JPH09511668A - Orthopedic prosthesis device - Google Patents

Abstract

(57) SUMMARY An improved orthopedic joint prosthesis (10) includes a first surface (17) for engaging a patient's joint and a second surface (16) for receiving a polymer liner (15). ) With a prosthesis (14). The second surface (16) is highly polished or mirror-like to prevent debris from forming from the polymer liner and for optical pattern inspection.

Description

Description: TECHNICAL FIELD The present invention relates to an orthopedic prosthetic joint device for implanting in a joint of a human or animal body, or as an alternative thereto. Some commercially available prosthetic devices for implantation in a patient's joint or for complete joint replacement include a metal portion and a plastic liner that at least partially forms the articulating surface of the joint. For example, US Pat. No. 4,828,565 discloses an acetabular element for a cementless gluteal prosthesis. This element comprises two parts, a hemispherical shell made of titanium and a polymeric cup body that engages therein. Other patents and patent applications describing cups for the acetabulum include European Patent Application No. 212,087 published on April 3, 1987, in which metallic pins are attached to the surface of the cup body. It has a hole that projects and allows tissue to grow. In EP 341,198 published Nov. 8, 1989, an acetabular cup body comprises a metallic outer shell and a plastic body for holding the hip joint head. The use of a plastic liner and base member combination is also a feature of other joint prostheses such as those for implantation in the shoulder or knee. One example of a tibial prosthesis having a plate or insert that forms a joint surface for the joint is described in US Pat. No. 4,462,120. The present invention provides an improved orthopedic joint prosthesis in which the prosthetic device body has a base member (eg, tray, cup or shell) and a polymeric liner. The polymeric liner adheres to the prosthetic device body and forms an articulating surface that engages other prosthetic components. The prosthetic device body has a non-articulating, mirror-like or polished surface for receiving a plastic liner. The surface has a polished surface that faces the liner and prevents the generation of liner debris. The roughness of the polished surface is preferably 8 micro inches or less. Combining a polymeric liner with an orthopedic base having a specular or polished surface finish provides a number of advantages. First of all, this surface finish forms a low friction, low wear surface that distributes the contact force between the polyethylene liner (eg, UHMWPE) and the prosthesis body shell. Therefore, it is possible to suppress the generation of polyethylene scraps due to wear caused by the movement between the liner and the main body. This movement may be due to various mechanisms including the Poisson volumetric distortion of polyethylene. This results in the liner surface being locally inflated and deflated relative to the body as a result of the loading of the liner and the micro-motion caused by the force from the liner in and around the interior region of the prosthesis body. Become. For example, in the case of an acetabular prosthetic device, the femoral head presses down on the liner. Micromotion may occur in the hip prosthesis due to the force generated by the femoral head pushing the liner within and around the prosthetic device body or acetabular cup body region having a concave abrasive surface that receives the liner. . Micro-motion may occur in the knee prosthesis as the tibial tray liner receives the forces generated by the femoral prosthesis. The shoulder or glenoid component also has the force transmitted at the joint to the plastic liner of the metallic portion of the glenoid. The mirror finish also makes it possible to perform an optical non-contact inspection inside the surface of the metallic part and thereby check the shape accuracy of that part. Using this non-contact optical inspection, the entire surface of a 2D / 3D configuration can be completely checked at once. The usual method of optical three-dimensional inspection is to project a regular pattern of light onto the surface to be inspected. The resulting two-dimensional projection of the scene can be used to make highly accurate full-surface measurements. The distortion of the regular pattern indicates the distortion on the partial surface, and indicates the deviation from the desired partial shape. This method is not effective on highly smooth surfaces. This is because the projected light of the regular figure bounces off the measurement target and cannot be two-dimensional mapped. In this device, the highly smooth surface is further polished to act as a reflector. Then, this mirror surface is used as a lens for visually observing a two-dimensional figure such as a blank figure or a lattice figure drawn on a series of concentric rings. Therefore, the distortion of the viewed image is a result of the distortion of the lens, i.e. the surface on which the measurement is desired. Such polishing makes it possible to inspect a highly smooth surface of the prosthetic device body. This inspection method may be performed by a trained human inspector or by image analysis. In image parsing, the reflected image is captured with a video camera, the image is digitized, and computer analysis is used to measure the amount of feature deviation from the surface profile tolerance. Thus, the advantage of this smooth and polished surface is that it allows non-contact and non-destructive (non-scratch) measurements inside the acetabular device. This inspection method requires a surface that provides a reflection resolution sufficient to provide adequate reflection image quality for analysis. Current inspection limits require surface finishes of 8 microinches or less to achieve this resolution quality. In one embodiment, the present invention provides an improved acetabular prosthetic device. In the acetabular prosthesis, the acetabular cup body preferably comprises a through-opening which acts as a drill guide for the surgeon after the cup has been placed in the patient's acetabulum. A second embodiment of the present invention is a glenoid prosthetic device for implantation in the shoulder. Another embodiment of the present invention is a knee prosthetic device, such as is commonly used as a complete knee replacement implant. BRIEF DESCRIPTION OF THE DRAWINGS For a better understanding of the nature and objects of the present invention, reference should be made to the following detailed description, taken in conjunction with the accompanying drawings. In the figure, similar portions are represented by similar symbols. 