JP2023526662A - Customized Tibial Tray, Method and System for Knee Replacement Surgery - Google Patents

Abstract

A tibial tray system for a resurfaced proximal portion of a tibia for knee replacement surgery in a patient includes, for example, a tibial tray and at least one screw. The tibial tray has a body that is contactable with superior and underlying cortical bone and/or has an inferior tibia engaging portion with a peripheral inferior extension spaced from the inner surface of the underlying cortical bone of the patient's tibia. include. In some embodiments of total knee arthroplasty, the tibial tray and the proximal portion of the patient's tibia compared to the portion of the shear force resisted along the medial inferior surface of the tibial tray and the resected cancellous surface. A greater portion of the shear force laterally applied to the resected portion of the segment is resisted by the at least one inferior extensor wall and the perimeter of the resected proximal portion of the tibia. The screw suppresses liftoff. A method, robotic system, and cutting guide are also disclosed.

Description

Cross-reference to related applications

This application claims priority to U.S. Provisional Patent Application No. 63/027,098, entitled "Customized Tibial Trays, Methods, And Systems For Knee Replacement," filed May 19, 2020, and this application is incorporated herein by reference in its entirety.

This application is a continuation-in-part of International Patent Application No. PCT/US2020/020279, entitled "Customized Tibial Trays, Methods, And Systems For Knee Replacement," filed February 28, 2020, and Below, the international application WO2020/176824 in English was published on September 3, 2020 (atty. dock. No. 5247.004 AWO), and this international application was filed on February 28, 2019, " U.S. Provisional Patent Application Serial No. 62/811,855, entitled "Customized Tibial Trays Contactable With An Underlying Cortical Bone, Methods, And Systems For Knee Replacement" (atty. dock. No. 5247.004P) claiming priority Further, this international application is subject to U.S. Provisional Patent Application No. 62/879,800, entitled "Customized Tibial Trays, Methods, And Systems For Knee Replacement," filed July 29, 2019 (atty. dock. No. 5247.004P2), which applications are hereby incorporated by reference in their entireties.

TECHNICAL FIELD This disclosure relates generally to surgical implants, methods, and systems for use in knee repair, and more particularly to patient-specific surgical procedures and customized tibias for use in knee replacement. It relates to trays.

In general, the most common indications for revision total knee arthroplasty are aseptic loosening (29.8%) and subsidence. Aseptic loosening is also a major cause of postoperative pain. These dysfunctions are associated with poor osseointegration, incomplete coverage of the implant, limited support and shear forces provided by flat cutting surfaces.

SUMMARY OF THE INVENTION The shortcomings of the prior art are overcome by providing in one embodiment a tibial tray system for cutting extending across the proximal portion of a patient's tibia for use in total knee arthroplasty and further advantages is provided, and the shaved proximal portion of the tibia includes a shaved cancellous bone surface, a shaved peripheral cortical bone surface, and an underlying peripheral of the shaved cancellous bone. ), the tibial tray system includes, for example, a tibial tray and at least one screw. The tibial tray includes a body that includes an upper portion and a lower tibial engagement portion. The top includes a top surface and a rim and includes at least one passageway extending therethrough. the inferior tibia engaging portion has a peripheral inferior surface that can be supported on the resected peripheral cortical bone surface; a central inferior surface that can be positioned on the resected central cancellous bone surface; at least one inferiorly-extending wall extending around at least a portion of the central inferior surface, the at least one inferiorly-extending wall formed around the resected cancellous bone surface; It can be received within the cavity. At least one screw is extendable through at least one passageway of the tibial tray. In a total knee arthroplasty, at least one screw extends through the tibial tray and into cancellous bone to inhibit lift-off of the tibial tray, the medial inferior surface of the tibial tray, and the milled screw. A greater portion of the shear force acting laterally to the tibial tray and cutting portion of the patient's proximal tibia compared to the portion of the shear force resisted along the cancellous bone surface of at least one It is resisted by the inferior extensor wall and the machined circumference of the proximal tibia.

In another embodiment, a method is, for example, cutting a proximal portion of a patient's tibia, wherein the cut proximal portion of the tibia is a cancellous bone surface cut laterally, laterally a peripheral cortical bone surface to be cut into and at least one cavity formed around the cancellous bone to be cut;
providing a tibial tray having at least one inferior extensor wall spaced medially from the periphery of the tibial tray and extending around at least a portion of the central inferior surface and at least one passageway extending therethrough; ,
inserting at least one inferior extensor wall into at least one cavity formed around the resected cancellous bone surface;
placing the peripheral edge of the tibial tray on the laterally cut peripheral cortical bone surface and placing the central inferior surface on the laterally cut cancellous bone surface;
securing at least one screw within the at least one passageway and within the cancellous bone;
including
In a total knee arthroplasty, the at least one screw inhibits lift-off of the tibial tray compared to a portion of the shear forces resisted along the medial inferior surface of the tibial tray and the cut cancellous bone surface. and a greater portion of the shear forces acting laterally on the cut portion of the patient's proximal tibia are resisted by the at least one inferior extensor wall and the circumference of the cut proximal tibia.

In another embodiment, a method of forming a patient-specific tibial tray for total knee replacement surgery in a patient comprises:
for example,
Acquiring, via at least one processor, first data representing a proximal portion of the patient's tibia, the first data indicating that the proximal portion of the patient's tibia is the medial cancellous bone and the lateral and medial surfaces. corresponding to having peripheral cortical bone with
The method also
determining, via at least one processor, second data representing a patient-specific resected proximal portion of the patient's tibia based on the first data;
The resected proximal portion of the patient's tibia has a central cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed around the underside of the resected cancellous bone; the cavity has an outer contoured surface portion corresponding to an adjacent inner surface portion of the cortical bone to be cut;
The method also
forming a patient-specific tibial tray based on the second data, via at least one processor, the patient-specific tibial tray having a body having upper and lower tibial engagement portions including a top surface; the inferior tibia engaging portion has a central portion contactable with the resected midcancellous bone surface; the at least one inferior extensor wall is received within the at least one cavity; , extending from the top surface to the bottom surface,
In total knee arthroplasty,
the at least one screw inhibits liftoff of the tibial tray;
The amount of shear force acting laterally on the patient-specific tibial tray and the cutting portion of the patient's proximal tibia compared to the portion of the shear force that can be resisted along the central inferior surface of the tibial tray and the cut cancellous bone surface. , a larger portion may be resisted by at least one inferior extensor wall and the circumference of the resected proximal tibia.

SUMMARY OF THE INVENTION The shortcomings of the prior art are overcome and additional advantages are provided in one embodiment by providing a tibial tray for cutting extending across the proximal portion of a patient's tibia for use in total knee replacement surgery. be. The resected proximal portion of the tibia includes a resected cancellous bone surface, a resected peripheral cortical bone surface, and at least one cavity formed around an underlying layer of the resected cancellous bone. The tibial tray includes a body that includes an upper portion and a lower tibial engagement portion. The top includes a top surface and a rim. The inferior tibia engaging portion is spaced medially from the peripheral inferior surface that can be rested on the resected peripheral cortical bone surface, the central inferior surface that can be positioned on the resected central cancellous bone surface, and the peripheral inferior surface. and at least one inferior extension wall extending around at least a portion of the central inferior surface. At least one inferior extensor wall is receivable within at least one cavity formed peripherally of the resected cancellous bone surface. The body includes a thickness between the upper surface and the central lower surface, and the at least one indentation wall has a depth from the central lower surface, the depth being greater than the thickness. In total knee arthroplasty, laterally to the tibial tray and the cut portion of the patient's proximal tibia compared to the portion of the shear force resisted along the medial inferior surface of the tibial tray and the cut cancellous bone surface. A greater portion of the acting shear force is resisted by at least one inferior extensor wall and the perimeter of the resected proximal tibia.

In another embodiment, a method is, for example, cutting a proximal portion of a patient's tibia, wherein the cut proximal portion of the tibia is a cancellous bone surface cut laterally, laterally a peripheral cortical bone surface to be cut into and at least one cavity formed around an underlying layer of cancellous bone to be cut;
providing a tibial tray having at least one inferior extensor wall spaced medially from the periphery of the tibial tray and extending around at least a portion of the central inferior surface and at least one passageway extending therethrough; ,
inserting at least one inferior extensor wall into at least one cavity formed around the underlayer of the cancellous bone surface to be cut;
placing the central inferior surface against the laterally cut cancellous bone surface;
In total knee arthroplasty, laterally to the tibial tray and the cut portion of the patient's proximal tibia compared to the portion of the shear force resisted along the medial inferior surface of the tibial tray and the cut cancellous bone surface. A greater portion of the acting shear force is resisted by at least one inferior extensor wall and the perimeter of the resected proximal tibia.

In another embodiment, a method of forming a patient-specific tibial tray for total knee replacement surgery in a patient, for example, comprises:
Acquiring, via at least one processor, first data representing a proximal portion of the patient's tibia, the first data indicating that the proximal portion of the patient's tibia is the medial cancellous bone and the lateral and medial surfaces. corresponding to having peripheral cortical bone with
The method also
determining, via at least one processor, second data representing a patient-specific resected proximal portion of the patient's tibia based on the first data;
The resected proximal portion of the patient's tibia has a central cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed around the underside of the resected cancellous bone; the cavity has an outer contoured surface portion corresponding to an adjacent inner surface portion of the cortical bone to be cut;
The method also
forming, via at least one processor, a patient-specific tibial tray based on the second data;
A patient-specific tibial tray includes a body having upper and lower tibial engaging portions including an upper surface, the lower tibial engaging portion having a central portion contactable with a cut central cancellous bone surface, and at least one inferior extension wall is received within the at least one cavity;
In total knee arthroplasty, laterally to the tibial tray and the cut portion of the patient's proximal tibia compared to the portion of the shear force that can be resisted along the medial inferior surface of the tibial tray and the cut cancellous bone surface. A greater portion of the acting shear force can be resisted by the at least one inferior extensor wall and the perimeter of the resected proximal tibia.

The shortcomings of the prior art are overcome and additional advantages are provided by providing, in one embodiment, a tibial tray for cutting a proximal portion of a patient's tibia for knee replacement surgery. The cut proximal portion of the tibia includes a central cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the cancellous bone that exposes at least a portion of the inner surface of the underlying cortical bone. The tibial tray includes a body having an upper portion with an upper surface and a lower tibial engaging portion. The inferior tibia engaging portion includes a central portion having a central surface contactable with the central cancellous bone surface and a peripheral inferior extension receivable in at least one cavity formed in the cancellous bone. A surface of the peripheral inferior extension can contact the exposed inferior inner surface of the cortical bone of the patient's tibia.

