, infrared, ultraviolet, etc.); sound waves (e.g., ultrasound, etc.); magnetic waves (e.g., MRI, etc.); and / or other types of electromagnetic waves (e.g., microwaves, visible light, infrared, ultraviolet, etc.). In one non-limiting embodiment, the marking material is visible to X-rays (i.e., not radiolucent). The marking material may form all or part of the medical device and / or be coated on one or more portions of the medical device (on flared portions and / or body portions, at the ends of the medical device, 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 medical device. The sizes of the one or more areas including the marking material may be the same or different. The marking materials may be spaced apart from each other at a defined distance to form a ruler-like mark on the medical device to facilitate positioning of the medical device within a body passage. The labeling material can be rigid or flexible. It can be biostable or biodegradable. When the labeling material is rigid, it is typically formed of a metallic material (e.g., a metal strip, a metal plating, etc.); however, other or additional materials may be used. A metal that at least partially forms the medical device can serve as the labeling material; however, this is not mandatory. When the labeling material is flexible, it is typically formed of one or more polymers that are themselves labeling materials and / or include one or more metal powders and / or metal compounds.

[0073] According to another and / or alternative non-limiting aspect of this disclosure, a medical device or one or more regions of a medical device may optionally be constructed using one or more microelectromechanical manufacturing (MEMS) technologies (e.g., micromachining, laser micromachining, laser microforming, microforming, 3D printing, etc.); however, other or additional manufacturing technologies may be used.

[0074] According to another and / or alternative non-limiting aspect of this disclosure, the medical device may optionally include one or more surface structures (e.g., holes, channels, pits, ribs, slots, notches, bumps, teeth, needles, wells, cavities, grooves, etc.). These structures may be formed at least in part by MEMS (e.g., micromachining, etc.) technology and / or other types of technology (e.g., 3D printing).

[0075] According to another and / or alternative non-limiting aspect of this disclosure, a medical device may optionally include one or more microstructures (e.g., microneedles, micropores, micropillars, microcones, micropyramids, microtubes, microparallelograms, microprisms, microhemispheres, teeth, ribs, spines, ratchet wheels, hinges, zippers, cable tie structures, etc.) located on the surface of the medical device. 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. As should be understood, when a medical device includes one or more surface structures, 1) all surface structures may be microstructures, 2) all surface structures may be non-microstructures, or 3) a portion of the surface structure may be a microstructure while a portion may be a non-microstructure. Non-limiting examples of structures that may be formed on a medical device are shown in U.S. Patent Publications 2004 / 0093076 and 2004 / 0093077, which are incorporated herein by reference. Typically, microstructures (when formed) extend from or into the outer surface by no more than about 400 micrometers (0.01 to 400 micrometers and all values ​​and ranges therebetween), and more typically less than about 300 micrometers, and more typically about 15 to 250 micrometers; however, other sizes may also be used. Microstructures may aggregate together or be distributed across the entire surface of the medical device. Microstructures and / or surface structures of similar shape and / or size may be used, or microstructures of different shapes and / or sizes may be used. When one or more surface structures and / or microstructures are designed to extend from the surface of the medical device, one or more surface structures and / or microstructures may be formed at the extension location and / or designed to extend from the medical device during and / or after deployment of the medical device in the treatment area. Microstructures and / or surface structures may be designed to include and / or fluidly connect to channels, cavities, etc.; however, this is not required. Once the medical device has been positioned on and / or inside a patient's body, one or more surface structures and / or microstructures can be used to engage and / or penetrate surrounding tissues or organs; however, this is not required. One or more surface structures and / or microstructures can be used to facilitate the formation and maintenance of the shape of the medical device. In a non-limiting embodiment, one or more surface structures and / or microstructures may be formed at least partially by a formulation and / or by a polymer. One or more of the surface structures and / or microstructures may include one or more internal channels, which may include one or more materials (e.g., formulations, polymers, etc.); however, this is not required. One or more surface structures and / or microstructures may be formed by a variety of processes (e.g., machining, chemical modification, chemical reaction, MEMS (e.g., micromachining, etc.), etching, laser cutting, 3D printing, photolithography, etc.).One or more coatings and / or one or more surface structures and / or microstructures of a medical device may be used for a variety of purposes, such as, but not limited to: 1) increasing the adhesion and / or bonding of one or more formulations, adhesives, labeling materials and / or polymers to the medical device; 2) altering the appearance or surface properties of the medical device and / or 3) controlling the release rate of one or more formulations. One or more microstructures and / or surface structures may be biostable, biodegradable, etc. One or more regions of a medical device formed at least partially by MEMS technology may be biostable, biodegradable, etc. A medical device or one or more regions of a medical device may be at least partially covered and / or filled with a protective material to at least partially protect one or more regions of the medical device and / or one or more microstructures and / or surface structures on the medical device from damage. One or more regions of the medical device and / or one or more microstructures and / or surface structures on the medical device may be damaged when the medical device 1) is packaged and / or stored; 2) is unpackaged; 3) is attached to and / or otherwise secured and / or placed on another medical device; 4) is inserted into a treatment area and / or 5) is handled by a user. It should be understood that the medical device may be damaged in other or additional ways. Protective materials can be used to protect medical devices and / or one or more microstructures and / or surface structures from such damage. Protective materials may include one or more polymers previously identified above. Protective materials may be 1) biostable and / or biodegradable and / or 2) porous and / or non-porous. In another and / or additional non-limiting design, the protective material includes, but is not limited to, sugars (e.g., glucose, fructose, sucrose, etc.), carbohydrate compounds, salts (e.g., NaCl, etc.), parylene, PLGA, POE, PGA, PLLA, PAA, PEG, chitosan, and / or derivatives of one or more of these materials; however, other and / or additional materials may be used. In yet another and / or additional non-limiting design, the thickness of the protective material is typically less than about 300 micrometers (e.g., 0.01 micrometers to 299.9999 micrometers and all values ​​and ranges therein), and typically less than about 150 micrometers; however, other thicknesses may be used. The protective material may be coated by one or more mechanisms previously described herein.

[0076] According to another and / or alternative non-limiting aspect of this disclosure, the medical device may optionally be an expandable device that can be expanded by using some other device (e.g., a balloon, etc.).

[0077] According to another and / or alternative non-limiting aspect of this disclosure, the medical device may optionally be made of a material that does not have or substantially does not have shape memory properties.

[0078] According to another and / or alternative non-limiting aspect of this disclosure, a prosthetic heart valve is provided, configured for insertion into a desired location in the body (e.g., an aortic valve, tricuspid valve, pulmonary valve, mitral valve). The frame of the prosthetic heart valve may be at least partially formed of a plastic expandable material that allows the frame to be rolled into a smaller profile to deliver the prosthetic heart valve and expand it to a larger profile. Expansion of the rolled-up frame may optionally utilize an expansion device, such as, but not limited to, a balloon on a balloon catheter. As should be understood, the medical device may be a device other than a prosthetic heart valve (e.g., a stent, etc.) that includes a frame at least partially formed of a plastic expandable material that allows the frame to be rolled into a smaller profile to deliver the medical device and expand it to a larger profile.

[0079] A non-limiting object of this disclosure is to provide an apparatus and method for curling up a curlable or malleable portion of a medical device.

[0080] Another and / or alternative non-limiting object of this disclosure is to provide an apparatus and method for curling a curlable or malleable portion of a medical device comprising one or more leaflets.

[0081] Another and / or alternative non-limiting object of this disclosure is to provide an apparatus and method for curling a curlable or malleable portion of a medical device comprising one or more leaflets to reduce the void space around the leaflets after curling of the curlable or malleable portion of the medical device is completed.

[0082] Another and / or alternative non-limiting object of this disclosure is to provide an apparatus and method for curling a curlable or malleable portion of a medical device comprising one or more leaflets to obtain a desired folded profile of the leaflet after curling of the curlable or malleable portion of the medical device.

[0083] Another and / or alternative non-limiting object of this disclosure is to provide an apparatus and method for curling a curlable or malleable portion of a medical device comprising one or more leaflets to facilitate a desired folded profile of the leaflets of the prosthetic heart valve during the framing of the prosthetic heart valve, thereby reducing the number and volume of gap spaces between and around the leaflets and reducing the outer diameter profile of the prosthetic heart valve after curling, while reducing the risk of damage to the leaflets and other components of the prosthetic heart valve during the curling process.

[0084] Another and / or alternative non-limiting object of this disclosure is to provide an apparatus and method for curling a curlable or malleable portion of a medical device comprising one or more leaflets to reduce the outer diameter or cross-sectional area of ​​the portion of the curlable or malleable portion of the medical device comprising leaflets.

[0085] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, the method comprising: a) providing a medical device including a rollable or malleable portion; b) providing a curling device; the curling device including a curling assembly having a device opening; the device opening being configured to receive at least a portion of the medical device; the device opening being configured to decrease in diameter or cross-sectional area during operation of the curling device; c) inserting at least a portion of the rollable or malleable portion of the medical device into the device opening; and d) operating the medical device to reduce the diameter or cross-sectional area of ​​at least a portion of the device opening, such that a curling force is initially applied only to a first portion of the rollable or malleable portion of the medical device, causing the first portion of the rollable or malleable portion of the medical device to decrease in cross-sectional area, and thereafter continuing to use the curling device to subsequently apply a curling force to a second portion of the rollable or malleable portion of the medical device, causing the second portion of the rollable or malleable portion of the medical device to decrease in cross-sectional area.

[0086] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein a curling device is configured to continue applying a curling force to both the first and second portions of the curlable or malleable portion of the medical device after an initial curling force is applied to the second portion, so as to further reduce the diameter or cross-sectional area of ​​both the first and second portions of the curlable or malleable portion of the medical device.

[0087] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein a curling device is configured to apply a curling force to a first portion until the diameter or cross-sectional area of ​​the first portion of the curlable or malleable portion of the medical device is reduced by at least 1% before the curling device initially applies a curling force to a second portion of the curlable or malleable portion.

[0088] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein a curling device is configured to apply a curling force to a first portion until the diameter or cross-sectional area of ​​the first portion of the curlable or malleable portion of the medical device is reduced by at least 5% before the curling device initially applies a curling force to a second portion of the curlable or malleable portion.

[0089] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein a curling device is configured to apply a curling force to a first portion until the diameter or cross-sectional area of ​​the first portion of the curlable or malleable portion of the medical device is reduced by at least 25% before the curling device initially applies a curling force to a second portion of the curlable or malleable portion.

[0090] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein a curling device is configured to apply a curling force to a first portion until the diameter or cross-sectional area of ​​the first portion of the curlable or malleable portion of the medical device is reduced by at least 50% before the curling device initially applies a curling force to a second portion of the curlable or malleable portion.

[0091] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein during the reduction of the diameter or cross-sectional area of ​​a first and a second portion of a rollable or malleable portion of the medical device by means of a roller device, both the first and second portions of the rollable or malleable portion of the medical device are simultaneously positioned in a device opening.

[0092] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein a first portion of a rollable or malleable deformable portion of the medical device includes an inflow end portion of the medical device.

[0093] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein a second portion of a rollable or malleable portion of the medical device includes an outflow portion of the medical device.

