Docking device with varying elasticity

Abstract

A docking device comprising a wire core is disclosed, where the wire core has a length, a first end region, a second end region, a coiled section disposed between the first end region and the second end region, and an extension disposed between the coiled section and the first end region. The wire core has a constant diameter and varying elasticity along the length, where the wire core is heat treated using at least one laser to increase and vary elasticity along the length. A method of fabricating a wire core for a docking device is also disclosed, where the method comprises forming a length of the wire core with a constant diameter along the length, and heat treating at least a portion of the wire core using a laser to increase an elasticity of the at least a portion of the wire core.

Description

Attorney Docket No: THVVA-13339WO01 DOCKING DEVICE WITH VARYING ELASTICITY CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 574,769, filed April 4, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates generally to wire cores for docking devices configured to secure a prosthetic valve at a native heart valve, as well as methods of manufacturing such wire cores. BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

[0004] In some instances, a prosthetic heart valve may not be appropriately sized to be placed inside a particular native valve and / or in a patient with a larger native valve. Additionally orAttorney Docket No: THVVA-13339WO01 alternatively, the native tissue at the implantation site may not provide sufficient structure for the prosthetic heart valve to be secured in place relative to the native tissue. Docking devices can be used to secure a prosthetic heart valve at a native heart valve, where the docking devices are configured to open to a deployed configuration from a delivery configuration. Docking devices can be coiled and / or have a wire core. SUMMARY

[0005] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. Also described herein are docking devices comprising wire cores, where the docking devices secure prosthetic heart valves to native tissue and where the wire cores have a constant diameter and varying elasticity. The disclosed wire cores and methods can, for example, simplify wire core manufacturing while maintaining elasticity in sections under higher strain. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves, docking devices, and / or prosthetic valve delivery apparatuses.

[0006] A docking device for a prosthetic implant can comprise a wire core with a length. In addition to this feature, a prosthetic heart valve can further comprise one or more of the features disclosed herein.

[0007] In some examples, at least a portion of the wire core can be heat treated.

[0008] In some examples, the heat treatment can comprise at least one laser.

[0009] In some examples, the duration of the at least one laser can vary.

[0010] In some examples, the intensity of the at least one laser can vary.

[0011] In some examples, the wire core can have a constant diameter along the length.

[0012] In some examples, the wire core can have varying elasticity along the length.

[0013] In some examples, the wire core can have a first end region and a second end region.

[0014] In some examples, the wire core can have a coiled section disposed between the first end region and the second end region.Attorney Docket No: THVVA-13339WO01

[0015] In some examples, the wire core can have an extension.

[0016] In some examples, the extension can be disposed between the coiled section and the first end region.

[0017] In some examples, the extension can have an elasticity that is different than an elasticity of the first end region, the second end region, or both the first and second end regions.

[0018] In some examples, the first end region can have a first elasticity, the second end region can have a second elasticity, and the coiled section can have a third elasticity.

[0019] In some examples, the first, second, and third elasticities can be the same.

[0020] In some examples, the first, second, and third elasticities can be different.

[0021] In some examples, the extension can have a fourth elasticity, where the fourth elasticity can be greater than the first, second, and third elasticities.

[0022] In some examples, the extension can have a length and the fourth elasticity can vary along the length of the extension.

[0023] In some examples, the extension can have a length and the fourth elasticity can be constant along the length of the extension.

[0024] In some examples, the extension can be heat treated.

[0025] In some examples, the wire core can comprise a proximal transition section between the extension and the first end region.

[0026] In some examples, the wire core can comprise a distal transition section between the extension and the coiled section.

[0027] In some examples, the proximal transition section can have an elasticity that is greater than the first, second, and third elasticities.

[0028] In some examples, the distal transition section can have an elasticity that is greater than the first, second, and third elasticities.Attorney Docket No: THVVA-13339WO01

[0029] In some examples, an elasticity of the proximal transition section can be less than an elasticity of the extension.

[0030] In some examples, an elasticity of the distal transition section can be less than an elasticity of the extension.

[0031] In some examples, the proximal transition section can be heat treated.

[0032] In some examples, the distal transition section can be heat treated.

[0033] In some examples, the at least one laser can be applied around an entire circumference of the wire core.

[0034] In some examples, the at least one laser can be applied to a portion of a circumference of the wire core.

[0035] In some examples, the heat treatment can comprise a temperature and / or a heat gradient.

[0036] In some examples, the heat treatment can be applied to a portion of the wire core bent in a radius less than 12 mm.

[0037] In some examples, the heat treatment can be applied to a portion of the wire core where the wire core is bent at an angle less than 100 degrees.

[0038] In some examples, a docking device for a prosthetic implant comprises a wire core with a length, where the wire core has a first end region, a second end region, a coiled section disposed between the first end region and the second end region, and an extension disposed between the coiled section and the first end region. The wire core has a constant diameter along the length and the extension has an elasticity that is different than the elasticity of the first end region or the second end region.

[0039] In some examples, a docking device for docking a prosthetic valve at a native valve of a heart comprises a wire core with a proximal tip, a distal tip, a first end region adjacent to the proximal tip, a second end region adjacent to the distal tip, and a constant diameter from the proximal tip to the distal tip. The wire core forms a coil disposed between the first end region and the second end region, and an extension disposed between the coil and the first end region.Attorney Docket No: THVVA-13339WO01 The extension has a higher elasticity than at least one of the first end region, the second end region, and the coil.