In another embodiment, a method of forming a patient-specific tibial tray for knee replacement surgery in a patient includes, for example,
determining a patient-specific proximal cut portion of the patient's tibia, wherein the cut proximal portion of the patient's tibia includes an upper central cancellous bone surface, a peripheral cortical bone surface, and an underlying cortical bone of the tibia. one or more cavities and/or openings in cancellous bone exposing at least a portion of the inner surface of the
The method also
forming a patient-specific tibial tray including a body having an upper portion having an upper surface and a lower tibia engaging portion, the lower tibia engaging portion comprising a central portion contactable with a cancellous bone surface; or a peripheral inferior extension received in a plurality of cavities and/or openings, and further having one or more surfaces contactable with the exposed inferior inner surface of the cortical bone of the patient's tibia.

In another embodiment, a robotic method for cutting a proximal portion of a patient's tibia for knee replacement surgery comprises, for example,
obtaining, via a processor, first data representing a proximal portion of the patient's tibia including central cancellous bone and peripheral cortical bone;
Via the processor, based on the first data, a central cancellous bone surface, a peripheral cortical bone surface, at least one cavity formed in the cancellous bone exposing at least a portion of the inner surface of the underlying cortical bone; determining second data of a resected proximal portion of a patient-specific tibia having
forming, via a processor, the patient's tibia based on second data of a patient-specific resected proximal portion of the tibia;
The resected proximal portion of the patient's tibia has a central cancellous bone surface, a peripheral cortical bone surface, and at least one cavity exposing the inner surface of the cancellous bone of the tibia.

The shortcomings of the prior art are overcome and additional advantages are provided by providing, in one embodiment, a tibial tray for resected proximal portions of a patient's tibia for total knee replacement surgery. The resected proximal portion of the tibia comprises at least one formed on a central cancellous bone surface, a peripheral cortical bone surface, and a peripheral portion of the cancellous bone spaced from the cortical bone to expose an underlying portion of the cancellous bone of the tibia. a cavity; The tibial tray includes a body having an upper portion with an upper surface and a lower tibial engaging portion. The inferior tibia engaging portion has a central portion having a central surface contactable with the central cancellous bone surface, and a cancellous portion such that the peripheral inferior extension is spaced from the inner surface of the underlying cortical bone of the patient's tibia. a peripheral inferior extension received in at least one cavity formed in the bone surface.

In another embodiment, a method of forming a patient-specific tibial tray for total knee replacement surgery for a patient comprises, for example,
determining a patient-specific resected proximal portion of the patient's tibia, wherein the resected proximal portion of the patient's tibia comprises an upper central cancellous bone surface, a peripheral cortical bone surface, and a cancellous peripheral portion. having at least one cavity formed in and exposing the underlying portion of cancellous bone of the tibia;
The method also
forming a patient-specific tibial tray including a top portion having an upper surface and a body having a lower tibial engagement portion;
The inferior tibia engaging portion has at least one central portion contactable with the central cancellous bone surface and a peripheral inferior extension spaced from the exposed inner surface of the underlying cortical bone of the patient's tibia. and a peripheral lower extension received within the cavity.

In another embodiment, a robotic method for cutting a proximal portion of a patient's tibia for total knee replacement surgery comprises, for example,
obtaining, via a processor, first data representing a proximal portion of the patient's tibia including central cancellous bone and peripheral cortical bone;
Via the processor, based on the central cancellous bone surface, the peripheral cortical bone surface, and the first data, forming a peripheral portion of the cancellous bone spaced from the cortical bone to expose an underlying portion of the cancellous bone of the tibia. determining second data of a patient-specific cut proximal tibia portion having at least one cavity;
forming, via the processor, the patient's tibia based on second data representing a patient-specific resected proximal portion of the tibia;
The resected proximal portion of the patient's tibia comprises a central cancellous bone surface, a peripheral cortical bone surface, and a peripheral cancellous bone spaced from the cortical bone to expose at least an underlying portion of the cancellous bone of the tibia. and one cavity.

Shortcomings of the prior art are also overcome and additional advantages are provided by providing, in one embodiment, a tibial tray for cutting a proximal portion of a patient's tibia for total knee replacement surgery. The cut proximal portion of the tibia includes a central cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed around the cancellous bone spaced from the cortical bone to expose an underlying portion of the cancellous bone of the tibia. and including. The tibial tray includes a body having an upper portion with an upper surface and a lower tibial engaging portion. The inferior tibia engaging portion has a central portion having a central surface contactable with the central cancellous bone surface, and a peripheral inferoextensive outer surface portion that rests against the cancellous bone surface so as to correspond to the undulations of the inner surface of the underlying cortical bone of the patient's tibia. and a peripheral underextension received in the at least one cavity formed. In other embodiments, the peripheral inferior extension extends from a proximal portion of the peripheral inferior extension to a distal portion of the periphery, and at least a portion of the peripheral inferior extension lateral surface portion abuts the underlying concave inner surface of the cortical bone. at least a portion of the outer surface portion of the peripheral inferior extension contoured to correspond to the contour of the superior edge portion of the cortical bone along the cutting surface.

The shortcomings of the prior art are also overcome and further advantages are provided by providing, in one embodiment, a tibial tray for cutting a medial or lateral proximal portion of a patient's tibia for partial knee replacement surgery. be. The cut medial or lateral proximal portion of the tibia includes a central cancellous bone surface, a partial peripheral cortical bone surface, and a periphery of cancellous bone in the cut medial or lateral proximal portion of the tibia. at least one cavity formed in the The tibial tray includes a body having an upper portion with an upper surface and a lower tibial engaging portion. The inferior tibia engaging portion has a central portion having a central surface contactable with the resected central cancellous bone surface and a peripheral inferior extensor lateral surface portion such that it conforms to the contours of the inner surface of the underlying cortical bone of the patient's tibia. , a peripheral inferior extension received in at least one cavity formed in the cancellous bone surface to be cut.

The shortcomings of the prior art are also overcome by providing, in one embodiment, a cutting guide for forming at least one cavity in a cut proximal portion of a patient's tibia for knee replacement surgery, with further advantages. is provided. The proximal portion of the tibia to be cut has a central cancellous bone surface and a peripheral cortical bone surface. The cutting guide includes a planar member having a first planar surface and a second planar surface. The planar member has a peripheral outer edge, a portion of which corresponds to at least a portion of the outer peripheral cortical bone along the cut of the proximal portion of the patient's tibia, and the planar member from the first planar surface to the second planar surface. and at least one U-shaped opening extending therethrough and spaced from the peripheral outer edge. The U-shaped opening defines a U-shaped axis, and the U-shaped opening has a constant width in a direction perpendicular to the U-shaped axis. The U-shaped opening has an inner edge and an outer edge, the outer edge being parallel to the peripheral outer edge. The cutting guide may further include a milling tool having a proximal diameter sized larger than the width of the opening and a distal diameter sized to pass through the opening.

The shortcomings of the prior art are also overcome by providing, in one embodiment, a cutting guide for forming a pair of cavities in a cut proximal portion of a patient's tibia for total knee replacement surgery, providing further advantages. is provided, and the resected proximal portion of the tibia has a central cancellous bone surface and a peripheral cortical bone surface. The cutting guide includes a planar member having a first planar surface and a second planar surface. The planar member includes an outer peripheral edge corresponding to the perimeter cortical bone along the cut of the proximal portion of the patient's tibia. A pair of U-shaped openings extend through the planar member from the first planar surface to the second planar surface and are spaced apart from the peripheral outer edge. Each of the pair of U-shaped openings defines a U-shaped axis, with the U-shaped openings having a constant width in a direction perpendicular to the U-shaped axis. Each of the pair of U-shaped openings has an inner edge and an outer edge, the outer edge being parallel to the peripheral outer edge. The cutting guide may further include a milling tool having a proximal diameter sized larger than the width of the opening and a distal diameter sized to pass through the opening.

The disclosed subject matter is particularly pointed out and distinctly claimed in the concluding portion of the specification. However, the present disclosure may best be understood by referring to the following detailed description of various embodiments and accompanying drawings.

