Implant Imaging System

Abstract

An implant imaging system (200) is disclosed. The implant imaging system (200) may be provided on a polymeric joint implant. The implant imaging system (200) includes one or more metal plates (212) including at least one bone contacting surface 'B'. The metal plates (212) are disposed on the joint implant. Further, the bone contacting surface 'B' of the metal plates (212) are coated with one or more coatings of osteoconductive material. The presence of the osteoconductive material enhances the osteointegration rate of the joint implant.

Description

Technical Field

[0001] The present invention relates to an implant imaging system. More specifically, the present invention relates to an implant imaging system for joint implants.

Background Art

[0002] There are various types of joints in the human body. For example, to name a few, there are the knee joint, hip joint, elbow joint, and shoulder joint. Basically, a joint is formed where the ends of two or more bones come into contact. A healthy joint is important for performing daily activities.

[0003] Several conditions can cause joint pain and disorders. For example, joint pain and disorders can be caused by damage to articular cartilage (a smooth substance that protects the bones and allows the bones to move easily within the joint). Usually, all components of a joint work in harmony. However, illness or injury can disrupt this harmony and, as a result, cause pain, muscle weakness, and loss of function. For example, in the case of the knee joint, the most common cause of chronic joint pain and / or disorder is arthritis.

[0004] If non-surgical treatments such as medication, physical therapy, and behavior modification do not relieve pain and disorders, a doctor may recommend joint replacement surgery.

[0005] Implants used in joint replacement surgery can include a unique system designed to replace damaged, diseased, or malfunctioning natural structures. Conventionally, implants use a combination of cobalt-chromium (CoCrMo) alloy and ultra-high molecular weight polyethylene (UHMWPE). For example, in a knee joint implant, the femoral component and the tibial tray (tibial platform) are made of CoCrMo alloy, and the rotatable or slidable tibial pad is made of ultra-high molecular weight polyethylene.

[0006] However, conventional metallic materials such as CoCrMo alloys are used as femoral or tibial trays but have several clinical drawbacks. Furthermore, joint replacement implants are subjected to high loads and wear, which results in inducing movements that lead to the release of abrasive particles. The contact stress between the polyethylene seating surface of the implant and the metallic component may cause wear and contribute to the release of metal ions. Abrasive debris and metal ions are the main causes of inflammation, premature loosening, and metal toxicity associated with joint replacement implants. Additionally, CoCrMo alloys contain small amounts of nickel that can cause allergic reactions within the human body.

[0007] Furthermore, conventional implants are not compatible with known diagnostic devices such as computed tomography (CT) and magnetic resonance imaging (MRI) techniques, so that physicians are unable to track bone growth and healing after implantation.

[0008] Due to these drawbacks, a new generation of polymer material, polyetheretherketone (PEEK), which has high chemical stability, high strength, and high biocompatibility, is widely used in orthopedic endophytes.

[0009] However, polyetheretherketone (PEEK) materials are invisible in X-rays (insufficient radiopacity). Even when the polyetheretherketone (PEEK) substrate is provided with a titanium coating or a hydroxyapatite layer, the implant remains mostly invisible in X-ray images. Conventionally, to solve the problem of low radiopacity, metal inlays have been used in joint implants. One such implant with a metal inlay is disclosed in Patent Document 1. However, such metal inlays do not fully address the problem of low radiopacity in an efficient manner. The metal inlays of the said patent have limited visibility and cannot show the entire structure of the implant for accurate placement and postoperative follow-up.

[0010] Furthermore, for implantation purposes, it is very important to have cell adhesion properties that depend on the surface chemistry and topography of the implant. However, polyetheretherketone (PEEK) material has low osteointegration due to its high chemical stability. Therefore, its low bioactivity may be the cause of poor bone-implant interaction. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] ES2815658T3 Summary of the Invention [Problem to be solved by the invention]

[0012] Therefore, a need has arisen for an imaging system that can overcome the existing problems of joint implants. [Means for solving the problem]

[0013] The present invention relates to an implant imaging system. The implant imaging system may be mounted on a polymeric joint implant. The implant imaging system 200 includes one or more metal plates having at least one bone-contacting surface 'B'. The metal plates are disposed on the joint implant. Furthermore, the metal plates at the bone-contacting surface 'B' are coated with one or more coatings of an osteoconductive material. The presence of the osteoconductive material enhances the osteointegration rate of the joint implant.

[0014] The above and other features and advantages of the present invention will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings.

