WO2025169469A1 - Biological implant and surgical instrument - Google Patents
Biological implant and surgical instrumentInfo
- Publication number
- WO2025169469A1 WO2025169469A1 PCT/JP2024/004581 JP2024004581W WO2025169469A1 WO 2025169469 A1 WO2025169469 A1 WO 2025169469A1 JP 2024004581 W JP2024004581 W JP 2024004581W WO 2025169469 A1 WO2025169469 A1 WO 2025169469A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- liner
- acetabular cup
- shaft
- biological implant
- bearing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/34—Acetabular cups
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
Definitions
- This disclosure relates to biological implants and surgical instruments used in hip replacement surgery.
- Total hip replacement surgery in which the hip joint is replaced with an artificial joint.
- Total hip replacement surgery involves placing a cup (shell) in the pelvis and fitting a liner inside the cup.
- a stem is then inserted into the femur, and a femoral ball (head) that serves as the femoral head is attached to the tip of the stem.
- the femoral ball is then placed so that it slides within the liner, thereby recreating the ball-and-socket motion of the hip joint.
- a bearing is placed between the femoral head ball and the liner, and the bearing slides on the inner surface of the liner, while the femoral head ball slides on the inner surface of the bearing, thereby widening the range of motion in ball movement (Patent Document 1).
- the biological implant comprises an acetabular cup and a liner positioned inside the acetabular cup, the liner having an outer surface that contacts the acetabular cup, the liner being positioned on the periphery of the outer surface and having a first tapered surface that contacts the periphery of the inner surface of the acetabular cup, the first tapered surface having a protrusion.
- FIG. 1A and 1B are schematic diagrams illustrating an example of a method for attaching a biological implant according to a first embodiment of the present disclosure.
- FIG. 2 is an exploded perspective view showing an example of the biological implant shown in FIG. 1.
- 2A and 2B are perspective and cross-sectional views showing an example of the acetabular cup shown in FIG. 1 .
- 2A and 2B are a perspective view and a cross-sectional view showing an example of the liner shown in FIG. 1 .
- 2A and 2B are a perspective view and a cross-sectional view showing an example of the bearing shown in FIG. 1 .
- 2A and 2B are a perspective view and a cross-sectional view showing an example of the femoral head ball shown in FIG. 1 .
- FIG. 1 is an exploded perspective view showing an example of the biological implant shown in FIG. 1.
- 2A and 2B are perspective and cross-sectional views showing an example of the acetabular cup shown in FIG. 1 .
- FIG. 2 is a cross-sectional view showing a state in which the components of the biological implant shown in FIG. 1 are assembled together.
- FIG. 2 is a schematic diagram illustrating the range of motion of the biological implant shown in FIG. 1 .
- 2 is a schematic diagram illustrating protrusions formed on the liner shown in FIG. 1 .
- FIG. 2 is a schematic diagram illustrating a tapered fit between the liner and the acetabular cup shown in FIG. 1 .
- FIG. FIG. 2 is a schematic diagram illustrating the thickness of the liner shown in FIG. 1 .
- FIG. 10 is a front view showing an example of a surgical instrument according to a second embodiment of the present disclosure.
- FIG. 13 is a perspective view of the surgical instrument shown in FIG. 12.
- FIG. 13 is a schematic diagram illustrating a ratchet structure of the surgical instrument shown in FIG. 12 .
- Fig. 1 is a schematic diagram illustrating an example of a method for attaching the biological implant 1 according to the first embodiment of the present disclosure.
- the hip joint 91 is composed of a ball-shaped femoral head (not shown) at the tip of the femur 92 and a dome-shaped recessed acetabulum 94 on the side of the pelvis 93. If the hip joint 91 is damaged due to illness or fracture, total hip joint replacement surgery is performed to replace the damaged hip joint 91 with an artificial hip joint.
- the bioimplant 1 according to embodiment 1 of the present disclosure can be used as an artificial hip joint in total hip replacement surgery.
- the bioimplant 1 is composed of a combination of an acetabular cup 2, a liner 3, a bearing 4, and a femoral head ball 5.
- the acetabulum 94 on the pelvis 93 side is thinned and the acetabular cup 2 is attached.
- the liner 3 is fitted into the acetabular cup 2.
- a stem 90 is inserted into the femur 92 from which the femoral head has been removed, and a femoral head ball 5 fitted into a bearing 4 is attached to the tip 901 of the stem 90.
- the stem 90 may also be inserted into the femur 92 with the femoral head ball 5 attached to the tip 901 of the stem 90, and the femoral head ball 5 fitted into the bearing 4.
- Fig. 2 is an exploded perspective view showing an example of the bioimplant 1.
- the bioimplant 1 is composed of an acetabular cup 2, a liner 3, a bearing 4, and a femoral head ball 5 in combination.
- the biological implant 1 has a so-called dual mobility (double sliding) structure.
- double sliding motion of the biological implant 1 can widen the range of motion of the biological implant 1.
- Figure 3 shows perspective views of an example of an acetabular cup 2.
- the views indicated by reference numerals 300A and 300B are perspective views of the acetabular cup 2
- the view indicated by reference numeral 300C is a cross-sectional view of the acetabular cup 2 taken along line III-III shown in 300A.
- C2 indicates the central axis of the acetabular cup 2 in the fitting direction.
- the acetabular cup 2 has an outer surface 21, an inner surface 22, a storage space 23, and an insertion hole 24.
- the acetabular cup 2 has a dome-like (roughly hemispherical bowl-like) shape.
- “roughly hemispherical” not only refers to a geometric hemispherical shape, but also includes a shape in which part of the hemisphere is missing, or a shape having an area protruding from part of the hemisphere.
- a second tapered surface 221 is located around the entire circumferential direction near the peripheral edge 222 of the inner surface 22.
- the second tapered surface 221 is shaped so that the diameter of the inner surface 22 increases toward the peripheral edge 222.
- the accommodation space 23 is a space for fitting the liner 3.
- the accommodation space 23 is located inside the acetabular cup 2.
- the diameter of the accommodation space 23 is slightly larger than the diameter of the liner 3. This allows the liner 3 to be fitted into the accommodation space 23 of the acetabular cup 2, and the liner 3 is fixed to the acetabular cup 2.
- the insertion hole 24 is located at the top of the acetabular cup 2.
- the protrusion 34 of the liner 3, which will be described later, is inserted into the insertion hole 24.
- Figure 4 shows perspective views of an example of a liner 3.
- the view indicated by reference numeral 400A is a perspective view of the liner 3
- the view indicated by reference numeral 400B is a front view
- the view indicated by reference numeral 400C is a cross-sectional view taken along line IV-IV shown in 400A.
- C3 indicates the central axis of the liner 3 in the mating direction.
- the liner 3 has an outer surface 31, an inner surface 32, a storage space 33, and a protrusion 34.
- the liner 3 has a dome-like (approximately hemispherical bowl-like) shape.
- a first tapered surface 311 is located around the entire circumferential direction near the peripheral edge 312 of the outer surface 31.
- the diameter of the first tapered surface 311 increases as it approaches the peripheral edge 312.
- the protrusion 34 is inserted into the insertion hole 24 of the acetabular cup 2.
- the liner 3 can be easily aligned when inserted into the acetabular cup 2.
- the liner 3 does not necessarily have to have the protrusion 34.
- the accommodation space 33 is a space for fitting the bearing 4.
- the accommodation space 33 is located inside the liner 3.
- the diameter of the accommodation space 33 is slightly larger than the diameter of the bearing 4. This allows the bearing 4 to be fitted into the accommodation space 33 of the liner 3.
- the bearing 4 fitted into the accommodation space 33 is held in the liner 3 so that the outer surface 41 of the bearing 4 and the inner surface 32 of the liner 3 slide against each other.
- Figure 5 shows perspective views of an example of a bearing 4.
- the view indicated by reference numeral 500A is a perspective view of the bearing 4, the view indicated by reference numeral 500B is a front view, and the view indicated by reference numeral 500C is a cross-sectional view taken along the line V-V shown in 500A.
- C4 indicates the central axis of the bearing 4 in the fitting direction.
- the bearing 4 has an outer surface 41, an inner surface 42, a storage space 43, and an opening 44.
- the bearing 4 is made of a resin such as polyethylene.
- the accommodation space 43 is a space for fitting the femoral head ball 5 and is formed inside the bearing 4.
- the diameter of the accommodation space 43 is formed to be slightly larger than the diameter of the femoral head ball 5. This allows the femoral head ball 5 to be fitted into the accommodation space 43 of the bearing 4.
- the bearing 4 accommodates the femoral head ball 5 within the accommodation space 43 so as to cover most of the outer surface 51 of the femoral head ball 5.
- the femoral head ball 5 is fitted into the accommodation space 43 with the inner surface 42 of the bearing 4 and the outer surface 51 of the femoral head ball 5 slidable against each other.
- the outer surface 41 of the bearing 4 slides against the inner surface 32 of the liner 3, and the inner surface 42 slides against the outer surface 51 of the femoral head ball 5.
- the opening 44 has a diameter smaller than the diameter of the femoral head ball 5.
- Figure 6 shows perspective views of an example of a femoral head ball 5.
- the view indicated by the reference numeral 600A is a perspective view of the femoral head ball 5
- the view indicated by the reference numeral 600B is a front view
- the view indicated by the reference numeral 600C is a cross-sectional view taken along the line VI-VI shown in 600A.
- C5 indicates the central axis of the femoral head ball 5 in the mating direction.
- the femoral head ball 5 has an outer surface 51 and a recess 53.
- the femoral head ball 5 is fixed to the stem 90 by inserting the tip 901 of the stem 90 into the recess 53. Furthermore, when attaching the femoral head ball 5 to the fitting instrument 6 (surgical instrument) described below, the femoral head ball support portion 71 of the fitting instrument 6 is inserted into the recess 53.
- Fig. 7 is a cross-sectional view showing the assembled state of the components of the biological implant 1.
- Fig. 8 is a schematic diagram illustrating the range of motion of the biological implant 1.
- a liner 3 is placed inside the acetabular cup 2, and a bearing 4 is placed inside the liner 3.
- the inner surface 32 of the liner 3 and the outer surface 41 of the bearing 4 are in slidable contact with each other.
- a femoral head ball 5 is housed inside the bearing 4, and the inner surface 42 of the bearing 4 and the outer surface 51 of the femoral head ball 5 are in slidable contact with each other.
- the liner 3 may have a protrusion 313 arranged on the first tapered surface 311.
- Figure 9 is a schematic diagram illustrating the protrusion 313 formed on the liner 3. As shown in Figure 9, the protrusion 313 is provided on the outer surface 31 of the liner 3, facing the inner surface 22 of the acetabular cup 2. The tip of the protrusion 313 has an acute angle. The protrusion 313 catches on the inner surface 22 of the acetabular cup 2, strengthening the fit between the acetabular cup 2 and the liner 3.
- the protrusions 313 may be formed by arranging grooves in the first tapered surface 311. By forming grooves, the space between the grooves can become the protrusions 313.
- the grooves may be arranged in a direction different from the line connecting any point on the edge of the liner 3 and the apex of the liner 3, i.e., the protrusion 34 (see Figure 4). This allows the protrusions 313 to be arranged in a direction different from the mating direction between the acetabular cup 2 and the liner 3, thereby strengthening the fit between the acetabular cup 2 and the liner 3.
- the grooves may be arranged approximately parallel to the edge of the liner 3.
- the protrusion 313 may be shaped to protrude from the first tapered surface 311.
- the protrusion 313 may be shaped to protrude from the first tapered surface 311 toward the acetabular cup 2.
- the protrusion 313 may protrude in a direction different from a line connecting any point on the edge of the liner 3 and the apex of the liner 3.
- the protrusion 313 may have an obtuse tip.
- the cross section of the protrusion 313 may be triangular, rectangular, or trapezoidal.
