Device for maintaining shape of cross-sectional profile of elongate element comprising composite material and device for bending elongate element

Abstract

A device for maintaining a cross-sectional profile shape of an elongate orthopedic implant during molding may include first and second elongate portions having contact surfaces, each of the first and second elongate portions including: an outer surface, and an inner surface, the inner surface including: a central recessed portion, and two outer peripheral portions disposed on each side of the central recessed portion, wherein each of the two outer peripheral portions is mirrored with half of the central recessed portion closest to the respective outer peripheral portion.

Description

Technical Field

[0001] The present invention relates to the field of devices for bending an elongate element, and more particularly to a device for bending an elongate element comprising a thermoplastic polymer. Background Art

[0002] An elongate element comprising a thermoplastic polymer must be heated to be formed. Forming the heated elongate element may undesirably distort the cross-sectional profile of the elongate element in the formed area. Summary of the Invention

[0003] Some embodiments of the present invention may provide a device for maintaining the cross-sectional profile shape of an elongate orthopedic implant during forming, the device comprising: first and second elongate portions having contact surfaces, each of the first and second elongate portions comprising: an outer surface, and an inner surface, the inner surface comprising: a central recessed portion, and first and second outer peripheral portions disposed on opposite sides of the central recessed portion, wherein each of the first and second outer peripheral portions is a mirror image of one half of the central recessed portion closest to the respective first and second outer peripheral portions.

[0004] In some embodiments, the inner surface of each of the first and second elongate portions comprises first and second ridges disposed on opposite sides of the central recessed surface between the central recessed surface and the respective first and second outer peripheral portions.

[0005] In some embodiments, the first and second elongate portions contact each other along flat portions of their first and second ridges.

[0006] In some embodiments, the central recessed portion of the inner surface of each of the first and second elongate portions is configured to support half of the perimeter of the cross-sectional profile of the elongate orthopedic implant.

[0007] In some embodiments, the first and second elongate portions are configured to support the elongate orthopedic implant between the central recessed portions of their inner surfaces.

[0008] In some embodiments, the first and second elongate portions are configured to support the elongate orthopedic implant between the central recessed portions of their inner surfaces along the entire length of the forming area of the elongate orthopedic implant.

[0009] In some embodiments, the outer surface of each of the first and second elongate portions is flat.

[0010] In some embodiments, the device comprises first and second heating elements respectively coupled to the outer surfaces of the first and second elongate portions, the first and second heating elements being configured to heat the elongate orthopedic implant supported between the first and second elongate portions.

[0011] In some embodiments, the device includes two mesh structures disposed on opposite sides of the first and second elongate portions, the two mesh structures coupling the first and second elongate portions to hold the first and second elongate portions together.

[0012] In some embodiments, each of the two mesh structures has at least one of stretchability and bendability during molding.

[0013] In some embodiments, the device includes a clamp for releasably holding the first and second elongate portions together, the clamp including: two arms pivotable about a central point, the two arms including opposing clamping ends configured to hold the first and second elongate portions together, and a mechanism for changing the distance between the opposing clamping ends of the two arms.

[0014] In some embodiments, the device includes a clamp for releasably holding the first and second elongate portions together, the clamp including: two arms movable relative to each other along the longitudinal axis of each of the two arms, the two arms including opposing clamping ends configured to hold the first and second elongate portions together, and a mechanism for changing the distance between the opposing clamping ends of the two arms.

[0015] Some embodiments of the present invention may include a device for shaping an elongate orthopedic implant supported by a support device, the device may include: a housing including: an interior, and a guide rail; and three or more sliders, each of the three or more sliders including: a first arm including a clamp disposed inside the housing and configured to releasably hold the support device supporting the elongate orthopedic implant, and a second arm coupled to the guide rail of the housing and slidable along the guide rail, the first arm movable relative to the second arm along an axis perpendicular to the longitudinal axis of the guide rail.

[0016] In some embodiments, each of the three or more sliders includes a nut coupled to the first arm and a screw coupled to the second arm of the respective slider.

[0017] In some embodiments, each of the three or more sliders includes a guide coupled to the first arm of the respective slider, the guide configured to support a physical indicator indicative of a desired shaping profile of the elongate orthopedic implant.

[0018] In some embodiments, the device includes a control unit configured to, upon activation, cause a heating element of the support device to heat the support device and the elongate orthopedic implant supported therein.

[0019] In some embodiments, the control unit is configured to lock the lid of the housing upon activation.

[0020] In some embodiments, the device includes a cooling unit disposed inside a housing, the cooling unit configured to cool the support device and the elongate orthopedic implant supported therein after molding.

[0021] Some embodiments of the present invention may provide a method of molding an elongate assembly, the method may include: providing an elongate assembly including: an elongate orthopedic implant including a thermoplastic polymer; and a support device that completely surrounds and supports the elongate orthopedic implant along the entire length of a molding region in which the elongate orthopedic implant is to be molded, such that the support device maintains a shape during molding and prevents distortion of the cross-sectional profile of the elongate orthopedic implant in the molding region when heating the elongate orthopedic implant; heating the elongate assembly to provide a heated elongate assembly; molding the heated elongate assembly according to a desired molding profile while maintaining the shape by the support device and preventing distortion of the cross-sectional profile of the elongate orthopedic implant in the molding region; and releasing the support device from the elongate orthopedic implant.

