Heating to set shape memory metal

Abstract

A shaping apparatus is provided that includes an electrical conductor and a forming die configured to physically couple a target shape-memory metal apparatus to the forming die to maintain at least a portion of the target shape-memory metal apparatus in conformance with at least a portion of the forming die. A method of shaping a shape-memory metal apparatus includes physically coupling a shape-memory metal apparatus to a shaped workpiece, injecting an electrical current through a conductor associated with the shaped workpiece to heat the shaped workpiece, and conducting thermal energy from the shaped workpiece to the shape-memory metal apparatus to shape at least a portion of the shape-memory metal apparatus in conformance with at least a portion of the shaped workpiece.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 584,312, filed on September 21, 2023, entitled “Heating for MEMORY METAL SHAPE-SETTING”, the entire disclosure of which is hereby incorporated by reference. Background Technology

[0003] This disclosure generally relates to the field of shape memory devices and processes. Depending on the application, a shape memory device can be shaped into a desired shape by heating the device structure according to an annealing / shaping process; the shape memory device may include a medical implantable device (e.g., a stent implantable device). Shaping heating can be performed by immersing the target structure in a molten salt bath. Molten salt bath systems can be relatively expensive, large-scale, and complex systems. Summary of the Invention

[0004] This document describes apparatus, methods, and systems relating to heating a shape memory metal device to a setting temperature using a tool / apparatus configured to generate heat using an electric current in one or more conductors. Such conductors may be associated with a forming die / workpiece configured to shape a target shape memory metal device when the generated heat is used to heat the device. In the example setting apparatus of this disclosure, the conductor used for heating may comprise an induction coil, wherein heat in the formed workpiece and / or target device is generated by inducing a current (e.g., alternating current) in the conductor to induce a current in the workpiece or target device, thereby producing a resistance heating effect, which in turn generates induced heat, and this induced heat is then used to generate heat.

[0005] In some instances, heat generation is at least partly due to an electric current passing through the conductor, thereby causing a resistance heating effect within the conductor itself. The conductor of the shaping device disclosed herein may be embedded within the volume of the associated formed workpiece, or may be disposed within and / or outside the workpiece mold. In some instances, the conductor itself is shaped to provide a forming mold for the device / tool. Furthermore, embodiments of this disclosure may have structural conductor and / or formed workpiece features (e.g., variable thickness, spacing, material composition, etc.) that produce a variable heat distribution over different regions of the device.

[0006] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features have been described. It should be understood that, depending on any particular instance, not all such advantages may be realized. Therefore, the disclosed instances may be carried out in a manner that implements or optimizes one or a set of advantages as taught herein, without necessarily implementing other advantages as may be taught or suggested herein. Attached Figure Description

[0007] For illustrative purposes, various examples are depicted in the accompanying drawings, and these examples should in no way be construed as limiting the scope of the invention. Furthermore, various features of different disclosed examples can be combined to form other examples that are part of this disclosure. Throughout the drawings, reference numerals may be used repeatedly to indicate correspondences between reference elements.

[0008] Figure 1 The image shows a shape memory implantation device in an anatomical structure based on several examples of implantation.

[0009] Figure 2 It is a flowchart illustrating the process of shaping a shape memory metal device using immersion heating, based on several examples.

[0010] Figure 3A A memory metal device mounted on a forming mandrel is shown according to one or more examples.

[0011] Figure 3B A shape-forming immersion system for shape-forming metals according to one or more examples is shown.

[0012] Figure 4 It is a block diagram of an induction coil heating system for shaping memory metal, based on one or more examples.

[0013] Figure 5A A side view of a shaped workpiece with an integrated induction coil is shown according to one or more examples.

[0014] Figure 5B and 5C It shows one or more instances Figure 5A A side cross-sectional view of an embodiment of a formed workpiece having an integrated induction coil therewith.

[0015] Figure 6A A side view of a formed workpiece with an associated induction coil, according to one or more examples, is shown.

[0016] Figure 6B and 6C It shows one or more instances Figure 6A A side cross-sectional view of an embodiment of a formed workpiece having an associated induction coil.

[0017] Figure 7A and 7B Perspective and side views of multiple formed workpieces according to one or more examples are shown respectively.

[0018] Figure 7CA side cross-sectional view of a multi-piece formed workpiece having an induction coil integrated with one or more of its internal components is shown, according to one or more examples.

[0019] Figure 7D A side cross-sectional view of a multi-piece formed workpiece having an induction coil integrated with one or more external components is shown, according to one or more examples.

[0020] Figure 8 A side cross-sectional view of multiple formed workpieces having induction coils associated with their inner and / or outer diameters, according to one or more examples, is shown.

[0021] Figure 9 Perspective and side views of a multi-piece formed workpiece having a dedicated / corresponding induction coil portion associated therewith, according to one or more examples, are shown.

[0022] Figure 10 It is a block diagram of a resistance heating system for shaping memory metals, based on one or more examples.

[0023] Figure 11A and 11B The diagram illustrates a resistance-heated workpiece formed by one or more electrical conductors, according to one or more examples.

[0024] Figure 12 It is a flowchart illustrating the process of heating a shape memory metal device using a heating tool, based on one or more examples.

[0025] Figure 13 A heated workpiece configured to produce shape variability of shape memory metal is shown according to one or more examples. Detailed Implementation

[0026] The titles provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0027] Although certain preferred examples are disclosed below, it should be understood that the subject matter of the invention extends beyond the specific examples disclosed, reaching other alternative examples and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the claims that may arise therefrom is not limited to any of the specific examples described below. For example, in any method or process disclosed herein, the actions or operations of the method or process can be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as multiple discrete operations in a manner that may aid in understanding certain examples; however, the order of description should not be construed as implying that these operations are sequentially related. Furthermore, the structures, systems, and / or apparatuses described herein may be embodied as integrated components or separate components. For the purpose of comparison, certain aspects and advantages of these examples are described. Not all such aspects or advantages are necessarily achieved through any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one or a set of advantages as taught herein, without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0028] To facilitate the reuse of certain reference numerals in different figures of this disclosure's atlas, certain reference numerals are used repeatedly to indicate that devices, components, systems, features, and / or modules may have similar characteristics in one or more aspects. However, with respect to any of the examples disclosed herein, the reuse of common reference numerals in the figures does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, those skilled in the art can understand from the context that the use of common reference numerals may imply the degree of similarity between the referenced subjects. The use of a particular reference numeral in the context of the description of a particular figure can be understood to relate to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified by the same reference numeral in another figure. Furthermore, aspects of individual figures identified by common reference numerals can be interpreted as sharing characteristics or being completely independent of each other.

[0029] When using alphanumeric reference numerals that include both numerical and alphabetic parts (e.g., '10a', where '10' is the numerical part and 'a' is the alphabetic part), a written description referring only to the numerical part (e.g., '10') may refer to any feature identified in the figure using such a numerical part (e.g., '10a', '10b', '10c', etc.), even if such a feature is identified by a reference numeral that connects its numerical part with one or more alphabetic characters (e.g., 'a', 'b', 'c', etc.). That is, by way of example, a reference to feature '10' in this written description may be understood to refer to feature '10a' identified in a particular figure of this disclosure, or to reference '10' or '10b' in the same or another figure. Furthermore, when using reference numerals that include a first numerical part followed by a dash (e.g., '-') and a second numerical part (e.g., '10-2', where '10' is the first numerical part and '2' is the second numerical part), a written description referring only to the first numerical part (e.g., '10') may refer to any feature identified in the figure using such a first numerical part (e.g., '10-1', '10-2', '10-3', etc.), even if such a feature is identified by reference numerals that connect its numerical part with a dash and a second numerical part. That is, as an example, a reference to feature '10' in this written description may be understood to refer to feature '10-1' identified in a particular figure of this disclosure, or to reference '10' or '10-2' in the same or another figure.

[0030] This document uses certain standard anatomical terms of location to refer to anatomical structures in the animal (i.e., human) for each instance. While certain spatially relative terms, such as “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it should be understood that, for ease of description, these terms are used herein to describe the positional relationship between elements / structures, as illustrated in the figures. It should be understood that, in addition to the orientations depicted in the figures, spatially relative terms are intended to cover different orientations of elements / structures in use or operation. For example, an element / structure described as “above” another element / structure may indicate a position relative to the subject patient or an alternative orientation of the element / structure located below or beside such other element / structure, and vice versa. It should be understood that spatially relative terms (including those listed above) can be understood relative to the corresponding orientations shown in the reference figures.

[0031] Shape memory implants / devices

[0032] This disclosure relates to shape memory devices, and more specifically to systems, apparatus, and methods for shaping shape memory devices by heating. The term "shape memory" is used herein in its broad and general sense and can refer to devices, structures, etc., that can recover a predefined shape when subjected to certain stimuli (such as heat, electricity, light, and / or magnetic fields). The shape memory devices disclosed herein may include shape memory alloys, shape memory polymers, shape memory ceramics / composite materials, and / or devices comprising any other type of shape memory material. The shape memory devices disclosed herein may include shape memory metal devices, which typically comprise shape memory devices made of shape memory alloys (such as nitinol, nickel-titanium alloys, etc.). Due to the biocompatibility properties of nitinol, it can be considered highly suitable for use in medical devices such as stent implants, frames, and / or other implantable devices disclosed in detail herein. Other shape memory metals that can be used in conjunction with the examples of this disclosure include copper-aluminum-nickel (CuAlNi) alloys, copper-zinc-aluminum (CuZnAl) alloys, iron-manganese-silicon (FeMnSi) alloys, nickel-aluminum (NiAl) alloys, platinum-cadmium (PtCd) alloys, gold-cadmium (AuCd) alloys, etc. In some cases, the terms "shape memory" and "memory metal" are used interchangeably herein.

[0033] As mentioned above, shape memory implants (e.g., scaffolds, docking frames, prosthetic valve frames, etc.) related to the solutions presented herein can be advantageously configured to return to their original fixed shape / form upon heating or in response to another stimulus after deformation. Shape memory materials can provide certain functions / features that make the use of such materials attractive for implant devices / structures and other applications. For example, shape memory devices typically provide a shape memory effect, wherein when a material / metal is deformed at low temperatures, the material / metal tends to return to its original fixed shape upon heating or other stimulation. Therefore, shape memory implants / devices can advantageously change shape in response to temperature changes.