- the protrusion 313 may have a rounded tip.
- the protrusion 313 may be located on only a portion of the first tapered surface 311.
- the protrusion 313 may be located around the entire circumference of the liner 3.
- the protrusions 313 may be located around the entire circumference of the liner 3, and the tips of the protrusions 313 may be annular in shape.
- the protrusions 313 may be located around the entire circumference of the liner 3, and the tips of the protrusions 313 may be spiral in shape.
- the liner 3 has a first tapered surface 311 arranged on the peripheral edge 312 of the surface 31.
- the first tapered surface 311 fits into the inner surface 22 of the acetabular cup 2, thereby fitting the acetabular cup 2 and the liner 3 together.
- a second tapered surface 221 may be arranged on the inner surface 22 of the acetabular cup 2, and the first tapered surface 311 of the liner 3 may fit into the second tapered surface 221 of the acetabular cup 2.
- the first tapered surface 311 may have a biting portion 314 that bites into the second tapered surface 221.
- the biting portion 314 may be formed by bending the first tapered surface 311 inward at an angle L toward the edge, i.e., toward the center of the circle formed by the edge of the liner 3.
- the biting portion 314 may be realized by an edge provided by providing a surface on the first tapered surface 311 whose angle with the mating direction is smaller than the angle of the second tapered surface 221 in a cross section cut along a plane parallel to the mating direction between the acetabular cup 2 and the liner 3.
- the tip of the biting portion 314 may be either an obtuse angle or an acute angle.
- the tip of the biting portion 314 When the tip of the biting portion 314 is an acute angle, it bites more firmly into the second tapered surface 221. When the tip of the biting portion 314 is an obtuse angle, the risk of the tip of the liner 3 chipping the inner surface of the acetabular cup 2 is reduced.
- the biting portion 314 bites into the inner surface of the acetabular cup 2. This strengthens the fit between the acetabular cup 2 and the liner 3.
- ⁇ Liner thickness> 11 is a schematic diagram illustrating the thickness of the liner 3.
- a straight line that passes through the center P0 of the ring formed by the peripheral edge portion 312 of the liner 3 and is parallel to the fitting direction of the acetabular cup 2 and the liner 3 is defined as a central axis C3.
- the outer shape of the liner 3 has a shape that includes arcs centered on points on the first side and the second side that are approximately symmetrical with respect to the central axis C3, i.e., point P1 on the first side and point P2 on the second side.
- the arcs do not necessarily refer only to geometric arcs, but also allow for deviations from the geometric arcs due to manufacturing errors, etc.
- the liner 3 has a region where the thickness W1 of the liner 3 in a cross section including the central axis C3 is greater than when the outer shape is formed by an arc centered at P0 on the central axis C3.
- the liner 3 has a region where the thickness W1 increases from the peripheral edge 312 side toward the convex portion 34 side.
- the outer diameter of the liner 3 can be made larger compared to when the center of the outer diameter is located on the central axis C3. Therefore, if the inner diameter of the liner 3 remains the same as before, the thickness of the liner 3 can be increased, and the strength of the liner 3 can be increased. Furthermore, if the inner diameter of the liner 3 is made larger than before, it becomes possible to place a larger bearing 4 inside the liner 3 than before.
- the bearing 4 has a hollow shape with an opening 44, and the femoral head ball 5 is accommodated in the accommodation space 43, allowing the femoral head ball 5 to slide on the inner surface 42 of the bearing 4. Because the diameter of the opening 44 of the bearing 4 is smaller than the diameter of the femoral head ball 5, a strong pushing force is required to accommodate the femoral head ball 5 in the accommodation space 43 of the bearing 4, and a dedicated tool is used. However, depending on the structure of the tool, the pushing part may be pushed back, making it impossible to accommodate the femoral head ball 5 in the accommodation space 43 of the bearing 4.
- the fitting instrument 6 (surgical instrument) according to embodiment 2 of the present disclosure has a ratchet structure.
- the ratchet structure can restrict the movement direction of the pushing portion 64 only to the direction in which the femoral head ball 5 is accommodated in the bearing 4 (the Y1 direction, first direction, described below). This prevents the pushing portion 64 from being pushed back, allowing the femoral head ball 5 to be accommodated efficiently. Restricting the movement direction of the pushing portion 64 only to the first direction means that a strong force is applied against movement in the direction opposite to the first direction.
- Figure 12 is a front view showing an example of a fitting device 6, and Figure 13 is a perspective view.
- Figure 12 shows the bearing 4 and femoral head ball 5 attached to the fitting device 6 in phantom lines.
- the fitting device 6 includes a main body 61, a shaft 63, a pushing portion 64, an operating portion 65, a fitting portion 66, and a stopper 67.
- the main body 61 includes a femoral head ball support 62 (support portion) that secures the femoral head ball 5.
- the femoral head ball support 62 has a base 621 and an insertion portion 622 that extends from the base 621. As described above, the femoral head ball 5 can be secured to the fitting device 6 by inserting the insertion portion 622 into the recess 53 of the femoral head ball 5.
- the shaft 63 is attached to the main body 61 so as to be movable in the axial direction by being inserted into an insertion hole 611 formed in the main body 61.
- the shaft 63 has multiple grooves 633 formed in the axial direction.
- a push-in portion 64 is attached to the first end 631 (first end) of the shaft 63, and a handle portion 68 is attached to the second end 632 (second end).
- the push-in portion 64 includes a cup-shaped bearing mounting portion 641.
- the bearing mounting portion 641 allows the bearing 4 to be mounted with the opening 44 of the bearing 4 facing downward (first direction).
- the bearing mounting portion 641 can be used for alignment when pressing the bearing 4 toward the femoral head ball 5, reducing the possibility of misalignment between the bearing 4 and the femoral head ball 5.
- the push-in portion 64 does not necessarily have to include the bearing mounting portion 641.
- the bearing mounting portion 641 is positioned to face the femoral head ball support portion 62.
- the shaft portion 63 By moving the shaft portion 63 in the axial direction and in a direction approaching the femoral head ball support portion 62 (Y1 direction, first direction), the femoral head ball 5 can be pushed into the bearing 4's accommodation space 43 through the bearing 4's opening 44.
- the operating unit 65 is a handle-shaped member used to operate the fitting device 6, and includes an operating handle 651 and a fixed handle 652.
- the operating handle 651 is fixed to the main body 61 so that it can rotate around a fixed part 6511.
- the user can move the shaft 63 in the Y1 direction by grasping the operating handle 651 and the fixed handle 652 and rotating the operating handle 651 in a direction approaching the fixed handle 652 (R1 direction).
- the operating handle 651 is biased in a direction (R2 direction) away from the fixed handle 652 by a biasing member such as a spring (not shown), and is configured so that when the user loosens their grip, it rotates in the R2 direction and returns to the position it was in before the user gripped it.
- a biasing member such as a spring
- the fitting portion 66 has a fitting claw 661 that fits into one of the grooves 633 formed in the shaft portion 63, and is fixed to the operating handle 651 by a fixing portion 662. As the operating handle 651 rotates, the fitting portion 66 moves parallel to the Y1 direction while rotating around the fixing portion 662. As will be described in more detail below, the rotational movement of the fitting portion 66 causes the fitting claw 661 to press the first surface 634a of the groove portion 633 in the Y1 direction, allowing the shaft portion 63 to move in the Y1 direction.
- the stopper 67 has a locking claw 671 that fits into one of the grooves 633 formed in the shaft 63, and is fixed to the main body 61 so as to be rotatable around a fixed portion 672.
- the stopper 67 is biased toward the shaft 63 by a spring 673.
- the locking claw 671 fits into the groove 633, preventing the shaft 63 from being pushed back in the direction opposite the Y1 direction (Y2 direction).
- the ratchet structure of the fitting device 6 is mainly composed of a stopper 67 and a fitting portion 66. Details of the stopper 67 and the fitting portion 66 will be described later.
- the handle portion 68 is attached to the second end portion 632 of the shaft portion 63. By turning the handle portion 68, the user can rotate the shaft portion 63 around its axis.
- the groove 633 is not formed around the entire circumference of the shaft 63, but only on a portion of the circumference.
- the groove 633 is formed only in the portion facing the main body 61. Therefore, by turning the handle 68, the user can position the groove 633 on the side opposite the side facing the main body 61. This allows the engagement of the engagement claw 661 and the locking claw 671 that are engaged with the groove 633 to be released.
- ⁇ Ratchet structure> 14 is a schematic diagram illustrating the ratchet structure of the fitting device 6. As shown in FIG. 14, the groove portion 633 functions as a ratchet tooth 634 and has a first surface 634a perpendicular to the shaft portion 63 and a second surface 634b oblique to the shaft portion 63.
- the mating portion 66 is provided with a mating pawl 661 that meshes with one of the ratchet teeth 634.
- the stopper 67 is provided with a locking pawl 671 that is biased toward the ratchet teeth 634 by a spring 673 and meshes with the other ratchet tooth 634.
- the fitting portion 66 fixed to the operating handle 651 rotates in the R1 direction around the fixed portion 6511 in conjunction with the rotation of the operating handle 651.
- the fitting pawl 661 presses the first surface 634a in the Y1 direction, moving the shaft portion 63 in the Y1 direction.
- the fitting portion 66 is biased by a biasing member in a direction diagonally away from the shaft portion 63, on the Y2 side of the fixed portion 662.
- the operating handle 651 is biased in the R2 direction
- the fitting claw 661 is biased in the X1 direction
- the entire fitting portion 66 is biased in the Y2 direction.
- the fitting claw 661 slides along the second surface 634b, causing the fitting portion 66 to move in the Y2 direction. Therefore, when the user loosens the operating handle 651, the fitting portion 66 moves in the Y2 direction and returns to its original position.
- the locking claw 671 of the stopper 67 locks the first surface 633a of the ratchet tooth 634 that meshes with the locking claw 671, preventing the shaft 63 from being pushed back and moving in the Y2 direction.
- the shaft 63 By operating the operating handle 651 again, the shaft 63 can be moved further in the Y1 direction. By repeating this operation, the shaft 63 can be moved in the Y1 direction by the desired length.
- a biological implant includes an acetabular cup and a liner positioned inside the acetabular cup, the liner having an outer surface that contacts the acetabular cup, the liner having a first tapered surface positioned on the periphery of the outer surface and contacting the periphery of the inner surface of the acetabular cup, the first tapered surface having a protrusion.
- the protrusion on the first tapered surface can increase the strength of the fit compared to when no protrusion is provided. Therefore, the strength of the fit between the acetabular cup and the liner can be increased.
- a biological implant according to aspect 2 of the present disclosure is the same as aspect 1, except that it includes a bearing having an outer surface that can slide against the inner surface of the liner. By including the bearing, sliding can be achieved between the outer surface of the bearing and the liner, thereby achieving double sliding, including sliding on the inner surface of the bearing.
- the biological implant according to aspect 3 of the present disclosure is the same as that of aspect 1 or 2, except that it includes a femoral head ball that is slidable against the inner surface of the bearing. By including a femoral head ball, sliding can be achieved between the bearing and the femoral head ball.
- the bioimplant according to aspect 4 of the present disclosure is the same as the bioimplant according to aspect 3, except that it includes a stem that is inserted into the femoral head ball. By including the stem, the bioimplant can be properly inserted into the femur.
- a biological implant according to aspect 5 of the present disclosure is any of aspects 1 to 4, wherein the protrusion is formed by arranging a groove on the first tapered surface, and the groove is arranged in a direction different from a line connecting any point on the edge of the liner to the zenith.
- the line connecting any point on the edge of the liner to the zenith is parallel to the mating direction between the acetabular cup and the liner. Therefore, with the above configuration, the groove is arranged in a direction different from the mating direction between the acetabular cup and the liner, and the protrusion formed by the groove is also arranged in a direction different from the mating direction between the acetabular cup and the liner. This increases the strength of the fit between the acetabular cup and the liner.