[0022] In some embodiments, before releasing the support device from the elongate orthopedic implant, the method includes cooling the heated elongate assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] What is regarded as the subject matter of the present invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. However, both the organization and method of operation of the present invention, together with its objects, features and advantages, will be best understood by reference to the following detailed description read in conjunction with the accompanying drawings, in which:

[0024] Figure 1 An elongate element that can be used with some embodiments of the present invention is illustrated.

[0025] Figure 2A and 2B An apparatus for maintaining the cross-sectional profile shape of an elongate element according to some embodiments of the present invention is illustrated.

[0026] Figure 3A and 3B An apparatus for maintaining the cross-sectional profile shape of an elongate element according to some embodiments of the present invention is illustrated.

[0027] Figure 4 A cross-sectional view of an apparatus for maintaining the cross-sectional profile shape of an elongate element according to some embodiments of the present invention is shown.

[0028] Figure 5 An apparatus for maintaining the cross-sectional profile shape of an elongate element according to some embodiments of the present invention is illustrated.

[0029] Figure 6 A side view of an apparatus for maintaining the cross-sectional profile shape of an elongate element in accordance with some embodiments of the present invention is shown.

[0030] Figure 7 A clamp that can be used with some embodiments of the present invention is illustrated.

[0031] Figure 8A and 8B A clamp that can be used with some embodiments of the present invention is illustrated.

[0032] Figure 9A 、 9B and 9C illustrate an apparatus for bending or shaping an elongate element while maintaining the cross-sectional profile shape of the elongate implant in accordance with some embodiments of the present invention.

[0033] Figure 10A 、 10B and 10C illustrate a movable clamp in accordance with some embodiments of the present invention.

[0034] Figure 11 A control unit that can be used with some embodiments of the present invention is illustrated.

[0035] Figure 12A A cross-sectional view of the elongate portion of an apparatus for maintaining the cross-sectional profile shape of an elongate element before and after bending in accordance with some embodiments of the present invention is shown.

[0036] Figure 12B and 12C A cross-sectional view of the elongate portion that cannot maintain the cross-sectional profile shape of the elongate element before and after bending is shown.

[0037] Figure 13 A flowchart of a method for shaping an elongate element in accordance with some embodiments of the present invention is shown. DETAILED DESCRIPTION

[0038] Those skilled in the art will recognize that the present invention can be embodied in other specific forms without departing from its spirit or essential characteristics. Accordingly, the foregoing embodiments are to be considered in all respects illustrative rather than limiting of the invention described herein. Thus, the scope of the present invention is designated by the appended claims rather than by the foregoing description, and all changes within the meaning and range of equivalents of the claims are intended to be embraced therein.

[0039] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, those skilled in the art will understand that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention. Some features or elements described for one embodiment may be combined with features or elements described for other embodiments. For the sake of clarity, the same or similar features or elements may not be discussed repeatedly.

[0040] Although embodiments of the present invention are not limited in this regard, discussions using terms such as "processing", "computing", "calculating", "determining", "establishing", "analyzing", "inspecting", etc. may refer to operations and / or processes of a computer, computing platform, computing system, or other electronic computing device that manipulate and / or transform data represented as a physical (e.g., electronic) quantity within a register and / or memory of the computer into other data represented as a physical quantity within a register and / or memory of the computer or other non-transitory storage medium that can store instructions for performing the operations and / or processes.

[0041] Although embodiments of the present invention are not limited thereto, as used herein, the terms "plurality" and "several" may include, for example, "a plurality" or "two or more". Throughout the specification, the terms "a plurality" or "several" may be used to describe two or more components, devices, elements, units, parameters, etc. As used herein, the term "set" may include one or more items.

[0042] Unless explicitly stated, the method embodiments described herein are not limited to a particular order or sequence. Additionally, some of the described method embodiments or their elements may occur or be performed simultaneously (at the same point in time) or in parallel.

[0043] The systems and methods of the present invention may improve existing techniques for forming elongated elements. For example, but not limited to, the systems and methods of the present invention may be easier to use than alternatives, the formed elongated devices may be easier to extract from the device / housing than alternatives, and the cross-sectional shape of the elongated element may be maintained more effectively than alternatives.

[0044] Generally, devices, systems, kits, and methods for forming elongated elements are described.

[0045] As used hereinafter, the term "elongated element" may refer to any elongated object that may comprise one or more thermoplastic polymers. For example, the elongated element may comprise a polyetheretherketone (PEEK) polymer. In another embodiment, the elongated element may comprise approximately 60% carbon fiber and approximately 40% PEEK polymer.

[0046] In some embodiments, the elongate element is an orthopedic implant or a part thereof. For example, the elongate element can be any one of the following list: an orthopedic rod (e.g., for a pedicle screw assembly), an orthopedic plate (e.g., a femoral plate, a humeral plate, etc.), a Kirschner wire (K-Wire), an orthopedic nail (e.g., a humeral nail, a cephalomedullary nail, etc.), etc.

[0047] The elongate element comprising a thermoplastic polymer should be heated or preheated for shaping. The shaping of the elongate element can be any mechanical action aimed at changing the initial shape of the elongate element. For example, the shaping can include any one or a combination of bending, twisting, stretching, and / or compressing of the elongate element. The following description takes bending as an example of shaping. It is worth noting that the devices, systems, kits, and methods described below can also be used for other types of shaping or combinations of shaping (such as twisting, stretching, and / or compressing).