[0034] In addition to shape memory effects, some shape memory devices can also provide hyperelasticity or pseudoelasticity. For example, some shape memory materials / metals can return to their original shape when deformed at a specific temperature without requiring heating. This functionality can be used in applications requiring significant elastic deformation. Some shape memory materials / metals (such as nitinol) further offer biocompatibility properties, making them particularly suitable for use in medical devices (such as stents). Shape memory devices associated with the examples of this disclosure can be used in any suitable or desired application. For example, the shape memory devices of this disclosure can be used in medical devices as described in detail below, as well as devices for the aerospace, automotive, and other industries.

[0035] As mentioned above, the shape memory device shaping combined with the various examples herein can be any type of implantable or non-implantable device. Example implantable devices that can be shaped according to various aspects of this disclosure may include shape memory / metallic heart valve frames, heart valves, vascular (e.g., aortic, coronary) stents, neural / brain stents, heart valve (e.g., mitral valve) repair devices, heart valve (e.g., lung / mitral valve) docking stations, suture clips, vascular (e.g., inferior vena cava) filters, ventricular remodeling devices (e.g., chainmail pouches, tethers), guidewires (e.g., shape memory tail fiber features), and / or any other shape memory implantable device / structure.

[0036] This article discloses certain examples in the context of shape memory metal vascular stents (such as stents that can be implanted in the coronary arteries or other arteries or veins). Figure 1 An example shape memory implantation device 10 is shown implanted in an example cardiac anatomy. The implantation device 10 is an example device that can be shaped according to the heating solution disclosed herein.

[0037] Figure 1 An example mammalian heart 1 is shown. The blood circulation facilitated by heart 1 typically includes coronary circulation, pulmonary circulation, and a larger systemic circulatory system, each comprising certain veins and arteries. The systemic circulatory system is supplied with oxygenated blood pumped from the heart into certain arteries, the largest of which is the aorta 16, which originates from the left ventricle 3 of heart 1 and is used to carry and distribute oxygenated blood to all parts of the body. Aorta 16 is divided into the ascending aorta 13, the aortic arch 12, and the descending aorta 15, the descending aorta being further divided into the thoracic aorta (in the chest) and the abdominal aorta.

[0038] Venous blood returns to the heart primarily through the superior vena cava 18 and the inferior vena cava 19, which are the largest veins in the body. The superior vena cava 18 carries deoxygenated blood from the upper part of the body back to the right atrium 5 of the heart 1, while the inferior vena cava 19 carries deoxygenated blood from the lower part of the body back to the heart 1 and also into the right atrium 5.

[0039] Pulmonary circulation provides a blood pathway between the heart 1 and the lungs. Deoxygenated blood returning to the heart 1 via the superior vena cava 18 and inferior vena cava 19 enters the right atrium 5 and moves into the right ventricle 4, which pumps blood to the lungs via the pulmonary artery 11. In the lungs, the blood becomes oxygenated and returns to the heart 1 via the pulmonary veins, entering the left atrium 2 and then the left ventricle 3.

[0040] The heart 1 comprises a vascular system that forms the coronary circulation, supplying oxygen and nutrients to the myocardium 1 itself. The coronary circulation includes various coronary arteries 14 that supply oxygenated blood to the myocardium or myocardial layers. Two main coronary arteries include the left coronary artery 14l and the right coronary artery 14r. The left coronary artery 14l is divided into the left anterior descending artery and the circumflex artery. The right coronary artery 14r typically supplies the right side of the heart and generally supplies the ventricles and the lower portion of the posterior cardiac structures. When the left ventricle 3 contracts, oxygenated blood is propelled into the aorta 16, which distributes blood throughout the body via systemic circulation. Simultaneously, some oxygenated blood from the aorta 16 is directed through the coronary arteries 14 to the myocardium itself. After delivering oxygen to the myocardium, this blood flows into the coronary sinuses, which in turn drain into the right atrium, where it merges with deoxygenated blood from the rest of the body.

[0041] Shape memory stent devices (such as stent 10) may comprise a flexible tubular structure made of shape memory metal or other shape memory materials, configured to be inserted into a target blood vessel or other body channel, wherein stent 10, once deployed, can be used to keep the target blood vessel segment open to allow blood flow. Shape memory stent devices can be implanted to treat certain cardiovascular conditions. For example, coronary artery stents (such as stent 10) can be used in angioplasty to treat coronary artery disease, which is narrowing or blockage of the coronary arteries due to plaque buildup. When the coronary artery 14 narrows or becomes blocked, it can cause symptoms including chest pain (angina) or a heart attack.

[0042] The stent implant 10 can be advanced into a target vascular segment within the delivery system / catheter, which can be accessed downstream of the target vascular segment via a percutaneous arterial (and / or venous) inlet (e.g., in the groin or wrist). As the delivery system is directed toward the target vascular segment (e.g., a narrowed or blocked coronary artery), the delivery system can maintain the stent 10 in a radially compressed delivery configuration. The tip of the delivery system / sheath may have a small balloon that inflates once the delivery system is in place to expand the stent 10, thereby compressing plaque against the arterial wall and restoring / improving blood flow. The shape memory of the stent 10 (which can be configured as an expansion configuration of the stent) can additionally or alternatively generate the desired stent expansion in the vessel 14. When expanding from the compressed delivery configuration, the struts 101 of the stent 10 can separate, thereby increasing the size of the unit 102 and conforming the stent 10 to the size and shape of the vessel 14. Coronary artery stents can provide a less invasive alternative to coronary artery bypass grafting.

[0043] In some embodiments, the stent 10 may be coated with a drug / substance that is slowly released from the stent and helps prevent re-occlusion of the target blood vessel. Such drugs can inhibit the formation of scar tissue that could otherwise form within the stent and narrow the vessel again.

[0044] As shown and mentioned above, shape memory scaffolds (such as...) Figure 1 The stent 10 may have a metal frame with struts 101 forming open units 102. This design provides the desired flexibility, fit, and stent support to keep the target vessel open. Typically, struts 101 are provided as separate molds constituting the stent structure. Struts 101 may be formed from thin, elongated metal pieces joined together to form the integral structure of the stent frame. The stent frame may have a generally tubular shape to conform to the cylindrical shape of the target vessel. The stent frame may advantageously be designed to be flexible, allowing it to pass through typically tortuous vascular pathways with radially compressed delivery configurations, while also possessing sufficient rigidity to provide the necessary support to keep the vessel open. The open units 102 of the stent 10 may be geometrically shaped (e.g., they may be rhomboid or circular) and uniformly distributed across the stent structure. The open unit design allows for flexibility while providing uniform support to the vessel wall, and also allows blood to flow into collateral vessels.

[0045] The support frame 10 can be formed by cutting a support pattern into shape memory (e.g., nitinol) tubes or wires (e.g., via a laser cutting process). Once cut, the support 10 can be subjected to a series of finishing processes, such as electropolishing and / or cleaning processes, which can be implemented to remove any residues or contaminants.

[0046] Compared to traditional non-shape memory stents, stents made of shape memory materials (such as stent 10) can offer several advantages. The use of shape memory materials / metals allows stent 10 to undergo deformation, compressing it for delivery, whereby the pre-defined expanded shape / construction of stent 10 naturally recovers when heated above its transition temperature. The use of shape memory materials can also provide stent 10 with hyperelasticity or pseudoelasticity, allowing it to undergo significant deformation and immediately return to its original shape with or without temperature increases. In some instances, the hyperelastic properties of stent 10 allow it to bend and conform to the natural movement of the artery without causing damage, which can be particularly beneficial in locations where the vessel is tortuous or flexed. Furthermore, the shape memory properties of stent 10 can provide it with self-expansion capabilities, allowing it to be delivered to the target site in a compressed construct (e.g., at relatively cool temperatures) and then expand to its pre-defined shape upon unfolding and at body temperature. Self-expansion can allow for less trauma and more precise placement of stent 10. In addition, the body generally tolerates shape memory materials / metals (such as nitinol) well, thus reducing the risk of inflammation or other adverse reactions. Once expanded, shape memory (e.g., nitinol) stents can resist external compression better than some other types of stents, which can help keep blood vessels in an open / closed state over time.

[0047] Shape memory metal devices

[0048] This disclosure relates to a process for manufacturing shape memory implantable components, and more specifically to a particular process for shaping / annealing nitinol scaffolds or other implantable components through heat treatment. Typically, devices comprising nitinol shape memory metals, such as nickel-titanium alloys and other shape memory alloys, can be heat-treated to cause the target component / device to 'remember' a specific shape that the metal has been set during the shaping / annealing process. For example, when exposed to temperatures above the material's 'activation temperature,' shaped nitinol or other shape memory metal forms readily recover / transform to their 'remembered' form / shape.

[0049] In some cases, the shaping of shape memory devices / materials according to examples of this disclosure can be considered and / or referred to as “annealing,” wherein such terms are used herein in their broad and general sense. As used herein, the terms “shaping” and “annealing” can be understood as any heating process that alters the physical and / or chemical properties of a shape memory material to set the shape memory behavior of the shape memory material (e.g., an alloy) and / or the transition / activation temperature and / or increases the ductility of the material, reduces its hardness, etc., to make the material more workable.

[0050] The shaping / annealing process for setting the shape of a shape memory metal device typically involves heating the metal / alloy material to a relatively high temperature (e.g., approximately 500°C (932°F)) sufficient to redirect the material's dynamic crystal structure to a more cubic structure that conforms to the metal's current shape upon heating. During shaping / annealing, a mandrel or similar forming tool can be used to hold the shape memory metal in the desired form so that the device remembers that desired shape after shaping / annealing. After heating, as the device cools to a lower temperature state (i.e., the "martensitic" state), the device can deform from the cubic crystal structure. Subsequent heating above the activation temperature (which is below the annealing temperature, typically between 30°C (86°F) and 130°C (266°F)), where a specific activation temperature can be generated / set by heating parameters, transforms the shape memory metal to its "austenitic" state, where the metal's crystal structure becomes more cubic, thus reforming it into the previously set cubic shape.

