Auxiliary materials for bone implants

Abstract

This disclosure relates to an auxiliary member 100 for an implant 10. The auxiliary member includes a longitudinal member 110 and a transverse member 130. The longitudinal member is positioned in the gap between the bone and the implant. The longitudinal member includes a curved portion corresponding to the curved portion of the implant. The transverse member is coupled to the longitudinal member, which will be positioned on top of the implant. The transverse member is positioned at a predetermined angle relative to the longitudinal member.

Description

【Technical Field】 【0001】 The present disclosure relates to an augment for a bone implant. More particularly, the present disclosure discloses an augment for a bone implant for enhancing contact with the host bone. 【Background Art】 【0002】 Those suffering from deterioration of the hip joint undergo hip replacement surgery. In hip replacement surgery, the hip joint is completely or partially replaced with a synthetic implant. 【0003】 The hip joint includes the femur (thigh bone) connected to the pelvic bone via a ball joint. In hip replacement surgery, a stem prosthesis (or implant) is attached to the femur to reinforce the hip joint. 【0004】 Conventional stem prostheses include an axially extending stem portion and a neck portion disposed at an angle with respect to the stem portion. The stem prosthesis is inserted into the intramedullary cavity of the femur. The neck portion indirectly connects the stem portion to the pelvic bone. 【0005】 Commercially available stem prostheses are either of the monoblock type or the modular type. As the name indicates, the monoblock stem prosthesis is formed by an integral structure of the neck portion and the stem portion. The monoblock stem prosthesis is easy to insert and has no risk of breakage. However, the monoblock stem prosthesis has problems of a higher incidence of subsidence and inability to restore the tension of soft tissues. 【0006】 In contrast, the modular stem prosthesis has a neck portion removably coupled to the stem portion. The modular stem prosthesis has a relatively high resistance to subsidence and is excellent in the ability to balance soft tissues. However, these are time-consuming to insert into the bone, and are particularly likely to break at the connection point between the stem portion and the neck portion when there is no bone support in the proximal portion of the stem prosthesis. 【0007】 In approximately 30% of cases, an undesirable gap is observed between the proximal portion of the stem and the femur after the insertion of the stem prosthesis, resulting in the proximal portion of the stem prosthesis being unsupported. If left unnoticed, such a gap is likely to cause implant failure and / or bone (femur) fracture. 【0008】 Traditionally, surgeons have had no options to correct undesirable gaps between implants and bone, or at best, they can only fill the gap with some kind of cement, which is not a sufficient solution. [Prior art documents] [Patent Documents] 【0009】 [Patent Document 1] Indian Patent Application No. 202321039103 [Overview of the Initiative] [Problems that the invention aims to solve] 【0010】 Therefore, the need arises for a system / device to address the aforementioned shortcomings. [Means for solving the problem] 【0011】 While specific embodiments of the Disclosure are described below with reference to the accompanying drawings, it should be understood that the disclosed embodiments are merely examples of the Disclosure as it can be embodied in various forms. To avoid obscuring the Disclosure with unnecessary detail, well-known functions or structures are not described in detail. Therefore, the specific details relating to the structures and functions disclosed herein should be interpreted not as limiting, but merely as a basis for the claims and as a representative basis for instructing those skilled in the art to utilize the Disclosure in various structures with substantially any appropriate details. 【0012】 This disclosure relates to an auxiliary material for bone implants. The auxiliary material includes a longitudinal portion and a transverse portion. The longitudinal portion and the transverse portion form a single structure. The longitudinal portion is positioned within a cavity defined between the bone and the implant and includes a curved portion corresponding to the curved portion of the implant. The transverse portion and the transverse portion of the auxiliary material form a predetermined angle. The transverse portion is positioned on the implant and coupled to the longitudinal portion. 