- the groove may be arranged approximately parallel to the edge of the liner.
- a biological implant according to aspect 6 of the present disclosure is any one of aspects 1 to 4, wherein the protrusion has a shape that protrudes from the first tapered surface toward the acetabular cup, and the protrusion protrudes in a direction different from a line connecting any point on the edge of the liner to the zenith apex. This increases the strength of the fit between the acetabular cup and the liner.
- a biological implant according to aspect 7 of the present disclosure is any one of aspects 1 to 6, wherein the acetabular cup has a second tapered surface on the periphery of its inner surface, and the first tapered surface and the second tapered surface fit together.
- tapered surfaces are provided on both the acetabular cup and the liner, making it easy to fit the acetabular cup and the liner together.
- a biological implant according to aspect 8 of the present disclosure is any of aspects 1 to 7, wherein the liner has a biting portion located on the peripheral side of the first tapered surface that bites into the second tapered surface.
- the biting portion increases the resistance force against the liner being removed from the acetabular cup, thereby increasing the strength of the fit between the acetabular cup and the liner.
- the biting portion may be realized by an edge provided by arranging a surface on the first tapered surface that forms an angle with the fit direction smaller than the angle of the second tapered surface in a cross section taken along a plane parallel to the fit direction between the acetabular cup and the liner.
- a biological implant according to aspect 9 of the present disclosure is any of aspects 1 to 8, wherein when a straight line passing through the center of the ring formed by the periphery of the liner and parallel to the direction of engagement between the acetabular cup and the liner is taken as the central axis, the liner has a region with a greater thickness in a cross section including the central axis than when the center of the outer shape is set at the central axis.
- This configuration allows the wall thickness of the liner to be increased, thereby increasing the strength of the liner.
- by making the inner diameter of the liner larger than conventional it becomes possible to place a larger bearing inside the liner than conventional.
- a biological implant according to aspect 10 of the present disclosure is any of aspects 1 to 9 described above, wherein a central axis is a straight line passing through the center of the periphery of the liner and parallel to the mating direction between the acetabular cup and the liner, and when a cross section is taken along a plane passing through the central axis and parallel to the mating direction, with one side of the central axis designated as a first side and the other side designated as a second side, the outer shape of the liner, on each of the first side and the second side, has a shape that includes an arc with its center at a point located approximately symmetrically with respect to the central axis.
- the outer shape of the liner can be made larger than when the center of the outer shape is located on the central axis. Therefore, if the inner diameter of the liner is the same as in conventional liner designs, the thickness of the liner can be increased, thereby increasing the strength of the liner. Furthermore, by making the inner diameter of the liner larger than in conventional liner designs, it is possible to place larger bearings inside the liner than in conventional liner designs.
- a biological implant according to aspect 11 of the present disclosure is any of aspects 1 to 10, wherein when a central axis is a straight line passing through the center of a ring formed by the periphery of the liner and parallel to the direction in which the acetabular cup and the liner are fitted together, the liner has a region in which the cross section including the central axis increases in size from the periphery of the liner toward the apex of the liner. This configuration allows the outer shape of the liner to be increased.
- a surgical instrument comprises a main body having a support portion that supports a femoral head ball; a pusher portion that pushes the bearing into a hollow bearing having an opening to accommodate the femoral head ball; a shaft portion that connects to the pusher portion at a first end; and an operating portion that connects to the side of the shaft portion and moves the shaft portion in the axial direction relative to the main body portion, and the connection between the shaft portion and the operating portion is structured so that the operating portion can move the shaft portion in the axial direction only in a first direction, which is the direction of the first end.
- a surgical instrument according to aspect 13 of the present disclosure is the same as aspect 12, except that the connection between the shaft and the operating unit is a ratchet structure that allows the operating unit to move the shaft in the axial direction only in a first direction, which is the first end direction.
- a ratchet structure can be used to achieve a structure in which the operating unit can move the shaft in the axial direction only in the first direction.
- a surgical instrument is the same as aspect 12 or 13, except that the side of the shaft has a plurality of grooves arranged side by side in the axial direction, the grooves being formed by a first surface perpendicular to the shaft and a second surface oblique to the shaft; the operating unit has a fitting portion that fits into one of the plurality of grooves, and moves the shaft in the axial direction by biasing the fitting portion in the axial direction, with the first surface being arranged closer to the first direction than the second surface.
- This configuration makes it possible to realize a structure in which the operating unit can move the shaft only in the first direction.
- a surgical instrument according to aspect 15 of the present disclosure is any one of aspects 12 to 14, in which the main body has a stopper that is biased against the shaft by an elastic body and fits into the groove. This configuration prevents the shaft from being pushed back in the direction opposite the first direction when no operation is being performed by the operating unit.
- a surgical instrument according to aspect 16 of the present disclosure is any of aspects 12 to 15, and has a handle portion at a second end of the shank opposite the first end, the handle portion having a diameter larger than the diameter of the shank.
- This configuration allows the shank to be easily rotated about its axis.
- the groove in the shank is arranged along a portion of the circumference of the shank, so that by rotating the shank about its axis, the engagement between the operating portion and the groove in the shank, and the engagement between the stopper and the groove in the shank, can be released.
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Abstract
Description
本開示は、股関節置換術に用いられる生体インプラントおよび手術器具に関する。 This disclosure relates to biological implants and surgical instruments used in hip replacement surgery.
股関節を人工関節に置換する人工股関節置換術が知られている。人工股関節置換術は、骨盤にカップ(シェル)を設置して、カップ内面にライナーを嵌め込むとともに、大腿骨にステムを挿入し、骨頭の代わりとなる骨頭ボール(ヘッド)をステムの先端に取り付け、ライナー内で骨頭ボールが摺動するように設置することにより、股関節の球運動を再現するものである。 Total hip replacement surgery is known, in which the hip joint is replaced with an artificial joint. Total hip replacement surgery involves placing a cup (shell) in the pelvis and fitting a liner inside the cup. A stem is then inserted into the femur, and a femoral ball (head) that serves as the femoral head is attached to the tip of the stem. The femoral ball is then placed so that it slides within the liner, thereby recreating the ball-and-socket motion of the hip joint.
また、デュアルモビリティシステムと呼ばれる、球運動の可動域が従来よりも広い人工関節も知られている。デュアルモビリティシステムでは、骨頭ボールとライナーとの間にベアリングを設置し、ライナーの内面でベアリングが摺動するとともに、ベアリングの内面で骨頭ボールが摺動する構造とすることで、球運動の可動域を広げている(特許文献1)。 Also known is an artificial joint called a dual mobility system, which allows for a wider range of motion in ball movement than conventional systems. In a dual mobility system, a bearing is placed between the femoral head ball and the liner, and the bearing slides on the inner surface of the liner, while the femoral head ball slides on the inner surface of the bearing, thereby widening the range of motion in ball movement (Patent Document 1).
本開示の一態様における生体インプラントは、寛骨臼カップと、前記寛骨臼カップと接する外面を有し、前記寛骨臼カップの内側に位置するライナーと、を備え、前記ライナーは、前記外面の周縁部に位置し、前記寛骨臼カップの内面の周縁部と接する第1テーパ面を有し、前記第1テーパ面は、突部を有する。 In one aspect of the present disclosure, the biological implant comprises an acetabular cup and a liner positioned inside the acetabular cup, the liner having an outer surface that contacts the acetabular cup, the liner being positioned on the periphery of the outer surface and having a first tapered surface that contacts the periphery of the inner surface of the acetabular cup, the first tapered surface having a protrusion.
〔実施形態1〕
<概要>
始めに、生体インプラント1についての理解を容易にするために、人工股関節置換術の工程の概要について、図1を参照して簡単に説明する。図1は、本開示の実施形態1に係る生体インプラント1の取付方法の一例を説明する模式図である。
[Embodiment 1]
<Overview>
First, to facilitate understanding of the biological implant 1, an outline of the steps of total hip replacement surgery will be briefly described with reference to Fig. 1. Fig. 1 is a schematic diagram illustrating an example of a method for attaching the biological implant 1 according to the first embodiment of the present disclosure.
図1に示すように、股関節91は、大腿骨92の先端にあるボール状の大腿骨骨頭(不図示)と、骨盤93側のドーム状に窪んだ寛骨臼94との組み合わせにより構成される。病気または骨折などにより股関節91を損傷した場合、損傷した股関節91を人工股関節に置換する人工股関節置換術が行われている。 As shown in Figure 1, the hip joint 91 is composed of a ball-shaped femoral head (not shown) at the tip of the femur 92 and a dome-shaped recessed acetabulum 94 on the side of the pelvis 93. If the hip joint 91 is damaged due to illness or fracture, total hip joint replacement surgery is performed to replace the damaged hip joint 91 with an artificial hip joint.
本開示の実施形態1に係る生体インプラント1は、人工股関節置換術において人工股関節として使用することができる。生体インプラント1は、寛骨臼カップ2、ライナー3、ベアリング4、および骨頭ボール5の組合せにより構成される。 The bioimplant 1 according to embodiment 1 of the present disclosure can be used as an artificial hip joint in total hip replacement surgery. The bioimplant 1 is composed of a combination of an acetabular cup 2, a liner 3, a bearing 4, and a femoral head ball 5.
人工股関節置換術では、まず骨盤93側において、寛骨臼94を薄く削り、寛骨臼カップ2を装着する。次に、寛骨臼カップ2へライナー3を嵌め込む。一方、大腿骨92側において、大腿骨骨頭を削り取った大腿骨92内にステム90を挿入し、ステム90の先端901に、ベアリング4に嵌め込まれた骨頭ボール5を取付ける。ステム90の先端901に骨頭ボール5を取り付けた状態で大腿骨92内にステム90を挿入し、骨頭ボール5をベアリング4に嵌め込んでもよい。骨盤93側のライナー3と、大腿骨92側のベアリング4とを係合させることにより、人工股関節として機能する。 In total hip replacement surgery, first, the acetabulum 94 on the pelvis 93 side is thinned and the acetabular cup 2 is attached. Next, the liner 3 is fitted into the acetabular cup 2. Meanwhile, on the femur 92 side, a stem 90 is inserted into the femur 92 from which the femoral head has been removed, and a femoral head ball 5 fitted into a bearing 4 is attached to the tip 901 of the stem 90. The stem 90 may also be inserted into the femur 92 with the femoral head ball 5 attached to the tip 901 of the stem 90, and the femoral head ball 5 fitted into the bearing 4. By engaging the liner 3 on the pelvis 93 side with the bearing 4 on the femur 92 side, it functions as an artificial hip joint.
<生体インプラント1の構成>
図2は、生体インプラント1の一例を示す分解斜視図である。図2に示すように、生体インプラント1は、寛骨臼カップ2、ライナー3、ベアリング4、および骨頭ボール5の組合わせにより構成される。
<Configuration of biological implant 1>
Fig. 2 is an exploded perspective view showing an example of the bioimplant 1. As shown in Fig. 2, the bioimplant 1 is composed of an acetabular cup 2, a liner 3, a bearing 4, and a femoral head ball 5 in combination.
生体インプラント1は、いわゆるデュアルモビリティ(二重摺動)構造を備える。ライナー3と骨頭ボール5との間に配置されるベアリング4は、外面41がライナー3の内面32と摺動し、内面42が骨頭ボール5の外面51と摺動する。このように、生体インプラント1を二重に摺動させることによって、生体インプラント1の可動域を広くすることができる。 The biological implant 1 has a so-called dual mobility (double sliding) structure. The outer surface 41 of the bearing 4, which is placed between the liner 3 and the femoral head ball 5, slides against the inner surface 32 of the liner 3, and the inner surface 42 slides against the outer surface 51 of the femoral head ball 5. In this way, the double sliding motion of the biological implant 1 can widen the range of motion of the biological implant 1.