[0048] Shaping the heated elongate element may distort the cross-sectional profile of the elongate element, for example, in the shaping area. For example, when a heated elongate element (e.g., a rod) having an initial circular cross-section is bent, the cross-sectional profile of the elongate element in the bending area may be distorted and may change from circular to, for example, oval or elliptical.

[0049] The disclosed devices, systems, kits, and methods can shape an elongate element comprising a thermoplastic polymer while preventing distortion of the cross-sectional profile shape in the shaping area. In addition, the disclosed devices and systems can be located in an operating room and can shape their elongate elements in the operating room during the operation.

[0050] One embodiment of the present invention can include a support device for maintaining the cross-sectional profile shape of an elongate element during shaping of the elongate element, which can include: two elongate portions, each elongate portion including a heating side (e.g., an outer side or surface) and an elongate element side (e.g., an inner side or surface), wherein the elongate element side of each elongate portion can closely support half of the lateral perimeter of the elongate element over substantially the entire length of the elongate element or at least the entire length of the shaping area of the elongate element, wherein the cross-section of the elongate element side of each elongate portion can include: a central cross-section portion and two outer peripheral cross-section portions, the central cross-section portion configured to closely support half of the lateral perimeter of the elongate element, and the outer peripheral cross-section portions being substantially mirror images of half of the central cross-section portion closest to each respective side on each side of the central portion. The heating side of each elongate portion can be connected, coupled, or attached to at least one heating element configured to heat the elongate element during shaping of the elongate element.

[0051] One embodiment of the present invention may include an apparatus for shaping an elongate element while maintaining the cross-sectional profile shape of the elongate element, wherein the elongate element is received or supported by a support apparatus according to an embodiment of the present invention, and the support apparatus may: heat the elongate element and the support apparatus by delivering an electric current to a heating element of the support apparatus; and shape the elongate element and the support apparatus using at least one movable clamp.

[0052] Figure 1 An elongate element or rod 105 according to some embodiments of the present invention is shown. It may have a cross-sectional profile 110B, a transverse perimeter 110A, and a length 115 and / or be defined by a cross-sectional profile 110A, a transverse perimeter 110B, and a length 115. Thus, the transverse perimeter is the perimeter of the cross-sectional profile at a given point on the elongate element. In Figure 1 the cross-sectional profile is depicted as circular, but may in fact be any shape suitable for the function of the elongate element. For example, the cross-sectional profile may have the shape of a circle, an ellipse, a triangle, a square, a pentagon, or a higher-order (possibly regular) polygon. The transverse perimeter may form the contour line of the shape. The length of the elongate element may be defined according to the usage requirements of the elongate element. For example, in the case where the elongate element is an orthopedic implant, the length may be the bone to which the implant is to be attached, or may be defined by the bone to which the implant is to be attached. As shown, the cross-sectional profile and the transverse perimeter may lie in a plane defined by the x-axis and the y-axis. Transverse may refer to the plane defined by the x-axis and the y-axis. The length of the elongate element may be along the z-axis. Although Figure 1 an essentially straight elongate element is shown, the elongate element may be produced or provided in a preformed or bent form. For example, when the elongate element is an orthopedic implant, it may be provided in a shape based on the average bone shape of a plurality of patients. The preformed form may limit the amount of shaping that must be performed by a user (e.g., a surgeon). In an example of a preformed form, any support apparatus (e.g., Figure 2A-6 the apparatus) will also be preformed.

[0053] Figure 2A and 2B show an apparatus 200 according to some embodiments of the present invention. The apparatus 200 is suitable for maintaining the cross-sectional profile shape of an elongate element 205 during shaping and / or bending of the elongate element 205. The apparatus may be referred to as a support apparatus or an elongate element support apparatus. Figure 2A The apparatus 200 may be depicted without the elongate element, while Figure 2BApparatus 200 having an elongate element 205 can be depicted. Apparatus 200 can include elongate element 205 and / or Apparatus 200 may be adapted to work with elongate element 205. The apparatus can include a first elongate portion 220 and a second elongate portion 225. Each of the first elongate portion 220 and the second elongate portion 225 can include an outer surface and an inner surface (e.g., as Figure 4 shown). Each elongate portion 220, 225 can be in the form of an irregular geometric prism; for example, each elongate portion can have a substantially constant cross-sectional profile, which can take a shape as further described herein.

[0054] The outer surface of each elongate portion 220, 225 can be substantially flat. A first heating element 230 and a second heating element 235 can be attached or coupled to the outer surfaces of the first elongate portion 220 and the second elongate portion 225, respectively. The heating elements 230, 235 can be configured to heat the elongate element 205 before or during the forming of the elongate element 205. The heating elements 230, 235 can be operated in a variety of different ways. The heating elements 230, 235 can include a conductive material configured to heat when an electric current passes through it. For example, circuit elements can be attached to either end of the heating elements 230, 235, and an electric current can pass through the heating elements. In some embodiments, an external electromagnetic field can generate an electromagnetic field around the heating elements 230, 235, which can induce eddy currents therein, thereby heating the heating elements 230, 235. In some embodiments, an external electromagnetic field can be generated around the elongate portions 220, 225 to directly heat them without using any heating elements. The elongate portions 220, 225 of the apparatus 200 can be made of a material that does not undergo thermal deformation at the temperature required for forming or bending the heating element 205 (e.g., about 400 degrees Celsius). For example, the apparatus 200 can be made of stainless steel.