1 is a front cross-sectional view of a resected proximal portion of a patient's tibia, according to an embodiment of the present disclosure; FIG. FIG. 2 is a top view of a resected proximal portion of a patient's tibia, in accordance with an embodiment of the present disclosure; FIG. 3 is a front cross-sectional view of a resected proximal portion of a patient's tibia and a tibial tray in accordance with an embodiment of the present disclosure; Fig. 4 is a front cross-sectional view of a resected proximal portion of a patient's tibia and a tibial tray in accordance with an embodiment of the present disclosure; FIG. 5 is a top view of a resected proximal portion of a patient's tibia, in accordance with an embodiment of the present disclosure; FIG. 6 is a flow diagram of steps for modifying a patient's knee joint in accordance with an embodiment of the present disclosure; FIG. 7 is a block diagram of a system for modifying a patient's knee joint in accordance with an embodiment of the present disclosure; FIG. 8 is a block diagram of a system for modifying a patient's knee joint in accordance with an embodiment of the present disclosure; FIG. 9 is an illustration of a proximal portion of a patient's tibia, in accordance with an embodiment of the present disclosure; FIG. 10 shows two bone-implant interfaces of a support pin according to an embodiment of the present disclosure. FIG. 11 is a flow diagram of a robotic process for modifying a patient's knee joint in accordance with an embodiment of the present disclosure; Fig. 12 is a top view of a tibial tray in accordance with an embodiment of the present disclosure; Fig. 13 is a rear perspective view of a tibial tray in accordance with an embodiment of the present disclosure; Fig. 14 is a bottom view of a tibial tray, according to an embodiment of the present disclosure; Fig. 15 is a top view of a tibial tray, in accordance with an embodiment of the present disclosure; Fig. 16 is a rear perspective view of a tibial tray in accordance with an embodiment of the present disclosure; Fig. 17 is a bottom view of a tibial tray according to an embodiment of the present disclosure; Fig. 18 is a rear perspective view of a tibial tray in accordance with an embodiment of the present disclosure; Fig. 19 is a front perspective view of a tibial tray in accordance with an embodiment of the present disclosure; FIG. 20 is a cross-sectional view of the tibial tray of FIG. 16 positioned on a resected proximal portion of the tibia; FIG. 21 is a cross-sectional view of the tibial tray of FIG. 16 positioned on a resected proximal portion of the tibia; Fig. 22 is a front cross-sectional view of a tibial tray in accordance with an embodiment of the present disclosure; 23 is a top view of the tibial tray of FIG. 22, in accordance with an embodiment of the present disclosure; FIG. Fig. 24 is a front cross-sectional view of a resected proximal portion of a patient's tibia and a tibial tray in accordance with an embodiment of the present disclosure; Fig. 25 is a front cross-sectional view of a resected proximal portion of a patient's tibia and a tibial tray in accordance with an embodiment of the present disclosure; FIG. 26 is a cross-sectional view of a tibial tray positioned on a resected proximal portion of a patient's tibia in accordance with an embodiment of the present disclosure; 27 is a bottom perspective view of the tibial tray of FIG. 26 in accordance with an embodiment of the present disclosure; FIG. Fig. 28 is a front cross-sectional view of a resected proximal portion of a patient's tibia and a tibial tray in accordance with an embodiment of the present disclosure; FIG. 29 is a cross-sectional view of a tibial tray positioned on a resected proximal portion of a patient's tibia in accordance with an embodiment of the present disclosure; 30 is a bottom perspective view of the tibial tray of FIG. 29 in accordance with an embodiment of the present disclosure; FIG. Fig. 31 is a bottom perspective view of a tibial tray in accordance with an embodiment of the present disclosure; 32 is a top view of a cut proximal portion of a tibia to receive the tibial tray of FIG. 31, according to an embodiment of the present disclosure; FIG. FIG. 33 is a flow diagram of steps for modifying a patient's knee joint, in accordance with an embodiment of the present disclosure; FIG. 34 is a flow diagram of a robotic process for modifying a patient's knee joint in accordance with an embodiment of the present disclosure; FIG. 35 is an anterior view of a proximal portion of a patient's tibia for knee replacement surgery in accordance with an embodiment of the present disclosure; 36 is a schematic illustration of a portion of a tibial tray, in accordance with an embodiment of the present disclosure; FIG. Fig. 37 is a schematic illustration of a portion of a tibial tray, in accordance with an embodiment of the present disclosure; Fig. 38 is an anterior view of a tibial tray for knee replacement surgery in accordance with an embodiment of the present disclosure; Fig. 39 is a schematic illustration of a portion of a tibial tray, according to an embodiment of the present disclosure; FIG. 40 is a partial cross-sectional view of a partially resected distal femur and proximal tibia portion, femoral component and tibial tray for a partial knee replacement, according to an embodiment of the present disclosure; is a front view including 41 is a side view of the tibial tray of FIG. 40 in accordance with an embodiment of the present disclosure; FIG. 42 is an inferior view of the tibial tray of FIG. 40, in accordance with an embodiment of the present disclosure; FIG. 43 is a top perspective view of a tibial cavity cutting guide of the tibial tray of FIG. 40 in accordance with an embodiment of the present disclosure; FIG. Fig. 44 is a perspective view of a milling tool according to an embodiment of the present disclosure; Fig. 45 is a perspective view of the three components of a total knee replacement surgery according to an embodiment of the present disclosure; Fig. 46 is a perspective view of components of a partial knee replacement surgery in accordance with an embodiment of the present disclosure; Fig. 47 is an inferior perspective view of a tibial tray in accordance with an embodiment of the present disclosure; 48 is a top perspective view of the tibial tray of FIG. 47 in accordance with an embodiment of the present disclosure; FIG. 49 is another top perspective view of the tibial tray of FIG. 47 in accordance with an embodiment of the present disclosure; FIG. 50 is a front cross-sectional view of the resected proximal portion of the tibia of FIG. 47 and the tibial tray in accordance with an embodiment of the present disclosure; FIG. Fig. 51 is a top perspective view of a tibial tray in accordance with an embodiment of the present disclosure; 52 is an inferior perspective view of the tibial tray of FIG. 51 according to an embodiment of the present disclosure; FIG. 53 is a posterior perspective view of the tibial tray of FIG. 51 in accordance with an embodiment of the present disclosure; FIG. FIG. 54 is a top view of the tibial tray of FIG. 51 according to an embodiment of the present disclosure; 55 is an inferior view of the tibial tray of FIG. 51 according to an embodiment of the present disclosure; FIG. 56 is a side view of the tibial tray of FIG. 51 according to an embodiment of the present disclosure; FIG. Fig. 57 is a top perspective view of a tibial tray in accordance with an embodiment of the present disclosure; 58 is a side view of the tibial tray of FIG. 57, according to an embodiment of the present disclosure; FIG. FIG. 59 is a top view of the tibial tray of FIG. 57 according to an embodiment of the present disclosure; FIG. 60 is an inferior view of the tibial tray of FIG. 57 according to an embodiment of the present disclosure; 61 is another inferior view of the tibial tray of FIG. 57 in accordance with an embodiment of the present disclosure; FIG. 62 is a top perspective view of a tibial cavity cutting guide of the tibial tray of FIG. 47 in accordance with an embodiment of the present disclosure; FIG. FIG. 63 is a flow diagram of a method according to an embodiment of the present disclosure; Fig. 64 is a bottom perspective view of a tibial tray system with a tibial tray and screws in accordance with an embodiment of the present disclosure; 65 is a top perspective view of the tibial tray of FIG. 64 in accordance with an embodiment of the present disclosure; FIG. 66 is an inferior perspective view of the tibial tray of FIG. 64 in accordance with an embodiment of the present disclosure; FIG. 67 is a front cross-sectional view of the resected proximal portion of the tibia of FIG. 64 and the tibial tray system in accordance with an embodiment of the present disclosure; FIG. Fig. 68 is a bottom perspective view of a tibial tray system having a tibial tray and multiple screws in accordance with an embodiment of the present disclosure; 69 is a top perspective view of the tibial tray of FIG. 68 according to an embodiment of the present disclosure; FIG. 70 is an inferior perspective view of the tibial tray of FIG. 68 according to an embodiment of the present disclosure; FIG. 71 is a front cross-sectional view of the resected proximal portion of the tibia of FIG. 68 and the tibial tray system in accordance with an embodiment of the present disclosure; FIG. FIG. 72 is a front, cross-sectional view, partially in cross-section, of a tibial tray system having a tibial tray and at least one screw in accordance with an embodiment of the present disclosure; Fig. 73 is a side view of a portion of a screw for use in a tibial tray system according to an embodiment of the present disclosure; FIG. 74 is a flow diagram of a method according to embodiments of the present disclosure;

In general, disclosed herein are a cut proximal portion of a tibia, a tibial tray, and methods and robotic systems for forming the same.

In this detailed description and in the claims that follow, the terms proximal, distal, anterior, posterior, medial, lateral, superior, and inferior refer to bones or implants according to their natural bone orientation or orientation terms. defined by their standard usage for denoting a particular part.

Position or orientation may be used herein with reference to anatomical structures or surfaces. For example, since the current devices and methods are described herein with reference to use with a knee bone, the knee bone is the surface, position, and location of the tibial tray, placement of the tibial tray, and surgical methods. , may be used to describe direction or orientation. Furthermore, the devices and surgical methods disclosed herein, and aspects, components, features, etc. thereof, are described with respect to one side of the body for purposes of brevity. However, because the human body is relatively symmetrical or a mirror image about a line of symmetry (midline), the devices and surgical methods, and aspects and components thereof, described and/or illustrated herein are , features, etc. may be altered, altered, modified, rearranged or otherwise for use or associated with other sides of the body for the same or similar purposes without departing from the spirit and scope of this disclosure. Modifications are expressly contemplated herein. For example, the devices and surgical methods, and aspects, components, features, etc., described herein with respect to the left knee may be mirrored so that they function similarly on the right knee, and vice versa. Yes.

Referring to the drawings, like reference numerals are used throughout the several views to denote like or analogous components, and in particular, for example, FIGS. and 23, 24, and 25, a portion of the tibial tray is attached to a cut proximal portion of the tibia that is engageable and/or contactable with the inner surface of the underlying cortical bone for use in knee replacement surgery. An exemplary embodiment of a tibial tray is illustrated. As will be appreciated from the discussion below, the hard cortical bone of the tibia is this dense bone versus conventional tibial trays that rest on hard cortical bone with a central keel in softer cancellous bone. can provide fixation such as a press fit to the For example, the present disclosure may provide improved fixation of non-cemented tibial trays. FIG. 6 illustrates a method for use in knee replacement surgery and FIG. 7 for effecting cutting of the proximal portion of the patient's tibia and forming a corresponding, oriented, or conforming tibial tray. system. The method and system may be operable to obtain a fully autonomous and automatically cut proximal tibia and corresponding tibial tray from CT scan data, for example. Referring to FIGS. 26-30, there is shown a portion of the tibial tray spaced from the inner surface of the underlying cortical bone and cut into the proximally adjacent tibia for use in knee replacement surgery. An exemplary embodiment of a tibial tray to be placed on the proximal portion is illustratively shown. As will be appreciated from the description below, the peripheral cancellous bone adjacent to the cortical bone of the tibia contrasts with conventional tibial trays that rest on cortical bone with a keel centrally located in the softer cancellous bone. can provide fixation to the proximal tibia. For example, the present disclosure may provide improved fixation of non-cemented tibial trays. FIG. 33 illustrates a method for use in knee replacement surgery employing, for example, the tibial tray of FIGS. , forming an oriented or conforming tibial tray. FIG. 34 illustrates a robotic method for use in knee replacement surgery, which method includes the steps of effectively performing a resection of a proximal portion of a patient's tibia. The method and system may be operable to obtain a fully autonomous and automatically cut proximal tibia and corresponding tibial tray from CT scan data, for example.

In some embodiments, for example, the patient-specific tibial tray design is sterile through a combination of high contact with the peripheral surface, inferior surface geometry, and patient-matched pegs that interface with the cortical metaphyseal bone. May reduce sexual sagging and depression. The present disclosure may resolve and/or overcome a major cause of knee implant failure: sterile loosening and subsidence of the tibial component.

In some embodiments, the present disclosure provides a method for generating a three-dimensional model of a tibia and inserting a custom tibial tray designed to increase or maximize cortical contact with the rim of the inner tibia wall. and generation of a cutting plan for excavating a portion of the tibia with a robot or robotic excavator according to the cutting plan.

In some embodiments, the techniques of the present disclosure are directed to maximizing contact of the tibial tray with cortical bone along the inner surface of the underlying cortical wall of the tibia. A virtual model of the proximal portion of the tibia may be used to determine a modified implant designed to achieve a higher level of cortical bone contact. A processor is employed to generate a drilling protocol for drilling bone from the tibia such that the amount of bone contact between the bone and the implant is increased, such as by 10% or more, compared to conventional tibial trays. may be configured to

FIG. 1 illustrates a tibial tray 20 attached to a resected proximal portion of a tibia 10 for knee replacement surgery, according to an embodiment of the present disclosure. In the illustrated embodiment, at least a portion of the tibial tray 20 when operably attached to the resected proximal portion of the tibia 10 is an inner surface or lateral portion of the cortical bone 12 of the proximal portion of the tibia 10. interface with and increase contact.

For example, the tibial tray 20 may include a body 22 having an upper portion 24 and a lower tibial engagement portion 26 . Top 24 may include a generally planar upper surface 25 for supporting a plastic bearing spacer (not shown in FIG. 1). In some embodiments, surface 25 includes a peripheral upwardly extending lip 27 for mounting and constraining a plastic bearing spacer via a typical snap-fit connection.