【0013】 The above summary and the following detailed description of exemplary embodiments will be better understood when read together with the distributed drawings. For illustrative purposes, exemplary structures of the disclosure are shown in the drawings. However, the disclosure is not limited to the specific methods and means disclosed herein. Furthermore, those skilled in the art will understand that the drawings are not drawn to exact scale. [Brief explanation of the drawing] 【0014】 [Figure 1] This is a cross-sectional view of a femur 1 with an implant 10 and an auxiliary material 100 attached according to an embodiment of the present disclosure. [Figure 2] This is a diagram of an auxiliary material 100 for an implant 10 according to an embodiment of the present disclosure. [Figure 3] This is a diagram of implant 10 according to an embodiment of the present disclosure. [Figure 4] This is a longitudinal cross-sectional view of a femur 1 with an implant 10 and an auxiliary material 100 attached according to an embodiment of the present disclosure. [Modes for carrying out the invention] 【0015】 Before describing the present invention in detail, we define certain words or phrases used throughout this patent document. The terms “include” and “comprise,” and their derivatives, mean to include without limitation. The term “or” means comprehensive and / or. The phrases “coupled with” and “associated therewith,” and their derivatives, may mean to include, contain in, interconnect with, encompass, be contained within, connect to or with, be linked to or with, be communicable with, cooperate with, alternate, juxtapose, be close to, be associated with or with, have the characteristics of, etc. Although definitions of certain words and phrases are given throughout this patent document, those skilled in the art will understand that such definitions often, if not most, also apply to earlier and later uses of the defined words and phrases. 【0016】 Throughout this specification, any reference to “one embodiment,” “an embodiment,” or similar phrases means that any particular feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment. Thus, throughout this specification, any use of the phrases “in one embodiment,” “in an embodiment,” and similar phrases means “one or more embodiments, but not all,” although they may all refer to the same embodiment, unless otherwise expressly noted. Unless otherwise expressly noted, any list of items does not imply that any or all of those items are mutually exclusive and / or mutually inclusive. The terms “a,” “an,” and “the” also mean “one or more,” unless otherwise expressly noted. 【0017】 The operations of the exemplary embodiments of the disclosed method may be described in a particular sequential order for presentation convenience, but it should be understood that the disclosed embodiments may embrace an order of operations other than the particular sequential order disclosed. For example, the operations described sequentially may in some cases be rearranged or performed concurrently. Further, the description and disclosure provided in connection with a particular embodiment are not limited to that embodiment and can be applied to any of the embodiments disclosed herein. Still further, for the sake of brevity, the attached figures may not show various ways in which the disclosed systems, methods, and devices can be used in combination with other systems, methods, and devices. 【0018】 Still further, the features, advantages, and characteristics described of the embodiments may be combined in any suitable manner. Those skilled in the relevant art will recognize that an embodiment can be practiced without one or more of the specific features or advantages of a particular embodiment. Also, in some cases, additional features and advantages may be recognized in a particular embodiment, but they may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and the appended claims, or may be understood by the practice of the embodiments described below. 【0019】 In the context of the present disclosure, a gap refers to the space between the bone and the implant after insertion of the implant. The term cavity refers to a shaped or redefined gap into which an auxiliary material is inserted. Usually, the dimensions of the cavity correspond to the dimensions of the auxiliary material. 【0020】 The present disclosure discloses an auxiliary material for a bone implant (or implant). The auxiliary material is closely fitted and disposed in a cavity between the implant and the inner surface of the bone. The auxiliary material thus minimizes the gap between the implant and the inner surface of the bone and maintains maximum implant-bone contact. Further, the risk of subsidence is greatly reduced. 【0021】 The auxiliary material of the present invention is designed to be installed in the femur of a patient during surgery. However, it is also contemplated that with some appropriate adjustments, this auxiliary material can be used together with a humerus implant for shoulder surgery. The configuration of the auxiliary material in such an embodiment is substantially as described below, but the overall size and shape of the auxiliary material will be configured to be able to install it in the humerus instead of the femur. Also, it is contemplated that at least some embodiments of the present invention can be applied instead in the context of a (distal) femur implant or a tibia implant for knee surgery. In this case too, the configuration of the implant in such an embodiment is substantially as described below, but the overall size and shape of the auxiliary material will be configured to be able to install it in the tibia or the distal part of the femur instead of the proximal part of the femur. 