[0040] In some examples, a docking device for a prosthetic implant comprises one or more of the components recited in Examples 1-15 and 25 below.

[0041] A method of fabricating a wire core for a docking device can comprise forming a length of the wire core. In addition to this step, the method of fabricating a wire core for a docking device can further comprise one or more of the steps disclosed herein.

[0042] In some examples, the wire core can have a constant diameter along the length.

[0043] In some examples, the wire core can have a first end region, a second end region, and an extension disposed between the first end region and the second end region.

[0044] In some examples, the method can further comprise heat treating the extension to increase an elasticity of the extension.

[0045] In some examples, the method can further comprise shaping the wire core to form a coiled section between the extension and the second end region.

[0046] In some examples, the method can further comprise heat treating a distal transition section of the extension.

[0047] In some examples, the method can further comprise heat treating a proximal transition section of the extension.

[0048] In some examples, the method can further comprise varying an intensity of the heat treating.

[0049] In some examples, the method can further comprise varying a duration of the heat treating.

[0050] In some examples, the method can further comprise heat treating using at least one laser.

[0051] In some examples, the method can further comprise revolving the at least one laser around the wire core.Attorney Docket No: THVVA-13339WO01

[0052] In some examples, the method can further comprise rotating the wire core while the laser is stationary.

[0053] In some examples, a method of fabricating a wire core for a docking device comprises forming a length of the wire core with a constant diameter along the length. The wire core has a first end region, a second end region, and an extension disposed between the first end region and the second end region. The method further comprises heat treating the extension to increase an elasticity of the extension.

[0054] In some examples, a method of fabricating a wire core for a docking device comprises one or more of the components recited in Examples 16-24 below.

[0055] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] FIG. 1 is a perspective view of a docking device, according to an example.

[0057] FIG. 2A is a stress-strain curve for a pseudo-elastic material before heat treatment, according to an example.

[0058] FIG. 2B is a stress-strain curve for the pseudo-elastic material of FIG. 2A after heat treatment.

[0059] FIG. 3A is schematic view of a straightened wire core of a docking device receiving heat treatment in a region, according to an example.

[0060] FIG. 3B is graph depicting elasticity as a function of length for the wire core of FIG. 3A.Attorney Docket No: THVVA-13339WO01

[0061] FIG. 4A is schematic view of the straightened wire core of FIG. 3A receiving additional heat treatment in regions.

[0062] FIG. 4B is graph depicting elasticity as a function of length for the wire core of FIG. 4A. DETAILED DESCRIPTION General Considerations

[0063] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0064] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0065] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically,Attorney Docket No: THVVA-13339WO01 mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0066] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0067] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0068] As introduced above, docking devices for prosthetic heart valves can be delivered to an implant site in a delivery configuration, which is typically in a straightened configuration within a delivery sheath or catheter. Docking devices made with wire cores of shape-memory material can expand to a deployed configuration at the implant site, where the docking devices can have shape-set coiled sections and other bent or curved sections. When relatively tight turns in the wire core are straightened in the delivery configuration for positioning within the delivery sheath or catheter, the straightening of the shape-set portions can result in high local strains at outer surfaces (i.e., high compression on a surface of an outside radius of a bend and high tension on an inside radius). Higher strains can correspond to higher stresses, which can, in some instances, lead to fatigue, fracture, and cracking. A need exists for increasing elasticity in higher strain portions of the wire core.

[0069] In some examples, portions of the wire core at risk of higher stresses can be ground to a reduced diameter, leading to increased elasticity in those portions of smaller diameter. Examples of wire cores with reduced diameter at the high stress regions are disclosed in U.S. Patent No.Attorney Docket No: THVVA-13339WO01 10,463,479, which is incorporated by reference herein. Alternatively, heat treatment can be used to impart increased elasticity to portions of the wire core under strain without the need for a secondary grinding step.

[0070] Described herein are wire cores for docking devices, where the wire cores have a constant diameter and are heat treated in specified areas to increase elasticity in those areas. In this way, heat treating can increase elasticity within portions of the wire core under higher strains and prevent or reduce the likelihood of cracking or fracture, while reducing or eliminating the need for secondary machining operations.

[0071] In some examples, docking devices can have a coiled section and an extension (also referred to herein as an “ascending portion”) as shown in FIG. 1. The stress-strain curves in FIGS. 2A and 2B demonstrate pictorially the before and after effect of heat treatment on stresses for given strains. In some examples, as shown in FIGS. 3A and 3B, a wire core extension can be heat treated to increase elasticity and reduce stresses. In some examples, as shown in FIGS. 4A and 4B, secondary heat-treating operations can increase and smooth elasticity in transitional areas. Examples of the Disclosed Technology

[0072] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0073] Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in some examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosedAttorney Docket No: THVVA-13339WO01 prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0074] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. In an example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated by reference herein.