The tibia engaging portion 26 may include a central tibia engaging portion 30 and a peripheral tibia engaging portion 40 . In this embodiment, the central tibia engaging portion 30 may include a planar surface capable of contacting the central cancellous surface of the resected proximal portion of the patient's tibia.

The peripheral tibial engagement portion 40 may include at least one inferior extension wall 50 . The downward extension wall 50 may include an inner wall surface 52 and an outer wall surface 54 . Inner wall surface 52 may be disposed at right angles or 90 degrees to upper surface 25, or at any suitable angle or angles. Outer wall surface 54 may be capable of aligning, abutting, or contacting inner surface 13 of cortical bone 12 .

For example, the outer wall surface 54 is angled with respect to the upper surface 25 of the tibial tray 20 at about 25 degrees to about 45 degrees, about 30 degrees to about 40 degrees, about 35 degrees, or other suitable angle. good too. Wall 50 is received in a cavity formed in the resected proximal portion of tibia 10 . The cavity may be formed in the cancellous, trabecular, spongy, or light porous bone of the tibia. The wall may increase the contact area with the inner surface 13 of the cortical bone 12 . The depth D1 of the wall 50 is about 0.5 millimeters (mm) to about 75 mm, about 1 mm to about 50 mm, about 2 mm to about 40 mm, about 4 mm to about 20 mm, 0.5 mm or more, about 1 mm or more, about 2 mm or more. , about 3 mm or more, about 5 mm or more, about 7 mm or more, or other suitable depths. In some embodiments, the inferior extension wall 50 may extend along at least 25 percent of the circumference of the body 22, along at least 50 percent of the circumference of the body 22, along the entire circumference of the body 22, or may extend along the periphery of body 22 by another suitable amount. The width W1 of wall 50 may be between about 5 mm and about 6 mm, and is desirably greater than about 0.5 mm and less than about 50 mm. In some embodiments, the peripheral edge 29 of the tibial tray 20 may include an inferior surface 28 that extends over the superior cutting cortical bone 19 , eg edge 18 . In some embodiments, the tibial tray 20 may include a keel 32 (shown in phantom in FIG. 1) and support pins (not shown in FIG. 1). The access cavity in the proximal portion of the tibia and the tibial tray may be sized and formed manually by the surgeon, or may be prepared automatically or fully automatically by a robot as described below.

FIG. 2 illustrates a top view of a resected proximal portion of a patient's tibia 110 for knee replacement surgery, according to an embodiment of the present disclosure. In this illustrated embodiment, the resected proximal portion of the tibia 110 includes a central cancellous surface 111, a cortical epiphyseal surface 118, and a first ridge located along one side of the proximal portion of the tibia 110. and a second U-shaped cavity 117 disposed along the opposite side of the proximal portion of the tibia 110 . Cavities 115 and 117 may extend into cancellous, trabecular, cancellous, or light porous bone of tibia 110 adjacent the inner surface of cortical bone 112 of the proximal portion of tibia 110 . The cavity has a depth of about 0.5 millimeters (mm) to about 75 mm, about 1 mm to about 50 mm, about 2 mm to about 40 mm, about 4 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 5 mm, about 7 mm. , or any other suitable depth. The wall width W2 may be from about 5 mm to about 6 mm, and is desirably greater than about 0.5 mm and less than about 50 mm. A corresponding tibial tray (not shown in FIG. 2) has a tibial tray outer edge portion designed to approximate the shape of the tibial edge portion along a cutting plane parallel to the tibial tray. may As described in more detail below, the proximal portion of the tibia may be cut or resurfaced, either manually or by a robot, such as fully automated, to receive a corresponding tibial tray.

FIG. 3 shows a tibial tray 320 attached to a resected proximal portion of the tibia 210 for knee replacement surgery, according to an embodiment of the present disclosure. In the illustrated embodiment, at least a portion of the tibial tray 320 when operably attached to the resected proximal portion of the tibia 210 aligns with the medial side of the cortical bone 212 of the proximal portion of the tibia 210. interface and increase the contact area.

Tibial tray 320 may include a body 322 having an upper portion 324 and a lower tibial engagement portion 326 . An upper surface 325 of upper portion 324 may be a generally planar surface for supporting a plastic bearing spacer (not shown in FIG. 3). In some embodiments, the upper surface includes a peripherally extending lip for securing a plastic bearing spacer.

The tibia engaging portion 326 may include a tibia engaging central portion 330 defining a recess 340 with respect to the peripheral tibia engaging portion 350 . Peripheral tibia engaging portion 350 may be a wall or flat portion disposed about part or all of tibia engaging central portion 330 and at a different height than tibia engaging central portion 330 . The peripheral tibia engaging portion 350 is positioned in a cavity formed in cancellous, trabecular, cancellous, or light porous bone of the proximal tibia adjacent to the inner surface of the cortical bone of the proximal tibia. good too. The peripheral tibia engaging portion 350 may include an inner wall surface 352 and an outer wall surface 354 . The inner wall surface 352 may be positioned at right angles or 90 degrees to the upper surface 325 of the top portion 324 . Outer wall surface 354 may be alignable and abuttable with inner surface 213 of cortical bone 212 . The depth D2 of the peripheral tibia engagement portion 350 may exceed 0.5 mm and may not exceed 75 mm. Geometric surfacing of the proximal portion of the tibia results in the upper and lower portions along the cutting surface (excluding the keel and pin) having a depth D3 greater than about 0.5 mm and less than or equal to about 15 mm. You can become In some embodiments, the tibial tray may include a keel and support pins. As will be described in more detail below, the proximal portion of the tibia 210 may be manually or robotically cut to receive a corresponding manually or robotically formed tibial tray 320 .

FIG. 4 is an illustration showing a tibial tray 420 attached to a resected proximal portion of a tibia 410 for knee replacement surgery, according to one embodiment of the present disclosure. In this illustrated embodiment, tibial tray 420 is designed to interface with the curved shape and support cavity of the cut proximal portion of tibia 410 .

For example, a typical proximal portion of the tibia has a concave minimum near the lateral condyle, a convex maximum near the intercondyle eminence, and a medial It may constitute a concave lowest point near the medial condyle. The cut proximal portion of the tibia 410 for knee replacement surgery of the present disclosure removes the damaged bone from the proximal portion of the tibia while molding the bone to include a general contour similar to that of a typical tibia. may be removed. The resurfaced proximal portion of the tibia 410 may feature a concave lowest point 416 near the lateral condyle, a convex highest point 417 near the intercondylar ridge, and a concave lowest point 418 near the medial condyle. The concave lowest point 416, the convex highest point 417, and/or the concave lowest point 418 may extend into cancellous, trabecular, cancellous, or light porous bone of the proximal portion of the tibia; The outer portions of the concave lowest point 416 , convex highest point 417 , and concave lowest point 418 may be positioned adjacent and/or in contact with the inner surface of the underlying cortical bone 412 of the proximal portion of the tibia 410 . good. The tibial tray 420 may include an inferior tibial engagement portion having an inferior convex surface 426, an inferior convex surface 428, and an inferior concave surface 427 disposed therebetween. The radius of the concave surface and the radius of the convex surface may be constant radii or may have varying curvatures. The outer edge of the convex surface may have an elliptical or generally oval configuration when viewed from below.

Tibial tray 420 may include one or more pins 490 designed to interface with underlying cortical bone 412 . For example, as shown in FIG. 5, an array of four holes 419 may be positioned in each quadrant of the resected proximal portion of tibia 410, these holes 419 receiving pins 490 (FIG. 4). Accept. Referring again to FIG. 4 , the bottom of pin 490 may include an outer cylindrical portion that engages the sides of the opening in cortical bone 412 . Such contacting portions may include contacting the inner edge portion of the opening in the cortical bone on the sides of the opening extending through the cortical bone and/or the inner surface of the cortical bone around the opening in the inner surface of the cortical bone. or a surface portion. A lower edge 492 of pin 490 may be aligned with outer surface 411 of cortical bone 412 . A peripheral edge of the tibial tray 420 may define a shelf or lip having a thickness T of about 4 mm and a width W3 of about 2 mm, for example.

The tibial trays disclosed herein may be operable with conventional plastic spacers and femoral components. For example, the top surface of the currently disclosed tibial tray may include a surface having a generally symmetrical or kidney bean shape designed to engage a plastic spacer component in a standard manner such as a snap fit. good. A tibial tray having a variable thickness (rim as a non-limiting example) may be used to maximize the amount of tibial tray coverage along the cutting surface, but not compromise the engagement of the plastic spacer components. It can reside on the periphery of the tibial tray. The thickness of the tibial rim may be approximately 4 mm. In other embodiments, the rim may be greater than about 0.5 mm and less than about 25 mm.

The tibial tray of the present disclosure may include a one-piece, monolithic, or unitary body, or may be formed from two or more pieces. The tibial tray may be made from standard metallic implant materials such as titanium, cobalt chromium, or other acceptable stainless steel. In other embodiments, the tibial tray of the present disclosure may be made from plastic or polymeric materials.

FIG. 6 illustrates a method 600 for use in knee replacement surgery, according to one embodiment of the present disclosure. In this illustrated embodiment, the method 600 is operable to provide a customized cutting plan for the proximal portion of the tibia for the patient and to provide a corresponding customized tibial tray. .

The method 600 may include, for example, at 610 acquiring first data representing a proximal portion of the patient's tibia. At 620, second data for a patient-specific resected proximal portion of the patient's tibia is determined based on the first data. The proximal portion of the patient's tibia to be cut has an upper surface and one or more cavities or openings that expose a lower portion of the inner surface of the underlying cortical bone of the tibia. At 630, a patient-specific tibial tray having an inferior surface is determined based on the second data. At 640, the patient's tibia is resected based on the second data. At 650, a tibial tray is formed based on the second data, and at 660, the formed tibial tray extends into one or more cavities and/or openings such that the lower portion of the tibial tray extends into the underlying cortex of the tibia. It is fixed onto the proximal portion of the tibia that has been prepared and cut so as to contact the inner surface of the bone.

FIG. 7 is a block diagram of a system 700 for use in knee replacement surgery, eg, for performing method 600 (FIG. 6), according to an embodiment of the present disclosure. In this exemplary system 700, for example, at least a portion of the tibial tray when operably attached to a resected proximal portion of the patient's tibia is the inner surface of the underlying cortical bone of the proximal portion of the patient's tibia. may be interfaced with to increase the contact area. System 700 may generally include a processing unit or processor 710 , input/output devices 720 , and memory 730 .