【0022】 Referring now to the drawings, FIG. 1 depicts a cross-section of the femur 1 with the implant 10 and the auxiliary material 100. The auxiliary material 100 minimizes the gap between the implant 10 and the femur 1, thereby minimizing implant malfunctions and / or femur fractures. The auxiliary material 100 is mounted on the implant 10 in the femur 1. The auxiliary material 100 can extend at least partially into the femur 1 along the surface of the implant 10. 【0023】 The auxiliary material 100 includes a longitudinal member 110 and a transverse member 130, the details of which are described in FIG. 2. The longitudinal member 110 includes two surfaces on opposite sides of each other. When mounted on the implant 10, the longitudinal member 110 of the auxiliary material 100 is disposed axially along the length of the main body 13 of the implant 10. One surface of the longitudinal member 110 is in contact with the implant 10, and the other surface of the longitudinal member 110 is in contact with the inner surface of the femur 1. The transverse member 130 is configured to be coupled on top of the shoulder 15 of the implant 10 as described below to properly fix the auxiliary material 100 to the implant 10. 【0024】 The support material 100 supports the implant 10 by filling the gap between the main body 13 and the inner surface of the femur 1. 【0025】 Figure 2 shows an auxiliary material 100 for the implant 10, which is used to reduce the gap between the implant 10 and the inner surface of the femur 1. Essentially, the auxiliary material 100 is attached to the shoulder portion 15 of the implant 10 to reduce / eliminate the gap between the implant 10 and the inner surface of the femur 1. 【0026】 The support material 100 is made of a porous material including, but not limited to, titanium, cobalt-chromium, and other metals, or alloys thereof. The support material 100 is made by 3D printing or machining. In an exemplary embodiment, the support material 100 is made by 3D printing using a titanium alloy (Ti-6Al-4V-ELI). The support material 100 supports the body 13 (and shoulder portion 15) of the implant 10, thereby helping to reduce the risk of sinking. Furthermore, the support material 100 promotes osseointegration of the implant 10, further increasing its resistance to sinking. The support material 100 also helps to utilize a trochanteric fragment together with the body 13 of the implant 10 when the bone quality of the trochanteric region is poor or fractured. 【0027】 As described above, the auxiliary member 100 includes a longitudinal member 110 and a transverse member 130. In an exemplary embodiment, the longitudinal member 110 and the transverse member 130 form an integral structure. 【0028】 The longitudinal member 110 includes a plate-shaped body having an optionally curved portion. In an exemplary embodiment, the radius of curvature of the longitudinal member 110 corresponds to the radius of the body 13 to which the auxiliary member 100 is attached, for example, the body of the stem. The edges of the plate-shaped body may be smooth, chamfered, rounded, etc. The distal portion of the longitudinal member 110 may be tapered or rounded. Alternatively, the distal portion of the longitudinal member 110 may be straight. The length of the longitudinal member 110 is at least 5 mm. 【0029】 The longitudinal member 110 and the transverse member 130 may have predetermined thicknesses. In exemplary embodiments, the longitudinal member 110 and the transverse member 130 have the same thickness. Alternatively, the longitudinal member 110 and the transverse member 130 may have different thicknesses. In exemplary embodiments, the thickness of the longitudinal member 110 (e.g., at least 1 mm) corresponds to the width of the cavity, which is the result of reaming the gap between the main body 13 of the implant 10 and the inner surface of the femur 1. The thickness of the gap between the main body 13 and the inner surface of the femur 1 varies based on the anatomical structure of the femur 1. The minimum thickness of the longitudinal member 110 is 1 mm. The minimum thickness of the transverse member 130 is 1 mm. 【0030】 In one embodiment, the thickness of the longitudinal member 110 and the transverse member 130 varies along their respective surfaces. For example, the thickness toward the edges of the longitudinal member 110 and the transverse member 130 may be less than the thickness around the central portion of each. Alternatively, the thickness of the longitudinal member 110 and the transverse member 130 may vary depending on the support that needs to be provided to the implant 10, and all such variations are within the scope of this disclosure. 【0031】 The shape and surface of the auxiliary material 100 are important for strengthening the osseointegration of the implant 10. In exemplary embodiments, the auxiliary material 100 includes a textured surface, a rough surface, or a lattice-like surface for promoting bone endografting or osseointegration. 