Segmented keel for prosthesis implants with stems

Abstract

To provide a segmented keel for a prosthetic implant having a stem.SOLUTION: A tibial implant comprises a tibial tray component comprising: a tray plate with proximal and distal surfaces; a stem and a segmented keel that extend from the distal surface, the segmented keel including a first wing having a first notch proximate to the stem; and a first taper extending along the stem in a first axial position axially aligned with the segmented keel. A sleeve for the stem comprises: an annular body; an inner passage extending through the annular body and comprising a Morse taper; and a first slot extending into the annular body to intersect the inner passage and the Morse taper. A method comprises: fabricating a stemmed prosthetic component from a metallic material; advancing a machining tool into a notch in a keel wing extending from the stem; and forming a Morse taper on the stem by means of the machining tool in the notch.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] Priority Claim This application claims the benefit of U.S. Provisional Patent Application No. 63 / 434,566, filed Dec. 22, 2022, and U.S. Patent Application No. 18 / 526,955, filed Dec. 1, 2023, the entire contents of which are hereby incorporated by reference.

[0002] The present disclosure generally relates to, but is not limited to, prosthetic implant devices having a stem configured to be inserted into bone. More specifically, but not limited to, the present application relates to prosthetic tibial and femoral components having a keeled stem for engaging bone material.

Background Art

[0003] Prosthesis implant devices, such as femoral and tibial components, may include a stem extending from the articular component. For example, a tibial component may include a tray attached to a bearing component and set in contact with the resected surface of the tibia at the epiphysis. The stem may extend from the tray into the tibia along the length of the diaphysis. In some cases, the metaphysis of the tibia below the epiphysis may contain damaged or unhealthy cancellous bone at the time of resection. Therefore, it may be desirable to remove weakened bone material, such as cancellous bone, using a broach or reamer to leave space in the metaphysis larger than the stem. In some cases, a sleeve is mechanically bonded to the stem of the tibial component for the purpose of filling the space and providing engagement with cortical bone or other bone material. Furthermore, a cone may be placed around the stem, but detached from the stem, to engage with bone material. The prosthesis implant device can thus be part of a component system to which different accessories, including sleeves, cones, and keels, can be attached to the stem. This system gives the surgeon the ability to select the accessories that will provide the best outcome for the patient.

[0004] Examples of attachable accessories for prosthesis implants having a stem are described in Patent Document 1 to Bonitati, Patent Document 2 to Habegger et al., Patent Document 3 to Yoko et al., Patent Document 4 to Mines et al., Patent Document 5 to Leszko et al., and Patent Document 6 to Keefer et al. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent No. 8,721,733 [Patent Document 2] U.S. Patent No. 10,835,382 [Patent Document 3] U.S. Patent No. 10,987,225 [Patent Document 4] U.S. Patent Application Publication No. 2014 / 0277528 [Patent Document 5] U.S. Patent Application Publication No. 2014 / 0277540 Specification [Patent Document 6] U.S. Patent Application Publication No. 2017 / 0000503 [Overview of the project]

[0006] The inventors recognized that using a link-type full knee prosthesis in which the tibial and femoral components are connected via a link mechanism can result in additional torque being applied from the femoral component to the tibial component. Such additional torque can result in fracture between the tibial component of the prosthesis and the bone material. Therefore, the inventors recognized that it is desirable to have an additional fixation or anti-rotation mechanism between the tibial component and the bone material.

[0007] The subject matter of the present invention can provide solutions to this and other problems, for example, by providing a prosthesis implant component having a stem with an integrated keel. The integrated keel can provide resistance to rotation of the tibial component due to various causes, such as the movement of the joint and femoral component. Thus, the subject matter of the present invention can facilitate the use of a connected full knee prosthesis, which can provide a full knee component that exhibits more stable and realistic performance.

[0008] The inventors recognize that, among other issues to be resolved in the use of stemmed implants, there may be the inconvenience of having to assemble the components of the prosthesis implant during surgery. As mentioned above, depending on the bone material of a particular patient, it may be advantageous to position accessories such as sleeves, cones, or keels around the stem of the tibial component. However, in some cases, the stem can be used without any accessories at all. Therefore, a typical surgical procedure may require attaching accessory components such as sleeves or keels to the main prosthesis component, leaving other accessory components unused. Furthermore, as a result of not using any or only one of the many accessories, the unused accessories may have to be reprocessed before reuse or discarded without ever being used.

[0009] The subject of the present invention is to provide a solution to this and other problems by providing a prosthesis implant component having a stem with an integrated keel having a segmented wing. The segmented wing can be configured to accommodate a sleeve, for example, by including slots or notches. The segmented wing can function as an integrated keel without the use of accessories. Furthermore, the slots inside the segmented wing allow the sleeve to engage with the stem closer to the tibial tray, facilitating interlocking along the longer length of the stem. The segmented keel can still allow the use of a cone. Thus, a tibial component having an integrated keel with a segmented wing can reduce the number of accessory components, in particular separate keel components, and eliminate the need to assemble the stem and accessories when keel functionality is desired. Therefore, a tibial component set or system can include only a tibial tray component with an integrated and segmented keel, cone, and sleeve. Such a system eliminates the need to manufacture and assemble separate keel accessories.

[0010] The inventors also recognized that attaching accessory components to a prosthesis implant having a stem can be difficult. Specifically, attaching the accessory component to the stem in place can be difficult due to the possibility of interference with tapered connections, such as Morse tapers. Morse tapers involve fitting the carefully machined outer and inner surfaces of the stem and sleeve. However, the presence of the keel's wings on the stem can interfere with the ability of the inner surface of the sleeve to contact the outer surface of the stem.

[0011] The subject matter of the present invention can provide solutions to this and other problems, for example, by providing a keel having segmented wings that allow a machining tool to advance along the outer surface of the stem and generate a conical tapered surface without interference from the wings of the keel. Thus, the machining tool can be brought closer to the tibial tray to form a tapered surface closer to the tibial tray. Subsequently, accessory components such as sleeves can have a longer engagement length for tapered connections closer to the tray.

[0012] In one embodiment, the tibial implant may include a tibial tray component comprising: a tray plate including a proximal surface and a distal surface; a stem extending from the distal surface; a segmented keel extending from the distal surface, the segmented keel including a first wing having a first notch near the stem; and a first taper extending along the stem at a first axial position axially aligned with the segmented keel.