Tibia data 702 , such as, for example, first data (block 610 in FIG. 6) representing the proximal portion of the patient's tibia, may be input into system 700 . Tibia data 702 may be obtained by, for example, computed tomography (CT) scans, computed axial tomography (CAT) scans, magnetic resonance imaging (MRI) scans, or other suitable two-dimensional or three-dimensional imaging or processing. Acquired three-dimensional data may also be included. Such data may be provided directly from the image processing device or may be obtainable from a database of stored medical image data. Additional input data may include surgeon input 704, such as desired schematic configuration of the tibial tray, desired tibial cut, and/or other information. Processor 710 may be, for example, a computer running a WINDOWS, OSX, UNIX or Linux operating system. In some embodiments, processor 710 may be a portable or handheld computing device. In other embodiments, processor unit 710 is one or more operatively connected processing, computing, or computing devices linked to or operating on one or more networks, such as a global communications network, e.g., the Internet. It may be a server.

Memory 730 may include various modules for processing input data. For example, memory 730 may include tibial cut generator 740 , robotic tibial cut plan generator 750 , and tibial tray generator 760 .

The tibia cut generator 740 may be operable to determine second data representing a patient-specific cut proximal portion of the patient's tibia based on the first data (block 620, Figure 6). For example, the second data may be based on the first data, wherein the first data includes the contour of the proximal tibia, the shape of the intercondylar eminence, the lateral condyle, the medial condyle, diseased or damaged portions thereof. , the inner surface of the cortical bone portion, the cancellous bone portion, and other features. For example, the second data may sub-voxel the position of the "cortical bone" (eg, the position of the inner surface of the cortical bone region) relative to the "outer surface of the cortical bone" (eg, the position of the outer surface of the cortical bone region). For example, volumetric pixel data) accuracy may be specified. Using such a high fidelity bone model to form a virtual representation of the proposed cut proximal portion of the tibia for receiving a tibial tray that can be produced with high compatibility with the patient's bone. suitable programming can be provided. The proximal portion of the patient's tibia to be cut may include one or more openings or cavities that expose the superior surface and the inferior or underlying surface of the cortical bone.

Cut generator 740 may include various modules such as cut generator 742 , cavity generator 744 , and optimization generator 746 . The cut generator 742 may, for example, allow the surgeon to designate a cutting surface, such a surface being provided, for example, by input by the surgeon, or based on predetermined data, or a predetermined number. may be provided and automatically generated using data from For example, the cutting surface may be determined as disclosed in U.S. patent application Ser. incorporated into the specification. Cavity generator 744 may include receiving initial input from the surgeon such as position, width, length, depth, or may be based on or utilizing predetermined data. good too. The optimization generator 746 receives an input or generated configuration of a tibial tray and, based on the forces likely to be experienced, virtually generates such a tibial tray placed on the cut tibia. can be tested or compared. The automatic resizing of dimensions may allow comparison with previously developed configurations to optimize the configuration of the patient-specific cut tibia and tibial tray. In some embodiments, the optimization generator 746 optimizes wall depth, wall thickness, and the amount and location of the wall extending around the tibial tray to reduce the amount of cancellous bone that needs to be removed, which can reduce trauma to the patient's tibia. In some embodiments, a suitable module in memory 730 is used to virtually test the resulting patient-specific proximal portion of the tibia and the corresponding tibial tray, or the resulting patient-specific proximal portion of the tibia. Appropriate programming or algorithms may be included to compare the metastatic portion and corresponding tibial tray against exemplary acceptable configurations. Such optimization techniques are described below.

The robotic tibia cut plan generator 750 is operable to determine data or instructions for operating a surgical robot 790 or other automated device to prepare the patient's tibia based on the second data. There may be (block 640, FIG. 6). In some embodiments, a 3D model of the proximal portion of the patient's tibia to be cut may be uploaded to the robot, which, for example, cuts to form one or more cavities or openings. is operable to autonomously or semi-autonomously resize the proximal portion of the tibia for or to perform a tibial resection plan to expose the medial aspect or portion of the underlying cortical bone for . The data or instructions may be combined with data received by surgical robot 790, such as data from local camera imagers or sensors. A suitable surgical robot may be the LBR iiwa Kuka robot manufactured by KUKA ROBOTICS Corporation of Shelby Township, Michigan, which operates with one or more bone saws, rasps, saws, drills, and/or other devices. It may be operable.

The tibial tray generator 760 may, for example, be operable to determine a patient-specific tibial tray configuration having an inferior surface based on the second data (block 630, FIG. 6). For example, tibial tray generator 760 may determine a tibial tray body having a perimeter and a lower surface that match or correspond to the resected proximal portion of the tibia. In some embodiments, the 3D model of the tibial tray may be used by a 3D printer 795 or other manufacturing equipment known in the art to generate the tibial tray. The 3D printer or manufacturing device, as described above, may be formed as a one-piece, monolithic, or unitary body, or from one or more components, such as titanium, cobalt chromium, or other acceptable stainless steel. It may be operable to form a tibial tray formed from standard metallic materials. Alternatively, to form a prototype or mold and cast or forge a tibial tray implant formed from standard metallic materials such as titanium, cobalt chromium, or other acceptable stainless steel. may be used.

The techniques of the present disclosure more closely match the native anatomy of the joint, thereby increasing the surface contact area for osseointegration and reducing shear forces along the implant-bone interface. can solve the problem. Osteosynthesis (organic fixation) can arise from cortical contact. For example, the system can introduce patient-specific walls, supports, or pegs that interface with the underlying cortical metaphysis to enhance stability and resist subsidence. The tibial tray can be formed by mapping the contour of the metaphyseal bone (the transition where the diaphysis and epiphysis of the bone come together) to form the tibial tray and facilitate insertion.

The force F is decomposed into two orthogonal components, the components along the coordinate axes. The unit vectors i and j along the X and Y axes are given by the equations and figures below.

Programming code or algorithms such as in tibial cut generator 750 may include the introduction of a non-planar shape to the bottom of the tibial tray that can significantly increase the surface contact area of the tibia being cut. As an example, the surface area of a circle in the plane is characterized by the equation (area of circle=πr ² ). The surface area of a hemisphere approximated by a hemisphere is characterized by the formula (surface area of hemisphere=2πr ² ). Therefore, the introduction of a hemispherical shape can significantly increase the contact area of the surface. As a non-limiting example, a hemisphere has twice the surface area of a circle of equal radius. Although the configuration of the normal proximal portion of the tibia is not a flat plane, the anatomy is characterized by irregularities, and the tibia cut generator 750 in determining the cut proximal portion of the tibia: It may be based on non-parallel surfaces.

An approximation of these uneven surface features 900 is shown in FIG. 9, where a patient-specific knee is designed like the tibial cut generator 740 (FIG. 7) to generally approximate these anatomical surface features. may Notably, these surface configurations have a minimum height measured between the lowest and highest members along the cutting surface, excluding keels and pins, greater than about 0.5 mm. The only difference is that it can be geometrically approximated such that the maximum height measured between the lowest and highest members along the cutting surface, except, should not exceed about 25 mm. It is understood that the medial and lateral condyles and the intercondylar eminence may generally approximate regions of local peaks and valleys or valleys and peaks along the cutting surface. In some embodiments, programming code or algorithms in the tibia cut generator 740 (FIG. 7) determines the cut proximal portion of the tibia based on one or more angled surfaces and resulting shear forces. You can decide. For example, the shear force at any point of the implant-bone interface may be characterized by and based on the equation Fx=Fcos(θ), where increasing θ increases the shear force Decrease.

FIG. 10 shows two bone-implant interfaces, a support pin and a cortical metaphyseal bone, which may be flat or curved so that the surface contact area is reasonably maximized. Such analysis may be employed in optimization generator 746 (FIG. 7).

In another embodiment, the automatic segmentation and implant generation algorithm creates a pre-planned semi-elliptical shape on the proximal tibial surface designed for engagement with the matching patient-specific tibial tray generated by the algorithm. It may be utilized with a surgical robot to introduce irregular shapes and cavities in the body. For example, the preoperative anatomy of the tibia is characterized by segmentation and implant generation algorithms designed to output a robotic surgical plan and corresponding patient-specific implants. The algorithm output is designed to loosely reconstruct the preoperative curvature of the native anatomy (the geometric approximation of the proximal tibia, specifically the medial and lateral condyles, the intercondylar eminence, the medial and lateral curvature plateaus). or may incorporate peg cavities of variable length and be designed to be highly conformable to the underlying bone. Algorithms can map the contours of the metaphyseal bone so that a well-fitting implant can be inserted. Surgical robots can use tissue-cutting tools (burrs, sagittal saws, drills, etc.) to prepare these surfaces and 3D print, forge, or cast the implants.

The tibial tray may be aligned at the surgeon's discretion and input, or by system 700 . A total knee arthroplasty (TKA) of the present disclosure may be aligned with the tibial component positioned perpendicular to the anatomical axis of the tibia, similar to conventional TKA. For example, an anatomical axis may be collinear with a mechanical axis as long as there is no abnormal deformation. Alternatively, so-called kinematic or anatomical techniques aimed at recreating the natural sagittal and coronal orientation of the tibial articular surface (e.g., returning the articular surface to its pre-arthritic state) is sometimes adopted. There is variation in the natural alignment of the tibia. Coronary artery alignment typically averages 3 degrees and sagittal alignment (posterior tilt) averages about 7 degrees, but can vary from 0 to 15 degrees or more. The tibial cut generator algorithm is potentially applicable to either technique.

FIG. 8 is a block diagram of a system 800 for use in knee replacement surgery, eg, for performing method 600 (FIG. 6), according to an embodiment of the present disclosure.

FIG. 11 is a block diagram of a robotic method 1200 for cutting a patient's tibia for knee replacement surgery. The method 1200 includes, for example, at 1210, acquiring, via a processor, first data representing a proximal portion of the patient's tibia. At 1220, the method performs, via the processor, a second, patient-specific resected proximal portion of the patient's tibia based on the first data and based on the position of the inner surface of the cortical bone of the tibia. It may further comprise determining the data. The method can also include, via the processor, forming the patient's tibia based on the second data of the patient-specific resected proximal portion of the tibia at 1230 , the resected portion of the patient's tibia. The proximal portion has one or more cavities and/or openings that expose the lower portion of the inner surface of the cortical bone of the tibia.

12-14 illustrate a tibial tray 1320 according to one embodiment of the present disclosure. In the illustrated embodiment, at least a portion of the tibial tray 1320 when operably attached to the resected proximal portion of the patient's tibia is laterally aligned with the inner surface of the cortical bone of the proximal portion of the tibia. Interface to increase contact area. For example, tibial tray 1320 may be configured similarly to tibial tray 20 (FIG. 1). In this embodiment, the tibial tray 1320 does not include a keel.

