Tibial implant

Abstract

A tibial tray including a peripheral rim, a first recess surrounded by the peripheral rim, the first recess being recessed relative to the peripheral rim, a stem extending from the first recess, and a reservoir partially defined by the stem and configured to receive a contaminant.

Description

Attorney Docket No. 093386-0032-WO01 TIBIAL IMPLANT CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The application claims priority to U.S. Provisional Patent Application No. 63 / 654,448, filed May 31, 2024, U.S. Design Patent Application No.29 / 928,831, filed February 15, 2024, and U.S. Provisional Patent Application No. 63 / 554,098, filed February 15, 2024, the entire contents of all of which are incorporated by reference herein. FIELD

[0002] Embodiments, examples, and aspects described herein relate to, among other things, orthopedic prostheses for knee replacement surgery. BACKGROUND

[0003] The number of total knee arthroplasties continues to increase each year in the United States with over a million performed each year. A subset of these patients will require revision surgery due to implant related complications. Aseptic loosening of the implant remains a prominent cause of implant failure. For example, patient characteristics, surgical techniques, and implant issues factor into implant fixation following total knee arthroplasty and may impact the longevity of the implant. SUMMARY

[0003] The present disclosure provides, in one aspect, a tibial tray including a peripheral rim, a first recess surrounded by the peripheral rim, the first recess being recessed relative to the peripheral rim, a stem extending from the first recess, and a reservoir partially defined by the stem and configured to receive a contaminant.

[0004] The present disclosure provides, in another aspect, a tibial tray including a peripheral rim, a first recess surrounded by the peripheral rim, the first recess being recessed relative to the peripheral rim, a stem extending from the first recess, and a plane bisecting the peripheral rim and the stem. The tibial facing side includes a first reservoir partially defined by the stem andAttorney Docket No. 093386-0032-WO01 configured to receive a contaminant, the first reservoir extends along an entirety of the stem and along the plane and a second reservoir partially defined by the stem, the second reservoir including a circular recess and an elongated recess.

[0005] The present disclosure provides, in another aspect, a tibial tray including a peripheral rim, a first recess surrounded by the peripheral rim, the first recess being recessed relative to the peripheral rim, a stem extending from the first recess, and a plane bisecting the peripheral rim and the stem. The tibial facing side includes a first reservoir partially defined by the stem and configured to receive a contaminant, the first reservoir extends along an entirety of the stem and along the plane, a second reservoir partially defined by the stem, the second reservoir including a circular recess and an elongated recess, a peripheral channel recessed relative to the first recess, the peripheral channel follows a perimeter of the peripheral rim, a third reservoir having a plurality of reservoirs recessed relative to the first recess, and rim channels disposed on the peripheral rim and being recessed relative to the peripheral rim.

[0006] Other aspects of the present disclosure will become apparent by consideration of the detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.

[0008] FIG.1A is a perspective view of a tibial tray of a known configuration.

[0009] FIG.1B is a side view of a tibial side of the tibial tray of FIG.1A.

[0010] FIG.1C is a side view of a femoral side of the tibial tray of FIG.1A.

[0011] FIG.2A is a perspective view of a tibial tray, according to an embodiment of the disclosure.

[0012] FIG.2B is a side view of a tibial side of the tibial tray of FIG.2A.Attorney Docket No. 093386-0032-WO01

[0013] FIG.3A is a perspective view of a tibial tray, according to an embodiment of the present disclosure.

[0014] FIG.3B is a side view of a tibial side of the tibial tray of FIG.3A.

[0015] FIG.4A is a perspective view of a tibial tray, according to an embodiment of the present disclosure.

[0016] FIG.4B is a side view of a tibial side of the tibial tray of FIG.4A.

[0017] FIG.5A is a perspective view of a tibial tray, according to an embodiment of the present disclosure.

[0018] FIG.5B is a side view of a tibial side of the tibial tray of FIG.5A.

[0019] FIG.6A is a perspective view of a tibial tray, according to an embodiment of the present disclosure.

[0020] FIG.6B is a side view of a tibial side of the tibial tray of FIG.6A.

[0021] FIG.7A is a perspective view of a tibial tray, according to an embodiment of the present disclosure.

[0022] FIG.7B is a side view of a tibial side of the tibial tray of FIG.7A.

[0023] FIG.8A is a perspective view of a tibial tray, according to an embodiment of the present disclosure.

[0024] FIG.8B is a side view of a tibial side of the tibial tray of FIG.8A.

[0025] FIG.9A illustrates the tibial tray of FIG. 2A inserted into a base.

[0026] FIG.9B illustrates the tibial tray of FIG.4A inserted into the base.

[0027] FIG.9C illustrates the tibial tray of FIG.5A inserted into the base.

[0028] FIG.9D illustrates the tibial tray of FIG. 6A inserted into the base.Attorney Docket No. 093386-0032-WO01

[0029] FIG.9E illustrates the tibial tray of FIG.7A inserted into the base.

[0030] FIG.9F illustrates the tibial tray of FIG.8A inserted into the base.

[0031] FIG.10A illustrates a total surface area of the tibial facing side of FIG.9A.

[0032] FIG.10B illustrates a surface area of the keel of FIG. 9A.