[0094] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein the medical device includes one or more leaflets connected to a rollable or malleable portion of the medical device.

[0095] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein the medical device is a prosthetic heart valve; a rollable or malleable deformable portion of the medical device includes the frame of the prosthetic heart valve; one or more leaflets are connected to the frame.

[0096] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a medical device frame, the method further comprising the steps of: a) before applying a curling force to a rollable or malleable portion of the medical device, and / or b) while applying the curling force to the rollable or malleable portion of the medical device, bending at least a portion of one or more leaflets toward the central longitudinal axis of the rollable or malleable portion of the medical device.

[0097] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a medical device frame, the method further comprising the steps of: a) applying a curling force to a rollable or malleable portion of the medical device before applying a curling force to the rollable or malleable portion of the medical device, and / or b) applying a rotational force about a central longitudinal axis of the rollable or malleable portion to one or more leaflets when the curling force is applied to the rollable or malleable portion of the medical device.

[0098] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, the method further providing a leaflet folding device configured to facilitate folding of one or more leaflets during a step of applying a curling force to a curlable or plastically deformable portion of the medical device.

[0099] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a medical device frame, the method further providing a leaflet folding device configured to facilitate folding of one or more leaflets during a step of applying a curling force to a curlable or malleable portion of the medical device, wherein the leaflet folding device is positioned within the leaflet such that the leaflet is positioned between the frame of the prosthetic heart valve and the leaflet folding device.

[0100] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a medical device frame, the method further providing a leaflet folding device configured to facilitate folding of one or more leaflets during a step of applying a curling force to a curlable or malleable deformable portion of the medical device, wherein the leaflet folding device is positioned within the leaflet such that the leaflet is positioned between the frame of the prosthetic heart valve and the leaflet folding device, and wherein the leaflet folding device includes: a) a hollow, collapsible body portion configured to be inserted into the prosthetic heart valve during the curling process; b) one or more leaflets extending radially from the body portion of the leaflet folding device. c) a hollow, collapsible body portion configured to be inserted into a prosthetic heart valve during a coiling process, and including one or more collapsible arms extending radially from the body portion of the leaflet folding device; d) a hollow, collapsible body portion configured to be inserted into a prosthetic heart valve during a coiling process, and including one or more collapsible arms extending radially from the body portion of the leaflet folding device; e) a non-collapsible body portion and one or more non-collapsible arms extending radially from the body portion of the leaflet folding device; or f) a body portion including two or more pins configured to engage a portion of two or more leaflets.

[0101] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, the method further comprising the steps of: positioning at least a portion of a leaflet folding device between one or more leaflets of the medical device and a rollable or malleable portion to facilitate a) bending at least a portion of one or more leaflets toward a central longitudinal axis of the rollable or malleable portion, and / or b) rotating at least a portion of one or more leaflets about the central longitudinal axis of the rollable or malleable portion.

[0102] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, the method further comprising the step of: completely disengaging a leaflet folding device from one or more leaflets before completing the application of a curling force to a curlable or malleable portion of the medical device.

[0103] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, wherein the leaflet folding device includes a handle portion and one or more leaflet engagement members attached to and extending from the handle portion; the one or more leaflet engagement members are at least partially formed of a flexible material that allows the one or more leaflet engagement members to flex and / or bend: a) when the one or more leaflet engagement members are positioned around one or more leaflets, and / or b) when a rollable or malleable portion of the medical device decreases in diameter or cross-sectional area as a rollable or malleable portion of the medical device is subjected to a rollable force.

[0104] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame for a medical device, wherein one or more leaflet engagement members include a wire loop.

[0105] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device, the method further comprising the step of positioning a portion of one or more leaflet engagement members between a portion of one or more leaflets of the medical device and a rollable or malleable portion, such that at least a portion of one or more leaflets is bent toward the central longitudinal axis of the rollable or malleable portion of the medical device.

[0106] Another and / or alternative non-limiting object of this disclosure is to provide a curler device configured to curl a curlable or malleable portion of a medical device. The curler device includes a curling assembly having a device opening; the device opening is configured to receive at least a portion of the medical device; the device opening is configured to decrease in diameter or cross-sectional area during operation of the curler device; a first portion of the device opening is configured to a) decrease in diameter or cross-sectional area at a different rate than a second portion of the device opening during operation of the curler device, and / or b) begin to decrease in diameter or cross-sectional area at a different time than a second portion of the device opening during operation of the curler device.

[0107] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the outer diameter of a coiled prosthetic heart valve, the method comprising: a) providing a prosthetic heart valve; the prosthetic heart valve including a frame and leaflet structures supported by the frame; the frame being in a partially coiled state; b) providing a diameter reduction device configured to reduce the outer diameter of the prosthetic heart valve; c) inserting the prosthetic heart valve at least partially into the diameter reduction device; and d) initially reducing the outer diameter of the prosthetic heart valve by using the diameter reduction device; and wherein the reduction step includes applying pressure to the frame of the prosthetic heart valve along the longitudinal length of the prosthetic heart valve. The curling force; and the steps of reducing it include A) applying the curling force gradually along the longitudinal length of the frame in a continuous and progressive manner by: i) initially applying the curling force at the inflow end of the frame, and subsequently applying the curling force at locations spaced apart from the inflow end of the frame, until the curling force is applied to the entire outer surface of the frame; or ii) initially applying the curling force at the outflow end portion of the frame, and subsequently applying the curling force at locations spaced apart from the outflow end portion of the frame, until the curling force is applied to the entire outer surface of the frame; or B) applying the curling force in a stepped manner along the longitudinal length of the frame by: i) initially applying the curling force at the inflow end portion of the frame, and subsequently applying the curling force at locations spaced apart from the outflow end portion of the frame, until the curling force is applied to the entire outer surface of the frame; or B) applying the curling force in a stepped manner along the longitudinal length of the frame by: i) initially applying the curling force at the inflow end portion of the frame, and subsequently applying the curling force at locations spaced apart from the outflow end portion of the frame, until the curling force is applied to the entire outer surface of the frame; or B) applying the curling force in a stepped manner along the longitudinal length of the frame by: i) initially applying the curling force at the inflow end portion of the frame, and subsequently applying the curling force at locations spaced apart from the outflow end portion of the frame, until the curling force is applied to the entire outer surface of the frame; or B) applying the curling force in a stepped manner along the longitudinal length of the frame in a stepwise manner ... Apply a curling force at the inflow area of ​​the frame until a portion or all of the inflow area is curled to 10 to 100% (and all values ​​and ranges therebetween) of the diameter or cross-sectional area after full curling, and then subsequently apply a curling force at one or more locations spaced apart from the inflow area of ​​the frame to curl one or more locations spaced apart from the inflow area of ​​the frame to 10 to 100% (and all values ​​and ranges therebetween) of the diameter or cross-sectional area after full curling, wherein the inflow area of ​​the frame extends from the inflow end of the frame to 0.1 to 75% (and all values ​​and ranges therebetween) of the longitudinal length of the frame; or ii) The curling force is initially applied at the outflow side of the frame until a portion or all of the outflow area of ​​the frame is curled to 10 to 100% (and all values ​​and ranges therebetween) of the diameter or cross-sectional area after full curling, and then subsequently applied at one or more locations spaced apart from the outflow area of ​​the frame to curl one or more locations spaced apart from the outflow area of ​​the frame to 10 to 100% (and all values ​​and ranges therebetween) of the diameter or cross-sectional area after full curling, wherein the outflow area of ​​the frame extends from the outflow end of the frame to 0.1 to 75% (and all values ​​and ranges therebetween) of the longitudinal length of the frame.

[0108] Another and / or alternative non-limiting object of this disclosure is to provide a method for reducing the profile of a frame of a medical device; the method comprising a) providing a medical device including a rollable or malleable portion; b) providing a roll-up device including a roll-up assembly having a device opening; the device opening being configured to receive at least a portion of the medical device; the device opening being configured to decrease in diameter or cross-sectional area during operation of the roll-up device; c) inserting at least a portion of the rollable or malleable portion of the medical device into the device opening; and d) operating the medical device such that at least a portion of the device opening is in The diameter or cross-sectional area is reduced so that initially only a curling force is applied to the first portion of the curlable or deformable part of the medical device, which reduces the cross-sectional area of ​​the first portion of the curlable or deformable part of the medical device, and thereafter the curling device is used to subsequently apply a curling force to the second portion of the curlable or deformable part of the medical device, which reduces the cross-sectional area of ​​the second portion of the curlable or deformable part of the medical device; the first portion of the curlable or deformable part of the medical device constitutes 0.01% to 75% of the longitudinal length of the curlable or deformable part of the medical device.

[0109] These and other advantages will become apparent to those skilled in the art upon reading and following this specification. Attached Figure Description

[0110] Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, wherein, unless otherwise specified, the same reference numerals refer to the same parts in the various views. The size and relative position of the elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements are selected, enlarged, and positioned to improve the readability of the drawings. Specific shapes of the drawn elements have been selected for easy identification in the drawings. Reference can now be made to the accompanying drawings, which illustrate various embodiments of this disclosure that can be taken in physical form and in certain arrangements of parts and portions, wherein: Figure 1A It is based on the illustration of TAV disclosed herein.

[0111] Figure 1B It is part of the existing technology conduit.

[0112] Figures 1C to 1E A typical TAVR procedure for inserting a TAV into a heart valve is demonstrated.

[0113] Figure 2 This is a diagram of a TAV including the inner skirt and leaflet structure.

[0114] Figures 3 to 4 A non-limiting coiler device that can be used to coil prosthetic heart valves was demonstrated; Figure 5The folded profile of the leaflets in a prosthetic heart valve is shown by using a curling process according to the present disclosure, wherein the leaflets will be aligned such that the gap space is reduced once the frame is fully curled. Figure 6 The folded profile of the leaflet in a fully rolled-up prosthetic heart valve is shown, wherein the prosthetic heart valve is rolled up by a roller device according to the present disclosure, and wherein the leaflet is folded according to one or more methods according to the present disclosure, and wherein the void space around the folded leaflet is reduced when the frame valve is in a fully rolled-up state. Figures 7A to 7C illustrate a non-limiting curling method for progressively or stepwise curling of a prosthetic heart valve using a curler device according to this disclosure to obtain a leaflet folding arrangement, thereby achieving... Figure 5 and Figure 6 The folded arrangement of the petals; Figures 8A to 8B The side and end views of a prosthetic heart valve that has undergone a non-limiting, progressively rolling process according to this disclosure are shown. Figures 9A to 9B The side and end views of a prosthetic heart valve that has undergone a non-limiting step-curving process according to this disclosure are shown. Figure 10 A non-limiting leaflet folding device is demonstrated, which can optionally be used with a roller device according to the present disclosure to facilitate obtaining a leaflet folding configuration during the roll-up of the frame of the prosthetic heart valve, thereby obtaining a folded leaflet configuration after the frame has been fully rolled up, such as... Figure 5 , 6 As shown in 8A to 8B and 9A to 9B; Figure 11 The outflow end of a fully rolled-up frame of a prosthetic heart valve is shown, with arrows indicating a counter-clockwise folded profile of the leaflet to reduce the void space around the leaflet, and wherein the rolling method according to this disclosure is used and optionally... Figure 10 The exhibited petal folding device is used to present the counterclockwise folded outline of the petals; Figure 12 The outflow end of a fully rolled-up frame of a prosthetic heart valve is shown, wherein the frame has been fully rolled up by a prior art roller and prior art rollup method, and wherein the leaflets are disordered, resulting in large gaps between the leaflets and crushing and potential damage to one or more leaflets. Figure 13 A non-restrictive radially collapsible insert is demonstrated, which can be used in a coiling method for coiling prosthetic heart valves to obtain a conformal shape. Figure 5 , 6The leaflet folding arrangement is the same as or similar to that of 11.