15-19 illustrate a tibial tray 1420 according to one embodiment of the present disclosure. For example, tibial tray 1420 is configured similarly to tibial tray 1320 (FIGS. 12-14) with the addition of keel 1421 (FIGS. 17-20). 20 and 21 illustrate a tibial tray 1420 placed over a resected proximal portion of a patient's tibia 1410. FIG.

22 and 23 show a tibial tray 1520 according to one embodiment of the present disclosure. In this illustrated embodiment, at least a portion of the tibial tray 1520 when operably attached to the resected proximal portion of the patient's tibia interfaces with the cortical inner surface of the proximal portion of the tibia. to increase the contact area. For example, tibial tray 1520 may be configured similar to the combination of tibial tray 20 (FIG. 1) and tibial tray 420 (FIG. 4). In this embodiment, the tibial tray 1520 may include a tibial engaging portion having a peripheral wall and a non-planar central portion. The central portion may be designed to interface with the curved shape and support cavity of the cut proximal portion of the tibia. For example, the central portion of the tibial tray may include a convex lowest point near the lateral condyle, a concave highest point near the intercondylar ridge, and a convex lowest point near the medial condyle. As shown in FIG. 23, the outer edge of the convex surface may have an elliptical or generally oval configuration.

FIG. 24 shows a tibial tray 1620 according to one embodiment of the present disclosure. In this illustrated embodiment, at least a portion of the tibial tray 1620 when operably attached to the resected proximal portion of the patient's tibia 1610 interfaces with the medial surface of the cortical bone of the proximal portion of the tibia. to increase the contact area. For example, the tibial tray 1620 may be configured to be received between inner surface portions of cortical bone. In this embodiment, the resected portion of the patient's tibia may lie along plane P1. A cavity may be provided in the patient's tibia to receive the inferior extensor peripheral portion 1650 of the tibial engagement portion of the tibial tray 1620 . In this embodiment, the tibial tray does not rest on the resected superior edge of the patient's tibial cortical bone, but instead extends over the resected superior edge of the patient's tibial cortical bone. .

FIG. 25 illustrates a tibial tray 1720 according to one embodiment of the present disclosure. In this illustrated embodiment, at least a portion of the tibial tray 1720, when operably attached to the resected proximal portion of the patient's tibia 1710, extends laterally from the inner surface of the cortical bone of the proximal portion of the tibia. interface with to increase the contact area. For example, the tibial tray 1620 may be configured to be received between inner surface portions of cortical bone. In this embodiment, the resected portion of the patient's tibia may lie along plane P1. An initial cavity may be formed having a lower surface disposed along plane P2, the cavity being provided in the patient's tibia for receiving the inferior extensor peripheral portion 1750 of the tibia engaging portion of the tibial tray 1720. good too. In this embodiment, the tibial tray does not rest on top of the resected superior edge of the patient's tibial cortex, but instead lies generally flush with the top surface of the resected superior edge of the patient's tibial cortex. extended.

Referring to FIGS. 26-29, there is shown a portion of a tibial tray spaced from the inner surface of the underlying cortical bone and cut into the proximally adjacent tibia for use in total knee arthroplasty. An exemplary embodiment of a tibial tray attached to the proximal portion of the tibial tray is illustrated.

In some embodiments, for example, the patient-specific tibial tray design enhances sterility through a combination of high inferior peripheral surface contact and inferior surface geometry that more closely interfaces with the surrounding cancellous bone adjacent to the cortical bone. slackness and depression. The present disclosure may resolve and/or overcome a major cause of knee implant failure: sterile loosening and subsidence of the tibial component.

In some embodiments, the present disclosure provides a method of generating a three-dimensional model of a tibia and a custom tibial tray having one or more peripheral inferior extensions designed to be spaced from the periphery of the underlying tibial cortical bone. It is directed to the generation of a resection plan for excavating a portion of the tibia using a robot or robotic excavator according to the resection plan so that a .

In some embodiments, the techniques of the present disclosure reduce the resected proximal portion of the tibia by employing one or more peripheral inferior extensions designed to be spaced apart from the periphery of the underlying tibial cortical bone. It is directed to increasing the stability of the tibial tray against the A virtual model of the proximal portion of the tibia can be used to determine improved implants designed to achieve higher levels of stability. A processor is employed to cut the proximal tibia to remove cancellous bone from the tibia such that the amount of contact between the tibia and the implant is increased by, for example, 10% or more compared to conventional tibial trays. may be configured to generate a drilling protocol for drilling the

FIG. 26 shows a tibial tray 2020 attached to a resected proximal portion of a tibia 2010 for total knee replacement surgery, according to an embodiment of the present disclosure. In this illustrated embodiment, at least a portion of the tibial tray 2020 when operably attached to the resected proximal portion of the tibia 2010 extends from the periphery of the underlying tibial cortical bone 2012 of the proximal portion of the tibia 2010 . It includes peripheral inferior extensions that extend over cancellous bone 2011 that are designed to be offset or spaced apart.

For example, as shown in FIG. 27, a tibial tray 2020 may include a body 2022 having an upper portion 2024 and a lower tibial engaging portion 2026. As shown in FIG. Top 2024 may include a generally planar upper surface 2025 (best shown in FIG. 26) for supporting a plastic bearing spacer (not shown). In some embodiments, planar upper surface 2025 includes a peripheral upwardly extending lip 2027 (Fig. 26) for mounting and constraining a plastic bearing spacer via a snap-fit connection.

With continued reference to FIG. 27, the tibia engaging portion 2026 may include a central tibia engaging portion 2030 and a first peripheral tibia engaging portion 2040 . In this embodiment, the central tibia engaging portion 2030 may include an undulating surface capable of contacting the central cancellous surface of the resected proximal portion of the patient's tibia. For example, the central tibia engaging portion includes one or more concave, convex, or planar surfaces capable of contacting the central cancellous surface of the resected proximal portion of the patient's tibia, also as described above. It's okay.

The peripheral tibia engaging portion 2040 may include at least one inferior extension wall and may include a first inferior extension wall 2050 and a second spaced apart inferior extension wall 2051 . First inferior wall 2050 may include an inner wall surface 2052 and an outer wall surface 2054 . For example, walls 2052 and 2054 may be U-shaped walls facing each other. The second downward extending wall 2051 may include an inner wall surface 2053 and an outer wall surface 2055 . Walls 2050 and 2051 may be mirror images of wall 2050 and may have a constant thickness, different thicknesses, varying thicknesses, or other suitable thicknesses. Inner wall surfaces 2052 and 2053 may be disposed at right angles or 90 degrees to top surface 2025, or at any suitable angle or angles. Outer wall surfaces 2054 and 2055 may be positioned at right angles or 90 degrees to top surface 2025 . In other embodiments, the outer wall surface may be angled with respect to the upper surface, such as being parallel to and spaced from the inner surface 2013 (FIG. 26) of the cortical bone 2012 (FIG. 26). good.

FIG. 28 is a top view of a resected proximal portion of a patient's tibia 2010 of FIG. 26 for total knee replacement surgery, according to an embodiment of the present disclosure. In this illustrated embodiment, the resected proximal portion of the tibia 2010 may include cancellous bone 2011 with a central cancellous bone surface 2015 and cortical bone 2012 with a cortical epiphyseal surface 2018 . Cancellous bone 2011 is disposed along a first U-shaped cavity 2115 disposed along one side, such as the medial side of the proximal tibia 2010, and along an opposite side, such as the lateral side of the proximal tibia 2010. and a second U-shaped cavity 2117 . First U-shaped cavity 2115 may include an inner surface 2125 and an outer surface 2126 . Second U-shaped cavity 2117 may include an inner surface 2127 and an outer surface 2128 . Cavities 2115 and 2117 extend into cancellous bone 2011 (eg, trabecular, cancellous, or porous bone) of tibia 2010 adjacent inner surface 2013 of cortical bone 2012 of the proximal portion of tibia 2010 . good too. Walls 2050 and 2051 ( FIG. 27 ) may be received within cavities 2115 and 2017 formed in the resected proximal portion of tibia 2010 . For example, cavities 2115 and 2017 may be sized and configured to correspondingly receive walls 2050 and 2051 ( FIG. 27 ) when tibial tray 2020 is placed on resected proximal tibia 2010 .

The inner wall surface 2052 of the first wall 2050 may be positioned adjacent to or abutting the inner surface 2125 of the first U-shaped cavity 2115, and the outer wall surface 2054 of the first wall 2050 may be positioned adjacent to or abutting the inner surface 2125 of the first U-shaped cavity 2115. may be positioned adjacent to or abutting the outer surface 2126 of one U-shaped cavity 2115 and the inner wall surface 2053 of the second wall 2051 is adjacent to the inner surface 2127 of the second U-shaped cavity 2117. The outer surface 2055 of the second wall 2051 may be positioned adjacent to or abutting the outer surface 2128 of the second U-shaped cavity 2117. good.

Referring again to FIG. 26, the depth D5 of wall 2050 can be, for example, from about 0.5 millimeters (mm) to about 75 mm, from about 1 mm to about 50 mm, from about 2 mm to about 40 mm, from about 4 mm to about 20 mm, 0.5 mm. It may range from about 1 mm or more, about 2 mm or more, about 3 mm or more, about 5 mm or more, about 7 mm or more, or any other suitable depth. Width W5 of wall 2050 may be, for example, between about 5 mm and about 6 mm, and is desirably greater than about 0.5 mm and less than or equal to about 50 mm. The lower portion of the outer surface 2054 of the wall 2050 is from the inner surface 2013 of the cortical bone 2012, e.g. They may be separated by a distance L5 of between 1 mm and about 2 mm, or other suitable distance.

Referring again to FIG. 27, in some embodiments, inferior extension walls 2050 and 2051 extend along at least 25 percent of the circumference of body 2022, along at least 50 percent of the circumference of body 2022, for example. or along another suitable amount along the circumference of body 2022 . In some embodiments, the peripheral edge 2029 of the tibial tray 2020 may include a lower surface 2028 that extends over the superior cutting cortical bone 2018 (FIG. 28). In some embodiments, tibial tray 2020 may include a keel (not shown in FIG. 27). The proximal tibia cut and cancellous bone access cavity and corresponding tibial tray may be sized and formed manually by the surgeon or prepared automatically by the robot as described above.

FIG. 29 illustrates a tibial tray 3020 attached to a resected proximal portion of a tibia 3010 for total knee replacement surgery, according to one embodiment of the present disclosure. In this illustrated embodiment, at least a portion of tibial tray 3020 includes a peripheral inferior extension that extends over cancellous bone 3011 when operably attached to the resected proximal portion of tibia 3010 . The peripheral inferior extension is designed to be offset and parallel to the periphery of the underlying tibial cortical bone 3012 of the proximal portion of the tibia 3010 .