[0013] In another embodiment, the stem sleeve of a prosthesis implant may include an annular body, an internal passage extending through the annular body and including a Morse taper, and a first slot extending into the annular body and intersecting the internal passage and the Morse taper.

[0014] In another embodiment, the prosthesis implant may include a prosthesis component comprising an articular component, a stem extending from the articular component, and a first segmented keel wing extending from the stem, and a slotted sleeve comprising an annular body, an internal passage extending through the annular body configured to accommodate the stem, and a first slot extending within the annular body and intersecting the internal passage, the first slot configured to align with the first segmented keel wing.

[0015] In an additional embodiment, a method for manufacturing a stemmed prosthesis component may include manufacturing the stemmed prosthesis component from a metallic material; positioning a machining tool around a stem extending from the stemmed prosthesis component; advancing the machining tool into a notch in a keel wing extending from the stem; and forming a Morse taper on the stem using the machining tool in the notch.

[0016] This summary is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive description of the invention. Further details are included to provide more information about this patent application. [Brief explanation of the drawing]

[0017] [Figure 1A] Figure 1A is an anterior or frontal perspective view of a prosthesis knee assembly, including a femoral component configured to rotate in conjunction with a tibial component. [Figure 1B] Figure 1B is an exploded view of the knee prosthesis assembly from Figure 1A, showing the various components, including a segmented keel configured for use with a slotted sleeve. [Figure 2] Figure 2 is a transverse section of the prosthesis knee assembly shown in Figure 1A, illustrating the shackle connecting the hinge axis of the femoral component to the hinge post of the tibial component. [Figure 3A-3B] Figures 3A and 3B are exploded top and bottom views of the tibial components of FIGS. 1A to 2, showing a tibial tray, a slotted sleeve, a bushing, and a cap. [Figure 4A-4B] Figures 4A and 4B are top and bottom, or upper and lower perspective views of the tibial components of FIGS. 3A and 3B, with a slotted sleeve attached to a segmented keel without a tibial bearing component. [Figure 5] Figure 5 is a side cross-sectional view of the tibial component of FIGS. 4A and 4B, showing a slotted sleeve mounted to the stem of the tibial component. [Figure 6A] Figure 6A is a rear or back view of the tibial tray of FIGS. 1 to 5, showing a pair of segmented keel wings extending from the stem. [Figure 6B] Figure 6B is an enlarged view of the tibial tray of FIG. 6A, showing a cutout forming the segmented keel wings in the stem. [Figure 7A] Figure 7A is a front perspective view of the slotted sleeve of FIGS. 1 to 5, showing slots extending from a central passage. [Figure 7B] Figure 7B is a bottom perspective view of the slotted sleeve of FIG. 7A, showing slots extending through to an external surface. [Figure 7C] Figure 7C is a front view of the slotted sleeve of FIGS. 7A and 7B, showing side lobes extending from the body. [Figure 7D] Figure 7D is a plan view of the slotted sleeve of FIGS. 7A to 7C, showing an internal ledge along a central passage. [Figure 8] Figure 8 is a cross-sectional view of the tibial tray of FIGS. 6A to 6B assembled with the slotted sleeve of FIGS. 7A to 7D cut along the segmented keel wings to show the engagement of the slotted sleeve with the stem on the front and rear sides of the stem. <00001Figure 9A is a cross-sectional view of a slotted sleeve assembled on a tibial tray, showing the engagement between the segmented keel and the slotted sleeve at various positions along the stem. [Figure 9B] Figure 9B is a cross-sectional view of a slotted sleeve assembled on a tibial tray, showing the engagement between the segmented keel and the slotted sleeve at various positions along the stem. [Figure 9C] Figure 9C is a cross-sectional view of a slotted sleeve assembled on a tibial tray, showing the engagement between the segmented keel and the slotted sleeve at various positions along the stem. [Figure 9D] Figure 9D is a cross-sectional view of a slotted sleeve assembled on a tibial tray, showing the engagement between the segmented keel and the slotted sleeve at various positions along the stem. [Figure 10] Figure 10 is a posterior bottom perspective view of the tibial tray shown in Figures 6A and 6B, assembled with the winged sleeve. [Figure 11] Figure 11 is an upper front perspective view of the sleeve with wings from Figure 10, showing the wings of the sleeve configured to fill the slots within the wings of the keel.

[0018] In drawings that are not necessarily drawn to actual size, similar numbers may represent similar components in different drawings. Similar numbers with different letter suffixes may represent different instances of similar components. Drawings generally illustrate, but not limited to, various embodiments discussed herein. [Modes for carrying out the invention]

[0019] Figure 1A is a front perspective view of the prosthesis knee assembly 100, which includes a tibial component 102 configured to rotate in conjunction with a femoral component 104. Figure 1B is an exploded view of the prosthesis knee assembly 100 of Figure 1A, showing various components, including a segmented keel 142 (Figures 6A and 6B) configured for use with a slotted sleeve 140 (Figures 7A to 7D). Figure 2 is a cross section of the prosthesis knee assembly 100 of Figure 1A, showing a shackle 106 connecting the hinge post 108 of the tibial component 102 to the hinge axis 110 of the femoral component 104. Figures 1A to 2 are discussed together.

[0020] The tibial component 102 may include a tibial tray 114, a bearing component 116, a bushing 118, and a cap 120. The femoral component 104 may include a bearing surface 121, a stem socket 122, and a side wall 124. Furthermore, the femoral component 104 can be connected to an extension 130 (see Figure 1B) as a stem socket 122, and the tibial component 102 can be connected to an extension 132 (see Figure 2) at a socket 134 (see Figure 2).

[0021] The tibial component 102 and the femoral component 104 can be connected using a shackle 106, a hinge post 108, and a hinge shaft 110. The shackle 106 can rotate around the hinge post 108 along axis AA to allow the femoral component 104 to rotate relative to the tibial component 102. The shackle 106 can pivot about the hinge shaft 110 on axis AB to allow the femoral component 104 to roll along the tibial component 102. Thus, the bearing surface 121 can roll in anterior-posterior direction along the bearing component 116 and can twist in contact with the bearing component 116 along the upper-lower axis.