[0051] In some implementations, shape memory metal shaping / annealing utilizes conductive heating, performed by exposure to / immersion in an overheated medium such as a molten salt bath, to heat the material (e.g., nitinol) and the forming tool / mandrel on which the target device is held / positioned. Figure 2 It is a flowchart illustrating the process of shaping a shape memory metal device using immersion heating, based on several examples.

[0052] At frame 202, process 200 involves cutting / etching a support frame as described above from a shape memory metal tube or sheet or other target shape memory metal device / structure. The operation associated with frame 202 produces a predetermined shape version of the support / device. The support may be relatively malleable prior to shaping / annealing, and the conditions may be suitable for cutting and / or forming the support frame.

[0053] Figure 3A A shape memory metal device (e.g., a support) 310, according to one or more embodiments, is shown mounted on a forming mandrel / workpiece 320. Further references... Figure 2 and 3A At frame 204, process 200 involves placing / positioning a support 310 on a shaping tool / workpiece 320, which in some cases can be considered a mandrel. For example, the shaping tool 320 may be shaped such that the support 310 conforms to the shape of the tool 320 when positioned on it, wherein the shape of the mandrel 320 corresponds to the desired shaping configuration of the support 310.

[0054] The shaping tool / workpiece 320 may be made of a heat-resistant material and is designed to hold the support 310 in the desired shape during the annealing process. In some instances, the tool / workpiece 320 comprises stainless steel, which can provide a suitablely high melting point for the heating process. The tool 320 may be designed to match the specific desired shape and size of the produced support 310. The tool / workpiece 320 may include a mandrel / mold for forming the support 310 into the desired shape. For example, the tool 320 may be used to form the support 310 into a specific diameter and / or produce certain complex shapes that include diameter variations along the length of the support 10, as shown in the figure. Figure 3A The specific shapes of the tool 320 and the support 310 are shown as non-limiting examples, and it should be understood that the supports and other devices disclosed herein can have any suitable or desired shape, including, for example, a straight cylinder. The tool / workpiece 320 may further include features, such as clamps, pins, or other fasteners, that help hold the support 310 in place during the annealing process. Such features help ensure that the support maintains its desired shape when heated and cooled.

[0055] Tool / workpiece 320 may consist of a single integral forming mold, or may comprise multiple parts configured to combine to form the forming mold shown / described. Examples of multi-part structures may facilitate molding bracket 310 into more complex geometries and / or allow encapsulation of at least a portion of bracket 310.

[0056] At frame 206, process 200 involves immersing the support 310 and mandrel / tool ​​320 together in a molten bath to heat the support 310 for shaping / annealing. Figure 3B A shape-forming immersion bath system 370 for shape memory metals is illustrated according to one or more examples. Immersing a support 310 in the bath container of the system 370 can help heat the support 310 to a specific temperature to induce a phase transformation, such that subsequent cooling “locks in” the desired shape of the support 310. The molten salt bath system 370 can provide a controlled environment for performing the shaping / annealing process, wherein a shaping tool 320 is used to produce the desired shape of the support 310 as it is heated.

[0057] The molten salt bath system 370 may comprise a container or tank filled with a molten salt solution, made of a heat-resistant material such as stainless steel. The system may be configured to heat the molten salt solution to a specific temperature and maintain it at that temperature for a predetermined amount of time to anneal the support 310, thereby producing desired characteristics such as stiffness, activation temperature, etc. The system 370 may have any suitable or desired size. Furthermore, the heating medium may be any suitable heating medium. For example, in some embodiments, the heating medium comprises a eutectic mixture of different salts (such as sodium chloride, potassium chloride, and / or lithium chloride). Such mixtures may advantageously provide a lower melting point than any single salt. The specific composition of the molten salt may depend on the specific annealing requirements / characteristics of the support 310. The molten salt bath may be heated using heating elements such as a furnace or electric heater. The temperature of the bath may be closely monitored and controlled to ensure it remains at the desired temperature throughout the shaping / annealing process. The support 310 is held in the bath for a predetermined amount of time to allow the formation of the desired crystalline structure, and then removed and cooled.

[0058] The heat and time of the shaping / annealing process can affect various properties of the shape memory metal support 310, including its mechanical properties and / or shape memory behavior. For example, specific heating temperatures and times determine the tensile strength, ductility, and / or fatigue life of the support 310. Generally, higher annealing temperatures and longer annealing times can increase the strength of the material while reducing its ductility. Furthermore, the heating temperature and / or time of the annealing process can affect the ratio of martensite to austenite crystal structures; higher annealing temperatures and longer annealing times can increase the amount of austenite crystal structure and decrease the amount of martensite crystal structure, which may affect the shape memory behavior of the support.

[0059] The shaping / annealing temperature and / or time can further determine the corrosion resistance properties of the support 310. For example, heating the support 310 during shaping / annealing may affect its surface properties and thus its corrosion resistance. Higher annealing temperatures and longer annealing times can allow an oxide layer to form on the surface of the support, which can improve its corrosion resistance. Although the shaping heating process according to this disclosure is described as "annealing" in some instances, it should be understood that the process may not involve heating the device to temperatures sufficient to relieve all stress and / or redissolve any precipitates that may have formed during the manufacturing process, and therefore may be considered not a fully metallurgical annealing based on some characterizations. The shaping heating process may be sufficient to achieve lattice reorientation of the atomic structure of the shape memory metal, but the heating temperature may or may not be raised to a level sufficient to achieve metallurgical treatments that reorient structures beyond the lattice, such as grain growth. The heating time in the bath may be between 3 and 30 minutes, such as between 5 and 20 minutes, or other desired durations.

[0060] At frame 208, process 200 involves cooling and / or finishing the holder 310 to produce the final shape memory product. After the annealing process is complete, the holder 310 can be removed from the bath and allowed to cool. In some embodiments, the holder 310 can be slowly cooled in a molten salt bath (e.g., to room temperature) to provide control over the cooling process, thereby preventing the formation of defects and ensuring the effectiveness of the annealing process.

[0061] The support 310 can be removed from the shaping tool / workpiece 320, and any excess material can be trimmed / polished. For example, chemical polishing can be performed as needed to remove impurities, defects, residual stress, and / or oxide films. In some embodiments, electropolishing can be performed based on the desired voltage, current density, electrode distance, and time.

[0062] Compared to the non-immersion heating solutions disclosed herein, the melt bath heating process 200 may exhibit undesirable complexity, cumbersomeness, and / or cost in some cases. For example, the melt bath system may be relatively large, and heating using such a system may take several minutes to complete. Furthermore, the melting point of the molten salt used for annealing the shape memory metal device / support may be greater than 200°C.

[0063] Inductive and resistive heating of shape memory devices

[0064] As described in detail above, molten salt bath annealing can be an undesirable, expensive, and slow process step for the fabrication of shape memory devices, and may require significant space and energy. Furthermore, immersion setting / annealing typically produces uniform metallurgical properties throughout the target device, rather than allowing the material to be variable to suit device requirements / functions. This paper discloses solutions for heating shape memory devices using certain induction heating and resistance heating-based devices and systems, which, compared to immersion heating, can advantageously reduce size, time, and complexity for shape memory heating / setting, while improving safety and cleanliness conditions.

[0065] Figure 4 This is a block diagram of an induction coil heating system 400 for shape memory metal according to one or more examples. System 400 is designed to use a coil 422 to implement induction heating, through which current (such as high-frequency (e.g., radio frequency (RF)) current) can be transmitted to achieve induction heating in a workpiece 424. System 400 can be configured to implement RF induction, magnetic induction, or other heating mechanisms.

[0066] As an alternative to conduction-based salt bath immersion heating for annealing shape memory metals, system 400 is designed to use a forming tool / workpiece 424 with an integrated / associated induction coil 422 for inducing current and heat to anneal / shape the target shape memory metal structure / device 410 (e.g., a support) relatively quickly, safely, and cleanly, and with fewer space requirements and less equipment complexity compared to salt bath annealing. The induction coil 422 can be associated with the forming tool / workpiece in any suitable or desired manner. The terms “associated” and “related to” are used herein according to their broad and general meaning. For example, where a first feature, element, component, device, or member is described as being “associated” with a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is directly or indirectly physically connected, attached or joined, integrated, at least partially embedded therein, or otherwise physically related to the second feature, element, component, device, or member.

[0067] Typically, induction heating processes require a coil or "workpiece" to generate heat by inducing a current in a metallic / conductive form. Certain embodiments of this disclosure advantageously combine a forming tool / mandrel 424, used as the induction workpiece, with an induction coil 422 into a single unit / device, thereby providing heating for shape memory shaping / annealing and forming within a single device / structure 420. The device 420 is designed to heat the forming workpiece 424 using magnetic, RF, or other induction modes, or alternatively, to induce a current in the implant / stent itself to heat the implant 410 via direct resistance heating. The induction coil 422 is advantageously configured to generate sufficient heat in the workpiece 424 (or directly in the implant 410) to produce a new shape by metallurgically transforming the shape memory metal component 410. The implant 410 can be any type of shape memory implant, such as a prosthetic valve (e.g., mitral valve), a vascular or cardiac valve docking device (e.g., pulmonary valve docking device), a valve repair device / clamp, a delivery system, or a component of any other device.

[0068] The disclosed induction heating solution combines the shape / function of a shaping tool / mandrel with an induction coil to produce a construction that facilitates relatively rapid processing of the shape memory metal assembly. For example, the shaping tool 424 may have a shape that is at least partially cylindrical. The induction coil tool 420 serves a dual purpose: to simultaneously heat and shape the shape memory metal part 410.

[0069] In some implementations, induction heating involves using electromagnetic induction to heat a conductive material. This type of induction heating is generated by eddy currents induced in the target material / workpiece by a rapidly changing magnetic field. The use of induction heating, as in system 400, provides an alternative to the purely conductive heating of salt bath systems, where heat transfer occurs when thermal energy is transferred from the heating medium (i.e., the salt bath) to the target through direct contact, without induction heating.