図3は、寛骨臼カップ2の一例を示す斜視図等である。符号300Aで示す図および符号300Bで示す図は、寛骨臼カップ2の斜視図であり、符号300Cで示す図は、寛骨臼カップ2を、300Aに示すIII-IIIで切ったときの断面図である。C2は、寛骨臼カップ2の嵌合方向における中心軸を示す。 Figure 3 shows perspective views of an example of an acetabular cup 2. The views indicated by reference numerals 300A and 300B are perspective views of the acetabular cup 2, and the view indicated by reference numeral 300C is a cross-sectional view of the acetabular cup 2 taken along line III-III shown in 300A. C2 indicates the central axis of the acetabular cup 2 in the fitting direction.
図2および図3に示すように、寛骨臼カップ2は、外面21、内面22、収容空間23、および挿入孔24を備える。寛骨臼カップ2は、ドーム状(略半球形の椀状)の形状を有する。ここで、略半球形とは、幾何学的な半球形状のみならず、半球の一部が欠けている形状、または、半球の一部から突出する領域を有する形状などを含むものとする。 As shown in Figures 2 and 3, the acetabular cup 2 has an outer surface 21, an inner surface 22, a storage space 23, and an insertion hole 24. The acetabular cup 2 has a dome-like (roughly hemispherical bowl-like) shape. Here, "roughly hemispherical" not only refers to a geometric hemispherical shape, but also includes a shape in which part of the hemisphere is missing, or a shape having an area protruding from part of the hemisphere.
内面22の周縁部222付近には、第2テーパ面221が周方向全周に亘って位置する。第2テーパ面221は、周縁部222に向かうにつれ内面22の径が大きくなるような形状である。 A second tapered surface 221 is located around the entire circumferential direction near the peripheral edge 222 of the inner surface 22. The second tapered surface 221 is shaped so that the diameter of the inner surface 22 increases toward the peripheral edge 222.
収容空間23は、ライナー3を嵌め込むための空間である。収容空間23は、寛骨臼カップ2の内部に位置する。収容空間23の直径は、ライナー3の直径よりわずかに大きい。これにより、寛骨臼カップ2の収容空間23内にライナー3を嵌め込むことができ、ライナー3は寛骨臼カップ2に固定される。 The accommodation space 23 is a space for fitting the liner 3. The accommodation space 23 is located inside the acetabular cup 2. The diameter of the accommodation space 23 is slightly larger than the diameter of the liner 3. This allows the liner 3 to be fitted into the accommodation space 23 of the acetabular cup 2, and the liner 3 is fixed to the acetabular cup 2.
挿入孔24は、寛骨臼カップ2の頂部に位置する。挿入孔24には、後述するライナー3の突出部34が挿入される。 The insertion hole 24 is located at the top of the acetabular cup 2. The protrusion 34 of the liner 3, which will be described later, is inserted into the insertion hole 24.
図4は、ライナー3の一例を示す斜視図等である。符号400Aで示す図は、ライナー3の斜視図、符号400Bで示す図は正面図、符号400Cで示す図は、400Aに示すIV-IVで切ったときの断面図である。C3は、ライナー3の嵌合方向における中心軸を示す。 Figure 4 shows perspective views of an example of a liner 3. The view indicated by reference numeral 400A is a perspective view of the liner 3, the view indicated by reference numeral 400B is a front view, and the view indicated by reference numeral 400C is a cross-sectional view taken along line IV-IV shown in 400A. C3 indicates the central axis of the liner 3 in the mating direction.
図2および図4に示すように、ライナー3は、外面31、内面32、収容空間33、および突出部34を備える。ライナー3は、ドーム状(略半球形の椀状)の形状を有する。 As shown in Figures 2 and 4, the liner 3 has an outer surface 31, an inner surface 32, a storage space 33, and a protrusion 34. The liner 3 has a dome-like (approximately hemispherical bowl-like) shape.
外面31の周縁部312付近には、第1テーパ面311が周方向全周に亘って位置する。第1テーパ面311は、周縁部312に向かうにつれ外面31の径が大きい。 A first tapered surface 311 is located around the entire circumferential direction near the peripheral edge 312 of the outer surface 31. The diameter of the first tapered surface 311 increases as it approaches the peripheral edge 312.
突出部34は、上述したように、寛骨臼カップ2の挿入孔24に挿入される。ライナー3は突出部34を有することで、寛骨臼カップ2へ挿入するときの位置合わせが容易となる。ライナー3は、突出部34を有していなくてもよい。 As described above, the protrusion 34 is inserted into the insertion hole 24 of the acetabular cup 2. By having the protrusion 34, the liner 3 can be easily aligned when inserted into the acetabular cup 2. The liner 3 does not necessarily have to have the protrusion 34.
収容空間33は、ベアリング4を嵌め込むための空間である。収容空間
33は、ライナー3の内部に位置する。収容空間33の直径は、ベアリング4の直径よりわずかに大きい。これにより、ベアリング4をライナー3の収容空間33内に嵌め込むことができる。収容空間33に嵌め込まれたベアリング4は、ベアリング4の外面41とライナー3の内面32とが摺動するように、ライナー3に保持される。
The accommodation space 33 is a space for fitting the bearing 4. The accommodation space 33 is located inside the liner 3. The diameter of the accommodation space 33 is slightly larger than the diameter of the bearing 4. This allows the bearing 4 to be fitted into the accommodation space 33 of the liner 3. The bearing 4 fitted into the accommodation space 33 is held in the liner 3 so that the outer surface 41 of the bearing 4 and the inner surface 32 of the liner 3 slide against each other.
図5は、ベアリング4の一例を示す斜視図等である。符号500Aで示す図は、ベアリング4の斜視図、符号500Bで示す図は正面図、符号500Cで示す図は、500Aに示すV-Vで切ったときの断面図である。C4は、ベアリング4の嵌合方向における中心軸を示す。 Figure 5 shows perspective views of an example of a bearing 4. The view indicated by reference numeral 500A is a perspective view of the bearing 4, the view indicated by reference numeral 500B is a front view, and the view indicated by reference numeral 500C is a cross-sectional view taken along the line V-V shown in 500A. C4 indicates the central axis of the bearing 4 in the fitting direction.
図2および図5に示すように、ベアリング4は、外面41、内面42、収容空間43、および開口部44を備える。ベアリング4は、例えば、ポリエチレン等の樹脂により構成される。 As shown in Figures 2 and 5, the bearing 4 has an outer surface 41, an inner surface 42, a storage space 43, and an opening 44. The bearing 4 is made of a resin such as polyethylene.
収容空間43は、骨頭ボール5を嵌め込むための空間であり、ベアリング4の内部に形成される。収容空間43の直径は、骨頭ボール5の直径よりわずかに大きくなるように形成される。これにより、骨頭ボール5をベアリング4の収容空間43内に嵌め込むことができる。ベアリング4は、骨頭ボール5の外面51の大部分を覆うように、骨頭ボール5を収容空間43内に収容する。 The accommodation space 43 is a space for fitting the femoral head ball 5 and is formed inside the bearing 4. The diameter of the accommodation space 43 is formed to be slightly larger than the diameter of the femoral head ball 5. This allows the femoral head ball 5 to be fitted into the accommodation space 43 of the bearing 4. The bearing 4 accommodates the femoral head ball 5 within the accommodation space 43 so as to cover most of the outer surface 51 of the femoral head ball 5.
骨頭ボール5は、ベアリング4の内面42と骨頭ボール5の外面51とが摺動可能な状態で収容空間43内に嵌め込まれる。ベアリング4は、外面41がライナー3の内面32と摺動し、内面42が骨頭ボール5の外面51と摺動する。 The femoral head ball 5 is fitted into the accommodation space 43 with the inner surface 42 of the bearing 4 and the outer surface 51 of the femoral head ball 5 slidable against each other. The outer surface 41 of the bearing 4 slides against the inner surface 32 of the liner 3, and the inner surface 42 slides against the outer surface 51 of the femoral head ball 5.
開口部44は、開口部44の直径が骨頭ボール5の直径より小さい形状である。このため、骨頭ボール5をベアリング4に嵌め込むために、強い押込み力が必要となり、後述する嵌合器具6(手術器具)が使用される。 The opening 44 has a diameter smaller than the diameter of the femoral head ball 5. As a result, a strong pushing force is required to fit the femoral head ball 5 into the bearing 4, and an engagement instrument 6 (surgical instrument) described below is used.
図6は、骨頭ボール5の一例を示す斜視図等である。符号600Aで示す図は、骨頭ボール5の斜視図、符号600Bで示す図は正面図、符号600Cで示す図は、600Aに示すVI-VIで切ったときの断面図である。C5は、骨頭ボール5の嵌合方向における中心軸を示す。 Figure 6 shows perspective views of an example of a femoral head ball 5. The view indicated by the reference numeral 600A is a perspective view of the femoral head ball 5, the view indicated by the reference numeral 600B is a front view, and the view indicated by the reference numeral 600C is a cross-sectional view taken along the line VI-VI shown in 600A. C5 indicates the central axis of the femoral head ball 5 in the mating direction.
図2および図6に示すように、骨頭ボール5は、外面51、および凹部53を備える。凹部53に、ステム90の先端901を挿入することにより、骨頭ボール5はステム90に固定される。また、後述する嵌合器具6(手術器具)に骨頭ボール5を取り付ける際にも、凹部53に嵌合器具6の骨頭ボール支持部71が挿入される。 As shown in Figures 2 and 6, the femoral head ball 5 has an outer surface 51 and a recess 53. The femoral head ball 5 is fixed to the stem 90 by inserting the tip 901 of the stem 90 into the recess 53. Furthermore, when attaching the femoral head ball 5 to the fitting instrument 6 (surgical instrument) described below, the femoral head ball support portion 71 of the fitting instrument 6 is inserted into the recess 53.
<二重摺動>
図7は、生体インプラント1の各構成要素を組み合わせた状態を示す断面図である。図8は、生体インプラント1の可動域を説明する模式図である。図7に示すように、寛骨臼カップ2の内側にライナー3が配置され、ライナー3の内側にベアリング4が配置される。そして、ライナー3の内面32とベアリング4の外面41とが摺動可能に接している。また、ベアリング4の内部に骨頭ボール5が収容され、ベアリング4の内面42と骨頭ボール5の外面51とが摺動可能に接する。
<Double sliding>
Fig. 7 is a cross-sectional view showing the assembled state of the components of the biological implant 1. Fig. 8 is a schematic diagram illustrating the range of motion of the biological implant 1. As shown in Fig. 7, a liner 3 is placed inside the acetabular cup 2, and a bearing 4 is placed inside the liner 3. The inner surface 32 of the liner 3 and the outer surface 41 of the bearing 4 are in slidable contact with each other. A femoral head ball 5 is housed inside the bearing 4, and the inner surface 42 of the bearing 4 and the outer surface 51 of the femoral head ball 5 are in slidable contact with each other.
これにより、図8の800Aに示すように、ベアリング4に対して骨頭ボール5が可動するとともに、図8の800Bに示すように、ライナー3に対してベアリング4が可動する。つまり、二重摺動を実現することができる。 As a result, the femoral head ball 5 moves relative to the bearing 4, as shown in 800A in Figure 8, and the bearing 4 moves relative to the liner 3, as shown in 800B in Figure 8. In other words, double sliding is achieved.
<突部>
人工股関節置換術では、骨盤の寛骨臼にカップを設置した後に、カップにライナーを嵌め込む。カップからライナーが外れることは望ましくなく、カップとライナーとの嵌合力は、強い方がよい。
<Protrusion>
In total hip replacement surgery, a cup is placed in the acetabulum of the pelvis, and then a liner is fitted into the cup. It is undesirable for the liner to come off the cup, so the fitting force between the cup and the liner should be strong.