[0022] The shackle 106 can mechanically connect the femoral component 104 and the tibial component 102 by a hinge post 108 that attaches the shackle 106 to the tibial tray 114 and a hinge shaft 110 that attaches the shackle 106 to the side wall 124. A portion of the shackle 106 can be housed in a recess in the support component 116, and this portion can be screwed into the hinge post 108 or connected in other ways. The hinge post 108 can extend distally and be housed in a recess in the tibial component 102 and a recess in the support component 116. The hinge post 108 may be movable (e.g., rotatable and / or extendable) relative to one or more of the femoral component 104 or the tibial tray 114. For example, the hinge post 108 can be rotatably connected to the femoral component 104 via the hinge axis 110, thereby causing movement of the femoral component around axis AA, as will be further detailed below.

[0023] When assembled, the shackle 106 can be positioned between the opposing side walls 124 of the femoral component 104. The polybox 128 can be positioned between the side walls 124 and the shackle 106. Furthermore, the shaft bushing 126 can be positioned on the hinge shaft 110 inside the opening on the proximal portion of the shackle 106. The shackle 106 and hinge post 108 can be formed from suitable materials such as titanium alloy or cobalt-chromium alloy, while the shaft bushing 126 and polybox 128 can be formed from different materials such as plastic, for example, UHMWPE. The shaft bushing 126 can function as a bearing between the shackle 106 and the hinge shaft 110. The polybox 128 can function as a bearing between the femoral component 104 and the shackle 106.

[0024] In this manner, the femoral component 104 and the tibial component 102 can work together to replace natural knee ligaments such as the posterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), replicating the natural movement and sensation of the anatomical joint. As described above, linking the femoral component 104 to the tibial component 102 may be desirable to transmit additional load to the tibial component 102, thereby providing additional fixation to the tibial component 102. As discussed herein, the tibial component 102 may include a segmented keel 142 to provide anti-rotation engagement with the bone. Furthermore, the segmented keel 142 may engage with the sleeve along a tapered interface close to the tray plate 144 despite the presence of the segmented keel 142, due to the segmented keel wings described herein.

[0025] Figure 3A is a top-view exploded assembly view of the tibial component 102 from Figures 1A and 2, showing the tibial tray 114, slotted sleeve 140, bushing 118, and cap 120. Figure 3B is a bottom-view exploded assembly view of the tibial component 102 from Figures 1A and 2. Figures 3A and 3B are discussed together.

[0026] A bushing 118 can be inserted into the bore 150, and this bushing 118 may include a sleeve into which a hinge post 108 can be inserted. For example, the bushing 118 may be pressure-fitted or motion-fitted into the bore 150, and this bushing may include internal threads to accommodate mating external threads on the hinge post 108. To prevent the bushing 118 from dislodging out of the bore 150 in the proximal direction, a cap 120 may be screwed into the mating threads on the bore 150. In the embodiment, the upper or upper surface of the bushing 118 may be separated from the bottom or lower surface of the cap 120 by a certain distance D1 (Figure 2) to provide an anti-dislocation stroke. For example, the gap provided by distance D1 can allow the femoral component 104 to move proximal to the tibial component 102 to prevent patellar dislocation or to accommodate the rolling of the support surface 121 of the femoral component 104 against the support component 116 of the tibial component 102. In the embodiment, distance D1 may be approximately 8 mm (about 0.315 inches). However, in additional embodiments of the present disclosure, the cap 120 and bushing 118 can be integrated into a single component to prevent the femoral component 104 from moving upward in relation to the tibial component 102.

[0027] Due to the linkage mechanism of the femoral component 104 (Figure 1A) to the tibial component 102, the tibial tray 114 may be subjected to additional rotational forces in the transverse plane along the superior-inferior axis AA. To counteract rotational movement around axis AA, the tibial tray 114 may include a segmented keel 142 to provide fixation within the bone material in a direction extending radially from axis AA. If desired, a slotted sleeve 140 can be positioned on the stem 146 to occupy additional space within the bone and provide additional fixation. For example, the segmented keel 142 can be used within the cancellous bone of the proximal portion of the resected tibia engaging with the tray plate 144 if the cancellous bone is generally healthy or has sufficient density to accommodate the wings 148A and 148B of the segmented keel 142 to provide rotational resistance in other ways. However, if the cancellous bone surrounding the stem 146 is unhealthy or otherwise lacks sufficient density, the slotted sleeve 140 can be fitted around the stem 146 and attached to it to move the inadequate cancellous bone (with or without removal using a reamer or broach) and engage with healthy or dense bone material, including, in some cases, engagement with cortical bone.

[0028] Figure 4A is a top perspective view of the tibial component 102 of Figures 3A and 3B, with a slotted sleeve 140 attached to the segmented keel 142, but without the bearing component 116. Figure 4B is a bottom perspective view of the tibial component 102 of Figure 4A, showing the slotted sleeve 140 attached to the segmented keel 142. Figures 4A and 4B are discussed together.

[0029] The tibial tray 114 may include a tray plate 144 and a stem 146. A segmented keel 142 can be connected to the tray plate 144 and the stem 146. The tibial tray 114 may further include a bore 150 extending within the tray plate 144 and the stem 146, and a mechanism for attaching the support component 116, such as a hook 152 and a ridge 154. The slotted sleeve 140 may include a body 160, a central passage 161, lobes 162A and 162B, slots 164A and 164B.

[0030] The bore 150 may allow the bushing 118 (Figure 1B) and the hinge post 108 (Figure 1B) to pass through the stem 146. The hook 152 and ridge 154 may be configured to attach the support component 116 to the tray plate 144.

[0031] The segmented keel 142 may include wings 148A and 148B that extend radially outward from the stem 146 and axially downward from the tray plate 144. Thus, wings 148 and 148B may extend into bone material such as cancellous bone with which the tray plate 144 is in contact and engages. As will be discussed in more detail with reference to Figures 6A and 6B, wings 148A and 148B may include slots 190A and 190B, respectively, to allow machining of the stem 146 and to allow the slotted sleeve 140 to engage with the stem 146. As will be discussed in more detail with reference to Figures 7A to 7D, the slotted sleeve 140 may include slots 164A and 164B to allow the slotted sleeve 140 to fit around wings 148A and 148B.