[0075] FIG. 1 shows a perspective view of a version of a docking device (also referred to herein as an “anchor”, “coil anchor” or “anchoring device”) 100. The docking device 100 in FIG. 1 comprises a wire core 102 and has a central region 110 with a coil 116 (also referred to herein as a “coiled section”), a first end region 118, and a second end region 120.

[0076] The docking device 100 includes an extension (also referred to herein as an “ascending portion “) 140 substantially positioned between the coil 116 and the first end region 118. In FIG. 1, the extension 140 is made up of or includes a vertical part of the central region 110 that extends substantially parallel to a central axis of the docking device 100. In some examples, the extension 140 can be angled relative to a central axis of the docking device 100, but will generally serve as a vertical or axial spacer that spaces apart the adjacent connected portions of the docking device 100 in a vertical or axial direction, so that a vertical or axial gap is formedAttorney Docket No: THVVA-13339WO01 between the coil 116 and the first end region 118 (e.g., a gap can be formed between an upper or atrial side and a lower or ventricular side of the docking device 100).

[0077] The extension 140 of the docking device 100 is intended to be positioned through (e.g., crossing) or near a native valve annulus, to reduce the amount of the docking device 100 that passes through or pushes or rests against the native annulus when the docking device 100 is implanted. This could potentially reduce the stress or strain applied by the docking device 100 on the native valve. In an arrangement, the extension 140 is positioned at and passes through or crosses at one of the commissures of a native mitral valve. In this manner, the extension 140 can space the first end region 118 apart from native mitral leaflets to prevent the first end region 118 from interacting with or engaging the native leaflets from the atrial side. The extension 140 also raises a position of the first end region 118, so that the contact that the first end region 118 makes against the atrial wall can be elevated or spaced farther away from the native valve, which could, for example, also reduce stresses on and around the native valve, as well as provide for a more secure holding of the position of the docking device 100. The extension 140 can have a length ranging from 5 to 100 mm, and in one example, is 15 mm. Although implantation of the docking device 100 is described as surrounding the native mitral valve, it is understood that the docking device may be implanted at any native valve of the heart.

[0078] The wire core 102 of the docking device 100 has a length that extends between a proximal end (also referred to herein as a “proximal tip”) 160 and a distal end (also referred to herein as a “distal tip”) 162. The wire core 102 can further include one or more through holes 150 at or near the proximal tip 160 and / or one or more through holes 152 at or near the distal tip 162 of the docking device 100. The through holes 150, 152 can serve, for example, as suturing holes for attaching a cover layer over the coil of the docking device 100, and / or for example, as an attachment site for delivery tools, such as a pull wire / suture for a pusher, a holding device / anchor (e.g., for holding the docking device and / or allowing retraction and retrievability of the device after being fully or partially deployed from the delivery catheter), or other advancement device or retention device.Attorney Docket No: THVVA-13339WO01

[0079] A width or diameter 168 of the wire core 102 of the docking device 100 is constant (or at least substantially constant) along the length of the docking device 100 between the proximal and distal tips 160, 162. Some variations in diameter can occur along the length of the wire core due to manufacturing tolerances, nicks, or abrasions, but the overall diameter 168 is approximately constant throughout the length without necking in any location. The wire core can comprise an elastic, pseudo-elastic, and / or shape memory material, such as Nitinol. As such, the wire core can be shape-set in its deployed shape form (see e.g., FIG. 1), wherein the docking device has a coil 116 or coiled section within the central region 110.

[0080] During delivery, the wire core 102 can be straightened and / or bent into other shapes for placement into a delivery sheath or catheter. Because the wire core 102 can be made a of shape memory material, the wire core 102 can return to its original, pre-formed shape (e.g., a coil or helical shape as seen in FIG. 1) when it exits the delivery catheter and is no longer constrained by the delivery catheter. As an example, the wire core 102 of the docking device 100 may originally be formed as a coil, and thus may wrap around the ventricular native valve leaflets as the docking device 100 exits the delivery catheter and returns to its original coiled configuration.

[0081] Additional information regarding exemplary delivery apparatus for implanting a docking device can be found, for example, in International Publication No. WO 2020 / 247907, which is incorporated by reference herein.

[0082] When the docking device 100 is straightened and / or bent into other shapes during delivery, the wire core 102 is strained. Due to the relatively sharp curves, the bends 170, 172 of the extension 140 have higher stresses for the strain necessary to straighten the docking device (e.g., during delivery).

[0083] To increase elasticity and reduce stresses, portions of a wire core undergoing significant strain can be heat treated. FIGS. 2A and 2B show stress-strain curves for a docking device wire core (such as, for example, wire core 102, or any other wire core described herein) before and after a heat treatment operation, where the wire core is Nitinol or another pseudo-elastic material. FIG. 2A shows a stress-strain curve for a wire core made of Nitinol or another pseudo-elastic material before heat treatment. As shown in FIG. 2B, after localized heat treatment, the overallAttorney Docket No: THVVA-13339WO01 stress decreases for the same amount of strain. Thus, heat treatment can, for example, eliminate or reduce the likelihood of fatigue, cracking, fracturing, etc.