[0055] The inner surface of each elongate portion 220, 225 can include two ridges along the length of the respective elongate portion. The inner surface of each elongate portion 220, 225 located between the ridges can be adapted to closely support the elongate element. Each elongate portion 220, 225 can support half (or substantially half) of the lateral perimeter of the elongate element 205 along the entire length of the forming region of the elongate element 205. Each elongate portion 220, 225 can support half (or substantially half) of the lateral perimeter of the elongate element 205 along the entire length of the elongate element 205. The elongate portions 220, 225 of the apparatus 200 can completely surround and support half of the lateral perimeter of the elongate element 205 along the entire length of the forming region of the elongate element 205 or along the entire length of the elongate element 205.

[0056] Figure 3Aand 3B FIG. 300 shows an apparatus 300 according to some embodiments of the present invention, which is adapted to maintain the cross-sectional profile shape of an elongate element 305 during shaping and / or bending of the elongate element. Figure 3A The apparatus 300 without the elongate element 305 may be depicted, while Figure 3B the apparatus 300 with the elongate element 305 may be depicted. The apparatus 300 may include a first elongate portion 320, a second elongate portion 325, a first heating element 330, and a second heating element 335. Figure 3A and 3B The apparatus 300 of Figure 2A and 2B may be substantially the same as the apparatus 200 of Figure 3A and 3B Each part of the apparatus 300 may be as described for its corresponding part of the apparatus 200. Figure 2A and 2B differ from

[0057] Figure 4 FIG. 400 shows a cross-sectional profile of an apparatus 400 according to some embodiments of the present invention. The apparatus 400 may be as described in Figure 2A-3B . Figure 4The view is a view of the x-y plane. The device 400 may include a first elongated portion 420 and a second elongated portion 425. There may be an interface 452 at the contact surface of the elongated portions 420, 425 between each pair of elongated elements 420, 425. Each elongated portion 420, 425 may include an outer surface 440 and inner surfaces 445A, 445B, and 445C. The inner surface may include a central portion 445A and two outer peripheral portions 445B and 445C located on either side of the central portion 445A. The central portion 445A may be concave. The outer peripheral portions 445B, 445C may be concave. The central portion 445A and each of the outer peripheral portions 445B and 445C may be separated by a ridge 450 extending along the length of the elongated portions 420, 425 (it can be said that these portions include the surface of the ridge). The surface defined by the central portion 445A and / or the two ridges 450 may be shaped to closely support the elongated element. For example, when the elongated element is substantially cylindrical (i.e., its cross-section is circular), the surface defined by the central portion 445A and the ridges 450 may form a notch or channel having a semi-circular cross-section. The radius of curvature of the semi-circle may be substantially equal to (or only slightly larger than) the radius of the cylindrical elongated element. The surface defined by each of the outer peripheral portions 445B, 445C and / or each corresponding ridge 450 may be a mirror image (or substantially a mirror image) of half of the central portion 445A closest to each corresponding outer peripheral portion. For example, for the above example of the semi-circular central portion 445A, the surface of each outer peripheral portion 445B, 445C may be defined by an arc of a quarter circle (e.g., with its open portion facing outward).

[0058] A person skilled in the art would not be inclined or taught to include the mirror-imaged outer peripheral portions 445B, 445C described herein in existing devices because their main advantages are not taught elsewhere and they would increase the material requirements of the device. The main advantage of the mirror-imaged outer peripheral portions 445B, 445C is that if the device is bent and the bending occurs in the y-z plane (e.g., see Figure 6 ), then the cross-sectional profile shape of each elongated portion 420, 425 will remain substantially unchanged. Accordingly, the cross-sectional profile shape of any elongated element held within the central portions 445A of the two elongated portions 420, 425 will also remain substantially unchanged. The cross-sectional profile of each elongated portion 420, 425 remains unchanged because of the fact that the mirror-imaged outer peripheral portions 445B, 445C mean that the internal forces that would otherwise deform the ridges 450 of the elongated portion are balanced due to the substantially symmetry of each ridge 450.

[0059] In some embodiments, the outer surface 440 of each elongate portion may be flat (or substantially flat). The first heating element 430 and the second heating element 435 may be attached or coupled to the outer surface 440 of the first elongate portion 420 and the second elongate portion 425, respectively. The heating elements 430, 435 may heat the elongate element during the forming of the elongate element. The heating elements 430, 435 may operate as described elsewhere herein. In Figure 4 and its corresponding description, various discussions (e.g., inner and outer portions and ridges) have been made only for the first elongate portion 420, but the discussions also apply to the second elongate portion 425 and are omitted here only to improve Figure 4 readability. The first elongate portion 420 and the second elongate portion 425 may be substantially the same.

[0060] Figure 5 FIG. 500 shows an apparatus 500 according to some embodiments of the present invention, which is adapted to maintain the cross-sectional profile shape of an elongate element during the forming and / or bending of the elongate element according to some embodiments of the present invention. The apparatus 500 may be as Figure 2A-4 described therein. The apparatus may include a first elongate portion 520 and a second elongate portion 525. These elongate portions 520 and 525 may be attached or coupled to a heating element (not shown).

[0061] The apparatus may include a temporary attachment mechanism 555. An example of the temporary attachment mechanism 555 is a long mesh structure, such as made of metal foil. The mesh structure may be attached to the side of the apparatus. It may be stretchable or bendable such that it does not break the bending of the apparatus during use and may be easily removed after bending (e.g., can be pulled off or cut by the user). In Figure 5 an example, the temporary connection mechanism 555 includes two mesh structures disposed on each side of the first elongate portion 520 and the second elongate portion 525.