[0032] Figure 5 is a side cross-sectional view of the tibial component 102 of Figures 4A and 4B. The slotted sleeve 140 can be positioned on the stem 146 so that its inner surface 172 engages with its outer surface 147. The inner surface 172 or a portion thereof may be configured to engage with the outer surface 147 or a portion thereof using a tapered interface such as a Morse taper. In this embodiment, the outer surface 147 of the stem 146 may be configured to have a Morse taper, and the inner surface 172 of the slotted sleeve 140 may be configured to have a mating recess so that a self-retaining connection can be made. Such configurations are discussed in detail in U.S. Patent No. 6,911,100 to Gibbs et al., which is incorporated herein by reference in its entirety for all purposes. In other embodiments, other tapered connections may be used, such as those described in U.S. Patent Application Publication No. 2015,0216667 to Monaghan, which is incorporated herein by reference in its entirety for all purposes. In the embodiment, both the sleeve 140 and the stem 146 can be manufactured from a metallic material such as stainless steel or titanium, which facilitates Morse taper connection. In the embodiment, the sleeve 140 can be manufactured from a porous metal structure. The use of a Morse taper may allow the sleeve 140 to be attached to the stem 146 without the use of fasteners or additional components. For example, the sleeve 140 can be separated from the lower surface 182 of the tray plate 144, thus avoiding the use of fasteners to connect the sleeve 140 to the tray plate 144.

[0033] As can be seen in Figure 5, the central portion of the sleeve 140 can engage with the stem 146, which has been separated from the segmented keel 142, within zone 156. Thus, as can be seen in Figure 9D, the internal surface 172 and the external surface 147 can engage along a 360-degree interface with respect to axis AA within zone 156. However, it is possible to position the proximal portion of the sleeve 140 in the same axial position as the segmented keel 142 with respect to axis AA. Thus, as can be seen in Figure 9C, only the portion of the internal surface 172 can engage with the external surface 147 within zone 158. Furthermore, as can be seen in Figures 9A and 9B, other portions of the sleeve 140 can be completely disengaged from the stem 146, such as at the nearest portion. The stem 146 can be disengaged from the sleeve 140 and extend into zone 159. As will be discussed in more detail with reference to Figures 8 to 9D, the nearest portion of the sleeve 140 in zone 158 can engage with the stem 146 along the foremost and rearmost segments of the stem 146 due to the locations of the wing sections 148A and 148B.

[0034] Figure 6A is a posterior view of the tibial tray 114 shown in Figures 1 to 5. Figure 6B is an enlarged view of the tibial tray 114 of Figure 6A, showing the slots 190A and 190B in the stem 146 that form the segmented keel wings 148A and 148B, respectively. Figures 6A and 6B are discussed together.

[0035] The tibial tray 114 may include a tray plate 144 and a stem 146. The tray plate 144 may include an upper surface 180 on which the support component 116 can be mounted. A lower surface 182 may be positioned opposite the upper surface 180. The outer edge 184 may connect the upper surface 180 and the lower surface 182 and may have an outer circumference that aligns with the outer circumference of the proximal portion of the tibia. The stem 146 may extend from the lower surface 182 along axis AA. As discussed, the stem 146 may have a proximal portion in zone 158 and a central portion in zone 156. The proximal portion may be an axial portion coexisting with the segmented keel 142, and the central portion may be the distal portion of the proximal portion. The stem 146 may include a furthest distal portion in zone 159, which is the distal portion of the central portion, and has a smaller diameter than the central portion to facilitate the positioning of the sleeve 140 around the stem 146.

[0036] The segmented keel 142 can further extend from the lower surface 182. The segmented keel 142 can be connected to the tray plate 144 and the stem 146. In detail, the segmented keel 142 may include wings 148A and wing 148B that can extend radially outward from the stem 146 along the tray plate 144. Wing 148A may include a distal portion 186A, a proximal portion 188A and a slot 190A. Wing 148B may include a distal portion 186B, a proximal portion 188B and a slot 190B. The distal portion 186A may include an inclined end 192A and a flat end 194A. The proximal portion 188A may include a trough 198A and a side wall 196A. The distal portion 186B may include an inclined end 192B and a flat end 194B. The proximal portion 188B may include a trough 198B and a side wall 196B. Slot 190A may be formed by trough 198A, and slot 190B may be formed by trough 198B. ​​As discussed below, the shapes of the wing portions 148A and 148B and slots 190A and 190B can be configured to accommodate machining tools for shaping the stem 146.

[0037] All or part of the stem 146 in the central zone 156, and all or part of the stem 146 in the nearest zone 158, can be formed to have a tapered surface for a Morse taper. For example, the proximal portion of the stem 146 in zone 156 and the distal portion of the stem 146 in the nearest zone 158 can be machined to have a Morse taper. The machining tool 200 ( schematically shown in Figure 6A) may include a cylindrical body 202 having an inner machined surface 204 and an outer wall 206. The cylindrical body 202 may have a wall 208 between the inner machined surface 204 and the outer wall 206. The machining process includes positioning the machining tool 200 over the entire stem 146. The cylindrical body 202 can be reciprocated and / or rotated to engage the inner machined surface 204 with the outer surface 147 of the stem 146 to form a tapered connecting surface, such as a Morse taper surface. The wings 148A and 148B may include slots 190A and 190B, respectively, so that the machining tool 200 can be brought close to the tray plate 144. The slots 190A and 190B may include notches that can receive the machining tool or a portion of the sleeve. The total outer diameter of the cylindrical body 202 may be smaller than the distance between the side walls 196A and 196B. Furthermore, the radial width of the slots 190A and 190B in relation to the axis AA, for example, the length of the troughs 198A and 198B, may be larger than the radial thickness of the outer wall 206. Thus, a portion of the sleeve 140 can be configured to engage with the stem 146 in the vicinity of the tray plate 144, despite the presence of the segmented keel 142. Furthermore, in various embodiments, the slots 190A and 190B can be used to accommodate a portion of the sleeve 140. For example, the portion of sleeve 140 can extend into slots 190A and 190B, as shown in Figure 10.