[0084] In some examples, a laser can be used to heat treat localized portions of a wire core (such as, for example, wire core 102, or any other wire core described herein). For wire cores made of Nitinol, which has pseudo-elastic material properties, for example, laser processing can be used to have pre-determined effects on the pseudo-elastic properties of the material. Laser processing can be used to apply a localized functional heat treatment to shape-set portions of a wire core (for example, the extension 140 and / or bends 170, 172, of the wire core 102 in FIG. 1, or any other portion of the wire core 102 described herein) to alter the pseudo-elastic properties in those shape-set areas. Laser processing can result in greater elasticity in areas receiving the heat treatment, leaving the mechanical properties of all other regions of the wire core and the docking device unchanged.

[0085] Referring back to the docking device 100 in FIG. 1, as an alternative to a grinding operation to reduce diameter, laser heat treatment can be implemented to reduce stresses experienced by at least the extension 140 and bends 170, 172 when the docking device 100 is loaded into a delivery system. In this way, the wire core 102 can be made from a single-diameter wire and have a constant diameter 168 between the proximal and distal tips 160, 162.

[0086] FIG. 3A shows the wire core 102 of the docking device 100 in a straightened, delivery configuration, where the wire core 102 is shown receiving localized heat treatment by a laser 210 to a portion of the wire core 102 on a first side 212 of the wire core 102. The first side 212 is directly opposite a second side 214 of the wire core 102. In some examples, as shown in FIG. 3A, the laser 210 can be applied to portions of the wire core 102 corresponding to the extension 140 and / or the bends 170, 172.

[0087] The laser 210 application of localized heat treatment results in a heat affected zone 220 surrounding a weld pool 230. The weld pool 230 produced by the laser can extend a radial distance from a point of laser impact on the first side 212 of the wire core 102. The heat affected zone 220 can extend a radial distance further beyond the radial distance of the weld pool 230.Attorney Docket No: THVVA-13339WO01

[0088] FIG. 3A schematically represents the heat affected zone 220 in gray scale, where darker values indicate higher temperatures and / or heat relative to surrounding untreated portions of the wire core 102 shown in white color. In this way, fading of the gray scale to the sides along a longitudinal axis 180 of the wire core 102 represents a temperature and / or heat gradient imparted by the laser 210 on the wire core 102. That is, an impact location 250 where the laser 210 strikes the first side 212 of the wire core 102 experiences the highest temperature, with the heat and temperature fading out radially therefrom. The gray scale shown in FIG. 3A is intended to represent one such example of temperature / heat during treatment. The temperature / heat during treatment can vary and can be specified according to a desired material outcome.

[0089] In the example shown in FIG. 3A, the temperature fades from the highest temperature at the impact location 250, to a lower, ambient temperature (i.e., white portions of the wire core 102), for example, in the first and second end regions 118, 120. The fading occurs in a radiating pattern along both the longitudinal axis 180 of the wire core 102 and the diameter 168. The temperature gradient can radiate along the longitudinal axis 180 a radius R1 from the impact location 250 in both directions, where the radius R1 can correspond to half a width W1 the heat affected zone 220. In some examples, the radius R1 can vary depending on an intensity of the laser 210 and / or a duration of laser treatment, as will be described later herein.

[0090] In some instances, the heat and / or the temperature at the impact location 250 on the first side 212 is greater than the heat and / or the temperature at a location 260 on the second side 214 directly opposite the impact location 250 on the wire core 102. In other words, a temperature gradient can occur across the diameter 168 of the wire core 102 along a depth D1, where the depth D1 corresponds to a depth of the heat affected zone 220.

[0091] In some examples, the location 260 may experience heat and / or elevated temperatures compared to the ambient temperature (i.e., white portions of the wire core 102), for example, in the first and second end regions 118, 120.

[0092] In some examples, the location 260 may not experience any change in heat and / or temperature. The depth D1 can vary depending on an intensity of the laser 210 and / or a duration of laser treatment, as will be described later herein.Attorney Docket No: THVVA-13339WO01

[0093] As previously discussed, an elasticity of the wire core 102 can increase with laser heat treating. FIG. 3B graphically depicts the elasticity of the wire core 102 in FIG. 3A as a function of the length of the wire core 102 along the first side 212. As shown in FIG. 3B, the elasticity of the wire core 102 in the heat affected zone 220 is elevated compared to surrounding portions of the wire core 102 (i.e., white portions of the wire core 102) for example, in the first and second end regions 118, 120. As seen in FIG. 3B, the first and second end regions 118, 120 are unaffected by the heat treatment.

[0094] A location of maximum elasticity 270 is shown in FIG. 3B as corresponding to the impact location 250 on the wire core 102. FIG. 3B illustrates the elasticity as decreasing along radius R1 in both directions along a first slope 280 and a second slope 282 until reaching untreated portions of the wire core 102, for example, the first and second end regions 118, 120.

[0095] The maximum elasticity 270 can vary depending on the intensity of the laser 210 and / or the duration of laser treatment. In some examples, if the intensity of the laser 210 is lower and the duration of laser treatment is short, a resulting change in elasticity can be minimal. In other examples, if the intensity of the laser 210 is higher and / or the duration of laser treatment is longer, the resulting change in elasticity can be greater. In this way, the intensity of the laser 210 and / or the duration of laser treatment can be specified to yield a prescribed maximum elasticity 270.