1 is a side sectional view of a preferred embodiment of the device of the present invention showing an acetabular cup. FIG. 2 is a side sectional view of a preferred embodiment of the device of the present invention showing an acetabular cup. FIG. 3 is an exploded perspective view of a preferred embodiment of the device of the present invention showing an acetabular cup. FIG. 4 is a top view of a preferred embodiment of the device of the present invention showing the glenoid component. FIG. 5 is a bottom view of a preferred embodiment of the device of the present invention showing the glenoid component. FIG. 6 is an elevational view of a preferred embodiment of the device of the present invention showing the glenoid component. FIG. 7 is a side view of a preferred embodiment of the device of the present invention showing the glenoid component. FIG. 8 is a bottom view of a preferred embodiment of the device of the present invention showing the tibial component. 9 is an elevational view of a preferred embodiment of the device of the present invention showing the tibial component taken along line 9-9 of FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. FIG. 11 is an elevational view of a preferred embodiment of the device of the present invention showing the tibial component. FIG. 12 is a side view of a preferred embodiment of the device of the present invention showing an asymmetric tibial component. FIG. 13 is a top view of a preferred embodiment of the device of the present invention showing an asymmetric tibial glenoid component. FIG. 14 is an elevational view of a preferred embodiment of the device of the present invention showing an asymmetric tibial component. FIG. 15 is a bottom view of a preferred embodiment of the device of the present invention showing an asymmetric tibial component. FIG. 16 is a schematic diagram of a grating used to inspect a polished surface to see strain. FIG. 17 illustrates an acetabular cup prosthesis device of the present invention which is a second embodiment of a test grid pattern used to inspect highly polished surface portions. FIG. 18 is a schematic diagram of a test grid without surface defects. FIG. 19 is a schematic diagram with local flaws on a polished surface inspected with a grid. Detailed Description of the Preferred Embodiments FIG. 1 is a cross-sectional view of a first embodiment of the apparatus of the present invention, generally designated apparatus 10. In FIG. 1, a hip prosthesis member 11 is attached to a femur 12 of a patient. This buttock prosthesis member 11 comprises an upper ball portion 13 which is positioned in the acetabular prosthesis device 10 of the present invention. The acetabular prosthesis 10 comprises a cup or shell prosthesis body 14, preferably made of a metal member and having a plastic liner portion 15. The metal cup body 14 has a concave inner surface 16 and a convex outer surface 17. These faces 16 and 17 are provided with a space therebetween, thereby forming the thickness of the cup body or the shell 14. The cup body 14 comprises a three-dimensional surface treatment that is sintered to the outer surface 17 (like sintered metal beads). The surface 17 can be machined after sintering. Other types of roughened outer surfaces 17, such as plasma sprayed metal surfaces, plasma sprayed hydroxyl apatite surfaces, or machined textured or machined rough surfaces may be provided. The shell or cup body 14 may include an outer surface 17 optimized for use with bone cement. A plurality of openings 18, preferably in the form of elongated holes, extend between the concave inner surface 16 and the convex outer surface 17. These openings are in the form of holes with hole walls 19. These openings 18 may serve as a drill guide for the surgeon. Thus, once the metal cup body portion 14 of the acetabular cup prosthesis device 10 has been placed in place in the patient's acetabulum, as shown in FIG. 1, the surgeon may simply use any one of these multiple holes. Can be drilled through to form an opening in the underlying bony tissue, generally designated 20. When the surgeon positions cup body 14 in place as shown in FIG. 1, the plurality of holes 18 may act as a drill guide for the surgeon. The hole wall 19 of each opening 18 can be shaped to form a guide for a correspondingly shaped and sized drill. The opening 18 allows the surgeon to form a surgical opening in the underlying bony tissue 20. As shown in FIG. 1, the selected and surgically formed opening 18 is then closed with a peg, eg, one of the pegs 25-28 (not necessarily all openings 18). In the preferred embodiment, each peg 25-28 extends into the bony tissue at a position that forms a different angle with respect to the other pegs to secure cup 14. The pegs 25-28 may be polymeric, metallic or resorbable polymers. In FIG. 2, the cup body 14 is fixed by a plurality of bone set screws 30 to 33. Each bone set screw has a frustoconical portion 34, and when the threaded shank 36 of each bone set screw 30-33 is fully engaged with the underlying bony tissue 20, A wedge lock or taper lock connection is formed with the frustoconical opening or hole 35 in the cup body 14. The cup body 12 is preferably made of metal having an annular base portion 38 forming a flat surface (see FIG. 3). The concave surface 16 of the cup body 12 is a glossy and polished surface facing the convex surface 39 of the polymer liner 15. The roughness of the polished concave surface 16 is 16 micro inches or less, preferably 8 micro inches or less. Such a highly polished surface 16 is specular. The polished concave surface 16 reduces the production of polymer liner debris. The liner 15 has a concave inner surface 40 that receives the femoral ball portion 13 during use (see FIGS. 1 and 2). 