[0038] Figure 7A is a front perspective view of the slotted sleeve 140 of Figures 1 to 5, showing slots 164A and 164B extending from the central passage 161. Figure 7B is a bottom perspective view of the slotted sleeve 140 of Figure 7A, showing slots 164A and 164B extending through to the outer surface 166. Figure 7C is a front view of the slotted sleeve 140 of Figures 7A and 7B, showing side lobes 162A and 162B extending from the main body 160. Figure 7D is a plan view of the slotted sleeve 140 of Figures 7A to 7C, showing internal ledges 175 and 177 along the central passage 161. Figures 7A to 7D are discussed together.

[0039] The slotted sleeve 140 may include a body 160, a central passage 161, lobes 162A and 162B, slots 164A and 164B. Slots 164A and 164B may include receptacles capable of receiving portions of the keel wings 148A and 148B. The body 160 may include an outer surface 166, a bottom surface 168, an upper surface 170 and an inner surface 172. Slots 164A and 164B may form a rear wall 174 with a ledge 175 and a front wall 176 with a ledge 177 within the body 160. Slot 164A may include a bottom wall 178A, a front wall 178B, and a rear wall 178C, and slot 164B may include a bottom wall 179A, a front wall 179B, and a rear wall 179C.

[0040] Figure 8 is a cross-sectional view of the tibial tray 114 of Figures 6A and 6B assembled with the slotted sleeve 140 of Figures 7A to 7D, cut along the segmented keel wing 148B to show the engagement of the stem 146 with the slotted sleeve 140 on the anterior and posterior sides of the stem 146. The outer surface 147 of the stem 146 can engage with the inner surface 172 along the anterior portion at interface 199A and along the posterior portion at interface 199B. As can be seen in Figure 8, interface 199A can extend proximal to the axial space of the wing 148B, while interface 199B can be positioned distal to the wing 148B.

[0041] In the embodiment, the axial height of the distal portions 186A and 186B, for example, the distance between the tray plate 144 and the flat ends 194A and 194B, may be less than or equal to about half the height of the sleeve 140 between the upper surface 170 and the bottom surface 168. In an additional embodiment, the height of the distal portions 186A and 186B may be in the range of about 30% to about 60% of the height of the sleeve 140.

[0042] In the embodiment, the axial height of the proximal portions 188A and 188B, for example, the distance between the tray plate 144 and the troughs 198A and 198B, may be about one-quarter or less of the length of the height of the sleeve 140 between the upper surface 170 and the bottom surface 168. In an additional embodiment, the height of the distal portions 186A and 186B may be in the range of about 0% to about 40% of the height of the sleeve 140. For example, the proximal portions 188A and 188B may be omitted.

[0043] In the embodiment, when the sleeve 140 is fully engaged with the stem 146, the upper surface 170 of the sleeve 140 can be configured to be below the lower surface 182 of the tray plate 144. In the embodiment, when the sleeve 140 is fully engaged with the stem 146, the bottom walls 178A and 179A can be below the flat ends 194A and 194B.

[0044] Figures 9A, 9B, 9C, and 9D are cross-sectional views of a slotted sleeve 140 assembled on a tibial tray 114, showing the engagement between the segmented keel 142 and the slotted sleeve 140 at various positions along the stem 146.

[0045] Figure 9A is a view of the section 9A-9A of Figure 8, cut along the proximal portions 188A and 188B and distal portions 186A and 186B of the wing portions 148A and 148B. The rear wall 174 and the front wall 176 can be disengaged from the stem 146. Furthermore, the rear wall 174 and the front wall 176 can be separated from the lower surface 182 of the tray plate 144. By disengaging the sleeve 140 from the tray plate 144, it is possible to avoid applying stress from the sleeve 140 to the tray plate 144.

[0046] Figure 9B is a cutaway view of the section 9B-9B of Figure 8 along the distal portions 186A and 186B of the wing sections 148A and 148B, where the stem 146 and sleeve 140 are not engaged. The rear wall 174 and front wall 176 can remain disengaged from the stem 146. The separation of the stem 146 from the sleeve 140 can be provided by ledges 175 and 177. Such separation provides a path for the Morse taper between the inner surface 172 of the sleeve 140 and the outer surface 147 of the stem 146 to interlock. That is, if the tapered surfaces of the outer surface 147 and the inner surface 172 are advanced all the way to the lower surface 182 of the tray plate 144, it is conceivable that the ability of the Morse taper to fully engage may be hindered. For example, a machining tool 200 (see Figure 6A) does not need to advance all the way to the lower surface 182 of the tray plate 144. Such a gap may be provided by the proximal portions 188A and 188B to prevent the cutting tool 200 from advancing.

[0047] Figure 9C is a cutaway view of section 9C-9C of Figure 8 along the distal portions 186A and 186B of the wing sections 148A and 148B, where the stem 146 and sleeve 140 are engaged. The rear wall 174 and the front wall 176 can engage with the stem 146. The engagement between the stem 146 and the sleeve 140 can be provided below or distal to the ledges 175 and 177. Thus, the foremost portion of the sleeve 140 on the front wall 176 can be engaged with the stem 146 using a tapered connection such as a Morse taper. Similarly, the rearmost portion of the sleeve 140 on the rear wall 174 can be engaged with the stem 146 using a tapered connection such as a Morse taper. The Morse taper surface shown in Figure 9C extends into the same axial space as the blades 148A and 148B and can provide an additional coupling force beyond what would be provided if the machining tool 200 only advanced to the blades 148A and 148B and did not enter the slots 190A and 190B.

[0048] Figure 9D is a cross-section of Figure 8 along the stem 146 and sleeve 140, cut at 9D-9D, showing the sleeve 140 engaged with the stem along its 360-degree circumference. The body 160 of the sleeve 140 can engage with the stem 146. The engagement between the stem 146 and the sleeve 140 can be provided around the entire 360-degree circumference of the stem 146 using tapered connections such as Morse tapers. Thus, the sleeve 140 can be securely engaged with the stem 146 without the use of fasteners. The lobes 162A and 162B can extend radially outward from the body 160 to cover the slots 190A and 190B.