For example, as shown in FIG. 30, a tibial tray 3020 may include a body 3022 having an upper portion 3024 and a lower tibial engaging portion 3026. As shown in FIG. Top 3024 may include a generally planar upper surface 3025 (best shown in FIG. 29) for supporting a plastic bearing spacer (not shown). In some embodiments, planar top surface 3025 includes a peripheral upwardly extending lip 3027 (FIG. 29) for mounting and constraining plastic bearing spacers via typical snap-fit connections.

The tibia engaging portion 3026 may include a central tibia engaging portion 3030 and a peripheral tibia engaging portion 3040 . In this embodiment, the central tibia engaging portion 3030 may include an undulating surface capable of contacting the central cancellous surface of the resected proximal portion of the patient's tibia. For example, the central tibia engaging portion includes one or more concave, convex, or flat surfaces capable of contacting the central cancellous surface of the resected proximal portion of the patient's tibia, also as described above. It's okay.

The peripheral tibia engaging portion 3040 may include at least one inferior extensor wall having portions located at different depths. The peripheral tibia engaging portion 3040 may, for example, include a first inferior extension wall 3050 and a second spaced apart inferior extension wall 3051 . The peripheral tibia engaging portion 3040 may further include a connecting inferior extension wall 3070 , a first medial extension wall 3080 and a second medial extension wall 3090 . A connecting inferior extension wall 3080 may extend between a first inferior extension wall 3050 and a second inferior extension wall 3051 spaced apart. Inwardly facing ends 3081 and 3091 of first and second inwardly extending walls 3080 and 3090 , respectively, may define a gap G disposed along the posterior side of tibial tray 3020 . Gap G may limit the need to sacrifice tendons and ligaments on the posterior side of the proximal tibia.

The first downward extending wall 3050 may include an inner wall surface 3052 and an outer wall surface 3054 . The second downward extending wall 3051 may include an inner wall surface 3053 and an outer wall surface 3055 . Walls 3050 and 3051 may have a generally constant thickness that is rounded at their lowest ends.

Inner wall surfaces 3052 and 3053 may be disposed at right angles or 90 degrees to top surface 3025, or at any suitable angle or angles. The outer wall surfaces 3054 and 3055 may be sized and configured to provide a generally constant space S (FIG. 29) between the outer wall surfaces 3054 and 3055 and the adjacent inner surface 3013 (FIG. 29) of the cortical bone 3012. good.

Referring again to FIG. 29, the outer surface of the wall may be spaced from the inner surface 3031 of the cortical bone, e.g. They may be spaced apart by a distance L6, such as between 5 mm, between about 1 mm and about 2 mm, or any other suitable distance.

Referring again to FIG. 30, the depth D6 of walls 3050 and 3051 can be, for example, about 0.5 mm to about 75 mm, about 1 mm to about 50 mm, about 2 mm to about 40 mm, about 4 mm to about 20 mm, about 0.5 mm. It may extend beyond about 1 mm or more, about 2 mm or more, about 3 mm or more, about 5 mm or more, about 7 mm or more, or any other suitable depth. The depth D7 of connecting wall 3070 and inwardly extending walls 3080, 3090 can be, for example, about 0.5 mm to about 75 mm, about 1 mm to about 50 mm, about 2 mm to about 40 mm, about 4 mm to about 20 mm, about 1 mm or more, about It can extend to a depth of 2 mm or greater, about 3 mm or greater, about 5 mm or greater, about 7 mm or greater, or other suitable depth. In some embodiments, the depth D7 of connecting wall 3070 and inwardly extending walls 3080, 3090 is, for example, about 20%, about 25%, about 30%, or other suitable percentage of depth D6. may Width W6 of walls 3050 and 3051 may be, for example, between about 5 mm and about 6 mm, and is preferably greater than about 0.5 mm and less than or equal to about 50 mm. The width W7 of walls 3070, 3080, and 3090 can be, for example, between about 5 mm and about 6 mm, and is desirably greater than about 0.5 mm and less than about 50 mm. In some embodiments, width W7 may be less than width W6, eg, half as wide as compared to width W6.

Referring again to FIG. 29, the cutting of the proximal tibia 3010 and the access cavity in the cancellous bone of the proximal tibia, and the corresponding tibial tray 3020 may be manually sized and formed by the surgeon or as described above. may be prepared automatically by the robot, such as

31 and 32 show a tibial tray 4020 (FIG. 31) according to one embodiment of the present disclosure that can be attached to a resected proximal portion of a patient's tibia 4010 (FIG. 32) for total knee replacement surgery. showing. In this illustrated embodiment, at least a portion of the tibial tray 4020, when operably attached to the resected proximal portion of the patient's tibia 4010 (FIG. 32), is positioned against the cortex of the resected proximal tibia. It includes a peripheral inferior extension extending over cancellous bone 4011 (Fig. 32) adjacent to the wall. The peripheral inferior extension may be spaced apart and designed to be offset and/or parallel to the periphery of the underlying tibial cortical bone of the patient's proximal tibia.

As shown in FIG. 31, the tibial tray 4020 has asymmetric convex surfaces 4030 and 4031 and asymmetric peripheral inferior extensions 4052 and 4053 extending from the inferior surface of the tibial tray 4020 to enhance force distribution across the medial and lateral compartments. and may include a rim 4018 that extends around part, substantially all, or all of the entire perimeter of the tibial tray 4020 . In addition to the asymmetry of a portion of the tibial tray, the peripheral inferior extension 4052 may be angled and thinner than the peripheral inferior extension 4053, which is thicker and more vertically aligned.

In various embodiments, the cavities and walls desirably do not penetrate the outer cortical bone. In other embodiments, a portion of the cavity or wall, such as its lower portion, may contact or extend into cortical bone.

FIG. 33 illustrates a method 6000 for use in total knee arthroplasty according to one embodiment of the present disclosure. In this illustrated embodiment, the method 5000 is operable in providing a customized cutting plan for the proximal portion of the tibia for the patient and providing a corresponding customized tibial tray. The method 5000 can include, for example, at 5100 acquiring first data representing a proximal portion of the patient's tibia. At 5200, second data for a patient-specific resected proximal portion of the patient's tibia is determined based on the first data. The proximal portion of the patient's tibia to be cut has an upper surface and at least one cavity within the cancellous bone that exposes a peripheral underlying portion of the cancellous bone of the patient's tibia. At 5300, a patient-specific tibial tray having an inferior surface is determined based on the second data. At 5400, the patient's tibia is resected based on the second data. At 5500, a tibial tray is formed based on the second data, and at 5600 the formed tibial tray is configured so that a peripheral lower portion of the tibial tray extends into at least one cavity from underlying cortical bone of the patient's tibia. Spaced apart and secured onto the resected proximal portion of the tibia.

FIG. 34 is a block diagram of a robotic method 6000 for cutting a patient's tibia for total knee replacement surgery. Method 6000 includes, for example, at 6100, acquiring, via a processor, first data representing a proximal portion of a patient's tibia having central cancellous bone and peripheral cortical bone. At 6200, the method includes forming, via the processor, a central cancellous bone surface, a peripheral cortical bone surface, and a cancellous bone surface spaced from the cortical bone to expose a peripheral underlying portion of the cancellous bone of the patient's tibia. Based on the first data, the method may further include determining second data representing a patient-specific cut proximal portion of the patient's tibia having at least one cavity to be cut. The method also includes, at 6300, forming, via the processor, the patient's tibia based on second data representing a patient-specific proximal resection of the tibia. The site has a central cancellous bone surface, a peripheral cortical bone surface, and at least one cavity spaced from the inner surface of the underlying cortical bone of the patient's tibia to expose the peripheral underlying portion of the cancellous bone.

In further embodiments, the patient-adapted or customized tibial tray may include, for example, inferior extension pegs, flanges, fins, etc., positioned at or near the periphery of the tibial tray, which during installation , is received in one or more cavities or holes in cancellous bone in close proximity to and spaced from the inner surface of the underlying cortical bone of the resected proximal portion of the patient's tibia. Alternate embodiments of the tibial tray include, for example, an asymmetrical convex element extending from the lower surface of the tray to improve force distribution across the medial and lateral compartments, and all, substantially all, or a portion of the top peripheral surface of the resected cortical bone. A rim may be provided extending around the portion.

The present disclosure may also be implemented using system 700 of FIG. 7 and system 800 of FIG. Three-dimensional cutting to excavate a portion of the proximal tibia for total knee replacement using a robot or robotic excavator according to a cutting plan to create a cavity to allow insertion of a custom tibial tray A method and system for generating plans is directed. The robot may employ images or cameras for optical tracking to navigate the anatomy, may actively create custom cavities, and may provide haptic feedback to perform cutting, for example. Or it may not be necessary to turn to a surgeon.

FIG. 35 illustrates a proximal portion of a patient's tibia 7000 for total knee replacement surgery, according to one embodiment of the present disclosure. The lateral portion and/or medial portion may include portions of cortical bone 7012 that extend inward toward the top of the tibia 7000 . For example, as shown in FIG. 35, the proximal lateral portion 7015 of the cortical bone 7012 of the tibia 7000 may extend medially toward the top of the tibia 7000 such that the medial surface 7016 of the cortical bone 7012 is medially concave. have

As noted above, tibial trays according to the present disclosure for use in total knee arthroplasty may include one or more inferior extensor walls having an outer wall surface and an inner wall surface. The outer wall surface may correspond to and be configured to contact the inner surface of the underlying cortical bone, or may be spaced apart from and adjacent to the underlying inner surface of the cortical bone. A tibial tray having an inferior extensor wall corresponding to the location of the lateral cortical bone with a medial concave surface 7016 below the cutting plane RP1, one or more inferior extensor walls are positioned to receive one or more inferior extensor walls. It is understood that it may result in not being insertable into a resected proximal tibia having one or more cavities.

As shown in FIG. 35, the planar cutting surface may be a cutting surface RP1 arranged perpendicular to the anatomical axis A of the tibia 7000. As shown in FIG. Referring to FIG. 36, in order for the tibial tray 8000 to be insertable adjacent the inner surface of the cortical bone 7012 (FIG. 35), the bottom surface 8003 of the tibial tray 8000 and the outer surface 8054 of one or more inferior extensor walls 8050 must be aligned. should be equal to or greater than 90 degrees, and this bottom surface 8003 rests on the flat cutting surface RP1. In order for the tibial tray 8000 to be insertable, the angle β between the bottom surface 8003 of the tibial tray 8000 and the inner surface 8052 of one or more inferior extension walls 8050 must be equal to or greater than 90 degrees. .