[0115] Figure 14 Another non-limiting radially collapsible insert, comprising one or more arms, is demonstrated, which can be used in a coiling method for coiling prosthetic heart valves to obtain a receptacle with... Figure 5 , 6 The leaflet folding arrangement is the same as or similar to that of 11.

[0116] Figure 15 A non-restrictive forming shaft comprising one or more arms is demonstrated, which can be used in a curling method for curling prosthetic heart valves to obtain a shape similar to... Figure 5 , 6 The leaflet folding arrangement is the same as or similar to that of 11; Figure 16 A folding guide device including multiple pins was demonstrated, which can be used in a curling method for curling prosthetic heart valves to obtain a connection with... Figure 5 , 6 The leaflet folding arrangement is the same as or similar to that of 11; and, Figure 17 This is a table showing the difference in outer diameter after curling and outer diameter after dilation of the same prosthetic heart valve, one of which is curled using conventional prior art curling methods, while the other is curled using one or more curling methods according to this disclosure. Detailed Implementation

[0117] 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.

[0118] 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.

[0119] Unless the context clearly indicates otherwise, the singular forms “a / kind”, “a / kind”, and “the” contain plural indicators.

[0120] As used in the specification and claims, the term "comprising" may include embodiments of "consisting of" and "substantially consisting of". The terms "comprising", "including", "having", "has", "may", "contains", 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.

[0121] 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.

[0122] 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).

[0123] The terms “about” and “approximately” can be used for any numerical value that can vary without altering the fundamental function of that value. When used with a range, “about” and “approximately” also disclose a range defined by the absolute values ​​of the 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 referred to.

[0124] Unless otherwise expressly stated, the percentage of an element shall be assumed to be the weight percentage of the element.

[0125] 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.

[0126] 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 implementation and can be readily discerned by those skilled in the art based on this disclosure.

[0127] Now for reference Figures 1A to 1E These figures illustrate an implantable prosthetic heart valve 100 (e.g., a TAV) and a method for inserting the prosthetic heart valve 100 into a valve region A (e.g., an aortic valve, etc.) of the heart H. The prosthetic heart valve 100 can be implanted in the annulus of an autologous aortic valve A; however, the prosthetic heart valve 100 can also be configured for implantation in other valves of the heart. Although the medical device shown is a TAV, this disclosure is not limited to a TAV or any other heart valve replacement.

[0128] Now for reference Figure 1A The prosthetic heart valve 100 typically includes a frame 110 formed by a plurality of axial longitudinal members and angled hinge members 112, 114, a strut connector 113, a leaflet structure 200 supported by the frame 110, and an inner skirt 300 fixed to the outer surface of the frame 110 and / or the leaflet structure 200. The frame may include one or more of an orientation structure or a mating flange marker 116. The frame 110 is partially or entirely formed of a rhenium-containing metal alloy. The prosthetic heart valve 100 has a “lower” end 120 and an “upper” end 130, wherein the lower end 120 of the prosthetic heart valve 100 is the inflow end, and the upper end 130 of the prosthetic heart valve 100 is the outflow end.

[0129] Frame 110 may optionally be coated with a polymeric material (e.g., silicone, PTFE, ePTFE, polyurethane, polyolefin, hydrogel, biomaterial [e.g., pericardium or biopolymers such as collagen, gelatin, or hyaluronic acid derivatives], etc.). This coating may be used to partially or completely encapsulate one or more vertically extending axial longitudinal members 112 and / or non-perpendicularly angled hinge members 114 on frame 110 and to partially or completely fill one or more openings between non-perpendicularly angled hinge members 114 and / or vertically extending axial longitudinal members 112.

[0130] The inner skirt 300 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 or completely form the inner skirt 300 can 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 300 can 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 300 can optionally be formed from a combination of fabric or woven materials coated with flexible or stretchable and / or compressible materials to provide additional structural integrity to the inner skirt 300. The dimensions, construction, and thickness of the inner skirt 300 are non-limiting (e.g., thicknesses from 0.1 to 20 mils and all values ​​and ranges therebetween). The inner skirt 300 can be secured to the inside and / or outside of the frame 110 in various ways (e.g., stitching, clamping devices, etc.).

[0131] The inner skirt 300 can be used to 1) at least partially seal and / or prevent paravalvular leakage, 2) at least partially secure the leaflet structure 200 to the frame 110, 3) at least partially protect one or more leaflets of the leaflet structure 200 from damage during the curling of the prosthetic heart valve 100, and 4) at least partially protect one or more leaflets of the leaflet structure 200 from damage during the operation of the prosthetic heart valve 100 in the heart H.

[0132] The prosthetic heart valve 100 may optionally include an outer skirt or sleeve (not shown) positioned at least partially around an outer region of the frame 110. The outer skirt or sleeve (when in use) is typically positioned completely around a portion of the outer exterior of the frame 110. Typically, the outer skirt is positioned around the lower portion of the frame 110 and does not completely cover the upper portion of the frame 110; however, this is not required. The outer skirt can be attached to the frame 110 by various methods, such as sutures, adhesives, fusion bonding, clamping devices, etc. At least a portion of the outer skirt may optionally be located on the inner surface of the frame 110; however, this is not required. Typically, the outer skirt is formed of a material that is more flexible and / or more compressible than the inner skirt 300; however, this is not required. The outer skirt may be formed of a variety of stretchable and / or compressible materials, such as 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).

[0133] The leaflet structure 200 may be attached to the frame 110 and / or the inner skirt 300. The connection methods used to secure the leaflet structure 200 to the frame 110 and / or the inner skirt 300 are not limited (e.g., sutures, fusion bonding, adhesives, clamping devices, etc.). Materials used to form one or more leaflets of the leaflet structure 200 include, but are not limited to, bovine pericardial tissue, biocompatible synthetic materials, or various other suitable natural or synthetic materials.

[0134] The leaflet structure 200 may consist of two or more leaflets (e.g., 2, 3, 4, 5, 6, etc.). In a non-limiting arrangement, the leaflet structure 200 includes three leaflets arranged in a tricuspid configuration of collapse. The size, shape, and construction of one or more leaflets of the leaflet structure 200 are non-limiting. In a non-limiting arrangement, the leaflets have substantially the same shape, size, construction, and thickness.

[0135] Two or more leaflets of the leaflet structure 200 may optionally be fixed to each other on their adjacent sides to form the mating edge (the edge where the leaflets meet) of the leaflet structure 200. The leaflet structure 200 may be fixed to the frame 110 and / or the inner skirt 300 by various connection methods (e.g., sutures, adhesives, fusion bonding, clamping devices, etc.).

[0136] One or more leaflets of the leaflet structure 200 may optionally include reinforcing structures or strips to 1) facilitate securing the leaflets together, 2) facilitate securing the leaflets to the inner skirt 300 and / or frame 110, and / or 3) inhibit or prevent tearing or other types of damage to the leaflets.

[0137] The prosthetic heart valve 100 is configured to be radially collapsible to a collapsed or coiled state for introduction into the body via a delivery catheter. Figure 1B ), and the prosthetic heart valve can be radially expanded to an expanded state to allow for implantation of the prosthetic heart valve 100 at a desired location in the heart H (e.g., aortic valve A, etc.). Figure 1E The frame of the prosthetic heart valve 100 is made of a plastic expandable material (e.g., a refractory metal alloy) that allows the frame to be rolled into a smaller profile for delivery and expansion of the prosthetic heart valve 100 using an expansion device. Figure 1B A universal frame F of a prosthetic heart valve is shown coiled on a universal balloon catheter C. A balloon B on the balloon catheter C can be used to expand the frame F from a coiled state to an expanded state. Various types of coiling devices and techniques can be used to coil a prosthetic heart valve on a balloon delivery catheter. The process of coiling a prosthetic heart valve using a coiling device is known in the art and will not be described herein. Damage to the leaflets of the leaflet structure should be avoided during the coiling process.

[0138] like Figures 1C to 1E As shown, once the prosthetic heart valve 100 is coiled around the balloon B of the balloon catheter C, the balloon catheter C is inserted through the blood vessel and reaches the location in the heart H, where the prosthetic heart valve 100 will be deployed (see...). Figure 1C At the treatment site, balloon B on balloon catheter C is inflated, thereby expanding and securing the prosthetic heart valve 100 within valve region A of heart H (see...). Figure 1D Afterward, balloon B was deflated, and balloon catheter C was removed from the patient (see...). Figure 1E ).

[0139] The frame 110 of the prosthetic heart valve 100 can be configured such that it can be rolled onto the delivery catheter C, allowing the rolled-up prosthetic heart valve 100 to be inserted into heart valves smaller than 22 Fr. Due to the materials used to form the frame of such prosthetic heart valves, commercially available prior art prosthetic heart valves can only be rolled to a diameter of about 24 to 27 FR (8 to 9 mm). Therefore, the prosthetic heart valve 100 according to this disclosure can be inserted into smaller-sized heart valves that were previously untreatable with prior art prosthetic heart valves. It should be understood that the size and construction of the prosthetic heart valve 100 according to this disclosure can be designed for insertion into heart valves larger than 22 Fr.

[0140] Metal alloy frames 110 of prosthetic heart valves 100 formed of refractory metal alloys or alloys containing at least 15 atomic weight percent rhenium, and other types of expandable medical devices (e.g., stents, etc.), can be rolled up to have a rolled-up outer diameter that is at least 5% and up to 33% smaller (e.g., smaller than 5% to 33% and all values ​​and ranges therebetween) than frames of the same size, construction and shape formed of Co-Cr alloys (e.g., L605; MP35N; Phynox; Eligory; 35Co-35Ni-20Cr-10Mo; 40Co-20Cr-16Fe-15Ni7Mo; Co-20Cr-15W-10Ni; 15 to 30 wt% Cr, 10 to 20 wt% W, 5 to 35 wt% Ni, 0 to 3 wt% Fe, 0 to 2 wt% Mn, 0 to 10 wt% Mo, 0 to 1 wt% Ti, 0.05 wt% Si).

[0141] Metal alloy frames 110 of prosthetic heart valves 100 formed of refractory metal alloys or alloys containing at least 15 atomic weight percent rhenium, and other types of expandable medical devices (e.g., stents, etc.) can be rolled up to have a rolled-up outer diameter that is at least 5% and up to 50% smaller (e.g., smaller than 5% to 50% and all values ​​and ranges therein) than a frame of the same size, construction and shape formed of stainless steel (e.g., 316, 316L).