[0049] Figure 10 is a bottom rear perspective view of the tibial tray 114 of Figures 6A and 6B assembled with the winged sleeve 250. Figure 11 is a top front perspective view of the winged sleeve 250 of Figure 10, showing wings 252A and 252B configured to fill slots 190A and 190B, respectively, within wings 148A and 148B of the segmented keel 142. The winged sleeve 250 includes a cylindrical body 254 from which wings 252A and 252B extend. An internal passage 256 can extend through the cylindrical body 254. Figures 10 and 11 are discussed together.

[0050] The cylindrical body 254 can be constructed in a similar shape to the body 160 of the sleeve 140, but the lobes 162A and 162B are replaced by wings 252A and 252B. The wings 252A and 252B may have the same or similar shape as the slots 190A and 190B. The wings 252A and 252B may be slightly smaller than the slots 190A and 190B to facilitate insertion of the wings 252A and 252B into the slots 190A and 190B. The wings 252A and 252B may have the same or equivalent thickness as the wings 148A and 148B. In the embodiment, the wings 252A and 252B may include tapered distal surfaces 258A and 258B that extend along the cylindrical body 254 to facilitate insertion into the bone and provide stability. For example, the distal surfaces 258A and 258B can provide a cutting surface. The wing portions 252A and 252B can extend to the same height as the nearest surface of the cylindrical body 254 to facilitate installation within the slots 190A and 190B. In the embodiment, the cylindrical body 254 can be synchronized with the stem 146 to facilitate the orientation of the wing portions 252A and 252B with the slots 190A and 190B. For example, the outer surface 147 of the stem 146 may include a slot or flange that can be aligned with a flange or slot on the inner passage 256.

[0051] The wings 252A and 252B can provide additional anti-rotation capability to the tibial tray 114, for example, to prevent the tibial tray 114 from rotating within the bone material of the excised tibia. In additional embodiments, the thickness of the cylindrical body 254 can be increased, the size of the wings 252A and 252B can be reduced, or the wings 252A and 252B can be omitted. Thus, the added thickness of the cylindrical body 254 can provide additional fixation within the bone material. Similarly, in additional embodiments, the wings 252A and 252B can have other shapes or thicknesses to facilitate engagement with the bone material, or the wings 252A and 252B can be offset from the wings 148A and 148B.

[0052] As discussed herein, segmented keels and associated slotted sleeves can facilitate the coupling of a sleeve to a keeled or winged stem by 1) reducing the number of assembly steps performed during surgery by providing a one-piece keel, 2) reducing the number of accessory components that may be used during surgery by eliminating separate keel accessories, and 3) providing a keel wing having segments or slots that can accommodate machining tools for forming tapered surfaces, such as those used for Morse tapers. [Examples]

[0053] Example 1 is a tibial implant comprising a tray plate including a proximal surface and a distal surface; a stem extending from the distal surface; a segmented keel extending from the distal surface, the segmented keel including a first wing having a first notch near the stem; and a first taper extending along the stem at a first axial position axially aligned with the segmented keel.

[0054] In Example 2, the subject of Example 1 optionally includes the first notch being adjacent to the stem.

[0055] In Example 3, the subject matter of any one or more of Examples 1 to 2 optionally includes that the first wing portion has a first height from the distal surface at the first notch and a second height from the distal surface away from the first notch, wherein the second height is greater than the first height.

[0056] In Example 4, the subject of any one or more of Examples 1 to 3 optionally includes a second wing portion extending from a distal surface separated from the first wing portion.

[0057] In Example 5, the subject matter of any one or more of Examples 1 to 4 optionally includes the first taper extending into the first notch.

[0058] In Example 6, the subject matter of any one or more of Examples 1 to 5 optionally includes the first taper being separated from the distal surface of the tray plate by a portion of the first wing within the first notch.

[0059] In Example 7, the subject matter of any one or more of Examples 1 to 6 optionally includes the provision that the first taper is a Morse taper.

[0060] In Example 8, the subject matter of any one or more of Examples 5 to 7 optionally includes a stem having a second taper at a second axial position at the distal tip of the stem, wherein the second taper comprises a constricted portion of the stem.

[0061] In Example 9, the subject of any one or more of Examples 1 to 8 optionally includes a sleeve that can be coupled to a stem, the sleeve including a first slot for housing a first wing section.

[0062] In Example 10, the subject of Example 9 optionally includes the first wing portion fitting into the first notch and the proximal surface of the sleeve being close to the distal surface of the tray plate.

[0063] In Example 11, the subject matter of any one or more of Examples 9 to 10 optionally includes the sleeve further comprising a first lobe protruding from the outer surface of the sleeve in the first slot.

[0064] In Example 12, the subject of Example 11 optionally further includes a channel that extends within the first lobe and forms an extended portion of the first slot.

[0065] In Example 13, the subject matter of any one or more of Examples 9 to 12 optionally includes the configuration in which the sleeve is fitted into a first notch spaced apart from the distal surface of the tray plate.

[0066] In Example 14, the subject of any one or more of Examples 1 to 13 optionally further includes a sleeve that can be coupled to a stem, the sleeve including a first sleeve wing portion configured to be housed within a first notch.

[0067] Example 15 is a sleeve for the stem of a prosthesis implant, comprising an annular body, an internal passage extending through the annular body and including a Morse taper, and a first slot extending within the annular body and intersecting the internal passage and the Morse taper.

[0068] In Example 16, the subject of Example 15 optionally includes the annular body comprising a first lobe extending from the outer surface of the annular body aligned with a first slot, the first lobe comprising a first channel extending from the first slot.

[0069] In Example 17, the subject of Example 16 optionally includes a second slot extending within the annular body and intersecting the inner passage and Morse taper; a second lobe extending from the outer surface of the annular body aligned with the second slot; and a second channel extending from the second slot.

[0070] In Example 18, the subject matter of any one or more of Examples 15 to 17 optionally includes the inner passage comprising a first ledge spaced a Morse taper apart from the proximal surface of the annular body.

[0071] Example 19 is a prosthesis implant comprising a prosthesis component including an articular component, a stem extending from the articular component, and a first segmented keel wing extending from the stem; and a slotted sleeve including an annular body, an internal passage extending through the annular body configured to accommodate the stem, and a first slot extending within the annular body and intersecting the internal passage, the first slot configured to align with the first segmented keel wing.