[0062] In some embodiments, it may be preferable to provide a temporary attachment mechanism to cause or maintain contact between the elongate portions 520, 525 during bending, thus ensuring that the cross-sectional profile of the elongate element is maintained. The temporary attachment mechanism may be released after bending is completed to decouple the elongate members 520 and 525 and allow the elongate element to be released from the apparatus 500. In other embodiments, a temporary attachment mechanism is not required.

[0063] Figure 6 FIG. shows an example demonstrating how an elongate element may be formed or bent according to some embodiments of the present invention. Figure 6The view is a y-z plane view. The device may include a first elongated portion 620 and a second elongated portion 625, as well as a first heating element 630 and a second heating element 635. The device may be as shown in Figure 2A-5 as shown. Figure 6 The arrows in give examples of the forces that may be applied to the elongated element during bending or forming. In some embodiments, the forces applied to the elongated element may be in the plane of the sheet; the force may be in the y-z plane. In some embodiments, there is substantially no force on the x-axis (e.g., see the x-axis in Figure 4 ).

[0064] Figure 7 shows an example of means 700 (e.g., a clamp) for gripping together the elongated portions of a device (e.g., the device in Figure 2A-6 ) according to some embodiments of the present invention. Figure 7 The embodiment of may be referred to as a scissor clamp. It may include two arms 760A and 760B pivotable about a central point 760C, and a mechanism 765 (e.g., allowing placement or release of the device from the clamp 700) for changing the displacement (e.g., distance) between one end of each arm, thereby changing the displacement between the opposite ends (the other ends) of each arm in an opposite manner. In some embodiments, the mechanism 765 for changing the displacement may include a screw and a nut (or the like) and (optionally) a handle. The opposite ends of each arm may include an opening having a ridge 755 adapted to grip the device (e.g., adapted to grip the elongated portion of the device during, for example, forming).

[0065] Figure 8A and 8B shows an alternative example of means (e.g., a clamp) 800 for gripping together the elongated portions of a device 200 (e.g., the device in Figure 2A-6 ) according to some embodiments of the present invention. Figure 8A and 8B The embodiment of may be referred to as a G-clamp. It may include two arms 860A and 860B that grip each other movably such that they can move relative to each other along the longitudinal axis 860C of each arm. The clamp 800 for gripping the device may include a mechanism 865 (e.g., allowing positioning or release of the device) for changing the displacement (e.g., distance) between the clamping ends of each arm. In some embodiments, the mechanism 865 for changing the displacement may include a screw and a nut (or the like) and (optionally) a handle. The opposite clamping ends of each arm 860A and 860B may include an opening having a ridge 855 adapted to grip the device (e.g., for contact-gripping the elongated portion of the contact device during forming).

[0066] One or more fixtures 700, 800 may be used to contactingly hold or grip an elongate portion of a support device (e.g., the device in Figure 2A-6 ) during bending, thus ensuring that the cross-sectional profile of the elongate element is maintained. The fixtures 700, 800 do not interfere with the bending of the support device and the elongate element. The fixtures 700, 800 can be easily removed or released after bending to allow the elongate portions of the support device to be moved apart from each other and the elongate element to be released from the support device.

[0067] Figure 9A and 9B 9C shows a device 900 for bending or shaping an elongate element 205 and simultaneously maintaining the cross-sectional profile shape of the elongate implant 205 according to some embodiments of the present invention, and wherein the elongate element 205 is contained or enclosed within a support device 200 (e.g., the device in Figure 2A-6 ). The device 900 may include a housing 970. The housing 970 may protect a user from high temperatures and / or electric shock during use. The device 970 may include at least one slider 972. The slider 972 may be configured to grip the support device 200. For example, one end of the slider 972 may include an adjustable opening or fixture 972A having ridges suitable for gripping (e.g., releasably gripping) the support device 200. The fixture 972A may be disposed within an interior 970A of the housing 970. Another portion of the slider 972 may be attachable or attached to the housing 970 via a guide rail 974, wherein the slider 972 may move along the guide rail 974 as needed. When the support device 200 is installed within the device 900 (e.g., in an unbent form), the guide rail 974 may be described as lying parallel (e.g., parallel to the z-axis) to the support device 200. The slider 972 may be attached to the guide rail 974 such that the longitudinal axis of the guide rail 974 and the longitudinal axis 972C of the slider 972 are perpendicular (or substantially perpendicular) to each other. In some embodiments, at least three sliders 972 are installed or attached to the device 900. The slider 972 may include a guide 984. The guide 984 may be helpful if there is a physical indicator of the desired shape of the elongate element (e.g., the desired forming or bending profile). The physical indicator may be aligned with the guides 982 of the plurality of sliders 972, such that a user can tell if the elongate element has the correct shape. The guide 982 may support the physical indicator.