[0070] The heating system 400 includes an induction coil 422 powered by a power source 432, which may include an electronic oscillator or other current source. In some embodiments, the power source 432 may generate a high-frequency alternating current passing through the induction coil 422, thereby generating a rapidly changing magnetic field that induces eddy currents in a workpiece 424, which may have the coil 422 at least partially embedded therein, or otherwise physically positioned near the coil 422. Eddy currents may advantageously flow through the volume of the workpiece 424, where the resistance of the workpiece material generates Joule / ohm / resistance heating. Typically, the heat generated is proportional to the square of the current flowing through the material of the workpiece 424 and the resistance of the material.

[0071] The induction coil 422, which may be referred to as a 'working coil' or 'heating coil', is a conductive coil comprising copper or other suitable conductor. The coil 422 can be advantageously designed and shaped to generate a high-frequency magnetic field. Furthermore, the coil can be shaped and positioned to direct the generated magnetic field toward the workpiece 424 to achieve effective induction heating within the workpiece. The shape and / or position of the induction coil 422 can at least partially determine the distribution of the magnetic field and thereby affect the heating pattern generated in the workpiece 424. For example, the number of turns and geometry of the coil 422 can be designed to generate a desired strength and distribution of the magnetic field.

[0072] System 400 can be configured to achieve induction heating in workpiece 424 using induction coil 422 with magnetic or radio frequency (RF) induction. For example, for magnetic induction, the frequency of the magnetic field generated by coil 422 can be in the range of 10 kHz to 1 MHz. For RF induction, the generated magnetic field can be in the range of 1 MHz to 1 GHz. In some solutions, RF induction may be preferred because high-frequency fields can provide a relatively more efficient heating process. Furthermore, while high-frequency RF fields may not provide the penetration depth of magnetic induction, depending on the construction and position of induction coil 422 relative to workpiece 424, a considerable penetration depth may not be required (e.g., within a few centimeters), and therefore in some embodiments, RF field penetration may be suitable for the shaping applications of this disclosure. Alternatively, in cases where the workpiece is relatively thick, magnetic induction may be preferred for the induction heating-based shaping described herein. Due to the manufacturing complexity and cost of RF generators, RF induction heating may be more expensive than magnetic induction heating, and therefore magnetic induction may be preferred, although it may be less efficient.

[0073] Power supply 432 may be associated with control system / circuit system 430, which is configured to regulate and / or monitor the heating process and / or perform certain temperature control and safety features. Power supply 432 may be configured to convert input power into a desired frequency and power level suitable for induction heating of workpiece 424. Depending on power requirements, power supply 432 may be, for example, solid-state or vacuum tube based. In some embodiments, control system / circuit system 430 includes a matching circuit system that matches the impedance of power supply 432 to induction coil 422 for efficient power transfer. In some embodiments, control system / circuit system 432 includes a capacitor bank configured to store electrical energy as needed and provide relatively high power surges. The use of capacitor banks can help improve the efficiency of energy transfer to workpiece 424 during the heating process and can compensate for power fluctuations and improve the power factor. Control system / circuit system 430 may further include one or more temperature sensors, a power controller, a feedback loop, a user interface, etc.

[0074] The terms “control circuit system” and “circuit system” are used herein in their broad and general sense and can refer to any collection of processors, processing circuit systems, processing modules / units, chips, dies (e.g., semiconductor dies comprising one or more active and / or passive devices and / or interconnecting circuit systems), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field-programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuit systems, analog circuit systems, digital circuit systems, and / or any means of manipulating signals (analog and / or digital signals) based on hard-coded and / or operational instructions of the circuit system. The control circuit system mentioned herein may further include one or more storage devices, which may be implemented in an embedded circuit system of a single memory device, multiple memory devices, and / or devices. Such data storage devices may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any means of storing digital information. It should be noted that in embodiments in which the control circuitry includes a hardware state machine and / or a software state machine, an analog circuitry, a digital circuitry, and / or a logic circuitry, the data storage device / register storing any associated operating instructions may be embedded within or outside the circuitry including the state machine, the analog circuitry, the digital circuitry, and / or the logic circuitry.

[0075] The workpiece mold 424 comprises a conductive material, which may at least partially comprise ferromagnetic materials (e.g., iron, steel) and / or non-ferromagnetic materials (e.g., aluminum, copper). In examples comprising ferromagnetic workpiece assemblies, heating of the workpiece 424 may be primarily caused by hysteresis losses resulting from the alignment / realignment of magnetic domains within the workpiece material. Regarding non-ferromagnetic workpiece assemblies, heating may be primarily achieved through resistive losses caused by eddy currents within the material, as explained above. In some embodiments, the workpiece 424 comprises at least one of steel, aluminum, copper, brass, or other conductive metals / alloys.

[0076] System 400 may further include a cooling assembly / system 444, which can be configured to promote / maintain a desired temperature for one or more system components. Cooling system 444 can be configured to dissipate excess heat and prevent overheating using methods such as water cooling or air cooling.

[0077] System 400 may further include certain magnetic field / electric field shaping components 442, which may be incorporated to shape and focus the magnetic field / electric field generated by induction coil 422. Such features may include magnetic concentrators, flux concentrators, magnetic shunts, and / or other features configured to improve / optimize the magnetic field / electric field distribution and / or increase heating efficiency.

[0078] As mentioned above, examples of this disclosure may include shaping tools comprising induction coil features integrated / built into the shaped workpiece itself, which can provide a relatively simple and efficient tool for heating memory metal devices (e.g., stents or other implanted components). Such integrated coil / workpiece devices can have any suitable or desired shape and / or configuration. Figure 5A A side view of an integrated shaping tool 520 comprising a shaped workpiece 524, having an integrated induction coil therewith, is shown according to one or more examples. Figure 5B and 5C Provided based on one or more instances Figure 5A A side cross-sectional view of an embodiment of the integrated shaping tool / workpiece 520, showing the integrated induction coil 522. As with certain other embodiments disclosed herein, the conductor / coil 522 is housed within the outer diameter 509 of the forming die 524.

[0079] Figure 5A A shaping tool 520 is shown, having a shape memory metal implant 510, such as a scaffold / frame or the like, disposed around a shaping mold 524 surrounding the tool 520, such that the implant 510 substantially conforms to the shape of the mold 524 on one or more of its sides / regions to produce a desired shape in the implant 510. While certain examples are disclosed herein in the context of shaping molds for producing hourglass-shaped scaffolds or frames, it should be understood that such shapes are shown for illustrative purposes only, and any example disclosed herein can be implemented with a shaping mold having any suitable or desired shape or construction. Furthermore, the shaping molds disclosed herein can have any number of pieces / segments that can mate and / or work together to produce a desired form in the target implant.

[0080] In some embodiments, the shaping tool / workpiece 520 includes certain structural support and / or processing features, such as one or more extensions 521, which may be separate from and / or integrated with certain electrical conductor components for supplying / transmitting current through an induction coil 522 integrated with and / or associated with the tool 520.

[0081] Figure 5B It shows Figure 5A The first example embodiment 520-1 of the shaping tool / workpiece 520 shown is illustrated. Figure 5BIn one example, the induction coil 522 is integrated with a single-piece molding die 524. In some embodiments utilizing a single-piece molding die, this shape can be a straight cylinder or other shapes that facilitate the sliding of the target implant / device over the molding die from one direction. That is, although the molding die 524 is shown as having a convex profile on its outer surface such that the diameter of the die 524 varies along the axis A1 of the tool 520-1, it should be understood that in some instances, the die 524 can be implemented as a substantially straight cylinder.

[0082] exist Figures 5A-5C In this example, the induction coil 522 is embedded within the volume of the spacer mold 524. Although the spacer mold 524 is shown as having a hollow axial volume / channel 505, which can advantageously reduce the bulk, cost, and / or other complexity of the structural mold 524, it should be understood that in some embodiments, the shape / mold 524 may be contained in a solid form without a channel or gap volume. The structural mold 524 is shown as being separated along an axial fracture 503.

[0083] The induction coil 522 can be wound circumferentially within the forming mold 524, thereby creating multiple axially offset windings / turns / coils within the coil 522. The diameter, thickness, spacing, and / or other aspects of the coil and winding configuration can be designed to provide the desired magnetic field that generates induction heating in the workpiece 524 (and / or implant 510).

[0084] The magnetic field generated by coil 522 can be facilitated by injecting current into / through the coil. For example, coil 522 can be electrically connected and / or associated with input lead 523-1, through which current can be injected into the coil and through the winding of coil 522 before exiting the winding via output lead 523-2, and vice versa. Coil 522 can advantageously be axially wound in the distal direction and wound back proximal to the exit lead / connector 523-2. Alternatively, exit lead 523-2 can be on the opposite end of device 520, so that it is not necessary to wind back the coil. In the case of the induction coil configured as shown, coil 522 can act as a resistor (e.g., a low-resistance resistor) in a closed circuit. Although the windings of coil 522 are shown as having an axial spacing / gap between adjacent windings of coil 522, it should be understood that in some embodiments, adjacent windings of coil 522 can be axially adjacent to each other, such that there is little or no axial gap / gap between adjacent windings.

[0085] As described in detail above, the forming mold / workpiece 524 may comprise ferromagnetic and / or non-ferromagnetic materials and may be configured to generate heat in response to a fluctuating magnetic field generated by the coil 522 when current flows through the coil. Therefore, when current flows through the coil 522, induction heating can be generated in the forming mold 524, wherein this heating is applied / transferred to the target implant 510 via conductive heating in contact with the forming mold 524, thereby heating the implant 510 to shape / anneal its shape memory metal material, as described in detail herein. Alternatively or additionally, the induction coil 522 may induce current in the shape memory metal frame 510 itself, thereby generating resistance heating in the supports of the frame 510 as a supplement to or alternative to the conductive heating from the forming mold 524.

[0086] The forming die / workpiece 524 can comprise any material configured to support eddy currents induced by a varying magnetic field to generate heat. The efficiency of induction heating of workpiece 524 may be influenced, at least in part, by the specific magnetic properties of the material. Example materials that workpiece 524 may comprise include stainless steel (e.g., ferritic and / or martensitic stainless steel) and / or other ferromagnetic materials such as nickel, cobalt, iron, nickel-cobalt alloys, carbon steel, etc. In some embodiments, non-ferromagnetic materials such as aluminum, copper, brass, titanium, nitinol, gold, silver, etc., can be used in workpiece 524. Ferromagnetic materials may be preferred because they tend to heat faster and more efficiently in induction heating systems due to their relatively high permeability, which is used to concentrate the magnetic field. However, in some instances, non-ferromagnetic materials can also be effectively heated by induction, particularly for high-frequency fields (e.g., radio frequency induction). The selection of the material for workpiece 524 can influence the heating characteristics of the device based on its corresponding resistivity and permeability.