[0072] In Example 20, the subject matter of Example 19 optionally includes the first slot being radially longer than the first notch extending into the first segmented keel wing portion.

[0073] In Example 21, the subject matter of any one or more of Examples 19 to 20 optionally includes the fact that the proximal surface of the slotted sleeve is separated from the articulating component when the internal passage is fully mounted on the stem.

[0074] In Example 22, the subject matter of any one or more of Examples 19 to 21 optionally includes a configuration in which the stem and inner passage are fitted with a first segmented keel wing using a Morse taper having an axially overlapping portion.

[0075] Example 23 is a method for manufacturing a stemmed prosthesis component, comprising: manufacturing a stemmed prosthesis component from a metal material; positioning a machining tool around a stem extending from the stemmed prosthesis component; advancing the machining tool into a notch in a keel wing extending from the stem; and forming a Morse taper on the stem using the machining tool in the notch.

[0076] In Example 24, the subject matter of Example 23 is further advanced by the machining tool passing through the most distal end of the keel blade and moving in the proximal direction.

[0077] These non-limiting embodiments may be independent, or they may be combined in various substitutions or combinations with one or more of the other embodiments.

[0078] Appendix The above detailed description includes references to the accompanying drawings, which form part of this detailed description. The drawings illustrate specific embodiments that can put the invention into practice. These embodiments are also referred to herein as “Examples.” Such embodiments may include other elements in addition to those illustrated or described. However, the inventors also intend embodiments comprising only those illustrated or described elements. Furthermore, the inventors also intend embodiments using any combination or substitution of those illustrated or described (or those comprising those embodiments) with respect to a particular embodiment (or one or more aspects thereof) or to other embodiments (or one or more aspects thereof) illustrated or described herein.

[0079] In the event of any usage conflict between this specification and any document incorporated by reference, the usage in this specification shall prevail.

[0080] In this specification, the terms "a" or "an" are used to include one or more, independently of any other instance or usage of "at least one" or "one or more," as is common in patent documents. In this specification, unless otherwise indicated, the term "or" is used to mean non-exclusive "or," or "A or B" is used to include "A but B," "B but not A," and "A and B." In this specification, the terms "including" and "in which" are used as plain English equivalents of the terms "comprising" and "wherein," respectively. Similarly, in the following claims, the terms “including” and “comprising” are open-ended; that is, systems, devices, articles, compositions, formulations, or processes that include other elements in addition to those listed after such terms in the claim are still considered to fall within the scope of the claim. Furthermore, in the following claims, the terms “first,” “second,” and “third” are used merely as labels and are not intended to impose numerical requirements on their objects.

[0081] The above description is intended to be illustrative, not restrictive. For example, the above embodiments (or one or more of their embodiments) may be used in combination with each other. For example, a person skilled in the art, after carefully examining the above description, may use other embodiments. An abstract is provided in accordance with 37 C. FR § 1.72(b) to allow the reader to quickly review the contents of the technical disclosure. The abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Similarly, in the above detailed description, various features may be grouped together in order to simplify the disclosure. This should not be interpreted as meaning that any unclaimed disclosed features are essential to any claim. Rather, the subject matter of the invention may be contained in fewer features than all of the particular disclosed embodiments. Accordingly, the following claims are incorporated herein as embodiments or embodiments within the detailed description, and each claim stands alone as a separate embodiment, and such embodiments are intended to be combinable with each other in various combinations or permutations. The scope of the present invention shall be determined by reference to the appended claims, along with the entire scope of equivalents for which rights are granted in the appended claims. According to embodiment (1), a tibial implant comprising a tibial tray component, The tibial tray component is, It is a tray plate, Proximal surface and Distal surface and A tray plate including, A stem extending from the distal surface, A segmented keel extending from the distal surface, comprising a first wing portion having a first notch near the stem, A first taper extending along the stem at a first axial position aligned axially with the segmented keel, This is a tibial implant that includes [a specific component]. According to embodiment (2), the first notch is adjacent to the stem. According to embodiment (3), the first wing portion has a first height from the distal surface at the first notch and a second height from the distal surface at a distance from the first notch, wherein the second height is greater than the first height. According to embodiment (4), the invention further includes a second wing portion that is separated from the first wing portion and extends from the distal surface. According to embodiment (5), the first taper extends within the first notch. According to embodiment (6), the first taper is separated from the distal surface of the tray plate by a portion of the first wing within the first notch. According to embodiment (7), the first taper includes a Morse taper. According to embodiment (8), the stem includes a second taper at a second axial position at the distal tip of the stem, and the second taper includes a constricted portion of the stem. According to embodiment (9), the invention further includes a sleeve that can be coupled to the stem, the sleeve including a first slot for accommodating the first wing portion. According to embodiment (10), the first wing portion is fitted into the first notch, and the proximal surface of the sleeve can come into close proximity to the distal surface of the tray plate. According to embodiment (11), the sleeve further includes a first lobe that protrudes from the outer surface of the sleeve in the first slot. According to embodiment (12), the invention further includes a channel that extends within the first lobe and forms an extended portion of the first slot. According to embodiment (13), the sleeve is configured to fit into the first notch spaced apart from the distal surface of the tray plate. According to embodiment (14), the present invention further includes a sleeve that can be coupled to the stem, the sleeve including a first sleeve wing portion configured to be housed within the first notch. According to embodiment (15), a sleeve for the stem of a prosthesis implant, The ring-shaped body and An inner passage extending through the aforementioned annular body, comprising an inner passage including a Morse taper, A first slot extending within the annular body and intersecting the inner passage and the Morse taper, This is a sleeve equipped with [features / equipment]. According to embodiment (16), the annular body includes a first lobe extending from the outer surface of the annular body aligned with the first slot, and the first lobe includes a first channel extending from the first slot. According to embodiment (17), a second slot extending within the annular body and intersecting the inner passage and the Morse taper, A second lobe extending from the outer surface of the annular body, aligned with the second slot, A second channel extending from the second slot, It also includes. According to embodiment (18), the inner passage includes a first ledge that provides a gap between the proximal surface of the annular body and the Morse taper. According to embodiment (19), a prosthesis implant, Joint connection components, A stem extending from the aforementioned joint connection component, A first segmented keel wing portion extending from the stem, Prosthesis components including, The ring-shaped body and An inner passage extending through the annular body configured to accommodate the stem, A first slot extending within the annular body and intersecting the inner passage, configured to align with the first segmented keel wing portion, Slotted sleeves including, This is a prosthesis implant equipped with [features / features]. According to embodiment (20), the first slot is radially longer than the first notch extending into the first segmented keel wing portion. According to embodiment (21), when the inner passage is fully mounted on the stem, the proximal surface of the slotted sleeve is separated from the articulating component. According to embodiment (22), the stem and the inner passage are configured to fit with the first segmented keel wing using a Morse taper having an axially overlapping portion. According to embodiment (23), a method for manufacturing a stemmed prosthesis component, Manufacturing the stemmed prosthesis component from a metal material, Positioning a machining tool around the stem extending from the aforementioned stemmed prosthesis component, The machining tool is advanced into a notch within the keel wing portion extending from the stem, A Morse taper is formed on the stem using the machining tool within the notch. This method includes [something]. According to embodiment (24), the machining tool is advanced in the proximal direction, passing through the most distal end of the keel blade.