そこで、ライナー3には、第1テーパ面311に突部313が配されていてもよい。図9に、ライナー3に形成される突部313を説明する模式図を示す。図9に示すように、突部313は、ライナー3の外面31で、寛骨臼カップ2の内面22方向に設けられている。突部313は、先端が鋭角である。突部313が寛骨臼カップ2の内面22に引っかかることにより、寛骨臼カップ2とライナー3との嵌合が強化される。 Therefore, the liner 3 may have a protrusion 313 arranged on the first tapered surface 311. Figure 9 is a schematic diagram illustrating the protrusion 313 formed on the liner 3. As shown in Figure 9, the protrusion 313 is provided on the outer surface 31 of the liner 3, facing the inner surface 22 of the acetabular cup 2. The tip of the protrusion 313 has an acute angle. The protrusion 313 catches on the inner surface 22 of the acetabular cup 2, strengthening the fit between the acetabular cup 2 and the liner 3.
突部313は、第1テーパ面311に溝が配されることにより形成されるものであってよい。溝を形成することにより、溝と溝との間を突部313とすることができる。溝は、ライナー3の縁における任意の点とライナー3の天頂点、すなわち突出部34(図4参照)とを結んだ線とは異なる方向に配されてよい。これにより、突部313が寛骨臼カップ2とライナー3との嵌合方向とは異なる方向に配されるので、寛骨臼カップ2とライナー3と嵌合を強化することができる。溝は、ライナー3の縁と略平行に配されてもよい。 The protrusions 313 may be formed by arranging grooves in the first tapered surface 311. By forming grooves, the space between the grooves can become the protrusions 313. The grooves may be arranged in a direction different from the line connecting any point on the edge of the liner 3 and the apex of the liner 3, i.e., the protrusion 34 (see Figure 4). This allows the protrusions 313 to be arranged in a direction different from the mating direction between the acetabular cup 2 and the liner 3, thereby strengthening the fit between the acetabular cup 2 and the liner 3. The grooves may be arranged approximately parallel to the edge of the liner 3.
突部313は、第1テーパ面311から突出する形状であってもよい。突部313は、第1テーパ面311から寛骨臼カップ2側に突出する形状であってもよい。突部313は、ライナー3の縁における任意の点とライナー3の天頂点とを結んだ線とは異なる方向に突出していてもよい。 The protrusion 313 may be shaped to protrude from the first tapered surface 311. The protrusion 313 may be shaped to protrude from the first tapered surface 311 toward the acetabular cup 2. The protrusion 313 may protrude in a direction different from a line connecting any point on the edge of the liner 3 and the apex of the liner 3.
突部313は、先端が鈍角であってもよい。例えば、突部313の断面は、三角形状、四角形状、または台形状などであってよい。突部313は、先端が丸まった形状であってもよい。突部313は、第1テーパ面311の一部のみに位置してもよい。突部313は、ライナー3の全周にわたって位置してもよい。 The protrusion 313 may have an obtuse tip. For example, the cross section of the protrusion 313 may be triangular, rectangular, or trapezoidal. The protrusion 313 may have a rounded tip. The protrusion 313 may be located on only a portion of the first tapered surface 311. The protrusion 313 may be located around the entire circumference of the liner 3.
突部313は、ライナー3の全周に位置し、突部313の先端が円環状の形状であってもよい。突部313は、ライナー3の全周に位置し、突部313の先端がらせん状の形状であってもよい。 The protrusions 313 may be located around the entire circumference of the liner 3, and the tips of the protrusions 313 may be annular in shape. The protrusions 313 may be located around the entire circumference of the liner 3, and the tips of the protrusions 313 may be spiral in shape.
<テーパ嵌合>
上述したように、ライナー3には、面31の周縁部312に第1テーパ面311が配されている。第1テーパ面311が寛骨臼カップ2の内面22と嵌合することにより、寛骨臼カップ2とライナー3とは嵌合する。寛骨臼カップ2の内面22に第2テーパ面221が配され、ライナー3の第1テーパ面311と寛骨臼カップ2の第2テーパ面221とが嵌合する構成であってもよい。
<Tapered fitting>
As described above, the liner 3 has a first tapered surface 311 arranged on the peripheral edge 312 of the surface 31. The first tapered surface 311 fits into the inner surface 22 of the acetabular cup 2, thereby fitting the acetabular cup 2 and the liner 3 together. A second tapered surface 221 may be arranged on the inner surface 22 of the acetabular cup 2, and the first tapered surface 311 of the liner 3 may fit into the second tapered surface 221 of the acetabular cup 2.
また、図10に示すように、第1テーパ面311は、第2テーパ面221に噛み込む噛込み部314を有していてもよい。噛込み部314は、第1テーパ面311が縁に向かって角度Lだけ内側、すなわち、ライナー3の縁によって形成される円の中心側に折れることにより形成されてよい。換言すれば、噛込み部314は、寛骨臼カップ2とライナー3との嵌合方向に平行な面で切った断面において、嵌合方向との角度が第2テーパ面221の角度よりも小さい面を第1テーパ面311に配することにより設けられるエッジにより実現してもよい。噛込み部314の先端は、鈍角であってもよく、鋭角であってもよい。噛込み部314の先端が鋭角である場合、第2テーパ面221への噛み込みがより強固となる。噛込み部314の先端が鈍角である場合、ライナー3の先端により寛骨臼カップ2の内面が欠ける虞が低減する。 10, the first tapered surface 311 may have a biting portion 314 that bites into the second tapered surface 221. The biting portion 314 may be formed by bending the first tapered surface 311 inward at an angle L toward the edge, i.e., toward the center of the circle formed by the edge of the liner 3. In other words, the biting portion 314 may be realized by an edge provided by providing a surface on the first tapered surface 311 whose angle with the mating direction is smaller than the angle of the second tapered surface 221 in a cross section cut along a plane parallel to the mating direction between the acetabular cup 2 and the liner 3. The tip of the biting portion 314 may be either an obtuse angle or an acute angle. When the tip of the biting portion 314 is an acute angle, it bites more firmly into the second tapered surface 221. When the tip of the biting portion 314 is an obtuse angle, the risk of the tip of the liner 3 chipping the inner surface of the acetabular cup 2 is reduced.
第1テーパ面311が噛込み部314を有していることにより、寛骨臼カップ2とライナー3が嵌合したときに、噛込み部314が寛骨臼カップ2の内面に食い込む。これにより、寛骨臼カップ2とライナー3との嵌合が強化される。 Because the first tapered surface 311 has a biting portion 314, when the acetabular cup 2 and the liner 3 are fitted together, the biting portion 314 bites into the inner surface of the acetabular cup 2. This strengthens the fit between the acetabular cup 2 and the liner 3.
<ライナーの肉厚>
図11は、ライナー3の厚みを説明する模式図である。ここで、ライナー3の周縁部312よりなる環の中心P0を通り、寛骨臼カップ2とライナー3との嵌合方向に平行な直線を中心軸C3とする。
<Liner thickness>
11 is a schematic diagram illustrating the thickness of the liner 3. Here, a straight line that passes through the center P0 of the ring formed by the peripheral edge portion 312 of the liner 3 and is parallel to the fitting direction of the acetabular cup 2 and the liner 3 is defined as a central axis C3.
図11に示すように、中心軸C3を通り、嵌合方向に平行な面で切った断面における、中心軸C3を挟んで一方を第1側、他方を第2側としたとき、ライナー3の外形は、第1側および第2側のそれぞれにおいて、中心軸C3に対して略対称に設けられた点、すなわち、第1側における点P1および第2側における点P2を中心とする円弧を含む形状である。ここで、円弧とは、必ずしも幾何学的な円弧のみを表すものではなく、幾何学的な円弧に対し、製造誤差などのズレを許容するものである。 As shown in Figure 11, in a cross section taken along a plane passing through the central axis C3 and parallel to the mating direction, with one side of the central axis C3 designated as the first side and the other side as the second side, the outer shape of the liner 3 has a shape that includes arcs centered on points on the first side and the second side that are approximately symmetrical with respect to the central axis C3, i.e., point P1 on the first side and point P2 on the second side. Here, the arcs do not necessarily refer only to geometric arcs, but also allow for deviations from the geometric arcs due to manufacturing errors, etc.
これにより、ライナー3は、中心軸C3に設けられたP0を中心とする円弧により外形が形成される場合と比較して、中心軸C3を含む断面におけるライナー3の厚さW1が大きい領域を有する。ライナー3は、周縁部312側から凸部34側に向かうにつれて、厚さW1が厚くなる領域を有する。 As a result, the liner 3 has a region where the thickness W1 of the liner 3 in a cross section including the central axis C3 is greater than when the outer shape is formed by an arc centered at P0 on the central axis C3. The liner 3 has a region where the thickness W1 increases from the peripheral edge 312 side toward the convex portion 34 side.
このように、中心軸C3に外形の中心を設ける場合と比較して、ライナー3の外形を大きくすることができる。よって、ライナー3の内径が従来と同じであれば、ライナー3の肉厚を厚くすることができ、ライナー3の強度を高めることができる。また、ライナー3の内径を従来よりも大きくすれば、従来よりも大きなベアリング4を、ライナー3の内部に配置することが可能となる。 In this way, the outer diameter of the liner 3 can be made larger compared to when the center of the outer diameter is located on the central axis C3. Therefore, if the inner diameter of the liner 3 remains the same as before, the thickness of the liner 3 can be increased, and the strength of the liner 3 can be increased. Furthermore, if the inner diameter of the liner 3 is made larger than before, it becomes possible to place a larger bearing 4 inside the liner 3 than before.
〔実施形態2〕
<嵌合器具6の構成>
上述したように、ベアリング4は、開口部44を有する中空形状であり、収容空間43に骨頭ボール5が収容されることにより、ベアリング4の内面42で骨頭ボール5が摺動する。ベアリング4の開口部44の径は、骨頭ボール5の径よりも小さいため、ベアリング4の収容空間43に骨頭ボール5を収容するときには、強い押込み力が必要となり、専用の器具が用いられる。しかし、器具の構造によっては、押込み部が押し戻され、ベアリング4の収容空間43に骨頭ボール5を収容できない可能性がある。
[Embodiment 2]
<Configuration of fitting device 6>
As described above, the bearing 4 has a hollow shape with an opening 44, and the femoral head ball 5 is accommodated in the accommodation space 43, allowing the femoral head ball 5 to slide on the inner surface 42 of the bearing 4. Because the diameter of the opening 44 of the bearing 4 is smaller than the diameter of the femoral head ball 5, a strong pushing force is required to accommodate the femoral head ball 5 in the accommodation space 43 of the bearing 4, and a dedicated tool is used. However, depending on the structure of the tool, the pushing part may be pushed back, making it impossible to accommodate the femoral head ball 5 in the accommodation space 43 of the bearing 4.
本開示の実施形態2に係る嵌合器具6(手術器具)はラチェット構造を備える。ラチェット構造は、押込み部64の移動方向を、ベアリング4に骨頭ボール5を収容する方向(後述するY1方向、第1方向)のみに規制することができる。これにより、押込み部64の押し戻しを抑え、効率的に骨頭ボール5を収容することができる。押込み部64の移動方向を第1方向にのみ規制する、とは、第1方向とは反対方向への移動に対し強固な力が加わることを意味する。 The fitting instrument 6 (surgical instrument) according to embodiment 2 of the present disclosure has a ratchet structure. The ratchet structure can restrict the movement direction of the pushing portion 64 only to the direction in which the femoral head ball 5 is accommodated in the bearing 4 (the Y1 direction, first direction, described below). This prevents the pushing portion 64 from being pushed back, allowing the femoral head ball 5 to be accommodated efficiently. Restricting the movement direction of the pushing portion 64 only to the first direction means that a strong force is applied against movement in the direction opposite to the first direction.