[0087] Figure 5C An alternative embodiment of the forming die 524 is shown, wherein the forming die 524 comprises a plurality of parts. Although the forming die 524 is Figure 5C The mold is shown to include a first axial offset member 524a and a second axial offset member 524b, but it should be understood that the mold 524 may have any modular / segmented construction, such as any circumferential, radial and / or axial modular / segmented construction.

[0088] In some implementations, when implementing a multi-part / modular forming die 524, it may be necessary or desirable to utilize multiple induction coils integrated with the forming die to facilitate the presence of coil windings in multiple individual parts / segments, while allowing the parts to be disconnected / separated. In such multi-coil implementations, such as Figure 5C As shown, for a single induction coil, multiple corresponding current input and output leads 523 may be desired or required. For example, in Figure 5CIn one embodiment, the first coil 522a integrated with the first molding 524a includes one or more input and output leads 523a dedicated to the coil 522a, while the second coil 522b includes separate input / output leads 523b electrically connected to / integrated with it and used to provide current for induction heating in the second molding 524b.

[0089] As with any of the examples disclosed herein, induction coil 522 can be used to heat workpiece 524 by induction heating, or alternatively, coil 522 can heat the surrounding shaped workpiece 524 by resistance heating and conduction to the volume of mold 524 surrounding coil 522. That is, the current in coil 522 can cause a resistance heating effect due to the resistance of the wire, wherein the proximity of the heating wire to the surrounding material of mold 524 can heat mold 524, which in turn can heat shape memory metal device 510 by conduction. Any induction or non-induction coil or conductor integrated with shaping tool disclosed herein can be configured to generate heat by resistance heating, which can be transferred to the target shape memory metal device by conduction heating. Using coils and other conductors to combine induction heating and resistance heating can advantageously increase the rate of heat transfer to the target device and / or increase the temperature associated with the shaped workpiece of the examples of this disclosure.

[0090] While some examples disclosed herein include induction coils integrated and / or embedded within one or more forming die assemblies / workpieces, it should be understood that induction coils associated with the shaping tools of this disclosure may be incorporated into the tool in some embodiments rather than embedded in the volume of the forming die. Figure 6A A side view of a formed workpiece 620 having an associated induction coil, according to one or more examples, is shown. Figure 6B and 6C It shows one or more instances Figure 6A A side cross-sectional view of an embodiment of a formed workpiece 620 having an associated induction coil 622. As with certain other embodiments disclosed herein, the conductor / coil 622 is disposed within the outer diameter 609 of the forming die 624.

[0091] Figure 6A A shaping tool 620 is shown, having a shape memory metal implant 610, such as a bracket / frame or the like, disposed around a forming mold 624 surrounding the tool 620. The shaping tool / workpiece 620 may include certain structural support and / or processing features, such as one or more extensions 621, which may be detached from and / or integrated with certain electrical conductor components for supplying / transmitting current through an induction coil associated with the tool 620.

[0092] Figure 6B It shows Figure 6AThe first example embodiment 620-1 of the shaping tool / workpiece 620 shown is illustrated. Figure 6B In this example, the forming die / workpiece 624 has a single-piece implementation. Figures 6A-6C In one example, the induction coil 622 is disposed within the inner diameter 607 of the forming mold / workpiece 624. For example, the spacer mold 624 may have a hollow axial volume / channel 605, in which at least some of the windings of the coil 622 are disposed within the channel 605. The induction coil 622 may be wound circumferentially within the channel 605, thereby creating multiple axially offset windings / turns / coils within the coil 622. The diameter, thickness, spacing, and / or other aspects of the coil and winding configuration may be designed to provide a desired magnetic field that generates induction heating in the workpiece 624 (and / or implant 610).

[0093] The magnetic field generated by coil 622 can be facilitated by injecting current into / through the coil. For example, coil 622 can be electrically connected and / or associated with input lead 623-1, through which current can be injected into the coil and through the winding of coil 622 before exiting the winding via output lead 623-2. Coil 622 can advantageously be axially wound in the distal direction and wound back proximal to the exit lead / connector 623-2. Alternatively, exit lead 623-2 can be on the opposite end of device 620, so that it is not necessary to wind back the coil. Although the windings of coil 622 are shown as having an axial spacing / gap between adjacent windings of coil 622, it should be understood that in some embodiments, adjacent windings of coil 622 can be axially adjacent to each other, such that there is little or no axial spacing / gap between adjacent windings.

[0094] As described in detail above, the forming mold / workpiece 624 may comprise ferromagnetic and / or non-ferromagnetic materials and may be configured to generate heat in response to a fluctuating magnetic field generated by the coil 622 when current flows through the coil. Therefore, when current flows through the coil 622, induction heating can be generated in the forming mold 624, wherein this heating is applied / transferred to the target implant 610 via conductive heating in contact with the forming mold 624, thereby heating the implant 610 to shape / anneal its shape memory metal material, as described in detail herein. Alternatively or additionally, the induction coil 622 may induce current in the shape memory metal frame 610 itself, thereby generating resistance heating in the supports of the frame 610 as a supplement to or alternative to the conductive heating from the forming mold 624.

[0095] Figure 6C An alternative embodiment of the forming die 624 is shown, wherein the forming die 624 comprises a plurality of parts. Although the forming die 624 is Figure 6CThe mold is shown to include a first axial offset member 624a and a second axial offset member 624b, but it should be understood that the mold 624 may have any modular / segmented construction, such as any circumferential, radial and / or axial modular / segmented construction.

[0096] In some multi-part forming die embodiments, the forming die includes an outer / outer part configured to constrain the target device from a radially external position and / or to shape the target device. Figure 7A and 7B Perspective and side views of multiple formed workpieces 720 according to one or more embodiments are shown respectively. The shaping tool 720 includes one or more internal forming parts and / or support mold parts 726, and one or more external forming parts / support mold parts 728. In some embodiments, the external forming assembly 728 comprises multiple parts, such as... Figure 7A As shown, each component may have a separate structure and / or electrical components / leads 721 associated with it.

[0097] The external molding 728 can be arranged circumferentially and can have a curved shape, said curved shape being configured to surround the target implant 510 (see...). Figure 7B An external container is formed that is at least partially cylindrical to hold the implant 510 in a radially external dimension and / or to shape it. Figure 7B The side view image shows an example positioning of the target implant / device 510 placed within the containment shell of the external mold 728.

[0098] Figure 7C It shows one or more instances Figure 7A and Figure 7B The image shows a side cross-sectional view of a first embodiment 720-1 of a multi-piece formed workpiece 720 having an induction coil 722 integrated with one or more of its internal components 726. Figure 7C In some examples, the induction coil 722 is integrated and / or at least partially embedded within the internal forming assembly 726 of the tool 720-1. Regarding the examples disclosed herein, the 'internal' forming assembly / mold can refer to a forming mold configured to be radially positioned relative to the axis of the implant within a shape memory metal implant. For example, with respect to a cylindrical stent, the internal forming assembly / mold may be at least partially disposed within the inner diameter of the cylinder / tube, such as within a flow channel of the target stent implant. The shaping tool 720 further includes an external forming mold / assembly 728, which may contain one or more pieces or segments (e.g., circumferentially separated / detached pieces).

[0099] The internal forming mold / assembly 726 and the external forming mold / assembly 728 can be configured to sandwich at least a portion of the implantation device 510 therebetween, which can advantageously shape the target implant 510 in multiple directions. In some embodiments, the external forming assembly 728 comprises an integral cylindrical assembly configured to slide above the implantation device 510, wherein the implantation device 510 is disposed on or can be disposed on the cylindrical internal forming cylinder. In some embodiments, one or both of the internal forming mold 726 and / or the external forming mold 728 can be axially separable / divided into multiple segments separable from each other in the axial dimension. When the induction coil 722 is associated with the internal forming mold 726, the coil 722 can be configured to guide a magnetic field in a manner that heats primarily through inductive heating in / by the internal assembly 726, which in turn heats the target implant 510 by conduction. Alternatively, the induction coil 722 may generate heat in the external component 728, allowing the external component 728 to be used to heat the implant device 510 by conduction from its outer diameter. In some embodiments, both the inner forming mold 726 and the outer forming mold 728 are heated in response to the operation of the induction coil 722, thereby generating a heating effect on the target implant 510 through both inner and outer diameter contact, which can advantageously increase the rate at which the implant device 510 is heated to the desired shaping / annealing temperature.

[0100] Figure 7C The example shown illustrates an induction coil 722 integrated only with the internal component 726 of the forming tool 720-1, while Figure 7D An example is shown in which the induction coil 725 is integrated with and / or embedded in at least a portion of the outer forming mold / assembly 728-2. However, in examples where the outer forming mold 728 comprises a plurality of circumferentially separated / arranged parts, it may be desirable for the coil 725 / 722 to be integrated with the inner forming mold 726.

[0101] When the induction coil 725 is associated with the external molding die 728-2, the coil 725 can guide the magnetic field in a manner that heats primarily through inductive heating of the external component 728-2, which in turn heats the target implant 510 by conduction. Alternatively, the induction coil 725 can generate heat in the internal component 726-2, allowing the external component to be used to heat the implant 510 by conduction from its inner diameter. In some embodiments, both the internal molding die 726-2 and the external molding die 728-2 are heated in response to the operation of the induction coil 725, thereby generating a heating effect on the target implant 510 through both inner and outer diameter contact.

[0102] In some embodiments, both the external forming assembly 728-2 and the internal forming assembly 726-2 have integrated / associated induction coil features. In such embodiments, conductive heating of the formed workpieces 726-2 and 728-2 may be relatively rapid compared to coil integration in only one of the internal or external assemblies. Figure 7D An optional internal conducting coil feature 729, which can be implemented in combination with the external conducting coil feature 725, is shown. In such a configuration, either or both of the internal coil feature 729 and the external coil feature 725 can generate / generate heat in either or both of the internal forming mold / workpiece 726-2 and / or the external forming mold / workpiece 728-2. In some embodiments, only one of the internal forming component 726-2 or the external forming component 728-2 is ferromagnetic or conductive to generate heat in response to an alternating magnetic field. That is, only one of the internal forming component 726-2 or the external forming component 728-2 can be heated in response to the operation of the induction coil and perform heating of the target device 510.