[0068] Device 900 may include a control unit 976. The control unit 976 may be configured to heat a heating element of the support device, for example, when an input has been received and / or when the housing 970 is closed (e.g., the lid 970C of the housing 970 has been locked to the body of the housing). The heating element of the support device 200 may include a conductive material configured to heat up when an electric current passes through it. The electric current may be provided to the heating element in different ways. For example, circuit elements (not shown) may be manually or automatically attached to either end of each heating element from the control unit 976, and the electric current may pass through the heating element. The electric current may be provided by the control unit 976. Alternatively, an electromagnet attached to a housing element (not shown) may be configured to generate a magnetic field around the heating element, and the magnetic field may induce an eddy current therein to heat the heating element (inductive heating). The control unit 976 may provide an electric current to the electromagnet. Those skilled in the art can also readily conceive of other devices for heating the heating element. The connector 980 may supply power / current to the control unit 976 from an external source (e.g., a main power socket).

[0069] Device 900 may include a cooling unit 978. Some embodiments may not use the cooling unit. In some embodiments, it may be preferable to incorporate the cooling unit 978 so that the elongate element and its support device can be cooled more rapidly. The cooling unit 978 may operate in a variety of ways. For example, the cooling unit 978 may utilize air cooling and blow air onto the support device and the elongate element (e.g., as shown). Some types of air cooling units may utilize an air intake 982 and / or an air outtake vent (not shown). The air intake and / or the air outtake vent may increase the cooling rate. Alternatively, the air cooling unit may utilize an internal fan. Alternatively, a liquid cooling system may be used. Different cooling techniques may be combined in an embodiment.

[0070] Figure 10A 、 10B Figures 9 and 10C show a slider 1072 according to some embodiments of the present invention. The slider 1072 may be configured to grip the support device. One end of the slider 1072 may include an adjustable opening or clamp 1086 having a ridge or an opening shape suitable for gripping (e.g., releasably gripping) the support device (e.g., the device in Figure 2A-6 ). The slider 1072 may also include a rail attachment 1088 that may be attachable or attached to the housing 970 via a rail 974, where the slider 1072 may move along the rail 974 as needed.

[0071] The slider may include two arms 1087 and 1089 movably fixed together such that they can move relative to each other along the longitudinal axis 1085 of each arm. One arm may be configured to move into and out of the other arm, for example, in a piston-like manner. The first arm 1087 may include an adjustable opening or clamp 1086. The second arm 1089 may include a rail attachment 1088. The slider 1072 may include a mechanism 1082 (e.g., using screws and nuts and / or pistons and / or servo motors) for changing the relative displacement between each arm. In some embodiments, the mechanism 1082 may be controlled by a control unit. In some embodiments, the mechanism 1082 may be manually operated (e.g., by a user). In Figure 10A-10C an example, the mechanism 1082 may include a nut 1082A coupled to the first arm 1087 and a screw 1082B coupled to the second arm 1089 (e.g., as Figure 10B shown). Rotation of the screw 1082B may cause the nut 1082A to move along the screw 1082B and cause the first arm 1087 to move relative to the second arm 1089 and the housing 970.

[0072] The slider 1072 may include a guide 1084. The guide 1084 may be part of or attached to the first arm 1087. Thus, the guide 1084 may give a relative indication of the position of the adjustable opening or clamp 1086 (e.g., relative to other guides 1084 of other sliders 1072). The guide 1084 may be helpful if there is a physical indicator of the desired shape of the elongate element. The physical indicator may be aligned with the guides 1084 of multiple sliders 1072 such that the user can see if the elongate element gripped in the slider 1072 has the desired shape.

[0073] Figure 11 A control unit 1176 is shown in accordance with some embodiments of the present invention. The control unit 1176 may include user input and / or output 1190. For example, this may include buttons, monitors, touchscreens, lights, etc. The control unit 1176 may include a power input 1180. The control unit 1176 may include an electromagnet or alternative unit 1192 to lock the lid 970C of the housing 970 during the process heat stage (as Figure 9A-9C shown). The control unit 1176 may include a connector 1194 that may be connected, for example, via a cable (not depicted) to heating elements, thermometers, clamps, sensors, electromagnets, and / or any internal devices or components that require power / current.

[0074] In operation, the clamps 972A, 1086 of the sliders 972, 1072 may be used to hold a support device for supporting an elongate element (e.g., Figure 2A-6The device) is coupled inside the interior 970A of the housing 970 of the device 900. The positions of the sliders 972, 1072 along the guide rails 974 can be adjusted according to the desired shape or bending profile of the elongate element. The guides 984, 1084 and / or physical indicators of the desired bending profile can be used to adjust the positions of the sliders 972, 1072 along the guide rails 974. The lid 970C of the housing 970 can be closed. The device 900 can be turned on using, for example, a user input 1190. After startup, the control units 976, 1176 can lock the lid 970C of the housing 970 via the unit 1192. The control units 976, 1176 can cause the heating element of the support device (e.g., as described above) to heat the support device and the elongate element supported therein. The control units 976, 1176 can use the user output 1190 to indicate that the heating of the elongate element is complete and that the elongate element has reached the desired temperature (e.g., 360 - 400 degrees Celsius). The control units 876, 1176 can be stopped such that the heating element of the support device stops heating. The positions of the clamps 972A, 1086 of the sliders 972, 1072 can be adjusted or changed to bend the heated support device and the heated elongate element supported by the support device to the desired bending profile. The guides 984, 1084 and / or physical indicators of the desired bending profile can be used to adjust the positions of the clamps 972A, 1086 of the sliders 972, 1072. For example, the physical indicator can be a deformable template, the shape and size of which can be similar to the shape and size of the elongate element. The physical indicator can be deformed (e.g., manually deformed by the user) to fit the target anatomical region and indicate the desired shaping or bending profile. Then, based on the deformed physical indicator, the positions of the sliders 972, 1072 and / or the positions of the clamps 972A, 1086 of the sliders 972, 1072 can be adjusted with the help of the guides 984, 1084. The control units 976, 1176 can turn on the cooling unit 978 to cool the support device and the elongate element. Once the cooling is complete (e.g., when the temperature of the support device and the heating element is below a certain temperature threshold), the control units 976, 1176 can release the lid 970C of the housing 970. The lid 970C can be opened and the bent support device with the bent elongate element can be released from the clamps 972A, 1086 of the sliders 972, 1072. The bent elongate portions of the support device can be moved apart from each other and the bent elongate element can be released from the support device.