[0033] FIG.10C-E illustrates portions of a surface area of contamination of FIG.9A. DETAILED DESCRIPTION

[0034] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways.

[0035] FIGS.1A and 1B illustrate a tibial tray 100 of a known configuration. The tibial tray 100 includes a tibial facing side 104 and a femoral facing side 108. The tibial facing side 104 includes a peripheral rim 112 that extends about a perimeter of the tibial tray 100 and surrounds a first recess 116. The tibial facing side 104 includes a plurality of second recesses 120 within the first recess 116. Each of the plurality of second recesses 120 are provided with an undercut 124. The tibial facing side 104 includes a stem 128 that extends from the first recess 116. The stem 128 is flanked on each side by a first keel 132 and a second keel 136. That is, the first keel 132 is disposed on an opposite side of the stem 128 relative to the second keel 136. The tibial facing side 104 of the tibial tray 100 is configured to be received by the patient’s tibia. Specifically, the stem 128 is inserted into the patient’s tibia and the peripheral rim 112, the first recess 116, and the plurality of second recesses 120 are coupled to the patient’s tibia via bone cement.

[0036] FIG.1C illustrates the femoral facing side 108 of the tibial tray 100. The femoral facing side 108 includes a planer face 140. In other embodiments, the femoral facing side 108Attorney Docket No. 093386-0032-WO01 includes recesses and / or projections such that femoral facing side 108 couples to an inlay configured to interact with a femoral component.

[0037] The known configuration of the tibial tray 100 is designed to improve the fixation strength of the tibial facing side 104 to a patient’s tibia. Specifically, each of the plurality of second recesses 120 include the undercut 124 to improve the interaction of the tibial facing side 104 with bone cement and therefore the connection between the tibial tray and the patient’s tibia.

[0038] However, even with the design of the tibial facing side 104, contaminants (i.e., bodily fluids and / or bodily tissues) may readily contaminate the area between tibial facing side 104 and bone cement placed on the patient’s tibia. Bodily fluids and bodily tissues may include, but are not limited to lipids, blood, and marrow. Therefore, this disclosure provides embodiments for the tibial facing side of the tibial tray to manage (e.g., receive, store, and direct) contaminants between the tibial tray and the patient’s tibia. Management of contaminates improve the fixation strength of the tibial tray to the patient’s tibia, thereby decreasing the likelihood of aseptic loosening.

[0039] FIGS.2A and 2B disclose a tibial tray 200 according to an embodiment of the present disclosure. The tibial tray 200 includes a tibial facing side 204 and a femoral facing side 208. The tibial facing side 204 includes a peripheral rim 212 that extends about a perimeter of the tibial tray 200 and surrounds a first recess 216. The tibial facing side 204 further includes a stem 220 that extends from the first recess 216. The stem 220 is flanked on each side by a first keel 224 and a second keel 228. The tibial facing side 204 further includes a first pair of reservoirs 232 and a second pair of reservoirs 236. The first pair of reservoirs 232 are on a first side S1 of the keels 224, 228. The second pair of reservoirs 236 are on second side S2 of the keels 224, 228. The second side S2 of the keels 224, 228 is opposite from the first side S1. Each of the first pair and the second pair of reservoirs 232, 236 are mirrored about a plane 238 that bisects the tibial tray 200.

[0040] Each of the first pair of reservoirs 232 include a circular recess 240 that extends through the stem 220 and into the first recess 216. In other words, the circular recess 240 is partially defined by the stem 220. In other embodiments, the circular recess 240 may be formed in a different shape such as a triangle, square, or hexagon. Each of the first pair of reservoirs 232Attorney Docket No. 093386-0032-WO01 include an elongated recess 244 that extends from the circular recess 240 and into the first recess 216. The elongated recess 244 is a rectangular groove with a semicircular end. In other embodiments, the groove of the elongated recess 244 may be formed in a different shape such as a triangle, square, or hexagons. The circular recess 240 and the elongated recess 244 are in fluid communication with one another.

[0041] Similar to the first pair of reservoirs 232, the second pair of reservoirs 236 include a circular recess 248 that extends through the stem 220 and into the first recess 216. In other words, the circular recess 248 is partially defined by the stem 220. In other embodiments, the circular recess 248 may be formed in a different shape such as a triangle, square, or hexagon. Each of the first pair of reservoirs 236 includes an elongated recess 252 that extends from the circular recess 248 and into the first recess 216. In contrast to the elongated recess 244, the elongated recess 252 is an arced groove with a semicircular end. In other embodiments, the groove of the elongated recess 252 may be formed in different shapes such as a triangle, square, or hexagon. In other embodiments, the elongated recess 244 and the elongated recess 252 are identical.

[0042] During insertion into the patient’s tibia, contaminant may accumulate near the stem 220. Additionally or alternatively, contaminate may accumulate near the first pair of reservoirs 232 and / or the second pair of reservoirs 236. The circular recesses 240, 248 provide an area to capture and direct the contaminants. The elongated recesses 244, 252 function similarly to the circular recesses 240, 248 in that the elongated recesses 244, 252 may capture and direct contaminate. Additionally or alternatively, the elongated recesses 244, 252 may function as auxiliary storage for the circular recesses 240, 248, respectively. For instance, if the amount of contaminant becomes too great for the circular recess 240 to manage, the contaminant may be directed to the elongated recesses 244. Additionally or alternatively, the circular recesses 240, 248 may function as an auxiliary storage for the elongated recesses 244, 252, respectively, if the amount of contaminant becomes too great for elongated recesses 244, 252 to manage.