[0096] The first and second slopes 280, 282 (i.e., corresponding to the heat / temperature gradient) can also vary depending on the intensity of the laser 210 and / or the duration of laser treatment. In some examples, if the intensity of the laser 210 is low and the duration of laser treatment is short, the resulting change in elasticity can be minimal, leading to steeper first and second slopes 280, 282.

[0097] In other examples, if the intensity of the laser 210 is high and / or the duration of laser treatment is long, the resulting changes in elasticity can be greater, leading to shallower first and second slopes 280, 282. In some examples, the first and second slopes 280, 282 can be symmetric about the maximum elasticity 270. In some examples, the first and second slopes 280, 282 can be asymmetric about the maximum elasticity 270. In this way, the intensity of theAttorney Docket No: THVVA-13339WO01 laser 210 and / or the duration of laser treatment can be specified to yield a prescribed maximum elasticity 270 at the impact location 250 and preferred elasticity gradients in immediately adjacent areas.

[0098] In some examples, the wire core 102 may be locally strained only on outer bend surfaces, due to surface compression and tension. Accordingly, the elasticity at the impact location 250 can be specified according to local strain and elasticity requirements while the location 260 directly opposite the impact location 250 may not require the same elasticity.

[0099] In some instances, it may be desirable to impart constant elasticity through the diameter 168 of the wire core 102. In such instances, the laser 210 can be applied around an entire circumference of the wire core 102 or along portions of the circumference of the wire core.

[0100] The laser 210, for example, can be revolved continuously around the circumference of the wire core 102. In some examples, the intensity of the laser 210 and / or the duration of laser treatment can be constant for an entire revolution. In some examples, the intensity of the laser 210 and / or the duration of laser treatment can vary as the laser 210 is revolved around wire core 102.

[0101] The laser 210 can also be revolved incrementally around at least a portion of the circumference of the wire core 102. In some examples, the intensity of the laser 210 and / or the duration of laser treatment can be constant for each increment. In some examples, the intensity of the laser 210 and / or the duration of laser treatment can vary between the increments.

[0102] It is also possible that the laser 210 can be held stationary while the wire core 102 is rotated in place about axis 180, thereby heat treating the entire circumference or portions of the circumference in a similar manner as described. In this way, the location, the intensity, and the duration of laser heat treatment around the circumference of the wire core 102 can be specified to suit particular surface strains and elasticity requirements.

[0103] It may be desirable to introduce areas of higher elasticity more gradually, reducing the likelihood of stress concentrations or discontinuities due to abrupt changes in material properties. Referring back to FIG. 1, the wire core 102 has a proximal transition section 142 disposedAttorney Docket No: THVVA-13339WO01 between the bend 170 and the first end region 118 and a distal transition section 144 disposed between the bend 172 and the coil 116. In some instances, the proximal and distal transition sections 142, 144 may have differing elasticity requirements than other portions of the wire core 102 that may necessitate separate heat treatment. For example, as described above, it may be advantageous for the elasticities of the proximal and distal transition sections 142, 144 to serve as gradual lead-ins to higher elasticities in the bends 170, 172 and / or the extension 140. As such, the proximal and distal transition sections 142, 144 may be heat treated separately from other portions of the wire core 102 in a secondary heat-treating operation that can smooth the transition between areas of differing material properties.

[0104] FIG. 4A shows the wire core 102 of the docking device 100 in the straightened configuration of FIG. 3A. In FIG. 4A the wire core 102 is receiving localized heat application by a first laser 310 and a second laser 312 to portions of the wire core 102 on the first side 212 of the wire core 102. In some examples, as shown in FIG. 4A, the first and second lasers 310, 312 can be applied to the proximal and distal transition sections 142, 144, respectively.

[0105] The first and second lasers 310, 312 are shown in FIG. 4A in gray scale with a lighter color than the laser 210 in FIG. 3A. The lighter color of the first and second lasers 310, 312 schematically represents lower or reduced laser intensity, for example, than the laser intensity of laser 210. It is understood that the intensity of the first and second lasers 310, 312, or any laser described herein, can be selected and / or adjusted according to particular material requirements along the wire core 102.

[0106] The first and second lasers 310, 312 provide localized heat treatment to portions of the wire core 102, for example, the proximal and distal transition sections 142, 144 as shown, resulting in a heat affected zone 320 surrounding a weld pool 330 for the first laser 310 and a heat affected zone 322 surrounding a weld pool 332 for the second laser 312. The weld pools 330, 332 produced by the first and second lasers 310, 312, respectively, can extend radial distances from points of laser impact on the first side 212 of the wire core 102. The heat affected zones 320, 322 can extend radial distances further beyond the radial distances of the weld pools 330, 332.Attorney Docket No: THVVA-13339WO01

[0107] FIG. 4A schematically illustrates the heat affected zones 320, 322 in gray scale, where darker values represent higher temperatures and / or heat relative to a surrounding white color. In this way, fading of the gray scale to the sides along a longitudinal axis 180 of the wire core 102 represents a temperature and / or heat gradient imparted by the first and second lasers 310, 312 on the wire core 102. That is, an impact location 350 where the first laser 310 strikes the first side 212 of the wire core 102 and an impact location 352 where the second laser 312 strikes the first side 212 of the wire core 102 can experience the highest temperatures.