[0015] The above summary and the following detailed description of the exemplary embodiments are better understood when read in conjunction with the assigned drawings. For purposes of illustrating the present disclosure, exemplary constructs of the present disclosure are shown in the drawings. However, the present disclosure is not limited to the specific methods and means disclosed herein. Further, those skilled in the art will understand that the drawings are not to scale.

Brief Description of the Drawings

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Embodiments for Carrying Out the Invention

[0017] Before explaining the present invention in detail, define the definition of a certain word or phrase used throughout this patent document: Terms such as "including" and "comprising" and their derivatives mean unlimited inclusion, and the term "or" is inclusive and means and / or. The definition of a certain phrase is defined throughout this patent document, and those skilled in the art will understand that such a definition will apply to the previous and future uses of such defined phrases in most, if not many, examples.

[0018] Whenever possible, the same reference numbers are used throughout the drawings to refer to the same or similar parts. Further, where two or more elements of the same type may exist, references to the various elements described herein are made collectively or individually. However, such references are merely exemplary in nature. It should be noted that any reference to an element in the singular, unless expressly indicated otherwise in the appended claims, may be considered to relate to the plural as well without limiting the scope of the disclosure to the exact number or type of such elements, and vice versa.

[0019] Certain embodiments of the present disclosure are described herein below with reference to the accompanying drawings. Of course, the disclosed embodiments are merely examples of the present disclosure and may be embodied in various forms. To avoid obscuring the present disclosure with unnecessary details, well-known functions or structures are not described in detail. Accordingly, the specific structural and functional details disclosed herein should not be construed as limiting, but rather should be regarded as merely a basis, a representative basis for the claims to teach those skilled in the art to practice the present disclosure with any appropriately detailed structure.

[0020] According to the present disclosure, an implant imaging system is disclosed. The implant imaging system of the present invention has enhanced visibility by a radiation device and / or promotes osseointegration.

[0021] In one embodiment, the implant imaging system of the present invention includes one or more metal plates having a bone contact surface. In one embodiment, the bone contact surface of the metal plate is coated with a bone conductive material. The metal plate improves the radiopacity of the implant, providing better visualization during surgery, and thus enabling accurate implantation and better postoperative follow-up by a radiation device. The metal components provide higher visibility in radiopaque techniques, and thus the implant can be easily used in complexly shaped bone structures.

[0022] Coating of the bone conduction material on the metal plate helps with better osseointegration and provides long-term stability of the implant. Further, the coating on the metal component promotes strong adhesion to bone, minimizes inflammation, and prevents premature loosening, metal toxicity, and allergic reactions in the body.

[0023] Here, specifically referring to the drawings, FIG. 1 shows an implant imaging system 200. The implant imaging system 200 can include one or more components such as, but not limited to, one or more metal plates 212 having a bone contact surface 'B' and one or more coating layers on the bone contact surface 'B' of the metal plates 212.

[0024] The implant imaging system 200 can be provided at a predetermined position on an articular implant (e.g., the knee joint implant 100 shown in FIG. 1A). The predetermined position can be a part of the articular implant that remains in contact with the natural bone structure and / or requires maximum bone ingrowth in order to be visualized under a radiation examination. The articular implant can be made of a polymer material. The metal plates 212 of the implant imaging system 200 serve for appropriate visibility for the accurate placement of the articular implant during surgery and for postoperative follow-up observation.

[0025] The metal plates 212 can be made of a metal material and can be made of, but not limited to, titanium, tantalum, gold, platinum, hafnium, CoCrMo alloy, or a combination (alloy) thereof. In one embodiment, the metal plates 212 are made of CoCrMo alloy.

[0026] The implant imaging system 200 can be provided on an articular implant. The articular implant can include a spinal implant, a shoulder joint implant, a femoral joint implant 300 (shown in FIG. 7), or a knee joint implant 100 (shown in FIG. 1A) at a predetermined position. The predetermined position can be a part of the articular implant that remains in contact with the natural bone structure and / or requires maximum bone ingrowth to be visualized under radiological examination. The metal plate 212 of the implant imaging system 200 can be disposed on the articular implant. The metal plate 212 of the implant imaging system 200 helps with proper visibility for the accurate placement of the articular implant during surgery and for postoperative follow-up. The metal plate 212 can be attached to the articular implant by a snap-on type, press-fitting, adhesive, etc., without limitation. In certain embodiments, the metal plate 212 is disposed by a snap-on mechanism.