本開示の実施形態2に係る嵌合器具6について、以下に説明する。説明の便宜上、上記実施形態1にて説明したものと同じ機能を有するものについては、同じ符号を付記し、その説明を繰り返さない。 The fitting device 6 according to the second embodiment of the present disclosure will be described below. For ease of explanation, components having the same functions as those described in the first embodiment above will be denoted by the same reference numerals, and their description will not be repeated.
図12は、嵌合器具6の一例を示す正面図であり、図13は斜視図である。図12には、嵌合器具6に取付けたベアリング4および骨頭ボール5を仮想線で示している。 Figure 12 is a front view showing an example of a fitting device 6, and Figure 13 is a perspective view. Figure 12 shows the bearing 4 and femoral head ball 5 attached to the fitting device 6 in phantom lines.
図12および図13に示すように、嵌合器具6は、本体部61、軸部63、押込み部64、操作部65、嵌合部66、およびストッパ67を備える。 As shown in Figures 12 and 13, the fitting device 6 includes a main body 61, a shaft 63, a pushing portion 64, an operating portion 65, a fitting portion 66, and a stopper 67.
本体部61は、骨頭ボール5を固定する骨頭ボール支持部62(支持部)を備える。骨頭ボール支持部62は、基台621および基台621から立設する挿入部622を有する。上述したように、骨頭ボール5の凹部53に挿入部622を挿入することにより、骨頭ボール5を嵌合器具6に固定することができる。 The main body 61 includes a femoral head ball support 62 (support portion) that secures the femoral head ball 5. The femoral head ball support 62 has a base 621 and an insertion portion 622 that extends from the base 621. As described above, the femoral head ball 5 can be secured to the fitting device 6 by inserting the insertion portion 622 into the recess 53 of the femoral head ball 5.
軸部63は、本体部61に形成された挿通孔611に挿通されることにより、軸方向に移動可能に本体部61に取付けられる。軸部63には、溝部633が軸方向に複数形成されている。軸部63は、第1端部631(第1端)に押込み部64、第2端部632(第2端)に取手部68が取付けられる。 The shaft 63 is attached to the main body 61 so as to be movable in the axial direction by being inserted into an insertion hole 611 formed in the main body 61. The shaft 63 has multiple grooves 633 formed in the axial direction. A push-in portion 64 is attached to the first end 631 (first end) of the shaft 63, and a handle portion 68 is attached to the second end 632 (second end).
押込み部64は、カップ状に形成されたベアリング取付部641を備える。ベアリング取付部641は、ベアリング4の開口部44を下(第1方向)に向けた状態で、ベアリング4を取付けることができる。ベアリング取付部641は、ベアリング4を骨頭ボール5の方向へ押圧する際の位置合わせに用いることができ、ベアリング4と骨頭ボール5とのずれが生じる可能性を減らすことができる。押込み部64は、ベアリング取付部641を有していなくてもよい。 The push-in portion 64 includes a cup-shaped bearing mounting portion 641. The bearing mounting portion 641 allows the bearing 4 to be mounted with the opening 44 of the bearing 4 facing downward (first direction). The bearing mounting portion 641 can be used for alignment when pressing the bearing 4 toward the femoral head ball 5, reducing the possibility of misalignment between the bearing 4 and the femoral head ball 5. The push-in portion 64 does not necessarily have to include the bearing mounting portion 641.
ベアリング取付部641は、骨頭ボール支持部62と対向するように配置される。軸部63を、軸方向かつ骨頭ボール支持部62に近接する方向(Y1方向、第1方向)に移動させることで、ベアリング4の開口部44から、骨頭ボール5をベアリング4の収容空間43内に押込むことができる。 The bearing mounting portion 641 is positioned to face the femoral head ball support portion 62. By moving the shaft portion 63 in the axial direction and in a direction approaching the femoral head ball support portion 62 (Y1 direction, first direction), the femoral head ball 5 can be pushed into the bearing 4's accommodation space 43 through the bearing 4's opening 44.
操作部65は、嵌合器具6を操作するハンドル状の部材であり、操作ハンドル651および固定ハンドル652を備える。操作ハンドル651は、固定部6511を中心として回転可能に本体部61に固定される。詳しくは後述するが、ユーザは、操作ハンドル651および固定ハンドル652を握り、操作ハンドル651を固定ハンドル652に近接する方向(R1方向)へ回転移動させることによって、軸部63をY1方向へ移動させることができる。 The operating unit 65 is a handle-shaped member used to operate the fitting device 6, and includes an operating handle 651 and a fixed handle 652. The operating handle 651 is fixed to the main body 61 so that it can rotate around a fixed part 6511. As will be described in more detail below, the user can move the shaft 63 in the Y1 direction by grasping the operating handle 651 and the fixed handle 652 and rotating the operating handle 651 in a direction approaching the fixed handle 652 (R1 direction).
操作ハンドル651は、バネ等の付勢部材(不図示)により、固定ハンドル652から離反する方向(R2方向)に付勢されており、ユーザが握る力を緩めることにより、R2方向に回転移動し、ユーザが握る前の位置に戻るように構成されている。 The operating handle 651 is biased in a direction (R2 direction) away from the fixed handle 652 by a biasing member such as a spring (not shown), and is configured so that when the user loosens their grip, it rotates in the R2 direction and returns to the position it was in before the user gripped it.
嵌合部66は、軸部63に形成される溝部633の1つと嵌合する嵌合爪661を備え、固定部662により操作ハンドル651に固定される。嵌合部66は、操作ハンドル651の回転移動に伴い、固定部662を中心として回転しながら、Y1方向に平行移動する。詳しくは後述するが、嵌合部66の回転移動により、嵌合爪661が溝部633の第1面634aをY1方向へ押圧し、軸部63をY1方向へ移動させることができる。 The fitting portion 66 has a fitting claw 661 that fits into one of the grooves 633 formed in the shaft portion 63, and is fixed to the operating handle 651 by a fixing portion 662. As the operating handle 651 rotates, the fitting portion 66 moves parallel to the Y1 direction while rotating around the fixing portion 662. As will be described in more detail below, the rotational movement of the fitting portion 66 causes the fitting claw 661 to press the first surface 634a of the groove portion 633 in the Y1 direction, allowing the shaft portion 63 to move in the Y1 direction.
ストッパ67は、軸部63に形成される溝部633の1つと嵌合する係止爪671を備え、固定部672を中心として回転可能に本体部61に固定される。ストッパ67は、バネ673によって軸部63方向に付勢される。操作部65による操作がなされていないときに、係止爪671が溝部633と嵌合することにより、軸部63がY1方向とは反対側の方向(Y2方向)に押し戻されるのを抑える。 The stopper 67 has a locking claw 671 that fits into one of the grooves 633 formed in the shaft 63, and is fixed to the main body 61 so as to be rotatable around a fixed portion 672. The stopper 67 is biased toward the shaft 63 by a spring 673. When no operation is being performed using the operating unit 65, the locking claw 671 fits into the groove 633, preventing the shaft 63 from being pushed back in the direction opposite the Y1 direction (Y2 direction).
嵌合器具6が備えるラチェット構造は、主に、ストッパ67および嵌合部66によって構成される。ストッパ67および嵌合部66の詳細については、後述する。 The ratchet structure of the fitting device 6 is mainly composed of a stopper 67 and a fitting portion 66. Details of the stopper 67 and the fitting portion 66 will be described later.
取手部68は、上述したように、軸部63の第2端部632に取付けられる。ユーザは取手部68を回すことにより、軸部63を、軸線を中心として回転させることができる。 As described above, the handle portion 68 is attached to the second end portion 632 of the shaft portion 63. By turning the handle portion 68, the user can rotate the shaft portion 63 around its axis.
溝部633は、軸部63の周方向の全周に亘って形成されておらず、周方向の一部分のみに形成されている。溝部633は、例えば、本体部61と対向する部分のみに形成されている。そのため、ユーザは、取手部68を回すことにより、溝部633を本体部61と対向する側と反対側に位置させることができる。これにより、溝部633と嵌合する嵌合爪661および係止爪671の嵌合を解除することができる。 The groove 633 is not formed around the entire circumference of the shaft 63, but only on a portion of the circumference. For example, the groove 633 is formed only in the portion facing the main body 61. Therefore, by turning the handle 68, the user can position the groove 633 on the side opposite the side facing the main body 61. This allows the engagement of the engagement claw 661 and the locking claw 671 that are engaged with the groove 633 to be released.
<ラチェット構造>
図14は、嵌合器具6のラチェット構造を説明する模式図である。図14に示すように、溝部633は、ラチェット歯634として機能し、軸部63に垂直な第1面634aと、軸部63に対して斜めとなる第2面634bとを備える。
<Ratchet structure>
14 is a schematic diagram illustrating the ratchet structure of the fitting device 6. As shown in FIG. 14, the groove portion 633 functions as a ratchet tooth 634 and has a first surface 634a perpendicular to the shaft portion 63 and a second surface 634b oblique to the shaft portion 63.
嵌合部66には、ラチェット歯634の1つに噛合する嵌合爪661が設けられる。ストッパ67には、バネ673によりラチェット歯634に向けて付勢され、ラチェット歯634の他の1つに噛合する係止爪671が設けられる。 The mating portion 66 is provided with a mating pawl 661 that meshes with one of the ratchet teeth 634. The stopper 67 is provided with a locking pawl 671 that is biased toward the ratchet teeth 634 by a spring 673 and meshes with the other ratchet tooth 634.
操作ハンドル651が操作されR1方向に回転移動すると、操作ハンドル651に固定された嵌合部66は、操作ハンドル651の回転移動に伴い、固定部6511を中心としてR1方向に回転移動する。嵌合爪661は、ラチェット歯634に噛合した状態で、第1面634aをY1方向へ押圧し、軸部63をY1方向へ移動させる。 When the operating handle 651 is operated and rotated in the R1 direction, the fitting portion 66 fixed to the operating handle 651 rotates in the R1 direction around the fixed portion 6511 in conjunction with the rotation of the operating handle 651. While engaged with the ratchet teeth 634, the fitting pawl 661 presses the first surface 634a in the Y1 direction, moving the shaft portion 63 in the Y1 direction.
嵌合部66は、付勢部材により、固定部662よりもY2方向側で、軸部63から斜めに離れる方向に付勢されている。これにより、操作ハンドル651による操作が一旦、完了すると、操作ハンドル651はR2方向に付勢され、嵌合爪661はX1方向に付勢され、嵌合部66全体はY2方向に付勢される。よって、嵌合爪661が、第2面634bを滑りながら嵌合部66がY2方向に移動することになる。したがって、ユーザが操作ハンドル651を緩めると、嵌合部66がY2方向に移動して、元の位置に戻ることになる。 The fitting portion 66 is biased by a biasing member in a direction diagonally away from the shaft portion 63, on the Y2 side of the fixed portion 662. As a result, once operation using the operating handle 651 is completed, the operating handle 651 is biased in the R2 direction, the fitting claw 661 is biased in the X1 direction, and the entire fitting portion 66 is biased in the Y2 direction. As a result, the fitting claw 661 slides along the second surface 634b, causing the fitting portion 66 to move in the Y2 direction. Therefore, when the user loosens the operating handle 651, the fitting portion 66 moves in the Y2 direction and returns to its original position.
一方、ストッパ67の係止爪671は、係止爪671と噛合するラチェット歯634の第1面633aを係止しているため、軸部63が押し戻されY2方向へ移動するのを防ぐことができる。 On the other hand, the locking claw 671 of the stopper 67 locks the first surface 633a of the ratchet tooth 634 that meshes with the locking claw 671, preventing the shaft 63 from being pushed back and moving in the Y2 direction.