[0142] Metal alloy frames 110 of prosthetic heart valves 100 formed of refractory metal alloys or alloys containing at least 15 atomic weight percent rhenium, and other types of expandable medical devices (e.g., stents, etc.) can be rolled up to have a rolled-up outer diameter that is at least 5% and up to 40% smaller (e.g., smaller than 5% to 40% and all values ​​and ranges therein) than that of frames of the same size, construction and shape formed of nitinol (self-expanding nitinol alloys—50 to 60 wt percent Ni and 40 to 60 wt percent Ti).

[0143] Metal alloy frames 110 of prosthetic heart valves 100 formed of refractory metal alloys or alloys containing at least 15 atomic weight percent rhenium, and other types of expandable medical devices (e.g., stents, etc.), can be rolled up to have a rolled-up outer diameter that is at least 5% and up to 40% smaller (e.g., smaller than 5% to 40% and in between) than that of frames of the same size, construction, and shape formed of TiAlV alloys (e.g., Ti-6Al-4V; 5.5-6.5 wt% Al, 3.5-4.5 wt% V and balance Ti; 3.5 to 4.5 wt% vanadium, 5.5-6.75 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, balance titanium).

[0144] Therefore, for those designed to expand to have at least 585 mm 2 For TAVR with an effective orifice area (EOA), the outer curl diameter 100 of the prosthetic heart valve is 6 to 7 mm (18 to 21 FR), which was previously unachievable using stainless steel, CoCr alloy, or nitinol, but can now be obtained by using a frame 110 formed of a refractory metal alloy or an alloy containing at least 15 atomic weight % rhenium.

[0145] Now for reference Figure 2 According to this disclosure, the pile width PW and / or post joint width SJW of a frame 110 formed of a refractory metal alloy or an alloy containing at least 15 atomic weight % rhenium can be smaller than the pile width PW and / or post joint width SJW of a frame formed of stainless steel, nitinol, Co-Cr alloy, or TiAlV alloy, and still have the same or greater radial strength as a frame formed of stainless steel, nitinol, Co-Cr alloy, or TiAlV alloy when the frame expands. A frame with a smaller pile width and post joint width can be used for a frame formed of a refractory metal alloy or an alloy containing at least 15 atomic weight % rhenium without sacrificing the strength of the frame, compared to a frame formed of stainless steel, CoCr, nitinol, or TiAlV alloy.

[0146] Typically, the average cross-sectional area of ​​refractory metal alloys (e.g., 40 to 60 wt% Mo, 40 to 60 wt% Re, 0 to 10 wt% one or more metal additives) used to form the struts and piles and strut joints of the expandable frame of the TAV frame is 5 to 40% smaller (and all values ​​and ranges therebetween) than that of struts and piles and strut joints of the TAV frame formed of CoCr alloys (e.g., L605; MP35N). Such struts, piles and / or strut joints formed of refractory metal alloys or alloys containing at least 15 atomic wt% rhenium have the same or greater strength as such struts, piles and strut joints formed of CoCr alloys.

[0147] Typically, the average cross-sectional area of ​​the refractory metal alloys (e.g., 40 to 60 wt% Mo, 40 to 60 wt% Re, 0 to 10 wt% one or more metal additives) used to form the struts and piles and strut joints of the expandable frame of the TAV frame is 5 to 50% smaller (and all values ​​and ranges therebetween) than that of the struts and piles and strut joints of the TAV frame formed of stainless steel (e.g., 316, 316L), and wherein such refractory metal alloy struts, piles and strut joints have the same or greater strength as such struts, piles and strut joints formed of stainless steel.

[0148] Typically, the average cross-sectional area of ​​the refractory metal alloys (e.g., 40 to 60 wt% Mo, 40 to 60 wt% Re, 0 to 10 wt% one or more metal additives) used to form the struts and piles and strut joints of the expandable frame of the TAV frame is 5 to 40% smaller (and all values ​​and ranges therebetween) than that of the struts and piles and strut joints of the TAV frame formed of TiAlV alloys (e.g., Ti-6Al-4V), and wherein such refractory metal alloy struts, piles and strut joints have the same or greater strength as such struts, piles and strut joints formed of TiAlV alloys.

[0149] Typically, the average cross-sectional area of ​​the refractory metal alloys (e.g., 40 to 60 wt% Mo, 40 to 60 wt% Re, 0 to 10 wt% one or more metal additives) used to form the struts and piles on the expandable frame of the TAV frame is 5 to 40% smaller (and all values ​​and ranges therein) than the cross-sectional area of ​​the struts and piles on the expandable frame of the TAV frame formed of nitinol (e.g., 50 to 60 wt% Ni and 40 to 60 wt% Ti), and wherein such refractory metal alloy struts, piles, and strut joints have the same or greater strength as such struts, piles, and strut joints formed of nitinol.

[0150] The use of refractory metal alloys or alloys containing at least 15 atomic weight percent rhenium to form the framework of a TAV allows for the fabrication of smaller expandable TAVs. Such smaller expandable TAVs can be inserted into smaller blood vessels or other bodily channels that were previously inaccessible using TAVs formed from other types of metal alloys.

[0151] Due to the properties of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium, TAV frames formed of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium [where both frames have a) the same number of piles and struts, b) the same pile and strut construction and shape, c) frames formed of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium can expand to the same or larger effective orifice area (EOA) as expanded frames formed of TiAlV alloys, and d) frames formed of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium can expand to the same or larger effective orifice area (EOA) as expanded frames formed of TiAlV alloys. A frame formed of rhenium alloy by weight percentage has the same or greater radial strength in the expanded state as a frame formed of TiAlV alloy in the expanded state. It may be 1) formed of at least 5% material (e.g., at least 5% to 50% material and all values ​​and ranges therein), 2) having a thinner SJW by at least 5% (e.g., thinner to 50% and all values ​​and ranges therein), c) having a thinner PW by at least 5% (e.g., thinner to 50% and all values ​​and ranges therein), and 3) having a smaller rolled outer diameter by at least 5% (e.g., smaller to 40% and all values ​​and ranges therein).

[0152] Therefore, the pile width and strut joint width using refractory metal alloys or alloys containing at least 15 atomic weight % rhenium can be reduced without compromising the strength of the expanded frame compared to the pile width and strut joint width on a frame formed of TiAlV alloys. Due to the smaller curl-out outer diameter of the frame achievable using refractory metal alloys or alloys containing at least 15 atomic weight % rhenium, the curl-out outer diameter of prosthetic heart valves using frames formed of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium is smaller than that of prosthetic heart valves using frames formed of TiAlV alloys.

[0153] Frameworks made of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium were found to have less rebound after expansion than those made of CoCr alloys. Specifically, frameworks made of MoRe alloys were found to have less than 2% rebound after expansion compared to frameworks made of CoCr alloys that had 9% or more rebound after expansion. Typically, frameworks made of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium have a rebound of 1.5 to 8 times (and all values ​​and ranges therebetween) less than those made of CoCr alloys, stainless steel, or TiAlV alloys. Therefore, frameworks made of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium will better conform to the shape of the channel in which the framework expands, thereby reducing the amount of paravalvular leakage or paraprosthetic leakage (PVL) around the prosthetic heart valve after expansion. Furthermore, frameworks made of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium will expand to their desired expansion state with a single inflation of the balloon in the balloon delivery catheter. Due to the significant rebound of the frame, formed from CoCr alloy, stainless steel, and TiAlV alloy, after expansion, the balloon of the balloon delivery catheter typically needs to be inflated multiple times to allow the frame to conform to the shape of the expanded cardiac passage within it. Such repeated balloon inflation can lead to an increased incidence of damage to the prosthetic heart valve and / or the expanded cardiac passage within it.

[0154] It has been found that wires formed from refractory metal alloys or alloys containing at least 15 atomic weight % rhenium (e.g., MoRe alloys, ReW alloys, MoReCr alloys, MoReTa alloys, MoReTi alloys, WCu alloys, ReCr alloys, Mo alloys, Re alloys, W alloys, Ta alloys, Nb alloys) exhibit approximately 15% to 45% (and all values ​​and ranges therein) better shape fit when bent to an ideal bend shape formed by a die than wires of the same size formed from stainless steel, CoCr alloys, and TiAlV alloys. This better shape fit exhibited by refractory metal alloys or alloys containing at least 15 atomic weight % rhenium is believed to be partly due to the reduced springback of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium, as well as one or more other properties of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium (e.g., alloy strength, etc.). Compared to frames formed from conventional metal alloys, this improved shape fit of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium results in an improved fit between the expanded TAV frame formed from refractory metal alloys or alloys containing at least 15 atomic weight % rhenium and the shape of the treatment area.

[0155] Because expandable TAV frames, made of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium, better conform to the shape of the body passage in which the TAV frame expands, the amount of perivalvular or paraprosthetic leakage (PVL) or other types of leakage around the TAV after expansion is reduced. Furthermore, expandable TAV frames made of refractory metal alloys or alloys containing at least 15 atomic weight % rhenium will expand to their desired expansion state from a single inflation of the balloon in the balloon delivery catheter. Due to the significant rebound of expandable TAV frames made of stainless steel, CoCr alloys, or TiAlV alloys after expansion, the balloon in the balloon delivery catheter typically needs to be inflated multiple times to ensure the expandable frame conforms as closely as possible to the shape of the body passage in which it expands. Such multiple inflations of the balloon can lead to an increased incidence of damage to the medical device and / or the body passage in which the expandable frame expands.

[0156] Compared to expandable TAV frames made of stainless steel, CoCr alloys, and TiAlV alloys, expandable TAV frames made at least partially of refractory metal alloys or alloys comprising at least 15 atomic weight percent rhenium result in the following non-limiting advantages: 1) the formation of frames for medical devices with thinner posts, struts, and / or strut joints, leading to i) safer vascular access when inserting the medical device through the body passage and to the treatment area, and / or ii) safer delivery of the medical device to the treatment area. And / or reduces the risk of bleeding and / or damage to the body passage and / or treatment area when expanding at the treatment area; 2) makes it easier to deliver the medical device to the treatment area, which can result in: i) reduced trauma to the body passage (e.g., vascular, aortic arch trauma, etc.) during insertion and / or expansion of the medical device at the treatment area, and / or ii) a reduced risk of neurological complications (stroke); 3) less rebound, which results in: i) a reduction in the size of the curled profile, ii) increased fit of the expanded medical device at the treatment area after expansion. iii) Increased radial strength of the medical device frame after expansion at the treatment area; iv) Requires only a single coiling cycle to coil the medical device onto a balloon catheter or other type of delivery device; v) Reduced incidence of damage to components of the medical device (e.g., struts, posts, strut joints and / or other components of the expandable frame, leaflets, skirts, coatings, etc.) during coiling, expansion, and operation; vi) Larger effective orifice area (EOA) of the medical device after expansion; vi) Increased radial strength of the medical device frame at the treatment area. After expansion, pulmonary valve regurgitation (PVR) is reduced, and / or vii) only a single expansion cycle of the balloon on the balloon catheter or other expansion mechanism is required to fully expand the medical device; and / or 4) the medical device is created with superior material biology properties to I) improve tissue adhesion and / or growth on or around the medical device, II) reduce adverse tissue reactions caused by the medical device, III) reduce the toxicity of the medical device, IV) potentially reduce intravalvular thrombosis during the life of the medical device, and / or V) reduce the incidence of infection during the life of the medical device.