[0103] Figure 8 A side cross-sectional view of multiple formed workpieces 820 having induction coils 822 associated with their inner diameter 807 and / or outer diameter 808, according to one or more examples, is shown. Figure 8 In one example, the induction coil 822 is disposed within the inner diameter 807 of the inner forming mold / workpiece 826 of the tool 820. For example, the spacer mold 826 may have a hollow axial volume / channel 805, in which at least some of the windings of the coil 822 are disposed within the channel 805. The induction coil 822 may be wound circumferentially within the channel 805, thereby creating multiple axially offset windings / turns / coils within the coil 822. The diameter, thickness, spacing, and / or other aspects of the coil and winding configuration may be designed to provide a desired magnetic field that generates induction heating in the inner workpiece 826 (and / or implant 510) and / or outer workpiece 828.

[0104] In some embodiments, as an alternative to or supplement to the internal coil 822, the shaping tool 820 may include one or more coils disposed and / or wound around the outer diameter / outer 808 of the shaping tool 820. For example, Figure 8 An optional coil 827 is shown positioned around the outer diameter 808 of the outer forming mold 828. Such an outer coil 827 can generate an alternating magnetic field that heats either or both of the outer forming workpiece 828 or the inner forming workpiece 826 to heat the target implant 510.

[0105] Regarding the shaping tools described herein that comprise multiple internal forming dies / assemblies and / or external forming dies / assemblies, wherein such parts provide circumferential breakage / splits relative to the tool's axis, it may be unsuitable for induction coils circumferentially wound within the forming parts to cut or damage the coils at the breakage / splits of adjacent forming components / parts integrated with or associated with them. Therefore, it may be desirable to implement the induction coils in such tools in a manner where the coils are not circumferentially wound around the tool's axis, but rather located in an alternative plane / dimension.

[0106] Figure 9 Perspective and side views of part 928a of a multi-piece formed workpiece 920 having a dedicated / corresponding induction coil portion 922a associated therewith, according to one or more examples, are shown. Figure 9 Examples include three circumferentially arranged formed parts 928a, 928b, and 928c. In Figure 9 In one example, the shaping tool 920 includes one or more coils (including coil 922a) that are integrated with and / or associated with a single corresponding segment / modular part of the inner forming mold 926 or the outer forming mold 928. For example, as Figure 9 As shown in the detailed image on the right, coil 922a, possibly associated with input and output connector 923, and multiple coil windings can be integrated / embedded in a single circumferential part / segment 928a of forming die 928. For example, in Figure 9 In the illustrated embodiment, coil 922a includes multiple complete windings within component 928a. In some embodiments, such as in... Figure 9 In the illustrated embodiment, coil 922a may include a plurality of windings at least partially located in a common plane. For example, the plane on which coil 922a is wound may be a curved circumferential plane having a radius of curvature corresponding to a radial segment of form 928a. That is, at least some windings of coil 922a may be located in a common curved plane passing through the associated form / segment 928a.

[0107] Despite Figure 9 Only the winding wire / lead 922a is visible, but it should be understood that the shaping tool 920 may include a corresponding coil for each of the multiple forming parts / segments. For example, regarding Figure 9 In the illustrated embodiment, tool 920 may include three separate coils, each associated with one of the three circumferential outer forming parts / segments 928. Although shown in the outer forming part 928a, it should be understood that the coils (such as coil 922a) may additionally or alternatively be implemented in one or more parts / segments of the inner forming die 926.

[0108] Figure 10This is a block diagram of a resistance heating system 1000 for shaping shape memory metals according to one or more embodiments. The system 1000 is designed to perform resistance heating using a conductive heating element 1022, which in some embodiments can be shaped to produce a shaping effect in addition to heating. For example, in some embodiments, the resistance conductor heating element 1022 and the forming die 1024 can be formed from an integral structure / die (e.g., a conductor).

[0109] As an alternative to salt bath immersion heating and similar processes for shaping / annealing shape memory metals, system 1000 is designed to use a forming tool / workpiece 1024 with an integrated / associated conductor (e.g., coil) 1022 configured to heat in response to an electric current and radiate / conduct such heat for relatively quick, safe, and clean annealing / shaping of the target shape memory metal device 1010 (e.g., support), and the system has fewer space requirements and equipment complexity compared to salt bath annealing.

[0110] Typically, resistance heating processes require a conductor for conducting current, where the resistance of the conductor generates heat as voltage dissipates within the conductor. Certain embodiments of this disclosure advantageously combine a forming tool / mandrel 1024, used as a forming workpiece, with a conductor 1022 into a single unit / device, thereby providing heating for shape memory shaping / annealing and forming within a device / structure 420. The conductor heat source 1022 is advantageously configured to generate sufficient heat in the workpiece 1024 to produce a new shape through metallurgical transformation of the shape memory metal component 1010. The implant 1010 can be any type of shape memory implant, such as a prosthetic valve (e.g., mitral valve), a vascular or cardiac valve docking device (e.g., a pulmonary valve docking device), a valve repair device / clamp, a delivery system, or a component of any other device.

[0111] Some of the disclosed resistance heating solutions combine the shape / function of the shaping tool / mandrel with a resistive conductor to produce a configuration that facilitates relatively rapid processing of shape memory metal components. For example, the shaped workpiece 1024 may have a shape that is at least partially cylindrical. The resistance / conductive heating tool 1020 serves a dual purpose: to simultaneously heat and shape the shape memory metal part 1010.

[0112] The heating system 1000 includes a resistance heating element 1022, which is powered by a power source 1032, which may include a DC or AC voltage / current source. The power source 1032 may include a power outlet, a battery, or a generator. Typically, the heat generated in the conductor 1022 is proportional to the square of the current flowing through the conductor 1022 and the resistance of the material of the conductor 1022.

[0113] The conductive heating element 1022 can contain any suitable conductor, such as tungsten, stainless steel, copper, aluminum, ceramic, nickel-chromium alloy, kanthal, or other ferroalloys. The conductor 1022 can be shaped and positioned to guide conducted and / or radiated heat within and / or toward the forming die / workpiece 1024 to efficiently conduct thermal energy to the target device 1010. The shape and / or position of the conductor 1022 can at least partially determine the distribution of thermal energy and influence the resulting heating pattern. For example, the resistance, thickness, width, and / or shape of the conductor 1022 can be designed to produce the desired heating target.

[0114] The conductor heating element 1022 includes a resistive component that converts electrical energy into heat. Therefore, it may be desirable to utilize a material with relatively high resistance, such as a nickel-chromium alloy wire or ceramic, for element 1022. The heating element 1022 is advantageously designed to withstand sufficiently high temperatures generated during the heating process to shape the target device 1010. The resistive heating element 1022 is a component passing through a closed circuit, whereby the closed circuit allows current to flow through the heating element 1022, which in turn converts the current into heat. The heating element 1022 advantageously has relatively high resistance, acting as a resistor in the circuit. Therefore, when current flows through the heating element 1022 (e.g., a wire), it encounters resistance, and this resistance converts electrical energy into heat. The heat generated by the heating element 1022 is then transferred to the forming mold 1024 (if separated from the heating element 1022) and / or to the target device 1010.

[0115] Power supply 1032 may be associated with control system circuitry 1030, which is configured to regulate and / or monitor the heating process and may provide certain temperature control and safety features. Control system / circuitry 1030 may include one or more temperature sensors, thermostats, power controllers, and / or control mechanisms to maintain desired temperature and / or power levels.

[0116] The forming die / workpiece 1024 may contain conductive and / or thermally conductive materials, and may (or may not) be at least partially formed of a resistive conductor itself. In some embodiments, workpiece 1024 contains at least one of steel, aluminum, copper, brass, or other conductive metals / alloys.

[0117] The shaping tool 1020 may include certain heat-reflective and / or insulating features configured to prevent heat loss and / or electrical hazards. Such features may include ceramics, mica, refractory materials, etc., which may be designed to enclose the heating element on one or more sides and / or guide the generated heat in the direction of the target 1010.

[0118] Figure 11A and 11B A resistance-heated workpiece 1120 formed of one or more electrical conductors is illustrated according to one or more embodiments. Similar to other embodiments disclosed herein, the resistance-heated workpiece 1120 can be configured to provide both shaping and heating functions for shaping a target device 510, such as a nitinol scaffold or other shape memory metal implant. For example, current can be injected into the resistance conductor heating element 1122 at the input / source terminal 1123-1, where the output terminal 1123-2 provides a current collection / outflow terminal, thereby allowing current to pass through the conductor 1122 in a closed circuit. The conductor 1122 can be shaped relative to its outer diameter or other portions to provide a desired shape for the target shape memory metal device 510, which can be placed on the shaping tool 1120, such as... Figure 11B As shown.

[0119] In addition to providing the desired shaping effect on the target device 510, the conductor 1122 can generate heat in response to the current flowing through it, based on the resistance of the conductor 1122. Since the device 510 is physically close to the heated conductor 1122, this resistive heating can be conducted to the target device 510, thereby shaping the shape memory metal device 510 into the shape forced / held by the forming mold of the conductor 1122. Alternatively, in some embodiments, an intermediate forming structure / mold is used to shape and heat the target device 510, wherein a coil heats the intermediate structure / mold, and the intermediate structure (e.g., a heat conductor having the desired shaped form) then heats the target device 510 through conductive and / or radiative heat transfer. In such examples, the conductor 1122 can be embedded / integrated in / with the intermediate structure / mold.

[0120] In some embodiments, conductor 1122 may be wound within the windings of a coil, which, as shown, may in some respects resemble the various induction coils disclosed herein in terms of its construction / shape. Alternatively and / or additionally, conductor 1122 may be arranged in any other configuration to form a desired forming mold and / or allow current to flow in and out along the length of conductor 1122, thereby facilitating resistance heating within conductor 1122.