[0043] The likelihood of aseptic loosening of the tibial tray 200 is decreased because the first and second pair of reservoirs 232, 236 manage the contaminant, thereby preventingAttorney Docket No. 093386-0032-WO01 contamination of an interface defined by the tibial facing side 204 of the tibial tray 200 and bone cement on the patient’s tibia.

[0044] FIGS.3A and 3B disclose a tibial tray 300 according to an embodiment of the present disclosure. The tibial tray 300 includes a tibial facing side 304 and a femoral facing side 308. The tibial facing side 304 includes a peripheral rim 312 that extends about a perimeter of the tibial tray 300 and surrounds a first recess 316. The tibial facing side 304 further includes a stem 320 that extends from the first recess 316. The stem 320 is flanked on each side by a first keel 324 and a second keel 328. The tibial facing side 304 includes a reservoir 336 (i.e., a stem channel) that extends along the entirety of the stem 320 and along the plane 238. In other words, the stem channel 336 is partially defined by the stem 320. The stem channel 336 is a semicircular groove that traverses the stem 320. In other embodiments, the groove of the stem channel 336 is a square or a triangle groove.

[0045] The tibial facing side 304 includes a reservoir 340 (i.e., peripheral channel) that is recessed into the first recess 316. The peripheral channel 340 is in fluid communication with the stem channel 336. In other words, the stem channel 336 and the peripheral channel 340 overlap. In the illustrated embodiment, the peripheral channel 340 is a semicircular groove that follows the perimeter of the peripheral rim 312. In other embodiments, the groove of the peripheral channel 340 is a square or a triangle groove. In the illustrated embodiment, the peripheral channel 340 is located between the peripheral rim 312 and the stem 320, the first keel 324, and the second keel 328.

[0046] The tibial facing side 304 includes reservoirs 344 (i.e., rim channels) recessed within the peripheral rim 312. In the illustrated embodiment, the rim channels 344 include a first rim channel 345 and a second rim channel 346. In other embodiments, the rim channels 344 includes additional channels in addition to the first and the second rim channels 344, 346 or includes a single channel. In the illustrated embodiment, the rim channels 344 are square grooves aligned with the plane 238. Additionally, the rim channels 344 are aligned with the stem channel 336. In other embodiments, the rim channels 344 are not aligned with the plane 238. In other words, the location of the rim channels 344 are not dependent upon the plane 238 and can be recessed at any location on the peripheral rim 312. In other embodiments, the grooves of theAttorney Docket No. 093386-0032-WO01 rim channels 344 are triangle or semicircle grooves. The rim channels 344 are recessed into the peripheral rim 312 such that the rim channels 344 are in fluid communication with the peripheral channel 340. In the illustrated embodiment of the tibial tray 300, the stem channel 336, the peripheral channel 340, and the rim channels 344 are all in fluid communication with one another.

[0047] During insertion into the patient’s tibia, contaminant may accumulate near the stem channel 336. Additionally or alternatively, contaminate may accumulate near the peripheral channel 340. Additionally or alternatively, contaminate may accumulate near the rim channels 344. The channels 336, 340, and 344 provide an area to capture and direct the contaminants. Since the channels 336, 340, and 344 are in fluid communication with one another, contaminate may be managed from one channel to another as described in the following paragraphs.

[0048] The stem channel 336 is configured to manage contaminant proximal to the stem 320. The stem channel 336 may store the contaminate proximal to the stem 320. In other words, the stem channel 336 may function as a reservoir. The stem channel 336 may direct contaminate out of the stem channel 336 and toward the peripheral channel 340 and / or the rim channels 344. The stem channel 336 may receive contaminate from the peripheral channel 340 and / or the rim channels 344 that is not originally proximal to the stem 320. In other words, the stem channel 336 may function as an auxiliary storage for the peripheral channel 340 and / or the rim channels 344.

[0049] The peripheral channel 340 is configured to manage contaminant proximal to the peripheral rim 312 and the first recess 316. The peripheral channel 340 may store the contaminate proximal to the peripheral rim 312 and the first recess 316. In other words, the peripheral channel 340 may function as a reservoir. The peripheral channel 340 may direct contaminate out of the peripheral channel 340 and toward the stem channel 336 and / or the rim channels 344. The peripheral channel 340 may receive contaminate from the stem channel 336 and / or the rim channels 344 that is not originally proximal to the peripheral rim 312 and the first recess 316. In other words, the peripheral channel 340 may function as an auxiliary storage for the stem channel 336 and / or the rim channels 344.Attorney Docket No. 093386-0032-WO01

[0050] The rim channels 344 are configured to manage contaminant proximal to the peripheral rim 312 and the first recess 316. The rim channels 344 may store the contaminate proximal to the peripheral rim 312 and the first recess 316. In other words, the rim channels 344 may function as a reservoir. The rim channels 344 may direct contaminate out of the rim channels 344 and toward the stem channel 336 and / or the peripheral channel 340. Additionally, the rim channels 344 may direct contaminate entirely out of the tibial facing side 304. The rim channels 344 may receive contaminate from the stem channel 336 and / or the peripheral channel 340 that is not originally proximal to the peripheral rim 312 and the first recess 316. In other words, the rim channels 344 may function as an auxiliary storage for the stem channel 336 and / or the peripheral channel 340.