4-7, a preferred embodiment 10 of the device of the present invention in the form of a glenoid prosthesis device is shown. The glenoid prosthesis device 10 includes an element 41 that can cooperate with a humeral element (not shown). The use of the glenoid component makes up the entire shoulder system part, for example the Smith and Nephew Richards publication entitled "Cofield Toal Shoulder System Surgical Technique" See US Pat. No. 5,108,396, incorporated herein by reference. The glenoid element 41 comprises a bone ingrowth surface 42 which is, for example, a plurality of metallic sintered beads 43. The bone ingrowth surface 42 is attached to the patient's bone tissue with bone cement and screws. This is, for example, as described in detail in Kyono Whole Shoulder System Surgical Techniques and US Pat. No. 5,108,396. Surface 44 is a mirror surface that receives an insert, such as polyethylene, that provides an articulating surface for articulating the humeral component. Thus, the mirror surface 44 is a non-articulating surface that engages the back or non-articulating surface of the polyethylene insert. The glenoid element can include a cylindrical hollow sleeve 46 that houses the shaft 45 and bone set screws. The annular shoulder 47 projects away from the mirror surface 44 and forms a structure that can hold the polyethylene insert during use. 8-11, a preferred embodiment 10 of the device of the present invention in the form of a tibial prosthesis device is shown. The tibial prosthesis device 10 comprises a tibial component 48 having a handle 49 that closes an opening surgically formed in the patient's tibia. The distal end of the tray 51, once surgically shaped to receive the tibial component 48, engages the patient's proximal tibia. The tibial element 48 has a mirror surface 50 that receives the polymeric insert 52 (see FIG. 11). The mirror surface 50 is provided on the near end side of the tray 51. During use, the polymeric insert 52 articulates with the femoral component 53. The femoral component 53 is attached to the patient's femur 54 (as shown in FIG. 11) and articulates against the polymeric insert 52 supported on the mirror surface 50. Surface 50 is the near end surface of tray 51. Thus, the mirror surface is the non-articulating surface that engages the back or distal surface of polymeric insert 52. The proximal surface of the polymeric insert 52 is the articulating surface that receives the polished metallic articulating surface of the femoral component 53. 12-15, there is shown a preferred embodiment 10 of the device of the present invention in the form of an asymmetric tibial prosthesis device. The prosthetic device 10 includes an asymmetric tibial component 56 having a bone engaging surface 57 that engages a surgically prepared surface of the proximal end of a patient's tibia. The surface opposite the bone engaging surface 57 is a proximal mirror surface 58 for receiving a polymeric insert (not shown). The peripheral shoulder 59 and the mirror surface 58 form a non-articulating surface that receives the polymeric insert, just as the polymeric insert 52 is retained in the tray 51 at the surface 50. The opening 60 allows the tibial component 56 to be attached to the patient's tibia, for example using a bone set screw. It should be understood that attaching polyethylene or polymeric inserts to tibial elements (such as tray 51) or asymmetric tibial elements (such as element 56) is a technique known per se. Such inserts are shown and described in the Smith and Nephew Richards publication entitled "Genesis Total Knee System Surgical Technique", published in 1992, Incorporated here by reference. However, the present invention provides an improvement featuring a specular portion in combination with the polymer insert described above as part of the overall prosthetic device 10. 16-19 show grid charts 200 and 205. The grids 16-19 are drawn, for example, on a blank sheet of paper and can be used to inspect for defects in the highly polished concave inner surface 16 of the acetabular cup body 14. In FIG. 16, the grating 200 is in the form of a plurality of concentric rings 201, 202, 203 ... When the flat grid 200 is placed on top of the cup body 14 to face the printing of the grid view 200 against the polished mirror-like concave surface 16, the user opens the inner surface 16 of the cup body 14 through the central opening 204. It can be visually inspected. In this way, the user visually recognizes the lines of the concentric rings 201 to 203 in the lattice diagram 200 as reflected from the mirror surface of the concave inner surface 16 of the cup body 14. FIG. 17 shows a generally square test grid 205. FIG. 18 shows a reflection pattern for the test grid 205, in which defects are not shown, as a pattern 206. FIG. 19 shows another test grid pattern reflection 207 with two local defects 208 and 209 marked. FIG. 16 illustrates an inspection method performed by a trained human inspector simply by looking through the central opening 204. If such a human inspection is to be performed, the inspector need only look through the opening 204 after placing the grids 200 and 205 against the concave side 16 of the acetabular cup body 14. Another inspection method is by image analysis. In image analysis, the reflected image is captured with a video camera, the image is digitized, and computer analysis is used to measure the amount of feature deviation from the surface shape tolerance. Thus, surface 16 forms a mirror that is used as a lens for viewing two-dimensional graphics such as grid graphics 200 and 205 drawn on white paper. Therefore, the distortion of the viewed image is the distortion of the lens surface 16, ie the distortion of the surface for which it is desired to measure. Table 1 below is a list of the numbers of the parts used in the text and drawings and the description of the corresponding parts. Various different embodiments are possible within the scope of the inventive concept taught herein, and many modifications are possible in the embodiments detailed herein in accordance with the explanatory requirements of law, and therefore It is to be understood that the details provided are illustrative and not limiting. What is claimed as the invention is the following.