[0121] The conductor 1122 is configured to allow its shape to be manipulated manually or otherwise, causing radial compression, for placement over the conductor mold 1124 of the shape memory metal implant / device 510. For example, the conductor 1122 itself can be shaped to the desired shape of the mold 1124 such that deformation of this shape stores energy in the device 1120, which returns the mold 1124 to its expanded shape after the compressive force is removed / reduced. In some embodiments, the conductor 1122 is configured as a winding of a coil with a spring-like configuration, which allows for radial compression or size reduction to facilitate placement of the target device 510 thereon. For example, winding or stretching the conductor mold 1124 can reduce the diameter of one or more portions thereof, thereby reducing the profile of the tool 1124 and allowing placement of the target device 510 thereon.

[0122] Figure 12 This is a flowchart illustrating a process 1200 of heating a shape memory metal device using a heating tool, according to one or more examples. Compared to some other solutions that rely solely on conductive heating via immersion in a heating bath (which can be relatively expensive and slow), such as in... Figure 12 As described in the subset of embodiments related to process 1200, the solutions of this disclosure can make the shaping / annealing of shape memory metal devices (e.g., nitinol supports) faster and cheaper. Furthermore, while immersion bath shaping typically produces parts with uniform metallurgical properties, examples of this disclosure can be designed to selectively utilize induction heating and / or resistance heating to produce parts with variable metallurgical properties across geometries (see, for example...). Figure 13 (and related descriptions), which can provide unique / customized component functions / features.

[0123] At block 1202, process 1200 involves placing a target memory metal device (e.g., such a stent implant, etc.) onto a shaping tool having a forming mold and one or more integrated conductor elements configured to generate a heating effect of the forming mold. The step at block 1202 may involve physically attaching the target device to the shaping tool in any manner such that the device at least partially conforms to the shape of at least a portion of the shaping tool. In some instances, the conductive element comprises one or more conductive coils integrated with and / or forming the forming mold. In some embodiments, the conductor is disposed within and / or outside the forming tool, but not embedded in its mold / volume.

[0124] At frame 1204, process 1200 involves injecting current into a conductive coil / conductor to induce or otherwise generate heat in a forming die / tool ​​(e.g., induction heating of a workpiece). For example, heat can be generated in the forming tool via inductive transfer from the conductive coil / conductor. Alternatively, heat can be generated within the conductor / coil itself due to the resistive heating effect of the conductor / coil's resistance, wherein such heat can be transferred via conduction to the forming tool and / or the target shape memory metal device.

[0125] At box 206, process 1200 involves shaping / annealing a target memory metal device using a heated forming tool. Heat in the forming tool can be conducted to the target memory metal device, wherein sufficient heat is generated in the forming tool to produce a shaping effect in the memory metal material of the target device, as described in detail herein.

[0126] Electrical conductors and / or forming tools / workpieces can be designed to subject forming dies to variable heating to achieve multiple desired metallurgical properties in predictable regions of the target device. For example, a conductor (e.g., a coil) can be modified to heat individual segments of a component to different temperatures and / or for different durations, which can be achieved, for example, by altering the sensitivity of the formed workpiece and / or by changing the design of the conductor in different regions to deliver different amounts of induced / generated heat to different parts of the target device. Using a single tool for selective / variable heating as described herein offers several advantages, including the ability to achieve different / variable mechanical properties in the target device depending on the heating method. Selective / variable heat treatment can also be advantageous for shaped parts made of materials other than nitinol.

[0127] At frame 1208, process 1200 involves cooling the target shape memory metal device (e.g., a stent / implant), removing the device from the shaping tool, and / or finishing the device according to one or more processes to produce a suitable final product. Cooling of the target device may occur while the implant is held in place on the shaping tool and / or after it has been removed from it.

[0128] The sizing / annealing process 1200 is superior to molten salt bath sizing / annealing because it offers improvements in space, energy, and / or cost compared to molten salt bath sizing / annealing. Furthermore, some embodiments of process 1200 can achieve multiple metallurgical properties within a single component, which is not possible in molten salt bath processes.

[0129] Figure 13A heated workpiece 1320 configured to produce shape variability of shape memory metal is illustrated according to one or more examples. Various regions or portions of the shaping device / tool ​​1320 may have different / varying material and / or conductor (e.g., coil) characteristics / properties associated therewith, which can produce variations in the magnetic field generated by the coil and / or the heating effect of the forming die 1324. For example, for illustrative purposes, Figure 13 Three axial portions / segments 1321a, 1321b, and 1321c of the device 1320 are shown, each with different conductor and / or material properties to produce potentially different heating effects in different regions of the device 1320. While three separate axial segments 1321a and 1321b, 1321c are shown, it should be understood that any embodiment of this disclosure may have any number or configuration of forming die material and / or electrical conductors (e.g., coils) designed or constructed to produce any desired variable heating effect in the forming device, including variable portions with circumferential and / or axial offsets.

[0130] Each of the individual parts / sections 1321 of tool 1320 may have a different or similar forming die material composition compared to one or more other parts / sections. For example, the first section 1321a may have an associated forming die section 1324a containing a first material, while the second section 1321b and the third section 1321c may have corresponding forming die sections 1324b, 1324c, which have a different or similar material composition than section 1324a. Material variability may include higher concentrations of certain components in various material sections to produce different ferromagnetic, electrical conductivity, and / or thermal conductivity properties, thereby producing the desired heating effect of target device 510 in their respective regions / sections.

[0131] Additionally, the conductor / coil 1322 may have varying characteristics between one or more segments of different sections 1321. For example, in the first section 1321a, the coil 1322a may have wire thickness and / or spacing characteristics between adjacent windings of the coil 1322a that differ from one or both of the other sections 1321b, 1321c. For example, section 1321b shows a coil with a larger axial spacing between adjacent windings of the coil compared to section 1321a, while the winding portion 1322c includes wires that are thinner than those in the first section 1321a and the second section 1321b.

[0132] Compared to immersion conduction heating / annealing (e.g., salt bath), which produces parts with uniform metallurgical properties, the variable conductor and / or workpiece material properties of tool 1320 can offer various benefits. The ability to control the specific application of heat to a target area / part of a target device (e.g., a nitinol implant) can advantageously produce variable shape-forming properties in a single device. Examples of such applications may include heating different regions of the geometry of a shape memory metal part for different time periods and / or to different temperatures. Tool 1320 can advantageously provide variable heating corresponding to different regions of the tool, and thus produce position-dependent metallurgical properties in the target assembly in a single process while achieving the desired shape. The variability in applying heat to different regions of the shape memory metal assembly can produce portions of the assembly with different strengths, different activation temperatures, or other properties in the austenitic form. Furthermore, variable heating using a device similar to tool 1320 can be used to apply heat of different intensities and / or durations to portions of the target assembly with different conductor thicknesses as a means of producing uniform properties with variable conductor / material thicknesses across the target geometry.

[0133] For example, such as Figure 13 An example embodiment of a variable heating device utilizing induction coils provides a relatively precise heating method, allowing for the application of very specific temperatures to a target. Furthermore, by tuning the induction coils to make certain components more active than others, different heating is achieved in different areas.

[0134] Changing the heating temperature of a selected region of the target device, thereby altering the corresponding transition temperature, may affect the upper plateau of the yield strength, causing the amount of force applied to the material during deformation to vary across the geometry. Therefore, the target 510 can be shaped such that it is relatively truly rigid in different regions, or soft / fine.

[0135] Other examples

[0136] The following provides a series of examples, each of which may include aspects of any other examples disclosed herein. Furthermore, aspects of any of the foregoing examples may be implemented in any of the numbered examples provided below.

[0137] Example 1: A shaping device comprising an electrical conductor and a forming mold, the forming mold being configured to physically attach a target memory metal device to the forming mold such that at least a portion of the target memory metal device maintains a shape conforming to at least a portion of the forming mold.

[0138] Example 2: According to any example in this document, specifically the shaping device described in Example 1, wherein the electrical conductor comprises an induction coil.

[0139] Example 3: According to any example in this document, specifically the shaping device described in Example 2, wherein the induction coil is at least partially embedded in the forming mold.

[0140] Example 4: According to any example in this document, specifically the shaping device described in Example 2, wherein the induction coil is disposed within the channel of the forming mold.

[0141] Example 5: According to any example in this document, specifically the shaping device described in Example 2, wherein the induction coil is circumferentially wound around the axis of the forming mold.

[0142] Example 6: According to any example in this document, specifically the shaping device described in Example 2, wherein the forming die comprises a ferromagnetic material configured to generate heat in response to a magnetic field generated by the induction coil.

[0143] Example 7: According to any example herein, specifically the shaping device of Example 1, wherein the forming mold includes an inner portion and an outer portion, the inner portion and the outer portion being configured to hold the target memory metal device between the inner portion and the outer portion of the forming mold.

[0144] Example 8: According to any example in this document, specifically the shaping device described in Example 7, wherein the electrical conductor is at least partially embedded within the internal portion of the forming mold.

[0145] Example 9: According to any example in this document, specifically the shaping device described in Example 7, wherein the electrical conductor is at least partially embedded within the outer portion of the forming mold.

[0146] Example 10: According to any example in this document, specifically the shaping device described in Example 7, wherein the outer portion of the forming mold comprises a plurality of circumferential parts.

[0147] Example 11: According to any example in this document, specifically the shaping device described in Example 10, wherein the electrical conductor comprises a plurality of complete windings in one of the plurality of circumferential members of the outer forming portion.

[0148] Example 12: According to any example in this document, specifically the shaping device described in Example 1, wherein the electrical conductor is configured to generate resistance heating in response to a current flowing through it.

[0149] Example 13: According to any example in this document, specifically the shaping device described in Example 12, wherein the forming mold is formed by the electrical conductor.

[0150] Example 14: According to any example in this document, specifically the shaping device described in Example 12, wherein the forming mold includes a heat conductor.

[0151] Example 15: According to any example in this document, specifically the shaping device described in Example 14, wherein the electrical conductor is at least partially embedded in the heat-conducting body.

[0152] Example 16: According to any example in this document, specifically the shaping device described in Example 14, wherein the electrical conductor is disposed within the inner channel of the forming mold.

[0153] Example 17: According to any example in this document, specifically the shaping device described in Example 14, wherein the electrical conductor and the forming mold are configured to clamp the target memory metal device.