[0108] The heat and / or temperature can fade from the highest temperature shown at the impact locations 350, 352, to a lower, ambient temperature (i.e., white portions of the wire core 102) for example, in the first and second end regions 118, 120. The fading can occur in radiating patterns along both the longitudinal axis 180 of the wire core 102 and the diameter 168. The heat and / or temperature gradient can radiate along the longitudinal axis 180 a radius R2 from the impact location 350 in both directions and a radius R3 from the impact location 352 in both directions. The radius R2 corresponds to the heat affected zone 320 and the radius R3 corresponds to the heat affected zone 322. In some examples, the radii R2, R3 can vary depending on an intensity of the first and second lasers 310, 312, respectively, and / or a duration of laser treatment, as will be described later herein. R2 can equal R3 or, in some cases, R2 and R3 can be different. In some examples, a width W2 of the heat affected zone 320 is not centered about the impact location 350 and a width W3 of the heat affected zone 322 is not centered about impact location 352.

[0109] In some instances, the heat and / or the temperature at the impact locations 350, 352 on the first side 212 are greater than the heat and / or the temperatures at locations 360, 362, where locations 360, 362 are shown on the second side 214 directly opposite the impact locations 350, 352, respectively, on the wire core 102. That is, a temperature gradient can occur across the diameter 168 of the wire core 102 along a depth D2 and a depth D3. The depth D2 corresponds to the heat affected zone 320 and the depth D3 corresponds to the heat affected zone 322. The locations 360, 362 may experience heat and / or elevated temperatures when compared to theAttorney Docket No: THVVA-13339WO01 ambient temperature (i.e., white portions of the wire core 102), for example, in the first and second end regions 118, 120.

[0110] In some examples, the locations 360, 362 may not experience any change in heat and / or temperature. The depths D2, D3 can vary depending on an intensity of the first and second lasers 310, 312, respectively, and / or a duration of laser treatment, as will be described later herein.

[0111] As previously discussed, an elasticity of the wire core 102 can increase with laser heat treatment. FIG. 4B graphically depicts the elasticity of the wire core 102 in FIG. 4A as a function of the length of the wire core 102 along the first side 212. As shown in FIG. 4B, the elasticities of the wire core 102 in the heat affected zones 320, 322 are elevated compared to surrounding portions of the wire core 102 (i.e., white portions of the wire core 102), for example, in the first and second end regions 118, 120. As shown in FIG. 4B, the elasticities of the wire core 102 in the heat affected zones 320, 322 are elevated compared also to their respective elasticities in FIG. 3B. As seen in FIG. 4B, the first and second end regions 118, 120 are unaffected by the heat treatment.

[0112] The first and second lasers 310, 312 can provide localized heat treatment to the proximal and distal transition sections 142, 144, respectively, where it may be desirable to introduce areas of higher elasticity more gradually. As such, the proximal and distal transition sections 142, 144 may be heat treated separately from other portions of the wire core 102 in separate heat treating operations, so that the proximal and distal transition sections 142, 144 can serve as gradual lead- ins to higher elasticities. A location of maximum elasticity 270 is shown in FIG. 4B corresponding to the location of maximum elasticity 270 in FIG. 3B and to the impact location 250 on the wire core 102 in FIG. 3A. Since only the proximal and distal transition sections 142, 144 are shown in FIG. 4A as having secondary heat treatment by the first and second lasers 310, 312, the elasticities of remaining portions of the wire core 102, for example the extension 140, are unchanged from FIG. 3B.

[0113] FIG. 4B illustrates the elasticity of the proximal and distal transition sections 142, 144 elasticity along a third slope 380 and a fourth slope 382. The third and fourth slopes 380, 382 inAttorney Docket No: THVVA-13339WO01 FIG. 4B are shown shallower than the first and second slopes 280, 282 in FIG. 3B due to additional heat treatment in the proximal and distal transition sections 142, 144 in the heat affected zones 320, 322. That is, with additional heat treatment in the proximal and distal transition sections 142, 144, the elasticity in the proximal and distal transition sections 142, 144 is higher than the elasticity shown in FIG. 3B, providing a more gradual lead-in to areas with higher elasticity, for example, bends 170, 172 and / or extension 140.

[0114] The third and fourth slopes 380, 382 (i.e., the heat / temperature gradient) can also vary depending on the intensity of the first and second lasers 310, 312 and / or the duration of laser treatment. In some examples, the intensity of the first and second lasers 310, 312 can be low and the duration of laser treatment can be short, resulting in minimal change in elasticity, leading to steeper third and fourth slopes 380, 382. In this way, the third and fourth slopes 380, 382 can be substantially similar to the first and second slopes 280, 282 in FIG. 3B.

[0115] In other examples, the intensity of the first and second lasers 310, 312 can be high and / or the duration of laser treatment can be long, resulting in greater changes in elasticity and leading to even shallower third and fourth slopes 380, 382. In some examples, the third and fourth slopes 380, 382 can be symmetric about the maximum elasticity 270. In some examples, the third and fourth slopes 380, 382 can be asymmetric about the maximum elasticity 270. The intensity of the first and second lasers 310, 312 and / or the duration of laser treatment can be specified to yield elasticity gradients and slopes as required and prescribed.