[0027] The metal plate 212 can include a predetermined thickness in the range from 1 mm to 3 mm, preferably from 1.5 mm to 2 mm. In certain embodiments, the thickness of the metal plate 212 is 1.5 mm. In various embodiments, the metal plate 212 can be a single structure and / or a plurality of structures according to the shape and dimensions of the articular implant shown in FIGS. 3 - 5.

[0028] The bone contact surface 'B' of the metal plate 212 can be defined as the surface that remains in contact with the natural bone during implantation of the articular implant. The surface 'B' can be coated with one or more coatings of a bone-conductive material. The bone-conductive material can include, without limitation, calcium sulfate, bioactive glass ceramics, hydroxyapatite, tricalcium phosphate, or combinations thereof. In certain embodiments, the surface 'B' is coated with hydroxyapatite (HA).

[0029] The HA coating can have an optimal thickness so that it does not cause any drawbacks that could affect the osseointegration rate. The thickness can be in the range from 110 μm to 190 μm. In certain embodiments, the thickness of the HA coating is 140 μm.

[0030] The HA coating on surface 'B' helps for better osseointegration and provides long-term stability to the implant 100. The HA coating provided on the metal component promotes strong adhesion as compared to the polyetheretherketone (PEEK) surface. Thus, the HA-coated surface 'B' of the present invention is more stable than the conventional implant with a polyetheretherketone (PEEK) bone contact surface. Refer to the pending Indian Patent Application No. IN202121028444 which discloses a coating process of hydroxyapatite (HA) on a hip joint implant.

[0031] In one exemplary embodiment, the implant imaging system 200 is described in the case of the knee joint implant 100 shown in FIG. 1a. The knee joint implant 100 may include one or more components including, but not limited to, the femoral component 110, the liner component 130, and the tibial component 150. These components of the knee joint implant 100 operate together as a functional unit and are designed to replace and realize the function of the natural knee joint.

[0032] The femoral component 110 may be attached to the femoral head 3 of the knee joint 1 and forms the upper articular surface (not shown). The liner component 130 may form the lower articular surface (not shown) together with the femoral head 3. The tibial component 150 may include a tibial stem 151 and a tibial baseplate 153. The liner component 130 may be coupled to the tibial baseplate 153 by any technique including, but not limited to, a press-fit mechanism, a medical adhesive, etc. The tibial stem 151 may be inserted into the medullary cavity of the tibia, and the tibial baseplate 153 contacts / holds the tibial stem 151.

[0033] The knee joint implant 100 can be made of a polymer material and / or a metal material. The polymer material can include, but is not limited to, polyetheretherketone (PEEK), polyethylene, polytetrafluoroethylene (PTFE), or combinations thereof. The metal material can include, but is not limited to, CoCrMo, ceramic, or combinations thereof. All of the aforementioned components of the knee joint implant 100 can be made of different materials and / or similar materials.

[0034] In one embodiment, the femoral component 110 and the liner component 130 are made of polyetheretherketone (PEEK), and the tibial component 150 is made of a CoCrMo alloy.

[0035] In another embodiment, the knee joint implant 100 is a metal-free implant, and all of the components are made of polyetheretherketone (PEEK).

[0036] In yet another embodiment, the knee joint implant 100 includes a femoral component 110 of polyetheretherketone (PEEK) that is coupled to an all-polyethylene liner component 130 and a tibial component 150, thereby making the implant metal-free.

[0037] Polyetheretherketone (PEEK) is more flexible compared to metal materials and can thus prevent loosening of the knee joint implant 100 due to stress shielding and / or bone resorption, so polyetheretherketone (PEEK) can be selected for manufacturing the knee joint implant 100. PEEK further prevents allergic reactions and wear debris resulting from joint components. The polyetheretherketone (PEEK) substrate exhibits excellent properties such as mechanical toughness, resistance to thermal degradation and chemical decomposition, and good biocompatibility.

[0038] Figures 2a - 2b show an exploded view of the femoral component 110 of the knee implant 100. The femoral component 110 may include an inner portion 111 and an outer portion 113. The inner portion 111 may be attached to the femoral head (bone) 3 (shown in Figure 1a). The outer portion 113 of the femoral component 110 may contact the liner component 130 (shown in Figure 1a).

[0039] The femoral component 110 may be injection - molded from polyetheretherketone (PEEK). Initially, when the femoral component 110 is manufactured, it includes smooth surfaces on both sides (the inner portion 111 and the outer portion 113). The inner portion 111 and the outer portion 113 of the femoral component 110 may undergo a surface modification process. The surface modification process introduces roughness to the inner portion 111 and the outer portion 113. The surface modification process may be carried out, without limitation, by grit blasting, sand blasting, micro - blasting, air - blasting, etc. The surface modification process provides a rough surface, thereby helping to enhance the adhesion properties by assisting in better osseointegration (bone ingrowth) and improved implant stability.