【0032】 The transverse member 130 can define a predetermined angle with the longitudinal member 110. The predetermined angle between the longitudinal member 110 and the transverse member 130 can correspond to the anatomical structure of the femur 1. In an exemplary embodiment, the predetermined angle between the longitudinal member 110 and the transverse member 130 is 90°, and it looks like an inverted L. 【0033】 The transverse member 130 may have one or more holes 130a. The number of holes 130a corresponds to the number of recesses 15a in the shoulder portion 15. The auxiliary member 100 is secured to the shoulder portion 15 of the implant 10 using a fastening mechanism including, but not limited to, snap fittings, tapered locks, fasteners, etc. The fastening mechanism secures the two together by passing through the holes 130a in the auxiliary member 100 and entering the recesses 15a in the implant 10. In exemplary embodiments, a fastener 130b is used to secure the auxiliary member 100 to the implant 10 in a desired orientation. Other functionally equivalent means are within the scope of the teachings of this disclosure. 【0034】 Before describing the assembly of the support material 100 and implant 10, an exemplary implant is shown in Figure 3. Note that the support material 100 can be used with any implant, including the exemplary embodiment shown in Figure 3. The implant 10 is configured to be inserted into a bone cavity to reinforce the bone (and / or adjacent joint). In the exemplary embodiment, the implant 10 is inserted into a cavity defined in the femur 1 to reinforce the hip joint. 【0035】 In an exemplary embodiment, the implant 10 is inserted into the cavity of the femur 1 using an implant applicator such as that described in Indian Patent Application No. 202321039103. 【0036】 The implant 10 has a proximal end 10a and a distal end 10b. Furthermore, the implant 10 includes a stem 11, a body 13, a shoulder portion 15, and a neck portion 17. The stem 11 is positioned toward the distal end 10b of the implant 10 such that the distal tip of the stem 11 defines the distal end 10b of the implant 10. 【0037】 The stem 11 may be tubular, conical, cylindrical, or any other preferred shape. As depicted, the stem 11 is cylindrical. In the exemplary embodiment, as shown in Figure 1, the stem 11 is at least partially tapered toward the distal end 10b. That is, the middle portion of the stem 11 has a larger diameter than the distal portion. The distal end of the stem 11 may be pointed. Alternatively, the distal end of the stem 11 may be any other shape, including but not limited to curved, rounded, bullet-shaped, etc., that allows the implant 10 to be easily inserted into the bone. The tapered structure of the stem 11 facilitates a more efficient implant insertion process, minimizing surgical time and surgeon effort, thus increasing the usefulness of the implant 10. 【0038】 In addition, or optionally, the stem 11 is provided with a plurality of ribs 11a on its outer surface. The ribs 11a may be distributed circumferentially on the outer surface of the stem 11. The ribs 11a may extend at least partially along the axis (or longitudinal direction) of the stem 11 on the outer surface of the stem 11. In one embodiment, the ribs 11a extend longitudinally from the distal end to the proximal end on the outer surface of the stem 11. 【0039】 In one embodiment, the rib 11a has a textured surface that facilitates frictional mating of the implant 10 with the surrounding bone after insertion of the implant 10 into the bone cavity. The rib 11a can include a variety of patterns, including but not limited to linear, zigzag, wavy, etc. In an exemplary embodiment, the rib 11a has a linear pattern on the surface of the stem 11. The rib 11a provides rotational resistance to the implant 10 in the bone cavity and increases the total contact surface area with the host bone. 【0040】 The main body 13 is positioned toward the proximal end 10a of the stem 11. In an exemplary embodiment, the main body 13 forms an integral structure with the stem 11. Alternatively, the main body 13 may be detachably coupled to the stem 11. 【0041】 In addition, or optionally, the main body 13 is provided with one or more holes 13a. In an exemplary embodiment, holes 13a in the intermediate region of the main body 13 allow the user to attach a wire to a trochanteric piece (not shown). This trochanteric piece functions as a synthetic substitute for the natural trochanteric bone, which is an anatomical structure located in the upper part of the femur. The trochanteric piece is used when the trochanteric bone is of poor quality or fractured. 【0042】 The main body 13 includes an outer surface that remains in direct contact with the femur 1 (or bone) once embedded in the femur 1. The outer surface of the main body 13 may be coated with at least one layer. In exemplary embodiments, the outer surface of the main body 13 is coated with one layer of coating, including but not limited to hydroxyapatite (HA), titanium coating, etc. This coating is chemically similar to the minerals of natural bone and therefore helps to strengthen the bone-implant joint between the implant 10 and the femur 1 after insertion of the implant 10 into the cavity of the femur 1. The coating further promotes bone tissue regrowth and increases the rate of osseointegration. 