[0051] The likelihood of aseptic loosening of the tibial tray 300 is decreased because the stem channel 336, the peripheral channel 340, and the rim channels 344 manage the contaminant, thereby preventing contamination of an interface defined by the tibial facing side 304 of the tibial tray 300 and bone cement on the patient’s tibia.

[0052] FIGS.4A and 4B disclose a tibial tray 400 according to an embodiment of the present disclosure. The tibial tray 400 includes a tibial facing side 404 and a femoral facing side 408. The tibial facing side 404 includes a peripheral rim 412 that extends about a perimeter of the tibial tray 400 and surrounds a first recess 416. The tibial facing side 404 further includes a stem 420 that extends from the first recess 416. The stem 420 is flanked on each side by a first keel 424 and a second keel 428. The tibial facing side 404 includes the first pair of reservoirs 232 and the second pair of reservoirs 236 that extend through the stem 420 and into the first recess 416. In the illustrated embodiment, the reservoirs 232, 236 of the tibial tray 400 are similar in construction to the tibial tray 200.

[0053] Additionally, the tibial facing side 404 includes the stem channel 336 that extends along the entirety of the stem 420 and along the plane 238. The tibial facing side 404 includes the peripheral channel 340 that is recessed within the first recess 416. The tibial facing side 404 includes the rim channels 344 recessed within the peripheral rim 412. In the illustrated embodiment, the stem channel 336, the peripheral channel 340, and the rim channels 344 of the tibial tray 400 are similar in construction to the tibial tray 300.Attorney Docket No. 093386-0032-WO01

[0054] The likelihood of aseptic loosening of the tibial tray 400 is decreased by the reservoirs 232, 236 and the channels 336, 340, 344 for the reasons described above in regard to FIGS.2A-3B. For the sake of brevity, these reasons are not repeated but apply to the tibial tray 400.

[0055] Although the reservoirs 232, 236 and the channels 336, 340, 344 of the tibial tray 400 are similar to the embodiments of FIGS.2A-3B, there are differences. For reference, the reservoirs 232, 236 of the tibial tray 200 are not in direct fluid communication with one another, another channel, and / or reservoir. Rather, the reservoirs 232, 236 of the tibial tray 200 are in indirect fluid communication via the first recess 216. In contrast to the tibial tray 200, the reservoirs 232, 236 of the tibial tray 400 are in fluid communication with the peripheral channel 340. Since the peripheral channel 340 is in fluid communication with the stem channel 336 and the rim channels 344, the reservoirs 232, 236 are also in fluid communication with the stem channel 336 and the rim channels 344. Since the reservoirs 232, 236 and the channels 336, 340, 344 are all in fluid communication with one another, the contaminate may be managed between the reservoirs 232, 236 and the channels 336, 340, 344. Specifically, each of the reservoirs 232, 236 and each the channels 336, 340, 344 may capture and direct contaminant. Additionally or alternatively, the reservoirs 232, 236 may function as auxiliary storage for the channels 336, 340, 344. Additionally or alternatively, the channels 336, 340, 344 may function as auxiliary storage for the reservoirs 232, 236.

[0056] The likelihood of aseptic loosening of the tibial tray 400 is decreased because the reservoirs 232, 236 and the channels 336, 340, 344 are in fluid communication with one another, enabling management of the contaminate between the reservoirs 232, 236 and the channels 336, 340, 344. As such, the management of contaminants by the reservoirs 232, 236 and the channels 336, 340, 344 prevents contamination of an interface defined by the tibial facing side 404 of the tibial tray 400 and bone cement on the patient’s tibia.

[0057] FIGS.5A and 5B disclose a tibial tray 500 according to an embodiment of the present disclosure. The tibial tray 500 includes a tibial facing side 504 and a femoral facing side 508. The tibial facing side 504 includes a peripheral rim 512 that extends about a perimeter of the tibial tray 500 and surrounds a first recess 516. The tibial facing side 504 further includes a stemAttorney Docket No. 093386-0032-WO01 520 that extends from the first recess 516. The stem 520 is flanked on each side by a first keel 524 and a second keel 528. The tibial facing side 504 further includes a plurality of reservoirs 532. The plurality of reservoirs 532 are recessed in the first recess 516 and extend along the entire surface of the first recess 516. In the illustrated embodiment, the plurality of reservoirs 532 are evenly spread on the first recess 516 in a grid pattern. In other embodiments, the plurality of reservoirs 532 are unevenly spread on the first recess 516. In the illustrated embodiment, each reservoir from the plurality of reservoirs 532 are in the shape of a hexagon. In other embodiments, each reservoir from the plurality of reservoirs 532 are in the shape of a circle, a square, a triangle, etc. In other embodiments, the plurality of reservoirs 532 may include an assortment of shapes mixed together. In the illustrated embodiment, some of the reservoirs of the plurality of reservoirs 532 are not complete shapes. For instance, reservoir 536 of the plurality of reservoirs 532 is a partial hexagon that is interrupted by the peripheral rim 512.