[0157] Medical devices (such as expandable heart valves) formed at least partially of refractory metal alloys or alloys containing at least 15 atomic weight percent rhenium, according to this disclosure, overcome several unmet needs present in expandable medical devices formed of CoCr alloys, TiAlV alloys, and stainless steel. Such unmet needs addressed by the medical devices according to this disclosure include: 1) reducing the incidence of fatal bleeding during treatment by eliminating the need to form large holes in aortic vessels or other blood vessels for initial insertion of the coiled medical device into atrial vessels or other blood vessels; and 2) enabling the delivery and implantation of medical devices (e.g., stents, prosthetic heart valves, etc.) with a smaller coiled profile than those formed of CoCr alloys, TiAlV alloys, and stainless steel, allowing the medical device to be delivered and implanted into anomalously shaped heart valves or through calcination in prosthetic heart valves and / or calcination in arterial vessels. 3) In arteries with abnormal shapes due to plaque; 4) When a medical device expands in the treatment area, by using a frame made of a refractory metal alloy or an alloy containing at least 15 atomic weight % rhenium, the incidence of paravalvular leakage and / or other types of leakage around the implanted medical device is reduced. This frame, compared with prior art prosthetic heart valves made of CoCr alloys, TiAlV alloys, and stainless steel, better conforms to the shape of abnormally shaped heart valve orifices during prosthetic heart valve expansion, thereby reducing the incidence of stroke and / or increasing the success rate of implanted medical devices; 5) Improve the expansion in expandable frames. 5) Reduce the radial strength of the struts, posts, and / or strut joints, as well as the strength of the expandable frame itself after the medical device expands; 6) Reduce the amount of rebound of the expandable frame during the curling and / or expansion of the medical device; 7) Enable the medical device to be used in hearts with permanent pacemakers; 8) Reduce the incidence of minor strokes during insertion and manipulation of the medical device at the treatment area; 9) Reduce the incidence of coronary ostial damage; 10) Improve anterior compression; 11) Reduce further aortic valve calcification and / or intravascular calcification after medical device implantation; 12) Reduce the risk of complications during insertion of the medical device into catheters or other types of delivery systems. 12) Reduce the need for multiple coiling cycles during implantation; 13) Reduce the incidence of frame breakage during coiling and / or expansion of the medical device; 14) Reduce the incidence of biomembrane-endocarditis after medical device implantation; 15) Reduce allergic reactions to the medical device after implantation; 16) Increase the hydrophilicity of the medical device to enhance tissue growth on and / or around the implanted medical device; 17) Reduce the magnetization of the medical device; 18) Reduce the toxicity of the medical device; 19) Reduce the amount of metal ion release from the medical device; and / or 10) Increase the lifespan of the leaflets and / or frame and / or other components of the medical device after medical device insertion.

[0158] Now for reference Figures 3 to 4This paper demonstrates a non-limiting retractor device 50 for use in retracting prosthetic heart valves. The retractor device 50 includes an opening 30 in which a prosthetic heart valve is placed for retracting.

[0159] Now for reference Figure 5 This shows a rear-end view or outflow side view of a coiled prosthetic heart valve that has been partially coiled by a coiler device and coiling process as disclosed herein. Figure 5 As shown, the petals are displayed as beginning to fold in an organized manner, which reduces the number and volume of void spaces present around the folded petals.

[0160] Now for reference Figure 6 This image shows a rear-end view or outflow side view of a rolled-up prosthetic heart valve, illustrating the folded outline of the leaflets in a fully rolled-up prosthetic heart valve, rolled using the roller device and rolling process disclosed herein. Rolling the prosthetic heart valve in an organized manner reduces the amount and volume of void space around the folded leaflets, thereby allowing the frame of the prosthetic heart valve to be rolled to a smaller outer diameter.

[0161] Referring now to Figures 7A to 7C, three cross-sectional portions of a prosthetic heart valve are shown along its longitudinal axis, with two leaflets connected to the frame of the prosthetic heart valve. Figures 7A to 7C18 show the inflow and outflow sides of the prosthetic heart valve. The leaflets are shown connected to the frame at or near the inflow side of the prosthetic heart valve.

[0162] Figure 7A shows a cross-sectional portion of the prosthetic heart valve before the frame is subjected to the curling force of the curler device. For example, when the handle is in the fully open position and the prosthetic heart valve is positioned in the opening 30, the diameter or cross-sectional area of ​​the opening 30 may allow no curling force to be applied to the prosthetic heart valve.

[0163] Figure 7B shows a cross-sectional portion of the prosthetic heart valve, where the inflow region of the frame has been subjected to a curling force to reduce the diameter or cross-sectional area of ​​the curled frame; however, the outflow region of the frame has not been subjected to a curling force, and therefore the diameter or cross-sectional area of ​​this region of the frame has not been reduced. For example, when the handle moves from the fully open position of opening 30 to the fully closed or minimum diameter or cross-sectional area position, the first set of jaws of the curler device can be configured to first contact the inflow region of the prosthetic heart valve and apply a curling force to the inflow region before the second set of jaws contacts the outflow region of the prosthetic heart valve and applies a curling force to the outflow region.

[0164] Figure 7C shows a cross-sectional portion of the prosthetic heart valve, where both the inflow and outflow regions of the frame have been subjected to curling forces to reduce the diameter or cross-sectional area of ​​the curled frame; for example, as the handle continues to move to the fully closed or minimum diameter or cross-sectional area position of opening 30, the second set of jaws finally contacts the outflow region of the prosthetic heart valve and applies a curling force to the outflow region, while the first set of jaws continues to apply a curling force to the inflow region of the prosthetic heart valve.

[0165] Now for reference Figure 8A , 8B 9A and 9B illustrate a non-limiting method for curling a prosthetic heart valve using the disclosed curler device, wherein: a) the prosthetic heart valve is progressively and continuously curled along its longitudinal axis from the inflow end, and advanced to the outflow end and terminated thereat (see 9A). Figures 8A to 8B (a) First, partially or completely roll up the inflow side of the prosthetic heart valve, and then partially or completely roll up the outflow side of the prosthetic heart valve (see...). Figures 9A to 9B This curling method produces an ordered leaflet profile for the curled prosthetic heart valve, which, like... Figure 5 , 6 The folded leaf contours shown in Figure 11 are the same or similar.

[0166] Now for reference Figure 10 The invention demonstrates a prosthetic heart valve HV, comprising a frame F, three leaflets L, and an inner and outer skirt OS. A leaflet folding device 600 is shown, which can optionally be used with a curler device to facilitate obtaining the desired leaflet folding configuration during curling of the frame of the prosthetic heart valve. The leaflet folding device 600 includes a handle 610 and three leaflet engagement members 620 in the form of a wire loop (e.g., a metal wire loop, a plastic wire loop, etc.) attached to and extending from the handle 610. Figure 10 Only a portion of the handle 610 is shown. Typically, the handle 610 is sized and shaped to be gripped by a user, enabling the user to position the leaflet engagement member into a portion of the prosthetic heart valve, thereby bending one or more leaflets.

[0167] The leaflet engagement member 620 is attached to the distal end or distal portion of the handle portion and is shown extending radially outward from the central longitudinal axis of the handle portion. Typically, the leaflet engagement members have the same dimensions, shape, and / or are formed of the same material; however, this is not required.

[0168] The leaflet engagement member can be formed of a flexible material that allows the leaflet engagement member to a) bend and / or flex during the frame roll-up of the prosthetic heart valve and while the leaflet engagement member is still engaged with one or more leaflets during the frame roll-up.

[0169] The leaflet folding device is configured to bend one or more or all of the ends of the leaflets located at or near the outflow end of the prosthetic heart valve toward the central axis of the frame of the prosthetic heart valve. This bending of one or more leaflets by the leaflet folding device typically occurs a) before the initial curling of the frame of the prosthetic heart valve, and / or b) during the curling of the frame of the prosthetic heart valve. Typically, the leaflet folding device is removed or disengaged from one or more leaflets before the outflow end of the frame of the prosthetic heart valve is fully curled, so as not to interfere with the full curling of the frame of the prosthetic heart valve.

[0170] When the leaflet folding device 600 is optionally used, a non-limiting method of use is as follows: a) the leaflet folding device moves along and toward the longitudinal axis of the frame until one or more leaflet engaging members engage the ends or tips of one or more leaflets; b) thereafter, the leaflet folding device continues to move along the longitudinal axis of the frame such that the ends or tips of one or more leaflet engaging members move between one or more leaflets and the inner surface of the frame; and c) thereafter, the leaflet folding device continues to move along the longitudinal axis of the frame such that the angular orientation of one or more leaflet engaging members relative to the central axis of the handle portion of the leaflet folding device causes the ends and tips of the leaflets to bend toward the central axis of the frame. Typically, the one or more leaflet engaging members are inserted only a portion of the longitudinal length through the frame and spaced apart from the area where one or more of the leaflets of the frame connect with the frame. Before and / or during the curling of the frame, the handle portion of the leaflet folding device may optionally rotate about the longitudinal axis of the frame to facilitate leaflet folding during the curling of the frame. This rotation is caused by... Figure 11 The arrows in the image are displayed.

[0171] like Figure 12 As demonstrated, when the leaflets of a prosthetic heart valve are not properly folded, the leaflets can be damaged (e.g., leaflet tearing, damage to the connection between the leaflet and the frame, damage to the connection between the leaflets, leaflet folding that adversely alters the leaflet shape when the frame expands at the treatment site, etc.), and generally prevent the frame from curling to its minimum profile. Repeatedly applying curling pressure to the frame in an attempt to obtain a smaller frame curl profile will result in a) the curl profile no longer decreasing further, b) damage or further damage to one or more leaflets, c) damage to the inner and / or outer skirts, and / or d) damage to the frame. Figure 12This illustrates the typical folded profile of the leaflet F after the frame F of the prosthetic heart valve HV has been rolled up using existing rolling devices and methods. Figure 12 What is shown is related to Figure 11 Compared to the folding arrangement of the leaflets shown, the folding of leaflet L is unorganized. Furthermore, in Figure 12 The curled prosthetic heart valve HV shown in the image has a distinct void space VS around the folded leaflet L. Figure 11 It shows a significantly smaller number and volume of void spaces VS between the organized folds of the leaflet L. Figure 12 It also shows that some leaflets within the leaflet are compressed together (compressed leaflets - SL), which leads to damage to leaflet L. This undesirable compression of leaflet L in... Figure 11 It is displayed in the middle.