[0040] The inner portion 111 may have a predetermined surface roughness that can vary within the range from 5μm to 100μm. The surface roughness of the inner portion 111 may extend over at least 50%, or at least 70%, or at least 80% of the inner portion 111. In one embodiment, the surface roughness of the inner portion 111 is 7μm and covers approximately 80% of the inner portion 111.

[0041] The femoral component 110 of the knee implant 100 may be provided with an implant imaging system 200. The implant imaging system 200 can provide higher visibility in the radiopaque technique, and thus the femoral component 110 can be easily used with complex - shaped bone structures. The implant imaging system provides strength, radiopacity, and better osseointegration to the femoral component 110.

[0042] The implant imaging system 200 can be provided on the inner portion 111 of the femoral component 110 of the knee implant 100. The inner portion 111 is selected because it remains in contact with the natural bone where maximum bone ingrowth is required. However, although the present invention is described with the implant imaging system 200 being present on the inner surface, the implant imaging system 200 can similarly be disposed on any other surface of the joint implant.

[0043] The inner portion 111 of the femoral component 110 can include a plurality of slots 111a for accommodating the implant imaging system 200. The metal plate 212 of the implant imaging system 200 can be disposed within the slots 111a of the inner portion 111 of the knee implant 100. The plurality of slots 111a can vary depending on the implant imaging system 200 being disposed on the inner portion 111 of the femoral component 110.

[0044] The implant imaging system 200 can be of any shape, such as, without limitation, a rectangular plate, a square plate, etc. The metal plate 212 of the implant imaging system 200 includes a shape that complements the shape of the slots 111a. The metal plate 212 of the implant imaging system 200 can be disposed within the slots 111a of the inner portion 111 by, without limitation, a snap - type mechanism, press - fitting, an adhesive, etc. In one embodiment, the metal plate 212 of the implant imaging system 200 is disposed by a snap - type mechanism.

[0045] In various embodiments, the metal plates 212 of the implant imaging system 200 can be a single structure and / or multiple structures according to the dimensions and shapes of the femoral components 110. In the first exemplary embodiment shown in FIG. 3, a femoral component 210 having an inner portion 211 is shown. The inner portion 211 includes two slots 211a. The two slots 211a can be arranged with the implant imaging system 200 provided. In the above embodiment, the implant imaging system 200 includes two metal plates 212 corresponding to the two slots 211a. This embodiment can be used in a patient's body having a complex shape of a natural joint that requires maximum radiopacity.

[0046] In a second exemplary embodiment, as shown in FIG. 4, the femoral component 220 includes an inner portion 221 having a plurality of slots 221a. The inner portion 221 can be covered using a plurality of metal plates 212 of the implant imaging system 200, such as four metal components 223. The metal plates 212 can be arranged at respective corners of the inner portion 221. The metal plates 212 can be cut according to the shape and dimensions of the plurality of slots 221a shown in FIG. 4. The metal components 223 can cover an area ranging from 50% to 80% of the inner portion 221 of the femoral component 210.

[0047] In a third exemplary embodiment, a femoral component 230 having an inner portion 231 is provided as shown in FIG. 5. The inner portion 231 of the femoral component 230 includes a plurality of slots 231a at a specific distance from each other. The plurality of metal plates 212 can be disposed within the plurality of slots 231a. The plurality of metal components 233 can be shaped according to the plurality of slots 231a and made to specific dimensions. In one exemplary embodiment, the inner portion 231 includes 22 slots and 22 corresponding metal plates 212. The plurality of metal plates 212 can cover an area ranging from 50% to 80% of the inner portion 231 of the femoral component 230. This embodiment can be used in a patient's body having a relatively simple shape of a natural knee joint.

[0048] Further, in another exemplary embodiment, the implant imaging system 200 is disclosed in the case of the hip joint implant 300 shown in FIG. 7. The hip joint implant 300 may include an acetabular component 301, a plastic liner 303, a femoral head 305, and a femoral stem 307. In the case of the hip joint implant 300, the metal plate 212 of the implant imaging system 200 is disposed on the upper surface of the acetabular component 301. The metal plate 212 may provide appropriate visibility for the hip joint implant 300 for accurate placement during implantation and postoperative follow-up.