[0058] During insertion into the patient’s tibia, contaminants may accumulate proximal to the tibial facing side 504. The plurality of reservoirs 532 provide an area to capture and direct the contaminants. Reservoirs of the plurality of reservoirs 532 are in indirect fluid communication with one another via the first recess 516. If the amount of contaminant becomes too great for a single reservoir (i.e., excess contaminant) of the plurality of reservoirs 532, the excess contaminant may be managed by surrounding reservoirs of the plurality of reservoirs 532. In other words, the surrounding reservoirs of the plurality of reservoirs 532 may function as auxiliary storage for the excess contaminant.

[0059] The likelihood of aseptic loosening of the tibial tray 500 is decreased because the plurality of reservoirs 532 manage contaminant, thereby preventing contamination of an interface defined by the tibial facing side 504 of the tibial tray 500 and bone cement on the patient’s tibia.

[0060] FIGS.6A and 6B disclose a tibial tray 600 according to an embodiment of the present disclosure. The tibial tray 600 includes a tibial facing side 604 and a femoral facing side 608. The tibial facing side 604 includes a peripheral rim 612 that extends about a perimeter of the tibial tray 600 and surrounds a first recess 616. The tibial facing side 604 further includes a stem 620 that extends from the first recess 616. The stem 620 is flanked on each side by a first keel 624 and a second keel 628. The tibial facing side 604 includes the first pair of reservoirs 232 andAttorney Docket No. 093386-0032-WO01 the second pair of reservoirs 236 that extend through the stem 620 and into the first recess 616. In the illustrated embodiment, the reservoirs 232, 236 of the tibial tray 600 are similar in construction to the tibial tray 200.

[0061] The tibial facing side 604 includes the plurality of reservoirs 532 are recessed in the first recess 616. In the illustrated embodiment, the plurality of reservoirs 532 of the tibial tray 600 are similar in construction to the tibial tray 500.

[0062] The likelihood of aseptic loosening of the tibial tray 600 is decreased by the reservoirs 232, 236 and the plurality of reservoirs 532 for the reasons described above in regard to FIGS.2A-3B and 5A-5B. For the sake of brevity, these reasons are not repeated but apply to the tibial tray 600.

[0063] Although the reservoirs 232, 236 and the plurality of reservoirs 532 of the tibial tray 600 are similar to embodiments of FIGS.2A-B and 5A-B, there are differences. For reference, the plurality of reservoirs 532 of the tibial tray 500 are not in direct fluid communication with one another, another channel, and / or reservoir. Rather, the plurality of reservoirs 532 of the tibial tray 500 are in indirect fluid communication via the first recess 516. However, some of the reservoirs of the plurality of reservoirs 532 of the tibial tray 600 are in fluid communication with one another. For instance, a reservoir 632 and a reservoir 636 of the plurality of reservoirs 532 are in fluid communication with each other via a reservoir of the first pair of reservoirs 232. Specifically, the reservoir 632 overlaps with the circular recess 240 and the elongated recess 244 and the reservoir 636 overlaps exclusively with the elongated recess 244. Since the reservoirs 232, 236 and reservoirs of the plurality of reservoirs 532 are in fluid communication with one another, the contaminate may be managed between the reservoirs 232, 236 and the plurality of reservoirs 532. Specifically, the reservoirs 232, 236 and the plurality of reservoirs 532 may capture and direct contaminant. Additionally or alternatively, the reservoirs 232, 236 may function as auxiliary storage for reservoirs of the plurality of reservoirs 532. Additionally or alternatively, the reservoirs of the plurality of reservoirs 532 may function as auxiliary storage for the reservoirs 232, 236. As illustrated in FIG.6A, it is worth noting that the depth of the reservoirs 232, 236 relative to the first recess 616 is greater than a depth of the plurality ofAttorney Docket No. 093386-0032-WO01 reservoirs 532 relative to the first recess 616. In the illustrated construction, the depth of the reservoirs 232, 236 is at least double the depth of the plurality of reservoirs 532.

[0064] The likelihood of aseptic loosening of the tibial tray 600 is decreased because the reservoirs 232, 236 and the plurality of reservoirs 532 are in fluid communication with one another, enabling management of the contaminate between the reservoirs 232, 236 and the plurality of reservoirs 532. As such, the management of contaminants by the reservoirs 232, 236 and the plurality of reservoirs 532 prevents contamination of an interface defined by the tibial facing side 604 of the tibial tray 600 and bone cement on the patient’s tibia.