[0172] Now for reference Figures 13 to 14 The illustration shows a front-end view or inflow-side view of a prior art prosthetic heart valve, demonstrating the use of two different leaflet folding devices 600 in the form of a collapsible foldable tube (FTB) according to this disclosure, which are used to achieve the desired effect. Figure 5 , 6 The leaflet folding arrangement is the same as or similar to that shown in Figure 11. The prosthetic heart valve HV includes a rollable frame F and multiple leaflets L that are connected to the frame at one or more leaflet connection regions LC. Figure 13 The FTB, a folded tube with a generally hollow cylindrical tube shape, is shown. Figure 14 It demonstrates the presence of and Figure 13 The foldable tube body (FTB) has a similar shape but also includes three radially extending foldable arms (AL). Each arm initially extends from the outer surface of the radially collapsible insert body at an angle α of 5 to 175° (and all values ​​and ranges therebetween). The length of the arm AL is typically 3 to 10 mm (and all values ​​and ranges therebetween). The collapsible foldable tube body (FTB) is configured to be partially or completely inserted into the interior of the prosthetic heart valve before the valve is rolled up. Once the collapsible foldable tube body (FTB) is inserted into the interior of the prosthetic heart valve, the prosthetic heart valve is partially rolled up, which causes the radially collapsible insert to partially or completely collapse. Thereafter, the collapsible foldable tube body (FTB) is removed from the prosthetic heart valve, and the prosthetic heart valve is then subjected to rolling up again until the prosthetic heart valve is fully rolled up. During the rolling up of the prosthetic heart valve, the leaflet folding device may optionally rotate and / or move longitudinally along the longitudinal axis of the prosthetic heart frame.

[0173] Now for reference Figure 15 This demonstrates a leaflet folding device 600 in the form of a forming shaft FTB comprising three arms A, which is consistent with the above reference. Figure 13 and14 The discussed leaflet folding device operates in a similar manner, except that the main body of the forming shaft is not foldable. The arms on the forming shaft are used to obtain... Figure 5 , 6 The leaflet folding arrangement is the same as or similar to that shown in Figure 11. Before the prosthetic heart valve is rolled up, the shaping shaft is partially or completely inserted into the interior of the prosthetic heart valve. Once the shaping shaft is inserted into the interior of the prosthetic heart valve such that the arm of the shaping shaft is at least partially positioned inside the prosthetic heart valve, the prosthetic heart valve is partially rolled up. Thereafter, the shaping shaft is removed from the prosthetic heart valve, and the prosthetic heart valve is then subjected to rolling up again until the prosthetic heart valve is fully rolled up. During the rolling up of the prosthetic heart valve, the leaflet folding device may optionally rotate and / or move longitudinally along the longitudinal axis of the prosthetic heart frame.

[0174] Now for reference Figure 16 The image shows a perspective view of the anterior or inflow side of a prosthetic heart valve HV, illustrating the use of a leaflet folding device 600 according to this disclosure, which is used to achieve a symmetrical arrangement with the prosthetic heart valve HV. Figure 5 , 6 The leaflet folding arrangement is the same as or similar to that shown in Figure 11. The leaflet folding device 600 includes a handle H and a plurality of pins P extending forward and radially outward from the central axis of the handle H. The pins P are configured to be partially or completely inserted into the interior of the prosthetic heart valve HV before and / or during its curling. Once the pins of the leaflet folding device 600 are inserted into the interior of the prosthetic heart valve, the prosthetic heart valve is partially curled, causing partial bending of the pins. During the partial curling of the prosthetic heart valve, the leaflet folding device 600 may optionally be rotated. Before the complete curling of the prosthetic heart valve, the pins of the leaflet folding device 600 are removed from the prosthetic heart valve, and then the prosthetic heart valve is subjected to curling again until it is completely curled.

[0175] Now for reference Figure 17A table comparing the outer diameter after roll-up of a prosthetic heart valve without using the roll-up method according to this disclosure with the roll-up diameter of a prosthetic heart valve using one or more roll-up methods according to this disclosure. The second column shows a prior art prosthetic heart valve rolled without using the roll-up method according to this disclosure, having a maximum fully rolled outer diameter of 7.86 mm, representing a 64.4% reduction in diameter compared to the diameter of the prosthetic heart valve before roll-up. The second column also shows the same prior art prosthetic heart valve rolled using one or more roll-up methods according to this disclosure, having a maximum fully rolled outer diameter of 5.98 mm, representing a 73.8% reduction in diameter compared to the diameter of the prosthetic heart valve before roll-up. Therefore, by controlling the folding profile of the leaflet using one or more roll-up methods according to this disclosure, a significantly smaller final rolled outer diameter of the prosthetic heart valve can be obtained.

[0176] Figure 17 The first column also compares the outer diameter of a prosthetic heart valve after expansion from its coiled state (where the prosthetic heart valve is coiled using conventional prior art coiling methods) with the outer diameter of a prosthetic heart valve after expansion from its coiled state (where the prosthetic heart valve is coiled using one or more coiling methods according to the present disclosure). The prosthetic heart valve coiled using conventional prior art coiling methods shows a smaller maximum outer diameter upon expansion compared to the prosthetic heart valve coiled using one or more coiling methods according to the present disclosure. It is believed that this increased outer diameter is partly due to the uniform folding of the leaflets resulting from using one or more coiling methods according to the present disclosure.

[0177] Throughout this specification, references to "various embodiments," "some embodiments," "one embodiment," "some exemplary embodiments," "one exemplary embodiment," or "embodiment" mean that a particular feature, structure, or characteristic described in connection with any embodiment is included in at least one embodiment. Therefore, the phrases "in various embodiments," "in some embodiments," "in one embodiment," "some exemplary embodiments," "one exemplary embodiment," or "in one embodiment" appearing throughout the specification do not necessarily refer to the same embodiment. Furthermore, specific features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0178] Therefore, it will be found that, effectively achieving the purposes set forth above and those that become clear from the foregoing description, 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, as well as all statements of scope of this disclosure, which may fall within the scope according to the language. This disclosure has been described with reference to certain embodiments. These and other modifications 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 invention is intended to include all such modifications and variations, provided they fall within the scope of the appended claims.

[0179] 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 method for reducing the outer diameter of a curled prosthetic heart valve, the method comprising: A prosthetic heart valve is provided; the prosthetic heart valve includes a frame and leaflet structures supported by the frame; the frame is in a partially curled state; A diameter reduction device is provided, which is configured to reduce the outer diameter of the prosthetic heart valve; The prosthetic heart valve is at least partially inserted into the diameter-reducing device; and The outer diameter of the prosthetic heart valve was initially reduced by using the diameter reduction device; and The initial reduction step includes applying a curling force to the frame of the prosthetic heart valve along its longitudinal length; and The initial reduction step includes A) gradually applying the curling force in a continuous and progressive manner along the longitudinal length of the frame by: i) initially applying the curling force at the inlet end of the frame, and subsequently applying the curling force at locations spaced apart from the inlet end of the frame, until the curling force is applied along the longitudinal length of the frame to the entire outer surface of the frame. Or ii) initially apply the curling force at the outflow end portion of the frame, and then apply the curling force at locations spaced apart from the outflow end portion of the frame until the curling force is applied along the longitudinal length of the frame to the entire outer surface of the frame. Alternatively, B) the curling force is applied in a stepped manner along the longitudinal length of the frame by: i) initially applying the curling force at the inflow area of ​​the frame until a portion or all of the inflow area of ​​the frame is curled to 10 to 100% of its fully curled diameter or cross-sectional area, and then subsequently applying the curling force at one or more locations spaced apart from the inflow area of ​​the frame to curl the one or more locations spaced apart from the inflow area of ​​the frame to 10 to 100% of their fully curled diameter or cross-sectional area, wherein the inflow area of ​​the frame extends from the inflow end of the frame to 5 to 75% of the longitudinal length of the frame; or ii) initially applying the curling force at the outflow side of the frame until a portion or all of the outflow area of ​​the frame is curled to 10 to 100% of the diameter or cross-sectional area after full curling, and then subsequently applying the curling force at one or more locations spaced apart from the outflow area of ​​the frame to curl the one or more locations spaced apart from the outflow area of ​​the frame to 10 to 100% of the diameter or cross-sectional area after full curling, and wherein the outflow area of ​​the frame extends from the outflow end of the frame to 5 to 75% of the longitudinal length of the frame.

2. The method of claim 1, wherein after the initial reduction step, the prosthetic heart valve is subjected to a further secondary curling process; the secondary curling process comprising a) simultaneously subjecting the prosthetic heart valve to the curling force along 80 to 100% of the longitudinal length of the frame, b) gradually applying the curling force in a continuous and progressive manner along 80 to 100% of the longitudinal length of the frame, or c) applying the curling force in a stepped manner along 80 to 100% of the longitudinal length of the frame.

3. The method according to claim 1, further comprising the following steps: Provides a leaflet folding device; Before or during the initial shrinking step, the leaflet folding device is inserted at least partially into at least a portion of the prosthetic heart valve; When the leaflet folding device is at least partially inserted into the prosthetic heart valve, the diameter or cross-sectional area of ​​at least a portion of the frame is reduced; as well as The leaflet folding device is removed from the prosthetic heart valve before the initial reduction step is completed.

4. The method according to claim 2, further comprising the following steps: Provides a leaflet folding device; Before or during the initial shrinking step, the leaflet folding device is inserted at least partially into at least a portion of the prosthetic heart valve; When the leaflet folding device is at least partially inserted into the prosthetic heart valve, the diameter or cross-sectional area of ​​at least a portion of the frame is reduced; as well as The leaflet folding device is removed from the prosthetic heart valve before the initial reduction step is completed.

5. The method of claim 3, further comprising the following steps: a) During the initial reduction step when the leaflet folding device is at least partially inserted into the prosthetic heart valve, the leaflet folding device is moved along the longitudinal length of the frame, and / or b) During the initial reduction step when the leaflet folding device is at least partially inserted into the prosthetic heart valve, the leaflet folding device is rotated within the frame.

6. The method of claim 4, further comprising the following steps: a) During the initial reduction step when the leaflet folding device is at least partially inserted into the prosthetic heart valve, the leaflet folding device is moved along the longitudinal length of the frame, and / or b) During the initial reduction step when the leaflet folding device is at least partially inserted into the prosthetic heart valve, the leaflet folding device is rotated within the frame.

7. The method of claim 3, wherein the leaflet folding device includes a radially collapsible insert portion.

8. The method according to any one of claims 4 to 6, wherein the leaflet folding device includes a radially collapsible insert portion.

9. The method of claim 7, wherein the radially collapsible insert portion has a generally circular or elliptical cross-sectional shape comprising 25% to 100% of the longitudinal length of the radially collapsible insert portion.

10. The method of claim 8, wherein the radially collapsible insert portion has a generally circular or elliptical cross-sectional shape comprising 25% to 100% of the longitudinal length of the radially collapsible insert portion.

11. The method of claim 7, wherein the radially collapsible insert portion has a substantially constant cross-sectional area along 60 to 100% of the longitudinal length of the radially collapsible insert portion.

12. The method according to any one of claims 8 to 10, wherein the radially collapsible insert portion has a substantially constant cross-sectional area along 60 to 100% of the longitudinal length of the radially collapsible insert portion.

13. The method of claim 7, wherein the radially collapsible insert portion comprises a hollow internal cavity of 25 to 100% along the longitudinal length of the radially collapsible insert portion.

14. The method according to any one of claims 8 to 12, wherein the radially collapsible insert portion comprises a hollow internal cavity of 25 to 100% along the longitudinal length of the radially collapsible insert portion.