[0075] Figure 12A Cross-sectional profiles of the elongate member 1220 (e.g., such as elongate members 420, 425) of a support device (e.g., such as support device 400) according to some embodiments of the present invention are shown before and after bending. The elongate member 1220 can include an outer surface 1240 and an inner surface 1245. The outer surface can be flat.

[0076] The inner surface 1245 may include a central portion 1245A and two peripheral portions 1245B and 1245C on both sides of the central portion 1245A. The central portion 1245A may be recessed. The peripheral portions 1245B, 1245C may be recessed. The central portion 1245A and each of the peripheral portions 1245B and 1245C may be separated by a ridge 1250 extending along the length of the elongate portion 1220. The peripheral portions 1245B, 1245C of the inner surface 1245 of the elongate portion 1220 may be mirror images (or substantially mirror images) of half of the central portion 1245A of the inner surface 1245 closest to each respective peripheral portion. For example, Figure 12A taking the semi-circular central portion 1245A of the inner surface 1245 as an example, the peripheral portions 445B, 445C of the inner surface 1245 may be defined by arcs of a quarter circle (e.g., with their open portions facing outward).

[0077] Thus, each ridge 1250 or each half 1220A, 1220B of the elongate member 1220 may be symmetric (or substantially symmetric) with respect to its symmetry line 1220C. The symmetric nature of each half 1220A, 1220B of the elongate member 1220 may balance the internal forces within the halves 1220A, 1220B during bending, thereby preventing deformation of the cross-sectional profiles of the halves 1220A, 1220B and the entire elongate member 1220 and maintaining its shape during bending and forming. Thus, the cross-sectional profile shape of any elongate element gripped between elongate members such as the elongate member 1220 will also be maintained (or substantially maintained).

[0078] Figure 12B and 12C Cross-sectional views of the elongate members 90, 80 before and after bending that cannot maintain the cross-sectional profile shape of the elongate element are shown. Different from the elongate member 1220 in which each half 1220A, 1220B of the elongate member 1220 is symmetric or substantially symmetric with respect to its symmetry line 1220C (which balances the internal forces during bending or forming, e.g., as described above), the halves 90A, 90B of the elongate member 90 and the halves 80A, 80B of the elongate member 80 do not have such a symmetry line. Thus, the internal forces within the halves 90A, 90B of the elongate member 90 and the halves 80A, 80B of the elongate member 80 are unbalanced during bending or forming. This unbalanced internal force causes distortion of the cross-sectional profiles of the halves 90A, 90B of the elongate member 90 and the halves 80A, 80B of the elongate member 80 during bending or forming. Thus, the cross-sectional profile shape of any elongate element (such as the elongate members 80, 90) gripped between the elongate members will also be distorted.

[0079] Figure 13A flowchart of a method of forming an elongate element according to some embodiments of the present invention is shown.

[0080] In operation 1302, an elongate assembly can be provided, the elongate assembly including an elongate element (e.g., elongate elements 105, 205, 305) disposed within a support device (e.g., support devices 200, 300, 400, 500, 600). The elongate element can include a thermoplastic polymer. The elongate element can include a forming or bending region within which the elongate element can be bent or formed. The support device can completely surround and support the elongate element along the entire length of the forming or bending region of the elongate element. During forming or bending while heating the elongate element, the support device can maintain a certain shape and prevent distortion of the cross-sectional profile of the elongate element in the forming or bending region.

[0081] In operation 1304, the elongate assembly can be heated to provide a heated elongate assembly (e.g., a heated elongate element and a heated support device) (e.g., as described above). The elongate assembly can be heated by a heating element of the support device.

[0082] In operation 1306, the heated elongate assembly can be formed or bent by a forming or bending device (e.g., such as device 900) to provide a formed or bent elongate assembly while maintaining the shape and preventing distortion of the cross-sectional profile of the elongate element in the forming or bending region by the support device. The formed or bent elongate assembly can include a formed or bent elongate element having a desired forming or bending profile supported by the formed or bent support device.

[0083] In operation 1308, the formed or bent support device can be released from the formed or bent elongate element. Before release, the bent elongate assembly can be cooled.

[0084] In some or all of the above embodiments, the components, devices, and / or equipment therein can be sterilized or capable of being sterilized. The components, devices, and / or equipment can be made of materials suitable for the sterilization process, such as metals (such as stainless steel or titanium) or plastics (such as PEEK polymers). Sterilization can be performed by any suitable method known in the art, such as by heating, chemicals, filtration, or radiation.

[0085] The systems and methods of the present invention can improve existing elongate element forming techniques. For example, the systems and methods of the present invention may be easier to use than alternatives, the formed elongate device may be easier to extract from the device / housing than alternatives, the cross-sectional shape of the elongate element may be maintained more effectively than alternatives, and so on.