[0065] FIGS.7A and 7B disclose a tibial tray 700 according to an embodiment of the present disclosure. The tibial tray 700 includes a tibial facing side 704 and a femoral facing side 708. The tibial facing side 704 includes a peripheral rim 712 that extends about a perimeter of the tibial tray 700 and surrounds a first recess 716. The tibial facing side 704 further includes a stem 720 that extends from the first recess 716. The stem 720 is flanked on each side by a first keel 724 and a second keel 728. The tibial facing side 704 includes the stem channel 336 that extends along the entirety of the stem 720 and along the plane 238. The tibial facing side 704 includes the peripheral channel 340 that is recessed within the first recess 716. The tibial facing side 704 includes the rim channels 344 recessed within the peripheral rim 712. In the illustrated embodiment, the stem channel 336, the peripheral channel 340, and the rim channels 344 of the tibial tray 700 are similar in construction to the tibial tray 300.

[0066] The tibial facing side 704 includes the plurality of reservoirs 532 are recessed in the first recess 716. In the illustrated embodiment, the plurality of reservoirs 532 of the tibial tray 700 are similar in construction to the tibial tray 500.

[0067] The likelihood of aseptic loosening of the tibial tray 700 is decreased by the channels 336, 340, 344 and the plurality of reservoirs 532 for the reasons described above in regard to FIGS.3A-3B and 5A-5B. For the sake of brevity, these reasons are not repeated but apply to the tibial tray 700.

[0068] Although the channels 336, 340, 344 and the plurality of reservoirs 532 of the tibial tray 700 are similar to embodiments of FIGS.3A-B and 5A-B, there are differences. ForAttorney Docket No. 093386-0032-WO01 reference, the plurality of reservoirs 532 of the tibial tray 500 are not in direct fluid communication with one another, another channel, and / or reservoir. Rather, the plurality of reservoirs 532 of the tibial tray 500 are in indirect fluid communication via the first recess 516. However, some of the reservoirs of the plurality of reservoirs 532 of the tibial tray 700 are in fluid communication with one another. For instance, a reservoir 732 and a reservoir 736 of the plurality of reservoirs 532 are in fluid communication with each other via the peripheral channel 340. Since the peripheral channel 340 is in fluid communication with the stem channel 336 and the rim channels 344, the plurality of reservoirs 532 are also in fluid communication with the stem channel 336 and the rim channels 344. Since the channels 336, 340, 344 and some reservoirs of the plurality of reservoirs 532 are in fluid communication with one another, the contaminate may be managed between the channels 336, 340, 344 and the plurality of reservoirs 532. Specifically, the channels 336, 340, 344 and the plurality of reservoirs 532 may capture and direct contaminant. Additionally or alternatively, the channels 336, 340, and 344 may function as auxiliary storage for reservoirs of the plurality of reservoirs 532. Additionally or alternatively, the reservoirs of the plurality of reservoirs 532 may function as auxiliary storage for the channels 336, 340, 344. As illustrated in FIG.7A, it is worth noting that the depth of the channels 336, 340, 344 into the first recess 716 is approximately the same as the depth of the plurality of reservoirs 532 into the first recess 716.

[0069] The likelihood of aseptic loosening of the tibial tray 700 is decreased because the channels 336, 340, 344 and the plurality of reservoirs 532 are in fluid communication with one another, enabling management of the contaminate between the channels 336, 340, 344 and the plurality of reservoirs 532. As such, the management of contaminants by the channels 336, 340, 344 and the plurality of reservoirs 532 prevents contamination of an interface defined by the tibial facing side 704 of the tibial tray 700 and bone cement on the patient’s tibia.

[0070] FIGS.8A and 8B disclose a tibial tray 800 according to an embodiment of the present disclosure. The tibial tray 800 includes a tibial facing side 804 and a femoral facing side 808. The tibial facing side 804 includes a peripheral rim 812 that extends about a perimeter of the tibial tray 800 and surrounds a first recess 816. The tibial facing side 804 further includes a stem 820 that extends from the first recess 816. The stem 820 is flanked on each side by a first keel 824 and a second keel 828. The tibial facing side 804 includes the first pair of reservoirs 232 andAttorney Docket No. 093386-0032-WO01 the second pair of reservoirs 236 that extend through the stem 820 and into the first recess 816. In the illustrated embodiment, the reservoirs 232, 236 of the tibial tray 800 are similar in construction to the tibial tray 200.

[0071] The tibial facing side 804 includes the stem channel 336 that extends along the entirety of the stem 820 and along the plane 238. The tibial facing side 804 includes the peripheral channel 340 that is recessed within the first recess 816. The tibial facing side 804 includes the rim channels 344 recessed within the peripheral rim 812. In the illustrated embodiment, the stem channel 336, the peripheral channel 340, and the rim channels 344 of the tibial tray 800 are similar in construction to the tibial tray 300.

[0072] The tibial facing side 804 includes the plurality of reservoirs 532 are recessed in the first recess 816. In the illustrated embodiment, the plurality of reservoirs 532 of the tibial tray 800 are similar in construction to the tibial tray 500.

[0073] The likelihood of aseptic loosening of the tibial tray 800 is decreased by the reservoirs 232, 236, the channels 336, 340, 344, and the plurality of reservoirs 532 for the reasons described above in regard to FIGS.2A-7B. For the sake of brevity, these reasons are not repeated but apply to the tibial tray 800.