[0116] As previously described with respect to FIGS. 3A-3B, the entire circumference of the wire core 102 or portions of the wire core 102 can be laser heat treated in the same manner as outlined. More specifically, the location, the intensity, and the duration of laser heat treatment around the circumference of the wire core 102 in FIGS. 4A-4B can be specified to suit particular surface strains and elasticity requirements in any separate heat treatment operation.

[0117] Although the extension 140, the bends 170, 172, and the proximal and distal transition sections 142, 144 are described herein as receiving laser heat treatment, it is understood that any portion of the wire core 102 can be laser heat treated in the manner described herein, forAttorney Docket No: THVVA-13339WO01 example, where the wire core is bent in a radius less than 12 mm and / or where the wire core is bent at an angle less than 100 degrees.

[0118] In other instances, laser heat treatment can be applied to wire cores with areas of reduced diameter, as an additional treatment option.

[0119] Additionally or alternatively, a plurality of lasers may be used for simultaneous heat treatment in various areas of the wire core 102, while in some examples, heat treatment can occur in stages or phases depending on need. In this way, wire cores (such as, for example, wire core 102 or any other wire core described herein) can be heat treated to increase elasticity and reduce stresses. Delivery Techniques

[0120] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.Attorney Docket No: THVVA-13339WO01

[0121] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0122] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0123] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.Attorney Docket No: THVVA-13339WO01

[0124] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0125] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Additional Examples of the Disclosed Technology

[0126] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0127] Example 1. A docking device for a prosthetic implant, comprising: a wire core with a length, wherein the wire core has a first end region, a second end region, a coiled section disposed between the first end region and the second end region, and an extension disposed between the coiled section and the first end region, wherein the wire core has a constant diameter along the length, and wherein the extension has an elasticity that is different than the elasticity of the first end region or the second end region.

[0128] Example 2. The docking device of any example herein, particularly example 1, wherein the first end region has a first elasticity, the second end region has a second elasticity, the coiledAttorney Docket No: THVVA-13339WO01 section has a third elasticity, and the extension has a fourth elasticity, wherein the fourth elasticity is greater than the first, second, and third elasticities.

[0129] Example 3. The docking device of any example herein, particularly example 2, wherein the first, second, and third elasticities are equal.

[0130] Example 4. The docking device of any example herein, particularly any one of examples 2-3, further comprising a proximal transition section between the extension and the first end region and a distal transition section between the extension and the coiled section, wherein the proximal transition section, the distal transition section, or both the proximal transition section and the distal transition section have elasticities greater than the first, second, and third elasticities.

[0131] Example 5. The docking device of any example herein, particularly example 4, wherein the extension, the proximal transition section, or the distal transition section is heat treated.

[0132] Example 6. The docking device of any example herein, particularly any one of examples 1-5, wherein a portion of the wire core is heat treated.

[0133] Example 7. The docking device of any example herein, particularly any one of examples 5-6, wherein at least one laser is used for heat treating.

[0134] Example 8. The docking device of any example herein, particularly example 7, wherein the at least one laser is applied around an entire circumference of the wire core.

[0135] Example 9. The docking device of any example herein, particularly example 7, wherein the at least one laser is applied to a portion of a circumference of the wire core.

[0136] Example 10. The docking device of any example herein, particularly any one of examples 2-9, wherein the extension has a length and the fourth elasticity varies along the length of the extension.

[0137] Example 11. The docking device of any example herein, particularly any one of examples 2-9, wherein the extension has a length and the fourth elasticity is constant along the length of the extension.Attorney Docket No: THVVA-13339WO01

[0138] Example 12. The docking device of any example herein, particularly any one of examples 1-11, wherein the wire core is made of Nitinol or another shape memory material.

[0139] Example 13. A docking device for docking a prosthetic valve at a native valve of a heart, the docking device comprising: a wire core with a proximal tip, a distal tip, a first end region adjacent to the proximal tip, a second end region adjacent to the distal tip, and a constant diameter from the proximal tip to the distal tip, wherein the wire core forms a coil disposed between the first end region and the second end region, and an extension disposed between the coil and the first end region, wherein the extension has a higher elasticity than at least one of the first end region, the second end region, and the coil.

[0140] Example 14. The docking device of any example herein, particularly example 13, further comprising a proximal transition section between the extension and the first end region and a distal transition section between the extension and the coil, wherein elasticities of the proximal transition section and the distal transition section are less than an elasticity of the extension.

[0141] Example 15. The docking device of any example herein, particularly example 14, wherein the elasticities of the proximal transition section and the distal transition section are greater than the elasticities of the first end region, the second end region, or both the first and second end regions.

[0142] Example 16. A method of fabricating a wire core for a docking device, the method comprising: forming a length of the wire core with a constant diameter along the length, wherein the wire core has a first end region, a second end region, and an extension disposed between the first end region and the second end region; and heat treating the extension to increase an elasticity of the extension.

[0143] Example 17. The method of any example herein, particularly example 16, further comprising shaping the wire core to form a coiled section between the extension and the second end region.

[0144] Example 18. The method of any example herein, particularly any one of examples 16-17, further comprising heat treating a distal transition section of the extension, a proximal transitionAttorney Docket No: THVVA-13339WO01 section of the extension, or the proximal transition section and the distal transition section of the extension.