再び操作ハンドル651を操作することによって、さらに軸部63をY1方向へ移動させることができる。このような動作を繰り返すことによって、軸部63を所望の長さだけY1方向へ移動させることができる。 By operating the operating handle 651 again, the shaft 63 can be moved further in the Y1 direction. By repeating this operation, the shaft 63 can be moved in the Y1 direction by the desired length.
これにより、軸部63の移動方向を、Y1方向のみに規制することによって、押し戻しを抑え、効率的に骨頭ボール5をベアリング4に収容することができる。 This restricts the movement direction of the shaft portion 63 to only the Y1 direction, thereby suppressing push-back and allowing the femoral head ball 5 to be efficiently accommodated in the bearing 4.
〔まとめ〕
本開示の態様1に係る生体インプラントは、寛骨臼カップと、前記寛骨臼カップと接する外面を有し、前記寛骨臼カップの内側に位置するライナーと、を備え、前記ライナーは、前記外面の周縁部に位置し、前記寛骨臼カップの内面の周縁部と接する第1テーパ面を有し、前記第1テーパ面は、突部を有する。前記の構成によれば、第1テーパ面に突部が配されているので、突部が配されていない場合と比較して、嵌合の強度を高めることができる。よって、寛骨臼カップとライナーとの嵌合の強度を高めることができる。
〔summary〕
A biological implant according to a first aspect of the present disclosure includes an acetabular cup and a liner positioned inside the acetabular cup, the liner having an outer surface that contacts the acetabular cup, the liner having a first tapered surface positioned on the periphery of the outer surface and contacting the periphery of the inner surface of the acetabular cup, the first tapered surface having a protrusion. According to the above configuration, the protrusion on the first tapered surface can increase the strength of the fit compared to when no protrusion is provided. Therefore, the strength of the fit between the acetabular cup and the liner can be increased.
本開示の態様2に係る生体インプラントは、前記態様1において、前記ライナーの内面と摺動可能な外面を有するベアリングを備える。ベアリングを備えることにより、ベアリング外面とライナーとの間で摺動を実現できるので、ベアリング内面における摺動との二重摺動を実現できる。 A biological implant according to aspect 2 of the present disclosure is the same as aspect 1, except that it includes a bearing having an outer surface that can slide against the inner surface of the liner. By including the bearing, sliding can be achieved between the outer surface of the bearing and the liner, thereby achieving double sliding, including sliding on the inner surface of the bearing.
本開示の態様3に係る生体インプラントは、前記態様1または2において、前記ベアリングの内面と摺動可能な骨頭ボールを備える。骨頭ボールを備えることにより、ベアリングと骨頭ボールとの間で摺動を実現できる。 The biological implant according to aspect 3 of the present disclosure is the same as that of aspect 1 or 2, except that it includes a femoral head ball that is slidable against the inner surface of the bearing. By including a femoral head ball, sliding can be achieved between the bearing and the femoral head ball.
本開示の態様4に係る生体インプラントは、前記態様3において、前記骨頭ボールに挿入されるステムを備える。ステムを備えることにより、生体インプラントを大腿骨に適切に挿入できる。 The bioimplant according to aspect 4 of the present disclosure is the same as the bioimplant according to aspect 3, except that it includes a stem that is inserted into the femoral head ball. By including the stem, the bioimplant can be properly inserted into the femur.
本開示の態様5に係る生体インプラントは、前記態様1~4の何れかにおいて、前記突部は、前記第1テーパ面に溝が配されることにより、形成され、前記溝は、前記ライナーにおける縁の任意の点と天頂点とを結んだ線とは異なる方向に配される。ライナーの縁の任意の点とライナーの天頂点とを結んだ線は、寛骨臼カップとライナーとの嵌合方向と平行になる。よって、前記の構成によれば、寛骨臼カップとライナーとの嵌合方向とは異なる方向に溝が配されることになり、溝により形成される突部も寛骨臼カップとライナーとの嵌合方向とは異なる方向に配される。これにより、寛骨臼カップとライナーとの嵌合の強度を高めることができる。例えば、溝は、ライナーの縁の略平行に配されてもよい。 A biological implant according to aspect 5 of the present disclosure is any of aspects 1 to 4, wherein the protrusion is formed by arranging a groove on the first tapered surface, and the groove is arranged in a direction different from a line connecting any point on the edge of the liner to the zenith. The line connecting any point on the edge of the liner to the zenith is parallel to the mating direction between the acetabular cup and the liner. Therefore, with the above configuration, the groove is arranged in a direction different from the mating direction between the acetabular cup and the liner, and the protrusion formed by the groove is also arranged in a direction different from the mating direction between the acetabular cup and the liner. This increases the strength of the fit between the acetabular cup and the liner. For example, the groove may be arranged approximately parallel to the edge of the liner.
本開示の態様6に係る生体インプラントは、前記態様1~4の何れかにおいて、前記突部は、前記第1テーパ面から前記寛骨臼カップ側へ突出する形状であり、前記突部は、前記ライナーにおける縁の任意の点と天頂点とを結んだ線とは異なる方向に突出している。これにより、寛骨臼カップとライナーとの嵌合の強度を高めることができる。 A biological implant according to aspect 6 of the present disclosure is any one of aspects 1 to 4, wherein the protrusion has a shape that protrudes from the first tapered surface toward the acetabular cup, and the protrusion protrudes in a direction different from a line connecting any point on the edge of the liner to the zenith apex. This increases the strength of the fit between the acetabular cup and the liner.
本開示の態様7に係る生体インプラントは、前記態様1~6の何れかにおいて、前記寛骨臼カップは、内面の周縁部に第2テーパ面を有し、前記第1テーパ面と前記第2テーパ面とが嵌合する。前記の構成によれば、寛骨臼カップとライナーとの両方にテーパ面が設けられているので、寛骨臼カップとライナーとの嵌合を容易に行うことができる。 A biological implant according to aspect 7 of the present disclosure is any one of aspects 1 to 6, wherein the acetabular cup has a second tapered surface on the periphery of its inner surface, and the first tapered surface and the second tapered surface fit together. With this configuration, tapered surfaces are provided on both the acetabular cup and the liner, making it easy to fit the acetabular cup and the liner together.
本開示の態様8に係る生体インプラントは、前記態様1~7の何れかにおいて、前記ライナーは、前記第1テーパ面の周縁側に位置し、前記第2テーパ面に噛みこむ噛込み部を有する。前記の構成によれば、噛込み部により、ライナーが寛骨臼カップから外れる方向に対する抵抗力が大きくなるので、寛骨臼カップとライナーとの嵌合の強度を高めることができる。噛込み部は、寛骨臼カップとライナーとの嵌合方向に平行な面で切った断面において、嵌合方向との角度が第2テーパ面の角度よりも小さい面を第1テーパ面に配することにより設けられるエッジにより実現してもよい。 A biological implant according to aspect 8 of the present disclosure is any of aspects 1 to 7, wherein the liner has a biting portion located on the peripheral side of the first tapered surface that bites into the second tapered surface. With this configuration, the biting portion increases the resistance force against the liner being removed from the acetabular cup, thereby increasing the strength of the fit between the acetabular cup and the liner. The biting portion may be realized by an edge provided by arranging a surface on the first tapered surface that forms an angle with the fit direction smaller than the angle of the second tapered surface in a cross section taken along a plane parallel to the fit direction between the acetabular cup and the liner.
本開示の態様9に係る生体インプラントは、前記態様1~8の何れかにおいて、前記ライナーの周縁よりなる環の中心を通り、前記寛骨臼カップと前記ライナーとの嵌合方向に平行な直線を中心軸としたとき、前記ライナーは、前記中心軸に外形の中心を設ける場合と比較して、前記中心軸を含む断面における厚さが大きい領域を有する。前記の構成によれば、ライナーの肉厚を分厚くすることができる。これにより、ライナーの強度を高めることができる。また、ライナーの内径を従来よりも大きくすることにより、従来よりも大きなベアリングを、ライナーの内部に配置することが可能となる。 A biological implant according to aspect 9 of the present disclosure is any of aspects 1 to 8, wherein when a straight line passing through the center of the ring formed by the periphery of the liner and parallel to the direction of engagement between the acetabular cup and the liner is taken as the central axis, the liner has a region with a greater thickness in a cross section including the central axis than when the center of the outer shape is set at the central axis. This configuration allows the wall thickness of the liner to be increased, thereby increasing the strength of the liner. Furthermore, by making the inner diameter of the liner larger than conventional, it becomes possible to place a larger bearing inside the liner than conventional.
本開示の態様10に係る生体インプラントは、前記態様1~9の何れかにおいて、前記ライナーの周縁の中心を通り、前記寛骨臼カップと前記ライナーとの嵌合方向に平行な直線を中心軸とし、前記中心軸を通り、前記嵌合方向に平行な面で切った断面における、前記中心軸を挟んで一方を第1側、他方を第2側としたとき、前記ライナーの外形は、前記第1側および前記第2側のそれぞれにおいて、前記中心軸に対して略対称に設けられた点を中心とする円弧を含む形状となる。前記の構成によれば、中心軸に外形の中心を設ける場合と比較して、ライナーの外形を大きくすることができる。よって、ライナーの内径が従来と同じであれば、ライナーの肉厚を厚くすることができ、ライナーの強度を高めることができる。また、ライナーの内径を従来よりも大きくすることにより、従来よりも大きなベアリングを、ライナーの内部に配置することが可能となる。 A biological implant according to aspect 10 of the present disclosure is any of aspects 1 to 9 described above, wherein a central axis is a straight line passing through the center of the periphery of the liner and parallel to the mating direction between the acetabular cup and the liner, and when a cross section is taken along a plane passing through the central axis and parallel to the mating direction, with one side of the central axis designated as a first side and the other side designated as a second side, the outer shape of the liner, on each of the first side and the second side, has a shape that includes an arc with its center at a point located approximately symmetrically with respect to the central axis. With this configuration, the outer shape of the liner can be made larger than when the center of the outer shape is located on the central axis. Therefore, if the inner diameter of the liner is the same as in conventional liner designs, the thickness of the liner can be increased, thereby increasing the strength of the liner. Furthermore, by making the inner diameter of the liner larger than in conventional liner designs, it is possible to place larger bearings inside the liner than in conventional liner designs.
本開示の態様11に係る生体インプラントは、前記態様1~10の何れかにおいて、前記ライナーの周縁よりなる環の中心を通り、前記寛骨臼カップと前記ライナーとの嵌合方向に平行な直線を中心軸としたとき、前記ライナーは、前記中心軸を含む断面が、前記ライナーの周縁から前記ライナーの天頂点に向かうにつれて大きくなる領域を有する。前記の構成によれば、ライナーの外形を大きくすることができる。 A biological implant according to aspect 11 of the present disclosure is any of aspects 1 to 10, wherein when a central axis is a straight line passing through the center of a ring formed by the periphery of the liner and parallel to the direction in which the acetabular cup and the liner are fitted together, the liner has a region in which the cross section including the central axis increases in size from the periphery of the liner toward the apex of the liner. This configuration allows the outer shape of the liner to be increased.
本開示の態様12に係る手術器具は、骨頭ボールを支持する支持部を有する本体部と、開口部を有する中空形状のベアリングの内部に、前記骨頭ボールを収容するように前記ベアリングを押し込む押込み部と、第1端で前記押込み部と接続する軸部と、前記軸部の側面に接続し、前記本体部に対して前記軸部を軸方向へ移動させる操作部と、を備え、前記軸部と前記操作部との接続は、前記操作部による前記軸部の前記軸方向への移動が、前記第1端方向である第1方向にのみ可能な構造である。前記の構成によれば、第1方向にのみ軸部が移動するので、ベアリングの内部に骨頭ボールの収容するために大きな力が必要となる場合でも、第1方向とは反対方向に押し戻されることなく、押込み部によりベアリングを押し込むことができる。 A surgical instrument according to aspect 12 of the present disclosure comprises a main body having a support portion that supports a femoral head ball; a pusher portion that pushes the bearing into a hollow bearing having an opening to accommodate the femoral head ball; a shaft portion that connects to the pusher portion at a first end; and an operating portion that connects to the side of the shaft portion and moves the shaft portion in the axial direction relative to the main body portion, and the connection between the shaft portion and the operating portion is structured so that the operating portion can move the shaft portion in the axial direction only in a first direction, which is the direction of the first end. With this configuration, because the shaft portion moves only in the first direction, even when a large force is required to accommodate the femoral head ball inside the bearing, the pushing portion can push the bearing in without being pushed back in the direction opposite to the first direction.