[0074] Although the reservoirs 232, 236, the channels 336, 340, 344, and the plurality of reservoirs 532 of the tibial tray 800 are similar to embodiments of FIGS.3A-B and 5A-B, there are differences. Specifically, the tibial tray 800 includes the reservoirs 232, 236, the channels 336, 340, 344, and the plurality of reservoirs 532 all in fluid communication with one another. Since the reservoirs 232, 236, the channels 336, 340, 344, and the plurality of reservoirs 532 of the tibial tray 800, the contaminate can be manage between the reservoirs 232, 236, the channels 336, 340, 344, and / or the plurality of reservoirs 532. For the sake of brevity, the management of contaminant between the reservoirs 232, 236, the channels 336, 340, 344, and the plurality of reservoirs 532 as described above with regard to FIGS.2A-7B not repeated but apply to the tibial tray 800.

[0075] The likelihood of aseptic loosening of the tibial tray 800 is decreased because the reservoirs 232, 236, the channels 336, 340, 344, and the plurality of reservoirs 532 are in fluidAttorney Docket No. 093386-0032-WO01 communication with one another, enabling management of the contaminate between the reservoirs 232, 236, the channels 336, 340, 344, and the plurality of reservoirs 532. As such, the management of contaminants by the reservoirs 232, 236, the channels 336, 340, 344, and the plurality of reservoirs 532 prevents contamination of an interface defined by the tibial facing side 804 of the tibial tray 800 and bone cement on the patient’s tibia.

[0076] FIGS.9A-9F disclose a simulation of cementing with the tibial trays (e.g., tibial trays 200, 400, 500, 600, 700, 800) illustrated in FIGS.2A-B and 4A-8B. A base 900 was provided to replicate a tibia and receive each of the tibial trays. After applying bone cement 904 and prior to inserting the tibial trays, fluid 908 having a marker (e.g., a red dye) was placed on the base 900 to replicate the bodily fluids and bodily tissues of a patient receiving the tibial tray. Each of the tibial trays were constructed from a transparent material (e.g., a transparent acrylic) such that an interface between the tibial facing side of the tibial tray and the base 900 could be observed through the femoral facing side of the tibial tray. Specifically, as shown in FIGS.9A-9F, the fluid 908 is easily visible when viewing from the femoral facing side of the tibial tray because the bone cement 904 is white and the fluid 908 contrasts with the bone cement 904.

[0077] FIG.9A illustrates the tibial tray 200 received by the base 900. FIG.9B illustrates the tibial tray 400 received by the base 900. FIG.9C illustrates the tibial tray 500 received by the base 900. FIG.9D illustrates the tibial tray 600 received by the base 900. FIG.9E illustrates the tibial tray 700 received by the base 900. FIG.9F illustrates the tibial tray 800 received by the base 900.

[0078] Next, the contamination percentage for FIGS.9A-9F was calculated. Specifically,the contamination percentage % is equivalent to a quotient of a difference of asurface area of contaminationwith a surface area of the keel and a difference of a total surface area of the tibial facing side of the tibial tray with the surfacearea of the keel (e.g., % =FIGS. 10A-10E illustratehow the surface area was calculated for the tibial tray 200. Specifically, an image processing program was used to calculate the various surface areas. In some constructions, the image processing program uses the number of pixels captured in a designated area 912 (e.g., a boundary) to calculate the surface area. In some constructions, the number of pixels can beAttorney Docket No. 093386-0032-WO01converted to a unit of measurement (e.g., mm ) by multiplying the pixels by a scaling factor. InFIGS.10A-10E, the boundary 912 of the surface area being calculated is illustrated with a thin, yellow boundary 912. FIG.10A illustrates the total surface area of the tibial facing side . As shown in FIG.10A, the boundary is illustrated as encompassing the peripheral rim 212. In the illustrated embodiment, the is 191990 pixels. FIG.10B illustrates the surface area of the keel . In the illustrated embodiment, the is 22112 pixels. FIGS.10C-E illustrate the surface area of contamination . Each FIG. of the FIGS. 10C-E each illustrate a surface area of the . FIG.10C illustrates the contamination in the vicinity of the keel (e.g., 59,722 pixels) and FIGS.10D and 10E illustrate contamination spaced from the keel (e.g., 2681 pixels and 1085 pixels respectively). In the illustrated construction, theis 63488 pixels (e.g., 59,722 pixels+ 2681 pixels+ 1085 pixels). As such, the% is approximately

[0079] The calculation of the % was calculated for each of FIGS. 9A-F. Thetibial tray 200 exhibited % =16.2% (e.g., FIG. 9A). The tibial tray 400 exhibited% =10.9% (e.g., FIG. 9B). The tibial tray 500 exhibited % =33.3%(e.g., FIG. 9C). The tibial tray 600 exhibited % =10.5% (e.g., FIG. 9D). Thetibial tray 700 exhibited % =15.2% (e.g., FIG. 9E). The tibial tray 800 exhibited% =5.5% (e.g., FIG. 9F). The results indicated a statistically significant difference(e.g., P<0.001) in underside contamination across all tibial trays (e.g., tibial trays 200, 300, 400, 500, 600, 700, 800). Specifically, the introduction of the reservoirs and channels to the tibial facing side resulted in significantly less undersurface contamination (e.g., P<0.02).