[0086] The present disclosure provides various embodiments. The features of certain embodiments may be combined with the features of other embodiments; thus, certain embodiments may be a combination of the features of multiple embodiments. The foregoing description of the embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Those skilled in the art will appreciate that many modifications, variations, substitutions, alterations, and equivalents are possible in light of the above teachings. Accordingly, it is to be understood that the appended claims are intended to cover all such modifications and variations that fall within the true spirit of the invention.

[0087] Although certain features of the invention have been illustrated and described herein, many modifications, alternatives, variations, and equivalents will now occur to those of ordinary skill in the art. Accordingly, it is to be understood that the appended claims are intended to cover all such modifications and variations that fall within the true spirit of the invention.

Claims

1. A device for maintaining the cross-sectional profile shape of an elongated orthopedic implant during molding, the device comprising: first and second elongated portions having a contact surface, each of the first and second elongated portions comprising: The outer surface, and An inner surface, the inner surface comprising: The central depression, and The first and second peripheral portions are disposed on opposite sides of the central recessed portion, wherein Each of the first and second peripheral portions is a mirror image of a half of the central recessed portion that is closest to the respective first and second peripheral portion.

2. The device of claim 1, wherein the inner surface of each of the first and second elongated portions comprises first and second ridges disposed on opposite sides of a central recessed surface between the central recessed surface and the respective first and second peripheral portions.

3. The device of claim 2, wherein the first and second elongated portions contact each other along flat portions of their first and second ridges.

4. The apparatus of claim 1, wherein the central recessed portion of the inner surface of each of the first and second elongated portions is configured to support half of the circumference of a cross-sectional profile of the elongated orthopedic implant.

5. The device of claim 1, wherein the first and second elongated portions are configured to support an elongated orthopedic implant between central recessed portions of their inner surfaces.

6. The apparatus of claim 1, the first and second elongated portions configured to support the elongated orthopedic implant between the central recessed portion of the inner surface thereof along the entire length of the shaped region of the elongated orthopedic implant.

7. The device of claim 1, wherein an outer surface of each of the first and second elongated portions is flat.

8. The device of claim 1, comprising first and second heating elements coupled to outer surfaces of the first and second elongated portions, respectively, the first and second heating elements configured to heat an elongated orthopedic implant supported between the first and second elongated portions.

9. The device of claim 1, comprising two mesh structures disposed on opposite sides of the first and second elongated portions, the two mesh structures coupling the first and second elongated portions to grasp the first and second elongated portions together.

10. The device according to claim 9, each of the two mesh structures has at least one of stretchability and bendability during molding.

11. The device of claim 1 , comprising a clamp for releasably grasping the first and second elongated portions together, the clamp comprising: two arms pivoting about a central point, the two arms including opposed clamping ends configured to grasp the first and second elongated portions together, and A mechanism for varying the distance between the opposing clamping ends of the two arms.

12. The device of claim 1, comprising a clamp for releasably grasping the first and second elongated portions together, the clamp comprising: two arms movable relative to each other along a longitudinal axis of each of the two arms, the two arms including opposed clamping ends configured to grasp the first and second elongated portions together, and A mechanism for varying the distance between the opposing clamping ends of the two arms.

13. An apparatus for forming an elongated orthopaedic implant supported by a supporting device, the apparatus comprising: A housing, the housing comprising: Internally, and Guide rails; and Three or more sliders, each of the three or more sliders comprising: A first arm comprising a clamp disposed within the interior of the housing and configured to releasably grasp a support device supporting an elongated orthopedic implant, and The second arm is coupled to the guide rail of the housing and is slidable along the guide rail, and the first arm is movable relative to the second arm along a longitudinal axis perpendicular to the guide rail.

14. The apparatus of claim 13, each of the three or more sliders comprising a nut coupled to the first arm and a screw coupled to the second arm of the corresponding slider.

15. The apparatus of claim 13, each of the three or more sliders comprising a guide coupled to the first arm of the corresponding slider, the guide configured to support a physical indicator indicative of a desired molding profile of the elongated orthopedic implant.

16. The apparatus of claim 13, the device comprising a control unit configured to cause a heating element of the support device to heat the support device and the elongated orthopaedic implant supported therein when activated.

17. The device of claim 16, the control unit being configured to lock the cover of the housing when activated.

18. The apparatus of claim 13, the device comprising a cooling unit disposed within the housing, the cooling unit configured to cool the support device and the elongated orthopedic implant supported therein after molding.

19. A method of forming an elongated component, the method comprising: An elongated assembly is provided, the elongated assembly comprising: an elongated orthopedic implant comprising a thermoplastic polymer; and a support device that completely surrounds and supports the elongated orthopedic implant along the entire length of a molding region in which the elongated orthopedic implant is to be molded, such that the support device maintains a certain shape during heated molding of the elongated orthopedic implant and prevents distortion of the cross-sectional profile of the elongated orthopedic implant in the molding region; heating the elongated member to provide a heated elongated member; forming the heated elongated component according to a desired forming profile while maintaining the shape by a support device and preventing distortion of the cross-sectional profile of the elongated orthopaedic implant in the forming area; and Releasing a support device from an elongated orthopedic implant.

20. The method of claim 19, comprising cooling the heated elongate component prior to releasing the support device from the elongate orthopaedic implant.

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