[0049] Furthermore, the knee joint implant 100 may be provided with a plurality of radiopaque markers. The markers may be provided at predetermined positions on the knee joint implant 100. In one embodiment, the markers are provided along the outer edge of the femoral component 110 of the knee joint implant 100.

[0050] The knee joint implant 100 may include one or more different types of markers, including but not limited to the first marker 171 and the second marker 173 shown in FIGS. 6a-6b. The radiopaque markers may have shapes including but not limited to cylindrical, hexagonal, circular, square, conical, hemispherical, elliptical, etc. In one embodiment, the first marker 171 is in the form of a rivet and the second marker 173 is in the form of a hexagon. The radiopaque markers may be made of a metal group including platinum, gold, tungsten, iridium, titanium, tantalum, hafnium, or combinations thereof. All of the above metals have the necessary biocompatible properties and have a sufficiently large atomic weight such that they are suitable for use as radiopaque metals.

[0051] The femur component 110 may include a plurality of slots (not shown) and the hole 117 shown in FIG. 2. The hole 117 may be sized to accommodate the first marker 171. The hole 117 may be sized to accommodate the second marker 173. The slots may be disposed on the outer periphery of the femur component 110 in proximity to the liner component 130.

[0052] Hereinafter, the present invention will be described using the following examples.

[0053] Example 1 (Prior Art): An implant with a femur component was fabricated from a conventional polyetheretherketone (PEEK) by an injection molding process. The femur component was observed under X-rays. The obtained X-ray image is shown in FIG. 8a. It was found from the image that the femur component was difficult to identify in the X-ray image. Therefore, it was difficult to track the exact position of the implant components in the postoperative evaluation.

[0054] Example 2 (The Present Invention): The materials and methods for manufacturing the femur component were the same as those described in Example 1. Further, an implant imaging system was disposed on the inner portion of the femur component of the knee joint implant. The implant imaging system included a plurality of metal plates coated with an HA material by a plasma spraying technique. The implant imaging system was attached to the inner portion of the first bone contact component by a snap-type mechanism.

[0055] The implant was tested for X-ray visibility. The results showed a better image compared to the prior art. The X-ray image of the femur component of the implant is shown in FIG. 8b. Further, the HA-coated metal plates helped in better osseointegration of the implant and thus improved stability.

[0056] The scope of the present invention is limited only by the appended claims. More generally, all parameters, dimensions, materials, and structures described herein are intended to be exemplary, and those skilled in the art will readily understand that actual parameters, dimensions, materials, and / or structures are determined by one or more specific applications in which the teachings of the present invention are used.

Explanation of Signs

[0057] 3, 305 Femoral head 100 Implant, knee joint implant 110, 210, 220, 230 Femoral components 111, 211, 221, 231 Inner part (of femoral component) 111a, 211a, 221a, 231a Slots (of inner part) 113 Outer part (of femoral component) 117 Hole part (of femoral component) 130 Liner component 150 Tibial component 151 Tibial stem 153 Tibial base plate 171 First marker 173 Second marker 200 Implant imaging system 212 Metal plate 223, 233 Metal components 300 Hip joint implant 301 Acetabular component 303 Plastic liner 307 Femoral stem B Bone contact surface

Claims

1. A plurality of metal plates (212) including at least one bone contact surface (B) and disposed on an articular implant, One or more coatings of an osteoconductive material applied on the bone contact surface (B) of the metal plate (212) to enhance the osteointegration rate, The articular implant is made of a polymer material, The articular implant has an inner portion (111) including a plurality of slots (111a), The metal plate (212) has a shape that complements the shape of the slot (111a), and the plurality of metal plates (212) are respectively disposed in the plurality of slots (111a), An implant imaging system (200).

2. The implant imaging system (200) according to claim 1, wherein the metal plate (212) is one of titanium, tantalum, gold, platinum, hafnium, CoCrMo alloy, or a combination (alloy) thereof.

3. The implant imaging system (200) according to claim 1, wherein the metal plate (212) has a thickness in the range of 1 mm to 3 mm.

4. The implant imaging system (200) according to claim 1, wherein the articular implant is a knee joint implant (100).

5. The implant imaging system (200) according to claim 4, wherein the knee joint implant (100) includes a femoral component (110) having the inner portion (111).

6. The implant imaging system (200) according to claim 1, wherein the osteoconductive material includes hydroxyapatite (HA).

7. The implant imaging system (200) according to claim 6, wherein the coating of the hydroxyapatite (HA) has a thickness in the range of 110 μm to 190 μm.

8. The implant imaging system (200) according to claim 1, wherein the articular implant is made of polyetheretherketone (PEEK).

Images