Claims

1. A tibial implant comprising a tibial tray component, The tibial tray component is, It is a tray plate, Proximal surface and Distal surface and A tray plate including, A stem extending from the distal surface, A segmented keel extending from the distal surface, comprising a first wing portion having a keel-side slot including a first notch near the stem, the first notch being formed by a trough extending from the stem and a side wall extending from the trough, the side wall being spaced away from the stem and extending along the longitudinal direction of the stem, and the segmented keel A first taper extending along the stem at a first axial position aligned axially with the segmented keel, Includes, A tibial implant in which the shape of the first wing portion and the slot on the keel side are configured to accommodate a machining tool for forming the first taper of the stem.

2. The tibial implant according to claim 1, wherein the trough includes the lowest point of the first notch adjacent to the stem.

3. The tibial implant according to claim 1, wherein the first wing portion has a first height from the distal surface at the first notch and a second height from the distal surface away from the first notch, the second height being greater than the first height and extending entirely along the stem.

4. The tibial implant according to claim 1, further comprising a second wing portion separated from the first wing portion and extending from the distal surface.

5. The tibial implant according to claim 2, wherein the first taper extends within the first notch so as to be opposite to the side wall.

6. The tibial implant according to claim 1, wherein the first taper is separated from the distal surface of the tray plate by a portion of the first wing within the first notch, and the first taper extends along the stem to the lowest point of the first notch.

7. The tibial implant according to claim 1, wherein the first taper includes a Morse taper.

8. The tibial implant according to claim 5, wherein the stem includes a second taper at a second axial position at the distal tip of the stem, and the second taper includes a constricted portion of the stem.

9. The tibial implant according to claim 2, further comprising a sleeve connectable to the stem, the sleeve comprising a first slot for accommodating the first wing portion.

10. The tibial implant according to claim 9, wherein the first wing portion is fitted into the first notch, and the proximal surface of the sleeve can be brought close to the distal surface of the tray plate.

11. The tibial implant according to claim 9, wherein the sleeve is configured to fit into the first notch spaced apart from the distal surface of the tray plate.

12. The sleeve further includes a first lobe that protrudes from the outer surface of the sleeve in the first slot, The tibial implant according to claim 11, further comprising a channel extending within the first lobe and forming an extended portion of the first slot.

13. The tibial implant according to claim 9, wherein the sleeve is configured to fit into the first notch spaced apart from the distal surface of the tray plate.

14. The tibial implant according to claim 1, further comprising a sleeve connectable to the stem, the sleeve comprising a first sleeve wing portion configured to be housed within the first notch.

15. Further comprising a sleeve that can be coupled to the stem, the sleeve is The ring-shaped body and An inner passage extending through the aforementioned annular body, comprising an inner passage including a Morse taper, A first slot extending within the annular body and intersecting the inner passage and the Morse taper, The tibial implant according to claim 1, comprising:

16. The tibial implant according to claim 15, wherein the annular body includes a first lobe extending from the outer surface of the annular body aligned with the first slot, and the first lobe includes a first channel extending from the first slot.

17. A second slot extending within the annular body and intersecting the inner passage and the Morse taper, A second lobe extending from the outer surface of the annular body, aligned with the second slot, A second channel extending from the second slot, The tibial implant according to claim 16, further comprising:

18. The tibial implant according to claim 15, wherein the medial passage includes a first ledge that spacees the Morse taper from the proximal surface of the annular body.

19. It is a prosthesis implant, Joint connection components, A stem extending from the aforementioned joint connection component, A first segmented keel wing portion extending from the stem, the first segmented keel wing portion including a first notch in the vicinity of the stem, the first notch being formed by a trough extending from the stem and a side wall extending from the trough, the side wall being spaced away from the stem and extending along the longitudinal direction of the stem, Prosthesis components including, The ring-shaped body and An inner passage extending through the annular body configured to accommodate the stem, A first slot extending within the annular body and intersecting the inner passage, configured to align with the first segmented keel wing portion, Slotted sleeves including, Equipped with, The first segmented keel wing portion has a keel-side slot including the first notch adjacent to the stem, A prosthesis implant in which the shape of the first segmented keel wing and the slot on the keel side are configured to accommodate a machining tool for forming the stem having a tapered surface.

20. The prosthesis implant according to claim 19, wherein the first slot is radially longer than the first notch extending into the first segmented keel wing portion.

21. The prosthesis implant according to claim 19, wherein when the internal passage is fully mounted on the stem, the proximal surface of the slotted sleeve is separated from the articular component.

22. The prosthesis implant according to claim 19, wherein the stem and the inner passage are configured to engage with the first segmented keel wing using a Morse taper having an axially overlapping portion.

23. A method for manufacturing a prosthesis implant according to claim 19, Manufacturing the aforementioned prosthesis implant from a metal material, Positioning a machining tool around the stem extending from the prosthesis implant, The machining tool is advanced into the first notch within the keel wing portion extending from the stem, A Morse taper is formed on the stem using the machining tool in the first notch. A method that includes this.

24. The method according to claim 23, wherein the machining tool passes through the most distal end of the keel blade and is advanced in the proximal direction.

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