【0043】 The shoulder portion 15 is positioned at the proximal end 10a of the implant 10. The shoulder portion 15 is provided with at least one recess 15a. The recess 15a can be circular, semicircular, oval, or any other desirable shape. Furthermore, the wall of the recess 15a may be threaded, partially threaded, or not threaded. The recess 15a extends at least partway along the length of the main body 13. Furthermore, the recess 15a may be aligned with the center of the shoulder portion 15, or it may be offset from the center by a predetermined distance. 【0044】 The recess 15a helps the user connect the auxiliary material 100 to the implant 10 using a connecting mechanism including, but not limited to, fasteners, rivets, etc. In an exemplary embodiment, the recess 15a connects the auxiliary material 100 to the shoulder portion 15 of the implant 10. Connecting mechanisms include, but are not limited to, fasteners 130b (as shown in Figure 2), press-fits, tapered-fits, etc. The fastener 130b can be made from any biocompatible material including, but not limited to, titanium, cobalt-chromium, and other metals or alloys thereof. In an exemplary embodiment, the fastener 130b is made of titanium. 【0045】 The neck portion 17 extends away from the body 13 of the implant 10. The neck portion 17 defines a predetermined angle with the axis of the stem 11. The angle is based on the orientation of the femur relative to the adjacent pelvic bones. The neck portion 17 indirectly forms a ball-and-socket joint with the pelvic bones. In exemplary embodiments, although not shown, the neck portion 17 is provided with a ball portion that connects to the natural fossa of the pelvic bone or to an implant provided in the pelvic bone, forming a ball-and-socket joint that replicates the movement of a natural joint. 【0046】 Figure 4 shows an example exploded view of the assembly. First, the implant 10 is inserted into the femur 1. To do this, the stem 11 of the implant 10 is inserted first. After properly positioning the stem 11 of the implant 10 in the bone 1, the gap between the implant 10 and the medullary cavity is analyzed. The gap is reamed to obtain a cavity of the appropriate thickness. Once the cavity is formed, an auxiliary material of the corresponding thickness is selected. 【0047】 Next, the auxiliary material 100 is attached to the implant 10. Specifically, the longitudinal member 110 of the auxiliary material 100 is inserted into the cavity between the implant and the bone. The auxiliary material 100 is pushed until the transverse member 130 of the auxiliary material 100 is positioned on the shoulder portion 15 of the implant 10. The two are then joined together using a fastener 130b. 【0048】 The scope of the present invention is limited only by the appended claims. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are intended to be illustrative, and that actual parameters, dimensions, materials, and / or configurations will depend on the specific application in which the teachings of the present invention are used.

Claims

[Claim 1] An auxiliary material (100) for an implant (10), a. A longitudinal member (110) which will be placed in a cavity defined between bone 1 and the implant (10), b. comprising a transverse member (130) coupled to the longitudinal member (110) which will be positioned on the implant (10), The transverse member (130) is provided at a predetermined angle with respect to the longitudinal member (110), The longitudinal member (110) includes a curved portion corresponding to the curved portion of the implant (10), and is an auxiliary member (100). [Claim 2] The auxiliary member (100) according to claim 1, wherein at least one edge of the longitudinal member (110) and the transverse member (130) is smooth or chamfered. [Claim 3] The auxiliary material (100) according to claim 1, wherein the longitudinal member (110) has an inconsistent thickness. [Claim 4] The auxiliary member (100) according to claim 1, wherein the transverse member (130) includes a hole 130a that allows the coupling mechanism to pass through. [Claim 5] The auxiliary material (100) according to claim 4, wherein the hole 130a is one of a threaded hole, a partially threaded hole, or an unthreaded hole. [Claim 6] The auxiliary material (100) according to claim 4, wherein the coupling mechanism includes a fastener 130b. [Claim 7] The auxiliary material (100) according to claim 1, wherein the longitudinal member (110) and the transverse member (130) form an integrated component. [Claim 8] The auxiliary material (100) according to claim 1, wherein the auxiliary material (100) is 3D printed or machined. [Claim 9] The auxiliary material (100) is made of a titanium alloy, as described in claim 1. [Claim 10] The auxiliary material (100) according to claim 9, wherein the auxiliary material (100) includes a textured surface or a rough surface. [Claim 11] The auxiliary member (100) according to claim 1, wherein the predetermined angle between the longitudinal member (110) and the transverse member (130) is 90° and it looks like an inverted L.

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