[0145] Example 19. The method of any example herein, particularly any one of examples 16-18, further comprising varying an intensity of the heat treating, a duration of the heat treating, or both the intensity and the duration of the heat treating in portions of the wire core.

[0146] Example 20. The method of any example herein, particularly any one of examples 16-19, wherein the heat treating includes at least one laser.

[0147] Example 21. The method of any example herein, particularly example 20, further comprising revolving the at least one laser around a circumference of the wire core during the heat treating.

[0148] Example 22. The method of any example herein, particularly example 20, further comprising rotating the wire core during the heat treating while the laser is stationary.

[0149] Example 23. The method of any example herein, particularly any one of examples 16-22, wherein the wire core is made of Nitinol or another shape memory material.

[0150] Example 24. A method comprising sterilizing the prosthetic heart valve, apparatus, docking device, and / or assembly of any example.

[0151] Example 25. A prosthetic heart valve, apparatus, docking device, and / or assembly of any one of examples 1-24, wherein the prosthetic heart valve, apparatus, device, and / or assembly is sterilized.

[0152] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one heat treatment, wire core, or docking device can be combined with any one or more features of another heat treatment, wire core, or docking device. As another example, any one or more features of one method can be combined with any one or more features of another method.Attorney Docket No: THVVA-13339WO01

[0153] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Attorney Docket No: THVVA-13339WO01 CLAIMS:

1. A docking device for a prosthetic implant, comprising: a wire core with a length, wherein the wire core has a first end region, a second end region, a coiled section disposed between the first end region and the second end region, and an extension disposed between the coiled section and the first end region, wherein the wire core has a constant diameter along the length, and wherein the extension has an elasticity that is different than the elasticity of the first end region or the second end region.

2. The docking device of claim 1, wherein the first end region has a first elasticity, the second end region has a second elasticity, the coiled section has a third elasticity, and the extension has a fourth elasticity, wherein the fourth elasticity is greater than the first, second, and third elasticities.

3. The docking device of claim 2, wherein the first, second, and third elasticities are equal.

4. The docking device of any one of claims 2-3, further comprising a proximal transition section between the extension and the first end region and a distal transition section between the extension and the coiled section, wherein the proximal transition section, the distal transition section, or both the proximal transition section and the distal transition section have elasticities greater than the first, second, and third elasticities.

5. The docking device of claim 4, wherein the extension, the proximal transition section, or the distal transition section is heat treated.

6. The docking device of any one of claims 1-5, wherein a portion of the wire core is heat treated.Attorney Docket No: THVVA-13339WO01 7. The docking device of any one of claims 5-6, wherein at least one laser is used for heat treating.

8. The docking device of claim 7, wherein the at least one laser is applied around an entire circumference of the wire core.

9. The docking device of claim 7, wherein the at least one laser is applied to a portion of a circumference of the wire core.

10. The docking device of any one of claims 2-9, wherein the extension has a length and the fourth elasticity varies along the length of the extension.

11. The docking device of any one of claims 2-9, wherein the extension has a length and the fourth elasticity is constant along the length of the extension.

12. The docking device of any one of claims 1-11, wherein the wire core is made of Nitinol or another shape memory material.

13. A docking device for docking a prosthetic valve at a native valve of a heart, the docking device comprising: a wire core with a proximal tip, a distal tip, a first end region adjacent to the proximal tip, a second end region adjacent to the distal tip, and a constant diameter from the proximal tip to the distal tip, wherein the wire core forms a coil disposed between the first end region and the second end region, and an extension disposed between the coil and the first end region, wherein the extension has a higher elasticity than at least one of the first end region, the second end region, and the coil.

14. The docking device of claim 13, further comprising a proximal transition section between the extension and the first end region and a distal transition section between theAttorney Docket No: THVVA-13339WO01 extension and the coil, wherein elasticities of the proximal transition section and the distal transition section are less than an elasticity of the extension.

15. The docking device of claim 14, wherein the elasticities of the proximal transition section and the distal transition section are greater than the elasticities of the first end region, the second end region, or both the first and second end regions.

16. A method of fabricating a wire core for a docking device, the method comprising: forming a length of the wire core with a constant diameter along the length, wherein the wire core has a first end region, a second end region, and an extension disposed between the first end region and the second end region; and heat treating the extension to increase an elasticity of the extension.

17. The method of claim 16, further comprising shaping the wire core to form a coiled section between the extension and the second end region.

18. The method of any one of claims 16-17, further comprising heat treating a distal transition section of the extension, a proximal transition section of the extension, or the proximal transition section and the distal transition section of the extension.

19. The method of any one of claims 16-18, further comprising varying an intensity of the heat treating, a duration of the heat treating, or both the intensity and the duration of the heat treating in portions of the wire core.

20. The method of any one of claims 16-19, wherein the heat treating includes at least one laser.

21. The method of claim 20, further comprising revolving the at least one laser around a circumference of the wire core during the heat treating.Attorney Docket No: THVVA-13339WO01 22. The method of claim 20, further comprising rotating the wire core during the heat treating while the laser is stationary.

23. The method of any one of claims 16-22, wherein the wire core is made of Nitinol or another shape memory material.

Images