[0154] Example 18: According to any example in this document, specifically the shaping device described in Example 17, wherein the electrical conductor is radially disposed outside the forming mold.

[0155] Example 19: According to any example in this document, specifically the shaping device described in Example 1, wherein the shaping device is configured to produce a variable heating effect in different regions of the shaping device in response to the current in the electrical conductor.

[0156] Example 20: According to any example in this document, specifically the shaping device described in Example 19, wherein at least one of the electrical conductor or the forming mold has variable physical properties to produce the variable heating effect.

[0157] Example 21: According to any example in this document, specifically the shaping device of Example 20, wherein the electrical conductor comprises an induction coil and the induction coil has at least one of the following characteristics along its length: the conductor thickness is variable or the winding spacing is variable.

[0158] Example 22: According to any example in this document, specifically the shaping device described in Example 20, wherein the forming die has at least one of the following characteristics on a portion of its volume: variable material composition or variable thickness.

[0159] Example 23: A shaping device comprising a cylindrical ferromagnetic workpiece and an induction coil, the induction coil forming a plurality of windings around the axis of the workpiece, the induction coil being at least partially disposed within the outer diameter of the workpiece.

[0160] Example 24: According to any example herein, specifically the shaping apparatus of Example 23, wherein the workpiece comprises one or more internal forming dies and one or more external forming dies, wherein the induction coil is disposed within at least one of the one or more internal forming dies, the one or more external forming dies, or an axial channel defined by the one or more internal forming dies.

[0161] Example 25: According to any example herein, specifically the shaping apparatus of Example 24, wherein the one or more external forming molds comprise a plurality of circumferentially arranged forming parts, and the induction coil is disposed within one of the plurality of circumferentially arranged forming parts.

[0162] Example 26: According to any example herein, specifically the shaping device described in Example 25, wherein the plurality of windings are located in a plane that is bent around the axis of the workpiece.

[0163] Example 27: According to any example in this document, specifically the shaping apparatus described in Example 23, wherein the induction coil is configured to generate resistive heat in response to a current therein and conduct the heat to the workpiece.

[0164] Example 28: A method for shaping a shape memory metal device, the method comprising: physically attaching the shape memory metal device to a preformed workpiece; injecting an electric current through a conductor associated with the preformed workpiece to heat the preformed workpiece; and conducting thermal energy from the preformed workpiece to the shape memory metal device to shape at least a portion of the shape memory metal device into a shape conforming to at least a portion of the preformed workpiece.

[0165] Example 29: According to any example in this document, specifically the method of Example 28, wherein the conductor comprises an induction coil and the current is alternating current.

[0166] Example 30: According to any example in this document, specifically the method of Example 29, wherein heating the formed workpiece comprises: generating an alternating magnetic field around the conductor using the alternating current, inducing eddy currents in the formed workpiece using the alternating magnetic field, and generating heat in the formed workpiece using the eddy currents and the resistivity of the formed workpiece.

[0167] Example 31: The method described in Example 30, specifically according to any example in this document, wherein the formed workpiece comprises a ferromagnetic material.

[0168] Example 32: The method described in Example 30, specifically according to any example in this document, wherein the formed workpiece comprises a non-ferromagnetic material.

[0169] Example 33: According to any example in this document, specifically the method of Example 28, wherein heating the formed workpiece comprises heating the conductor using the current and conducting heat from the conductor to the formed workpiece through physical contact.

[0170] Example 34: According to any example in this document, specifically the method of Example 28, wherein the conductor is at least partially embedded within the volume of the formed workpiece.

[0171] Example 35: The method described in Example 28, specifically according to any example in this document, wherein the conductor is disposed within the axial channel of the formed workpiece.

[0172] Depending on the instance, certain actions, events, or functions of any process or algorithm described herein may be performed in a different order, or may be added, combined, or omitted entirely. Therefore, in some instances, not all described actions or events are necessary for the practical process.

[0173] The conditional language used herein, such as “may,” “can,” “may,” “possibly,” “for example,” etc., unless otherwise expressly stated or understood as in the context in which they are used, is intended, and generally is intended, in its ordinary sense to express that certain instances include certain features, elements, and / or steps, while other instances do not include certain features, elements, and / or steps. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are necessary in any one or more instances, or that one or more instances must include logic for determining whether such features, elements, and / or steps are included in or will be performed in any particular instance, with or without author input or prompting. The terms “comprise,” “include,” “have,” etc., are synonyms used in their ordinary sense and in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that, for example, when used to connect a series of elements, the term “or” means one, some, or all of the elements in the list. Unless otherwise explicitly stated, connective language such as the phrase “at least one of X, Y, and Z” is generally understood in context to mean that an item, term, element, etc., can be X, Y, or Z. Therefore, such connective language is generally not intended to imply that certain instances require the presence of at least one of X, at least one of Y, and at least one of Z.

[0174] It should be understood that in the above description of the examples, various features are sometimes combined in a single example, drawing, or description for the purpose of simplifying this disclosure and aiding in the understanding of one or more aspects of the invention. However, this approach of the disclosure should not be construed as reflecting an intention that any claim requires more features than those expressly recited in the claim. Furthermore, any component, feature, or step illustrated and / or described in the specific examples herein can be applied to or used with any other example. Further, for each example, no component, feature, step, or group of components, features, or steps is necessary or indispensable. Therefore, the scope of the invention disclosed herein and claimed below is not intended to be limited by the specific examples described above, but should be determined solely by a careful reading of the appended claims.

[0175] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms (e.g., "first," "second," "third," etc.) used to modify elements (e.g., structures, components, operations, etc.) do not necessarily indicate the priority or order of said element relative to any other element, but can generally distinguish said element from another element with a similar or identical name (but using ordinal terms). Additionally, as used herein, indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, operations performed "based on" conditions or events may also be performed based on one or more other conditions or events not explicitly stated.

[0176] Unless otherwise defined, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which the example instances pertain. It should be further understood that, unless expressly defined herein, terms (as defined in a common dictionary) shall be interpreted as having the meaning consistent with their meaning in the context of the relevant art and shall not be interpreted in an idealized or overly formal sense.

[0177] For ease of description, the spatial relative terms “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms may be used herein to describe the relationship between one element or component and another, as illustrated in the figures. It should be understood that, in addition to the orientations depicted in the figures, the spatial relative terms are intended to cover different orientations of the device in use or operation. For example, in the case where the device shown in the figures is flipped, a device positioned “below” or “below” another device may be placed “above” the other device. Thus, the illustrative term “below” can include both lower and upper positions. The device may also be oriented in another direction, and therefore the spatial relative terms may be interpreted differently depending on the orientation.

[0178] Unless otherwise explicitly stated, comparative and / or quantitative terms such as “less,” “more,” and “greater” are intended to encompass the concept of equality. For example, “less” may mean not only “less” in the strictest mathematical sense, but also “less than or equal to.”

Claims

1. A shaping device comprising: Electrical conductors; and A forming die, the forming die being configured to physically attach a target memory metal device to the forming die such that at least a portion of the target memory metal device maintains a shape that conforms to at least a portion of the forming die.

2. The shaping device according to claim 1, wherein the electrical conductor comprises an induction coil.

3. The shaping device according to claim 2, wherein the induction coil is at least partially embedded in the forming mold.

4. The shaping device according to claim 2, wherein the induction coil is disposed within the channel of the forming mold.

5. The shaping device according to claim 2, wherein the induction coil is circumferentially wound around the axis of the forming mold.

6. The shaping apparatus of claim 2, wherein the forming die comprises a ferromagnetic material configured to generate heat in response to a magnetic field generated by the induction coil.

7. The shaping device according to any one of claims 1 to 6, wherein: The forming mold includes an inner portion and an outer portion, the inner portion and the outer portion being configured to hold the target memory metal device between the inner portion and the outer portion of the forming mold; and The electrical conductor is at least partially embedded in the inner portion of the forming mold or the outer portion of the forming mold.

8. The shaping device according to claim 7, wherein: The outer portion of the forming mold includes a plurality of circumferential parts; and The electrical conductor comprises multiple complete windings in one of the plurality of circumferential members of the outer portion of the forming mold.

9. The shaping apparatus according to any one of claims 1 to 6, wherein the electrical conductor is configured to generate resistance heating in response to a current flowing therethrough.

10. The shaping apparatus according to claim 9, wherein the forming mold is formed by the electrical conductor.

11. The shaping device according to claim 9, wherein: The forming mold includes a heat conductor; and The electrical conductor is at least partially embedded in the heat conductor.

12. The shaping device according to any one of claims 1 to 6, wherein the shaping device is configured to produce a variable heating effect in different regions of the shaping device in response to a current in the electrical conductor.

13. The shaping apparatus of claim 12, wherein at least one of the electrical conductor or the forming mold has variable physical properties to produce the variable heating effect.

14. The shaping device according to claim 13, wherein: The electrical conductor includes an induction coil; and The induction coil has at least one of the following characteristics along its length: the conductor thickness is variable or the winding spacing is variable.

15. The shaping apparatus of claim 13, wherein the forming die has at least one of the following characteristics on a portion of its volume: variable material composition or variable thickness.

16. A method for shaping a shape memory metal device, the method comprising: Physically attach shape memory metal devices to pre-formed workpieces; Injected current passes through a conductor associated with the formed workpiece to heat the formed workpiece; and Heat is transferred from the formed workpiece to the shape memory metal device to shape at least a portion of the shape memory metal device into a shape that conforms to at least a portion of the formed workpiece.

17. The method of claim 16, wherein: The conductor includes an induction coil; and The current is alternating current.

18. The method of claim 17, wherein heating the formed workpiece comprises: The alternating current is used to generate an alternating magnetic field around the conductor; The alternating magnetic field is used to induce eddy currents in the formed workpiece; and Heat is generated in the formed workpiece using the eddy currents and the resistivity of the formed workpiece.

19. The method according to any one of claims 16 to 18, wherein heating the formed workpiece comprises: Heating the conductor with the current; and Heat is conducted from the conductor to the formed workpiece through physical contact.

20. The method according to any one of claims 16 to 18, wherein the conductor is at least partially embedded within the volume of the formed workpiece.

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