15. The method of claim 13, wherein the hollow internal cavity has a generally circular or elliptical cross-sectional shape.

16. The method of claim 14, wherein the hollow internal cavity has a generally circular or elliptical cross-sectional shape.

17. The method of claim 7, wherein the radially collapsible insert portion includes one or more arms extending outward from the outer surface of the radially collapsible insert portion.

18. The method according to any one of claims 8 to 16, wherein the radially collapsible insert portion includes one or more arms extending outward from the outer surface of the radially collapsible insert portion.

19. The method of claim 17, wherein the one or more arms are collapsible and include an internal cavity.

20. The method of claim 18, wherein the one or more arms are collapsible and include an internal cavity.

21. The method of claim 7, wherein at least a portion of the radially collapsible insert portion is configured to at least partially collapse and / or reduce in cross-sectional area during the initial reduction step when the leaflet folding device is at least partially inserted into the prosthetic heart valve.

22. The method according to any one of claims 8 to 20, wherein at least a portion of the radially collapsible insert portion is configured to at least partially collapse and / or reduce in cross-sectional area during the initial reduction step when the leaflet folding device is at least partially inserted into the prosthetic heart valve.

23. The method of claim 3, wherein the leaflet folding device includes a shaping shaft configured to maintain its cross-sectional shape and cross-sectional area during the initial reduction step when the leaflet folding device is at least partially inserted into the prosthetic heart valve.

24. The method of any one of claims 4 to 6, wherein the leaflet folding device includes a shaping shaft configured to maintain its cross-sectional shape and cross-sectional area during the initial reduction step when the leaflet folding device is at least partially inserted into the prosthetic heart valve.

25. The method of claim 23, wherein the forming shaft has a generally circular or elliptical cross-sectional shape comprising 25% to 100% of the longitudinal length of the forming shaft.

26. The method of claim 24, wherein the forming shaft has a generally circular or elliptical cross-sectional shape comprising 25% to 100% of the longitudinal length of the forming shaft.

27. The method of claim 23, wherein the forming shaft has a substantially constant cross-sectional dimension along 60 to 100% of the longitudinal length of the forming shaft.

28. The method according to any one of claims 24 to 26, wherein the forming shaft has a substantially constant cross-sectional dimension along 60 to 100% of the longitudinal length of the forming shaft.

29. The method of claim 23, wherein the forming shaft comprises a hollow internal cavity of 25 to 100% along the longitudinal length of the forming shaft.

30. The method according to any one of claims 24 to 28, wherein the forming shaft comprises a hollow internal cavity of 25 to 100% along the longitudinal length of the forming shaft.

31. The method of claim 23, wherein the forming shaft includes one or more arms extending outward from the outer surface of the forming shaft.

32. The method according to any one of claims 24 to 30, wherein the forming shaft includes one or more arms extending outward from the outer surface of the forming shaft.

33. The method of claim 23, wherein the forming shaft includes a plurality of pins extending radially outward from the forming shaft and forward from an end of the forming shaft.

34. The method according to any one of claims 24 to 32, wherein the forming shaft includes a plurality of pins extending radially outward from the forming shaft and forward from an end of the forming shaft.

35. The method of claim 33, wherein the number of pins is equal to the number of leaflets in the prosthetic heart valve.

36. The method of claim 34, wherein the number of pins is equal to the number of leaflets in the prosthetic heart valve.

37. The method of claim 3, further comprising the following steps: Positioning at least a portion of the leaflet folding device between the one or more leaflets of the medical device and the flexible or malleable portion to facilitate a) bending at least a portion of one or more leaflets toward the central longitudinal axis of the flexible or malleable portion, and / or b) rotating at least a portion of one or more leaflets about the central longitudinal axis of the flexible or malleable portion.

38. The method according to any one of claims 4 to 6, further comprising the following steps: Positioning at least a portion of the leaflet folding device between the one or more leaflets of the medical device and the flexible or malleable portion to facilitate a) bending at least a portion of one or more leaflets toward the central longitudinal axis of the flexible or malleable portion, and / or b) rotating at least a portion of one or more leaflets about the central longitudinal axis of the flexible or malleable portion.

39. The method of claim 37, wherein the leaflet folding device comprises a handle portion and one or more leaflet engagement members attached to and extending from the handle portion; the one or more leaflet engagement members are at least partially formed of a flexible material such that the one or more leaflet engagement members are flexural and / or flexural when: a) the one or more leaflet engagement members are positioned around one or more leaflets, and / or b) when the rollable or malleable portion of the medical device decreases in diameter or cross-sectional area as the rollable or malleable portion of the medical device is subjected to the rollable or malleable portion of the medical device.

40. The method of claim 38, wherein the leaflet folding device comprises a handle portion and one or more leaflet engagement members attached to and extending from the handle portion; the one or more leaflet engagement members are at least partially formed of a flexible material such that the one or more leaflet engagement members are flexural and / or flexural when: a) the one or more leaflet engagement members are positioned around one or more leaflets, and / or b) when the rollable or malleable portion of the medical device decreases in diameter or cross-sectional area as the rollable or malleable portion of the medical device is subjected to the rollable or malleable portion of the medical device.

41. The method of claim 37, wherein the one or more leaflet engagement members comprise a wire loop.

42. The method according to any one of claims 38 to 40, wherein the one or more leaflet engagement members comprise a wire loop.

43. The method of claim 37, further comprising the following steps: A portion of one or more leaflet engagement members is positioned between a portion of one or more leaflets of the medical device and the flexible or malleable portion, such that at least a portion of the one or more leaflets is bent toward the central longitudinal axis of the flexible or malleable portion of the medical device.

44. The method according to any one of claims 38 to 42, further comprising the following steps: A portion of one or more leaflet engagement members is positioned between a portion of one or more leaflets of the medical device and the flexible or malleable portion, such that at least a portion of the one or more leaflets is bent toward the central longitudinal axis of the flexible or malleable portion of the medical device.

45. A method for reducing the profile of a frame of a medical device; the method comprising: Provide medical devices that include rollable or malleable parts; Provide a curling device; The curling device includes a curling assembly having a device opening; The device opening is configured to receive at least a portion of the medical device; The opening of the device is configured to decrease in diameter or cross-sectional area during operation of the curling device; At least a portion of the flexible or malleable portion of the medical device is inserted into the opening of the device; as well as The medical device is operated to reduce at least a portion of the opening of the device in diameter or cross-sectional area, thereby initially applying a curling force only to a first portion of the rollable or deformable portion of the medical device, which reduces the cross-sectional area of ​​the first portion of the rollable or deformable portion of the medical device, and thereafter the curling device is used to subsequently apply a curling force to a second portion of the rollable or deformable portion of the medical device, which reduces the cross-sectional area of ​​the second portion of the rollable or deformable portion of the medical device; the first portion of the rollable or deformable portion of the medical device constitutes 0.01% to 75% of the longitudinal length of the rollable or deformable portion of the medical device.

46. ​​The method of claim 45, wherein the curling device is configured to continue applying the curling force to both the first and second portions of the curlable or malleable portion of the medical device after the initial application of the curling force to the second portion, so as to further reduce the diameter or cross-sectional area of ​​both the first and second portions of the curlable or malleable portion of the medical device.

47. The method of claim 45, wherein the curling device is configured to apply the curling force to the first portion until the diameter or cross-sectional area of ​​the first portion of the flexible or malleable portion of the medical device is reduced by at least 1% before the curling device initially applies the curling force to the second portion of the flexible or malleable portion of the medical device.

48. The method of claim 46, wherein the curling device is configured to apply the curling force to the first portion until the diameter or cross-sectional area of ​​the first portion of the flexible or malleable portion of the medical device is reduced by at least 1% before the curling device initially applies the curling force to the second portion of the flexible or malleable portion of the medical device.

49. The method of claim 45, wherein the curling device is configured to apply the curling force to the first portion until the diameter or cross-sectional area of ​​the first portion of the flexible or malleable portion of the medical device is reduced by at least 5% before the curling device initially applies the curling force to the second portion of the flexible or malleable portion of the medical device.

50. The method of claim 46, wherein the curling device is configured to apply the curling force to the first portion until the diameter or cross-sectional area of ​​the first portion of the flexible or malleable portion of the medical device is reduced by at least 5% before the curling device initially applies the curling force to the second portion of the flexible or malleable portion of the medical device.

51. The method of claim 45, wherein the curling device is configured to apply the curling force to the first portion until the diameter or cross-sectional area of ​​the first portion of the flexible or malleable portion of the medical device is reduced by at least 25% before the curling device initially applies the curling force to the second portion of the flexible or malleable portion of the medical device.

52. The method of claim 46, wherein the curling device is configured to apply the curling force to the first portion until the diameter or cross-sectional area of ​​the first portion of the flexible or malleable portion of the medical device is reduced by at least 25% before the curling device initially applies the curling force to the second portion of the flexible or malleable portion of the medical device.

53. The method of claim 45, wherein the curling device is configured to apply the curling force to the first portion until the diameter or cross-sectional area of ​​the first portion of the flexible or malleable portion of the medical device is reduced by at least 50% before the curling device initially applies the curling force to the second portion of the flexible or malleable portion of the medical device.

54. The method of claim 46, wherein the curling device is configured to apply the curling force to the first portion until the diameter or cross-sectional area of ​​the first portion of the flexible or malleable portion of the medical device is reduced by at least 50% before the curling device initially applies the curling force to the second portion of the flexible or malleable portion of the medical device.

55. The method of claim 45, wherein during the reduction of the diameter or cross-sectional area of ​​the first and second portions of the rollable or deformable portion of the medical device by means of the curler device, the first and second portions of the rollable or deformable portion of the medical device are simultaneously positioned in the device opening.

56. The method according to any one of claims 46 to 54, wherein during the reduction of the diameter or cross-sectional area of ​​the first and second portions of the flexible or malleable portion of the medical device by means of the curler device, the first and second portions of the flexible or malleable portion of the medical device are simultaneously positioned in the device opening.

57. The method of claim 45, wherein the first portion of the flexible or malleable portion of the medical device comprises the inflow portion of the medical device.

58. The method according to any one of claims 46 to 56, wherein the first portion of the flexible or malleable portion of the medical device includes the inflow portion of the medical device.

59. The method of claim 45, wherein the second portion of the flexible or malleable portion of the medical device comprises the outflow portion of the medical device.

60. The method according to any one of claims 46 to 58, wherein the second portion of the flexible or malleable portion of the medical device includes the outflow portion of the medical device.

61. The method of claim 45, wherein the medical device includes one or more leaflets connected to the flexible or malleable portion of the medical device.

62. The method according to any one of claims 46 to 60, wherein the medical device includes one or more leaflets connected to the flexible or malleable portion of the medical device.

63. The method of claim 45, wherein the medical device is a prosthetic heart valve; the flexible or malleable portion of the medical device includes a frame of the prosthetic heart valve; and the one or more leaflets are connected to the frame.

64. The method according to any one of claims 46 to 62, wherein the medical device is a prosthetic heart valve; the flexible or malleable portion of the medical device includes a frame of the prosthetic heart valve; and the one or more leaflets are connected to the frame.