[0080] As such geometric modification of the undersurface of a tibial implant with combinations of grids, reservoirs, and / or channels lead to reductions in undersurface contamination. The fluid was either extruded through channels or contained within reservoirs, preventing dispersion through the undersurface of the implant. Modifications to the undersurface of tibial implants limit fluid contamination and prevent aseptic loosening.

Claims

Attorney Docket No. 093386-0032-WO01 CLAIMS What is claimed is:

1. A tibial tray comprising: a peripheral rim; a first recess surrounded by the peripheral rim, the first recess being recessed relative to the peripheral rim; a stem extending from the first recess; and a reservoir partially defined by the stem and configured to receive a contaminant.

2. The tibial tray of claim 1, wherein a plane bisects the peripheral rim and the stem, and wherein the reservoir extends along an entirety of the stem and along the plane.

3. The tibial tray of claim 2, wherein the reservoir is a semicircular groove.

4. The tibial tray of claim 1, further comprising a peripheral channel that is recessed relative to the first recess, wherein the peripheral channel follows a perimeter of the peripheral rim, and wherein the peripheral channel is in fluid communication with the reservoir.

5. The tibial tray of claim 1, further comprising rim channels disposed on the peripheral rim, and wherein the rim channels are recessed relative to the peripheral rim.

6. The tibial tray of claim 1, wherein the reservoir includes a circular recess and an elongated recess.Attorney Docket No. 093386-0032-WO01 7. The tibial tray of claim 6, wherein the reservoir includes a first pair of reservoirs, wherein the circular recess is a first circular recess and the elongated recess is a first elongated recess of the first pair of reservoirs, and wherein the reservoir includes a second circular recess and a second elongated recess of the first pair of reservoirs.

8. The tibial tray of claim 7, wherein a plane bisects the peripheral rim and the stem, wherein the first circular recess and the second circular recess are mirrored about the plane.

9. The tibial tray of claim 1, further comprising a first keel and a second keel, wherein the stem is flanked by the first keel and the second keel.

10. The tibial tray of claim 9, wherein the reservoir includes a first pair of reservoirs and a second pair of reservoirs, wherein the first pair of reservoirs are disposed on a first side of the first keel and the second keel, and wherein the second pair of reservoirs are disposed on a second side of the first keel and the second keel, the second side being opposite from the first side.

11. The tibial tray of claim 1, wherein the reservoir is a first reservoir, further comprising a second reservoir including a plurality of reservoirs, and wherein the plurality of reservoirs are recessed relative to the first recess.

12. The tibial tray of claim 11, wherein each reservoir of the plurality of reservoirs is a hexagon.

13. The tibial tray of claim 11, wherein the first reservoir defines a first depth relative to the first recess, wherein each reservoir of the plurality of reservoirs define a second depth relative to the first recess, and wherein the first depth is greater than the second depth.Attorney Docket No. 093386-0032-WO01 14. A tibial tray comprising: a peripheral rim; a first recess surrounded by the peripheral rim, the first recess being recessed relative to the peripheral rim; a stem extending from the first recess; a plane bisecting the peripheral rim and the stem; a first reservoir partially defined by the stem and configured to receive a contaminant, the first reservoir extends along an entirety of the stem and along the plane; and a second reservoir partially defined by the stem, the second reservoir including a circular recess and an elongated recess.

15. The tibial tray of claim 14, further comprising a peripheral channel, wherein the peripheral channel is recessed relative to the first recess, wherein the peripheral channel follows a perimeter of the peripheral rim, and wherein the peripheral channel is in fluid communication with the first reservoir and the second reservoir.

16. The tibial tray of claim 14, further comprising a rim channel disposed on the peripheral rim, wherein the rim channel is recessed relative to the peripheral rim, and wherein the rim channel is in fluid communication with the first reservoir.

17. The tibial tray of claim 14, further comprising a third reservoir having a plurality of reservoirs, wherein the plurality of reservoirs are recessed relative to the first recess, and wherein each reservoir of the plurality of reservoirs is a hexagon.Attorney Docket No. 093386-0032-WO01 18. A tibial tray comprising: a peripheral rim; a first recess surrounded by the peripheral rim, the first recess being recessed relative to the peripheral rim; a stem extending from the first recess; a plane bisecting the peripheral rim and the stem; a first reservoir partially defined by the stem and configured to receive a contaminant, the first reservoir extends along an entirety of the stem and along the plane; a second reservoir partially defined by the stem, the second reservoir including a circular recess and an elongated recess; a peripheral channel recessed relative to the first recess, the peripheral channel follows a perimeter of the peripheral rim; a third reservoir having a plurality of reservoirs recessed relative to the first recess and the peripheral channel; and rim channels disposed on the peripheral rim and being recessed relative to the peripheral rim.

19. The tibial tray of claim 18, wherein the peripheral channel is in fluid communication with the first reservoir, the second reservoir, the peripheral channel, the third reservoir, and the rim channels.

20. The tibial tray of claim 18, wherein the plurality of reservoirs are recessed relative to the peripheral channel, and wherein each reservoir of the plurality of reservoirs is a hexagon.

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