本開示の態様13に係る手術器具は、前記態様12において、前記軸部と前記操作部との接続は、前記操作部による前記軸部の前記軸方向への移動が、前記第1端方向である第1方向にのみ可能なラチェット構造である。前記の構成よれば、操作部による軸部の軸方向への移動が第1方向にのみ可能である構造をラチェット構造で実現できる。 A surgical instrument according to aspect 13 of the present disclosure is the same as aspect 12, except that the connection between the shaft and the operating unit is a ratchet structure that allows the operating unit to move the shaft in the axial direction only in a first direction, which is the first end direction. With this configuration, a ratchet structure can be used to achieve a structure in which the operating unit can move the shaft in the axial direction only in the first direction.
本開示の態様14に係る手術器具は、前記態様12または13において、前記軸部の側面に、前記軸に垂直な第1面と前記軸に対して斜めとなる第2面とにより切り込まれた溝が、前記軸方向に並んで複数配されており、前記操作部は、前記複数の溝の何れかと嵌合する嵌合部を有し、前記嵌合部を前記軸方向に付勢することにより、前記軸部を軸方向に移動させるものであり、前記第1面は、前記第2面よりも、前記第1方向側に配されている。前記の構成によれば、操作部により、軸部を第1方向にのみ移動できる構造を実現できる。 A surgical instrument according to aspect 14 of the present disclosure is the same as aspect 12 or 13, except that the side of the shaft has a plurality of grooves arranged side by side in the axial direction, the grooves being formed by a first surface perpendicular to the shaft and a second surface oblique to the shaft; the operating unit has a fitting portion that fits into one of the plurality of grooves, and moves the shaft in the axial direction by biasing the fitting portion in the axial direction, with the first surface being arranged closer to the first direction than the second surface. This configuration makes it possible to realize a structure in which the operating unit can move the shaft only in the first direction.
本開示の態様15に係る手術器具は、前記態様12~14の何れかにおいて、前記本体部に、弾性体により前記軸部に対して付勢されて前記溝に嵌合するストッパを有する。前記の構成によれば、操作部による操作がなされていないときに、軸部が第1方向とは反対側に押し戻されないようにすることができる。 A surgical instrument according to aspect 15 of the present disclosure is any one of aspects 12 to 14, in which the main body has a stopper that is biased against the shaft by an elastic body and fits into the groove. This configuration prevents the shaft from being pushed back in the direction opposite the first direction when no operation is being performed by the operating unit.
本開示の態様16に係る手術器具は、前記態様12~15の何れかにおいて、前記軸部の前記第1端とは反対側の第2端に、前記軸部の径よりも大きい径を有する取手部を有する。前記の構成によれば、軸部を容易に軸回転させることができる。軸部の溝は、軸の周方向の一部に配されているので、軸部を軸回転させることにより、操作部と軸部の溝との嵌合、およびストッパと軸部の溝との嵌合を解消することができる。 A surgical instrument according to aspect 16 of the present disclosure is any of aspects 12 to 15, and has a handle portion at a second end of the shank opposite the first end, the handle portion having a diameter larger than the diameter of the shank. This configuration allows the shank to be easily rotated about its axis. The groove in the shank is arranged along a portion of the circumference of the shank, so that by rotating the shank about its axis, the engagement between the operating portion and the groove in the shank, and the engagement between the stopper and the groove in the shank, can be released.
以上、本開示に係る発明について、諸図面および実施例に基づいて説明してきた。しかし、本開示に係る発明は上述した各実施形態に限定されるものではない。すなわち、本開示に係る発明は本開示で示した範囲で種々の変更が可能であり、異なる実施形態にそれぞれ開示された技術的手段を適宜組み合わせて得られる実施形態についても本開示に係る発明の技術的範囲に含まれる。つまり、当業者であれば本開示に基づき種々の変形または修正を行うことが容易であることに注意されたい。また、これらの変形または修正は本開示の範囲に含まれることに留意されたい。 The invention according to the present disclosure has been described above based on various drawings and examples. However, the invention according to the present disclosure is not limited to the above-described embodiments. In other words, the invention according to the present disclosure can be modified in various ways within the scope set forth in this disclosure, and embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the invention according to the present disclosure. In other words, it should be noted that a person skilled in the art would easily be able to make various modifications or corrections based on this disclosure. It should also be noted that these modifications or corrections are included in the scope of this disclosure.
1 生体インプラント
2 寛骨臼カップ
21 外面
22 内面
221 第2テーパ面
222 周縁部
23 収容空間
24 挿入孔
3 ライナー
31 外面
311 第1テーパ面
312 周縁部
313 突部
314 噛込み部
32 内面
33 収容空間
34 突出部
4 ベアリング
41 外面
42 内面
43 収容空間
44 開口部
5 骨頭ボール
51 外面
53 凹部
6 嵌合器具(手術器具)
61 本体部
62 骨頭ボール支持部(支持部)
63 軸部
64 押込み部
65 操作部
67 ストッパ
68 取手部
REFERENCE SIGNS LIST 1 Bioimplant 2 Acetabular cup 21 Outer surface 22 Inner surface 221 Second tapered surface 222 Peripheral edge portion 23 Storage space 24 Insertion hole 3 Liner 31 Outer surface 311 First tapered surface 312 Peripheral edge portion 313 Protrusion 314 Biting portion 32 Inner surface 33 Storage space 34 Protrusion 4 Bearing 41 Outer surface 42 Inner surface 43 Storage space 44 Opening 5 Femoral head ball 51 Outer surface 53 Recessed portion 6 Fitting instrument (surgical instrument)
61 Main body portion 62 Femoral head ball support portion (support portion)
63 Shaft portion 64 Push-in portion 65 Operation portion 67 Stopper 68 Handle portion
Claims (16)
前記寛骨臼カップと接する外面を有し、前記寛骨臼カップの内側に位置するライナーと、を備え、
前記ライナーは、前記外面の周縁部に位置し、前記寛骨臼カップの内面の周縁部と接する第1テーパ面を有し、
前記第1テーパ面は、突部を有する、生体インプラント。 an acetabular cup;
a liner positioned inside the acetabular cup and having an outer surface that contacts the acetabular cup;
the liner has a first tapered surface located on a periphery of the outer surface and in contact with a periphery of an inner surface of the acetabular cup;
The biological implant, wherein the first tapered surface has a protrusion.
前記溝は、前記ライナーにおける縁の任意の点と天頂点とを結んだ線とは異なる方向に配される、請求項1に記載の生体インプラント。 the protrusion is formed by arranging a groove in the first tapered surface,
The biological implant according to claim 1 , wherein the grooves are arranged in a direction different from a line connecting any point on the edge of the liner to the apex.
前記突部は、前記ライナーにおける縁の任意の点と天頂点とを結んだ線とは異なる方向に突出している、請求項1に記載の生体インプラント。 the protrusion has a shape that protrudes from the first tapered surface toward the acetabular cup,
The biological implant according to claim 1 , wherein the protrusion protrudes in a direction different from a line connecting an arbitrary point on the edge of the liner to the apex.
前記第1テーパ面と前記第2テーパ面とが嵌合する、請求項1に記載の生体インプラント。 the acetabular cup has a second tapered surface on the periphery of the inner surface;
The biological implant according to claim 1 , wherein the first tapered surface and the second tapered surface mate with each other.
前記ライナーは、前記中心軸に外形の中心を設ける場合と比較して、前記中心軸を含む断面における厚さが大きい領域を有する、請求項1に記載の生体インプラント。 When a straight line passing through the center of the ring formed by the periphery of the liner and parallel to the fitting direction of the acetabular cup and the liner is taken as a central axis,
The biological implant according to claim 1 , wherein the liner has a region where the thickness in a cross section including the central axis is greater than when the center of the outer shape is set at the central axis.
前記ライナーの外形は、前記第1側および前記第2側のそれぞれにおいて、前記中心軸に対して略対称に設けられた点を中心とする円弧を含む形状である、請求項1に記載の生体インプラント。 When a straight line passing through the center of the periphery of the liner and parallel to the fitting direction of the acetabular cup and the liner is defined as a central axis, and when a cross section cut along a plane passing through the central axis and parallel to the fitting direction is defined as a first side and a second side on either side of the central axis,
The biological implant according to claim 1 , wherein the outer shape of the liner is a shape including an arc having a center at a point located approximately symmetrically with respect to the central axis on each of the first side and the second side.
前記ライナーは、前記中心軸を含む断面が、前記ライナーの周縁から前記ライナーの天頂点に向かうにつれて大きくなる領域を有する、請求項1に記載の生体インプラント。 When a straight line passing through the center of the ring formed by the periphery of the liner and parallel to the fitting direction of the acetabular cup and the liner is taken as a central axis,
The biological implant according to claim 1 , wherein the liner has a region in which a cross section including the central axis increases in size from the periphery of the liner toward the apex of the liner.
開口部を有する中空形状のベアリングの内部に、前記骨頭ボールを収容するように前記ベアリングを押し込む押込み部と、
第1端で前記押込み部と接続する軸部と、
前記軸部の側面に接続し、前記本体部に対して前記軸部を軸方向へ移動させる操作部と、を備え、
前記軸部と前記操作部との接続は、前記操作部による前記軸部の前記軸方向への移動が、前記第1端方向である第1方向にのみ可能な構造である、手術器具。 a main body portion having a support portion that supports a femoral head ball;
a pusher for pushing the bearing into a hollow bearing having an opening so as to accommodate the femoral head ball;
a shaft portion that connects to the pusher portion at a first end;
an operating unit connected to a side surface of the shaft portion and configured to move the shaft portion in the axial direction relative to the main body portion;
A surgical instrument in which the connection between the shaft portion and the operating portion is structured such that the operating portion can move the shaft portion in the axial direction only in a first direction, which is the first end direction.
前記操作部は、前記複数の溝の何れかと嵌合する嵌合部を有し、前記嵌合部を前記軸方向に付勢することにより、前記軸部を軸方向に移動させるものであり、
前記第1面は、前記第2面よりも、前記第1方向側に配されている、請求項13に記載の手術器具。 a plurality of grooves are arranged in the axial direction on a side surface of the shaft portion, the grooves being formed by a first surface perpendicular to the shaft and a second surface oblique to the shaft;
the operating portion has a fitting portion that fits into any of the plurality of grooves, and the shaft portion is moved in the axial direction by biasing the fitting portion in the axial direction,
The surgical instrument according to claim 13 , wherein the first surface is disposed on the first direction side of the second surface.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/JP2024/004581 WO2025169469A1 (en) | 2024-02-09 | 2024-02-09 | Biological implant and surgical instrument |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/JP2024/004581 WO2025169469A1 (en) | 2024-02-09 | 2024-02-09 | Biological implant and surgical instrument |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025169469A1 true WO2025169469A1 (en) | 2025-08-14 |
Family
ID=96699622
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/JP2024/004581 Pending WO2025169469A1 (en) | 2024-02-09 | 2024-02-09 | Biological implant and surgical instrument |
Country Status (1)
| Country | Link |
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| WO (1) | WO2025169469A1 (en) |
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| US4834759A (en) * | 1986-04-15 | 1989-05-30 | Sulzer Brothers Ltd. | Endoprosthesis for a hip joint |
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