65. The method of claim 61, further comprising the following steps: a) Before applying the curling force to the rollable or malleable portion of the medical device, and / or b) when the curling force is applied to the roll of the rollable or malleable portion of the medical device, at least a portion of one or more leaflets is bent toward the central longitudinal axis of the rollable or malleable portion of the medical device.

66. The method according to any one of claims 62 to 64, further comprising the following steps: a) Before applying the curling force to the rollable or malleable portion of the medical device, and / or b) when the curling force is applied to the roll of the rollable or malleable portion of the medical device, at least a portion of one or more leaflets is bent toward the central longitudinal axis of the rollable or malleable portion of the medical device.

67. The method of claim 61, further comprising the following steps: a) Before applying the curling force to the rollable or malleable portion of the medical device, and / or b) when applying the curling force to the roll of the rollable or malleable portion of the medical device, apply a rotational force about the central longitudinal axis of the central longitudinal axis of the rollable or malleable portion to one or more of the leaflets.

68. The method according to any one of claims 62 to 66, further comprising the following steps: a) Before applying the curling force to the rollable or malleable portion of the medical device, and / or b) when applying the curling force to the roll of the rollable or malleable portion of the medical device, apply a rotational force about the central longitudinal axis of the central longitudinal axis of the rollable or malleable portion to one or more of the leaflets.

69. The method of claim 61, further comprising a leaflet folding device configured to facilitate folding of one or more leaflets during the step of applying the curling force to the flexible or malleable portion of the medical device.

70. The method according to any one of claims 62 to 68, further comprising a leaflet folding device configured to facilitate folding of one or more leaflets during a step of applying the curling force to the flexible or malleable portion of the medical device.

71. The method of claim 61, further comprising the following steps: Provide the leaflet folding device; Before the prosthetic heart valve is fully rolled up, the leaflet folding device is inserted at least partially into at least a portion of the prosthetic heart valve. When the leaflet folding device is at least partially inserted into the prosthetic heart valve, the curling force is applied to the prosthetic heart valve; Remove the leaflet folding device from the prosthetic heart valve before the prosthetic heart valve is fully rolled up; as well as After the step of removing the leaflet folding device, the prosthetic heart valve is further subjected to the curling force.

72. The method according to any one of claims 62 to 70, further comprising the following steps: Provide the leaflet folding device; Before the prosthetic heart valve is fully rolled up, the leaflet folding device is inserted at least partially into at least a portion of the prosthetic heart valve. When the leaflet folding device is at least partially inserted into the prosthetic heart valve, the curling force is applied to the prosthetic heart valve; Remove the leaflet folding device from the prosthetic heart valve before the prosthetic heart valve is fully rolled up; as well as After the step of removing the leaflet folding device, the prosthetic heart valve is further subjected to the curling force.

73. The method of claim 69, further comprising the following steps: a) During the step of applying the curling force to the prosthetic heart valve while at least partially inserting the leaflet folding device into the prosthetic heart valve, moving the leaflet folding device along the longitudinal length of the frame, and / or b) During the step of applying the curling force to the prosthetic heart valve while at least partially inserting the leaflet folding device into the prosthetic heart valve, rotating the leaflet folding device within the frame.

74. The method according to any one of claims 70 to 72, further comprising the following steps: a) During the step of applying the curling force to the prosthetic heart valve while at least partially inserting the leaflet folding device into the prosthetic heart valve, moving the leaflet folding device along the longitudinal length of the frame, and / or b) During the step of applying the curling force to the prosthetic heart valve while at least partially inserting the leaflet folding device into the prosthetic heart valve, rotating the leaflet folding device within the frame.

75. The method of claim 69, further comprising the following steps: Positioning at least a portion of the leaflet folding device between the one or more leaflets of the medical device and the flexible or malleable portion to facilitate a) bending at least a portion of one or more leaflets toward the central longitudinal axis of the flexible or malleable portion, and / or b) rotating at least a portion of one or more leaflets about the central longitudinal axis of the flexible or malleable portion.

76. The method according to any one of claims 70 to 74, further comprising the following steps: Positioning at least a portion of the leaflet folding device between the one or more leaflets of the medical device and the flexible or malleable portion to facilitate a) bending at least a portion of one or more leaflets toward the central longitudinal axis of the flexible or malleable portion, and / or b) rotating at least a portion of one or more leaflets about the central longitudinal axis of the flexible or malleable portion.

77. The method of claim 69, further comprising the following steps: Before applying the curling force to the flexible or malleable portion of the medical device, the leaflet folding device is completely disengaged from one or more of the leaflets.

78. The method according to any one of claims 70 to 76, further comprising the following steps: Before applying the curling force to the flexible or malleable portion of the medical device, the leaflet folding device is completely disengaged from one or more of the leaflets.

79. The method of claim 71, wherein the leaflet folding device comprises a handle portion and one or more leaflet engagement members attached to and extending from the handle portion; the one or more leaflet engagement members are at least partially formed of a flexible material such that the one or more leaflet engagement members are flexural and / or flexural when: a) the one or more leaflet engagement members are positioned around one or more leaflets, and / or b) when the rollable or malleable portion of the medical device decreases in diameter or cross-sectional area as the rollable or malleable portion of the medical device is subjected to the rollable or malleable portion of the medical device.

80. The method of any one of claims 72 to 78, wherein the leaflet folding device comprises a handle portion and one or more leaflet engaging members attached to and extending from the handle portion; the one or more leaflet engaging members are at least partially formed of a flexible material such that the one or more leaflet engaging members are flexural and / or flexural when: a) the one or more leaflet engaging members are positioned around one or more leaflets, and / or b) when the rollable or malleable portion of the medical device decreases in diameter or cross-sectional area as the rollable or malleable portion of the medical device is subjected to the rollable or malleable portion of the medical device.

81. The method of claim 79, wherein the one or more leaflet engagement members comprise a wire loop.

82. The method of claim 80, wherein the one or more leaflet engagement members comprise a wire loop.

83. The method of claim 79, further comprising the following steps: A portion of one or more leaflet engagement members is positioned between a portion of one or more leaflets of the medical device and the flexible or malleable portion, such that at least a portion of the one or more leaflets is bent toward the central longitudinal axis of the flexible or malleable portion of the medical device.

84. The method according to any one of claims 80 to 82, further comprising the following steps: A portion of one or more leaflet engagement members is positioned between a portion of one or more leaflets of the medical device and the flexible or malleable portion, such that at least a portion of the one or more leaflets is bent toward the central longitudinal axis of the flexible or malleable portion of the medical device.

85. The method of claim 71, wherein the leaflet folding device includes a radially collapsible insert portion.

86. The method of claim 72, wherein the leaflet folding device includes a radially collapsible insert portion.

87. The method of claim 85, wherein the radially collapsible insert portion has a generally circular or elliptical cross-sectional shape comprising 25% to 100% of the longitudinal length of the radially collapsible insert portion.

88. The method of claim 86, wherein the radially collapsible insert portion has a generally circular or elliptical cross-sectional shape comprising 25% to 100% of the longitudinal length of the radially collapsible insert portion.

89. The method of claim 85, wherein the radially collapsible insert portion has a substantially constant cross-sectional dimension along 60 to 100% of the longitudinal length of the radially collapsible insert portion.

90. The method according to any one of claims 86 to 88, wherein the radially collapsible insert portion has a substantially constant cross-sectional dimension along 60 to 100% of the longitudinal length of the radially collapsible insert portion.

91. The method of claim 85, wherein the radially collapsible insert portion comprises a hollow internal cavity of 25 to 100% along the longitudinal length of the radially collapsible insert portion.

92. The method according to any one of claims 86 to 90, wherein the radially collapsible insert portion comprises a hollow internal cavity of 25 to 100% along the longitudinal length of the radially collapsible insert portion.

93. The method of claim 91, wherein the hollow internal cavity has a generally circular or elliptical cross-sectional shape.

94. The method of claim 92, wherein the hollow internal cavity has a generally circular or elliptical cross-sectional shape.

95. The method of claim 85, wherein the radially collapsible insert portion includes one or more arms extending outward from the outer surface of the radially collapsible insert portion.

96. The method according to any one of claims 86 to 94, wherein the radially collapsible insert portion includes one or more arms extending outward from the outer surface of the radially collapsible insert portion.

97. The method of claim 95, wherein the one or more arms are collapsible and include an internal cavity.

98. The method of claim 96, wherein the one or more arms are collapsible and include an internal cavity.

99. The method of claim 85, wherein during the step of applying the coiling force to the prosthetic heart valve when the leaflet folding device is at least partially inserted into the prosthetic heart valve, at least a portion of the radially collapsible insert portion collapses at least partially and / or decreases in cross-sectional area.

100. The method according to any one of claims 86 to 98, wherein during the step of applying the curling force to the prosthetic heart valve when the leaflet folding device is at least partially inserted into the prosthetic heart valve, at least a portion of the radially collapsible insert portion collapses at least partially and / or decreases in cross-sectional area.

101. The method of claim 71, wherein the leaflet folding device includes a forming shaft configured to maintain its cross-sectional shape and cross-sectional area during the step of applying the curling force to the prosthetic heart valve when the leaflet folding device is at least partially inserted into the prosthetic heart valve.

102. The method of claim 72, wherein the leaflet folding device includes a forming shaft configured to maintain its cross-sectional shape and cross-sectional area during the step of applying the curling force to the prosthetic heart valve when the leaflet folding device is at least partially inserted into the prosthetic heart valve.

103. The method of claim 101, wherein the forming shaft has a generally circular or elliptical cross-sectional shape comprising 25% to 100% of the longitudinal length of the forming shaft.

104. The method of claim 102, wherein the forming shaft has a generally circular or elliptical cross-sectional shape comprising 25% to 100% of the longitudinal length of the forming shaft.

105. The method of claim 101, wherein the forming shaft has a substantially constant cross-sectional dimension along 60 to 100% of the longitudinal length of the forming shaft.

106. The method according to any one of claims 102 to 104, wherein the forming shaft has a substantially constant cross-sectional dimension along 60 to 100% of the longitudinal length of the forming shaft.

107. The method of claim 101, wherein the forming shaft comprises a hollow internal cavity of 25 to 100% along the longitudinal length of the forming shaft.

108. The method according to any one of claims 102 to 106, wherein the forming shaft comprises a hollow internal cavity of 25 to 100% along the longitudinal length of the forming shaft.

109. The method of claim 101, wherein the forming shaft includes one or more arms extending outward from the outer surface of the forming shaft.

110. The method according to any one of claims 102 to 108, wherein the forming shaft includes one or more arms extending outward from the outer surface of the forming shaft.

111. The method of claim 101, wherein the forming shaft includes a plurality of pins extending radially outward from the forming shaft and forward from an end of the forming shaft.

112. The method according to any one of claims 102 to 110, wherein the forming shaft includes a plurality of pins extending radially outward from the forming shaft and forward from an end of the forming shaft.

113. The method of claim 111, wherein the number of pins is equal to the number of leaflets in the prosthetic heart valve.

114. The method of claim 112, wherein the number of pins is equal to the number of leaflets in the prosthetic heart valve.

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