────────────────────────────────────────────────── ─── Continuation of front page    (72) Inventor Share, Jeff             38120 Men, Tennessee, United States             Fiss, South Yatis 623

Claims (1)

[Claims] 1. a) a prosthesis having a first body surface and a second body surface for engaging a patient's joint. ,     b) with a polymeric liner that covers the inside of the second surface prosthesis during use ,   The liner has first and second surfaces, the second surface having a segmented joint prosthesis. Articulation table positioned to receive and articulate the articulation engagement member of the binding device A surface, the first surface of the liner being opposite the second surface from the second surface Forming a non-articulated surface positioned on the body surface of the prosthesis. Orthopedic joint prosthesis device having a curved surface. 2. The polished surface has a roughness of less than 8 microns inches. Orthopedic Joint Prosthesis Device. 3. The polished inner surface has a roughness of less than 4 microns inches. Is an orthopedic joint prosthesis device according to 2. 4. The polished inner surface has a roughness of between 1 and 4 microns inches. The orthopedic joint prosthesis device according to any one of 3 above. 5. The polishing according to any one of claims 1 to 4, wherein the polished surface is mirror-like. -Shaped surgical joint prosthesis device. 6. 6. A grid means for inspecting the polished inner surface for blemishes. Orthopedic Joint Prosthesis Device. 7. 7. The lattice means according to claim 6, wherein the lattice means is a lattice composed of a plurality of concentric rings. Orthopedic joint prosthesis device. 8. An alignment according to claim 6 or 7, wherein the surface mirror forms a lens for viewing the grating. -Shaped surgical joint prosthesis device. 9. 9. The polymeric liner of any of claims 1 to 8 composed of polyethylene. The joint prosthesis device for orthopedic surgery according to any one of the above. 10. 10. The prosthetic device is an acetabular cup body prosthetic device. Orthopedic joint prosthesis device according to item 6. 11. 10. The prosthesis device is a glenoid prosthesis device according to claim 1. Orthopedic Joint Prosthesis Device. 12. The glenoid prosthesis device includes a handle and a cylindrical hollow sleeve that houses a bone set screw. The orthopedic joint prosthesis device according to claim 11, further comprising a glenoid element constituted by: 13. The prosthesis device according to claim 1, which is a tibial prosthesis device. Orthopedic joint prosthesis device. 14． The tibial prosthesis device includes a handle to be embedded in the tibia and a handle attached to the handle. Comprised of a tibial element with a lay, said polished surface provided on said tray The orthopedic joint prosthesis device according to claim 13. 15. 15. The tibial prosthetic device is an asymmetric tibial prosthetic device. Orthopedic Joint Prosthesis Device. 16. Further comprising means for connecting the liner to the prosthesis, The non-articulating surface abuts and contacts the polished second body surface of the prosthesis. Described in any one of 15 Orthopedic joint prosthesis device. 17． The means project away from the mirror surface and retain the polymeric insert during use. The orthopedic surgical implant of claim 16, wherein the orthopedic shoulder comprises an annular shoulder forming a retaining structure. Joint prosthesis device. 18. The means engage complementary grooves in a polymeric liner or other surface The orthopedic surgery of claim 16, wherein the non-articulating engagement surface comprises a protrusion on the surface. Joint prosthesis device. 19. The means comprises a peripheral shoulder adjacent the polished surface. 16. The orthopedic joint prosthesis device according to 16.