Referring to FIG. 37, in designing and/or fabricating a tibial tray using, for example, system 700 (FIG. 7) or system 800 (FIG. 8), the method includes placing one or more lower jaws on the resected proximal portion of the tibia. An algorithm or programming code may be included that maintains the ability to insert the tibial tray 8500 with extensor wall 8550 . To maintain the ability to insert a tibial tray implant, one or more constraints may be imposed on the design of the outer surface of one or more inferior extension walls 8550 of the tibial tray 8500. For example, in designing and/or fabricating one or more inferior extensor walls 8550 of the tibial tray 8500 where the underlying cortical bone of the cutting surface defines a medial concave surface (eg, medial concave surface 7016 in FIG. 35), the cutting surface RP1 (FIG. 35) of the cortical bone 7012 (FIG. 35) may define a constraint such that the resulting outer surface 8554 of the inferior extensor wall 8550 is vertical or extends inward. In some embodiments, relative to the anatomical axis A of the tibia 7000 (or any other axis or vertical reference), the horizontal distances d1 and d2 between the outer surface of the inferior extensor wall and the anatomical axis A may decrease from a proximal portion of the outer surface of the inferior extensor wall to a distal portion of the outer surface of the inferior extensor wall.

As shown in FIG. 38, the tibial tray 8700 may be designed and/or manufactured with constraints on the outer surface of the inferior extensor wall 8750 based on the inner surface of the underlying contoured cortical bone. For example, the outer surface portion 8757 of the inferior extensor wall 8750 may be configured to correspond to the contoured shape of the inner surface of the underlying cortical bone. The outer surface portion 8759 of the inferior extensor wall 8750 may be constrained by the superior edge 7400 (FIG. 35) of the cortical bone 7012 (FIG. 35) along the cutting plane RP1 (FIG. 35) such that the outer surface portion 8759 is aligned with the tibial tray. It will have an outer right angle wall or curved outer wall surface perpendicular to the bottom surface of the .

In some embodiments, for example for clinical reasons, the cutting surface may need to be arranged at an angle instead of being flat. Clinical problems can arise if the implant is designed for a flat cutting surface but is inserted into an angled cutting surface. For example, the downwardly extending wall may not correspond exactly to the inner surface of the cortical wall and/or may even contact and/or penetrate cortical bone.

39, in some embodiments, for clinical reasons such as injury or disease, the cutting surface RP2 is angled using system 700 (FIG. 7) or system 800 (FIG. 8). For example, the cutting surface RP2 may be a cutting surface arranged non-perpendicular to the anatomical axis A of the tibia, which may need to be designed and/or manufactured. To compensate for this approach, the tibial tray 9000 design process may consider the angle of the cutting surface relative to the anatomical axis A of the tibia, which angle may be determined by an algorithm or program code and/or by the surgeon. May be determined preoperatively. For angled cutting surfaces, the calculation for insertion described above may be adopted, but modified to account for the angle θ between the cutting surface RP2 and the horizontal plane HP perpendicular to the anatomical axis A of the tibia. may be For example, the angle θ may be added to the angles α and β.

FIG. 40 illustrates a tibial tray 10020 attached to a partially resected proximal portion of the tibia 10010 for partial knee replacement surgery, according to one embodiment of the present disclosure. As illustrated, such a partial unicompartmental knee replacement (PUKR) leaves at least one of the knee's natural bearing surfaces intact and replaces only a portion of the damaged proximal portion of the tibia. . For example, the tibial tray 10020 may replace either the medial portion of the proximal portion of the tibia or the lateral portion of the proximal portion of the tibia. In this illustrated embodiment, at least a portion of the tibial tray 10020 when operably attached to the resected proximal portion of the tibia 10010 is positioned on the inner surface or side of the cortical bone 100012 of the proximal portion of the tibia 10010. The parts may be interfaced to increase contact or be closely spaced.

For example, as shown in FIGS. 41 and 42, the tibial tray 10020 may include a body 10022 having an upper portion 10024 (FIG. 41) and a lower tibial engaging portion 10026. As shown in FIG. Body 10022 may include a peripheral edge 10023 corresponding to a portion of the outer surface of the cortical bone along the cut surface of the tibia, and a peripheral edge 10024 across the center of the cut surface of the tibia. good. The peripheral edge 10024 may be positioned across tibial axis A (FIG. 40) or may be spaced from tibial axis A (FIG. 40).

Top 10024 may include a generally planar upper surface 10025 (FIG. 41) for supporting a plastic bearing spacer (not shown). In some embodiments, the planar upper surface 10025 may include a peripheral upwardly extending lip (not shown) for mounting and constraining plastic bearing spacers via snap-fit connections.

Referring again to FIG. 41 , the tibia engaging portion 10026 may include a central tibia engaging portion 10030 and a peripheral tibia engaging portion 10040 . In this embodiment, the central tibia engaging portion 10030 may include a surface capable of contacting the central cancellous surface of the resected proximal portion of the patient's tibia. For example, the central tibia engaging portion may comprise one or more concave, convex, or planar surfaces capable of contacting the central cancellous surface of the partially resected proximal portion of the patient's tibia, also as described above. may contain. As shown in FIGS. 41 and 42, the central tibia engaging portion 10030 may include a convex surface 10031. As shown in FIGS. The convex lower surface may be designed to maximize surface contact area and reduce shear forces along the cutting surface.

The peripheral tibial engagement portion 10040 may include an inferior extensor wall 10050 . The inferior extension wall 10050 may include an inner wall surface 10052 (FIG. 42) and an outer wall surface 10054 . For example, walls 10052 and 10054 may be U-shaped walls. Walls 10050 may have a constant thickness, different thicknesses, varying thicknesses, or other suitable thicknesses. The inner wall surface 10052 may be arranged at right angles or 90 degrees to the top surface 10025, or may be arranged at any suitable angle or angles. The outer wall surface 10054 may be positioned at right angles or 90 degrees to the top surface 10025 . In other embodiments, the outer wall surface may be angled with respect to the upper surface, such as being parallel to and spaced from the inner surface 10013 (Fig. 40) of the cortical bone 10012 (Fig. 40). . As described above, the outer wall surface 10054 may be configured to contact the inner surface of the cortical bone or may be configured to be closely spaced from the inner side of the cortical bone.

As noted above, various surgical robotic methods have been employed to drill one or more cavities of cancellous bone in the resected proximal portion of the tibia for insertion of various tibial components. obtain.

FIG. 43 shows a patient-specific tool with an opening 11050 for receiving a non-robotic burr or milling tool 12000 (FIG. 44) to allow the surgeon to manually drill a cavity as described above. A tool or tibial cavity cutting guide 11000 is illustrated. For example, cutting guide 11000 may be used by a surgeon to form at least one cavity in a resected proximal portion of a patient's tibia for knee replacement surgery. The resected proximal portion of the tibia includes a central cancellous bone surface and a peripheral cortical bone surface, as described above. The cutting guide 11000 may include a planar member 11020 having a first planar surface 11022 and a second planar surface (not shown in FIG. 43).

The planar member 11020 may include a peripheral outer edge 11023 corresponding to the outer peripheral cortical bone along the resected proximal portion of the patient's tibia. A pair of U-shaped openings 11050 extend through the planar member from the first planar surface 11022 to a second planar surface (not shown) and are spaced from the peripheral outer edge. Each of the pair of U-shaped openings 11050 defines a U-shaped axis 11060, the U-shaped opening having a constant width W8 perpendicular to the U-shaped axis. Width W8 desirably corresponds to the width of the downwardly extending portion of the corresponding patient-specific tibial tray. Each of the pair of U-shaped openings has an inner edge 11061 and an outer edge 11062 . The outer edge 11062 may be arranged parallel to the peripheral outer edge 11023 . Cutting guide 11000 may be, for example, a patient-specific cutting guide and may be effective using system 700 of FIG. 7 and system 800 of FIG. For example, suitable algorithms and programming code stored in memory 730 (FIG. 7) along with patient tibia data 702 (FIG. 7) and surgeon inputs 704 (FIG. 7) are operatively processed in processor 710 (FIG. 7). A patient-specific cutting guide may be generated, which may be produced or manufactured using the 3D printer 795 (FIG. 7).

44, milling tool 12000 includes a proximal diameter X1 sized larger than width W8 of U-shaped opening 11050 (FIG. 43) and a distal diameter sized to pass through width W8 of U-shaped opening 11050. position diameter X2. Thus, the patient-specific tibial cavity cutting guide 11000 (FIG. 43) having an opening 11050 into which the milling tool 12000 fits constrains the motion of the milling tool 12000 in a fixed manner. Referring again to FIG. 43, the cutting guide 11000 may include one or more fixation holes 11070 to accommodate temporary fixation of the cutting guide to the resected tibia, e.g., via screws. . The circumference of the cutting guide may be sized to match the circumference of the tibia to be cut to facilitate visual alignment and proper placement on the cut tibia.

Referring again to FIG. 44, manual drilling of the cavity for the inferior extension of the tibial tray can be performed to the appropriate depth. For example, the cutting portion for the milling guide 12000 extends a length L corresponding to the depth of the inferior extension of the tibial tray, when the tibial tray is placed on the resected proximal portion of the patient's tibia. may be sized to allow reception of the lower extension of the

FIG. 45 illustrates a patient-specific implant system 13000 for total knee replacement surgery, according to one embodiment of the present disclosure. For example, the patient-specific implant system 13000 may include a tibial tray 13020, a spacer 13025, a femoral implant component 13050, and a patellar implant component 13070 configured and manufactured as described above. good.

FIG. 46 illustrates a patient-specific implant system 14000 for partial total knee replacement surgery, according to one embodiment of the present disclosure. For example, patient-specific implant system 14000 may include a partial tibial tray 14020, a spacer 14025, and a partial femoral implant component 14050 configured and manufactured as described above.

47-50 illustrate a tibial tray 15000 according to one embodiment of the present disclosure. For example, tibial tray 15000 may be configured similar to tibial tray 2020 (FIGS. 26-28) except having a peripheral wall or fin 15040. As shown in FIG. The tibial tray 15000 is placed on a resected proximal portion of the tibia with a circumferential wall or fin 15040 positioned closely adjacent to the inner surface of the underlying cortical bone for use in total knee arthroplasty. may

In this illustrated embodiment, the tibial tray 15000 may include a body 15022 having an upper portion 15024 and a lower tibial engaging portion 15026. As shown in FIG. Top 15024 may include a generally planar upper surface 15025 (best shown in FIG. 48) for supporting a plastic bearing spacer (not shown). In some embodiments, the planar upper surface 15025 may include a peripheral upwardly extending lip (not shown) for mounting and constraining a plastic bearing spacer via a snap-fit connection.

The lower tibia engaging portion 15026 may include a peripheral wall or fin 15040 that extends into the cancellous bone of the resected tibia when operably attached to the resected proximal portion of the tibia 10 (FIG. 50). The peripheral wall or fin 15040 may be designed to be offset or spaced from the periphery of the underlying tibial cortical bone of the proximal portion of the tibia.

As shown in FIG. 47, the tibia engaging portion 15026 may include a central tibia engaging portion 15030 and a single inferior extensor wall or fin 15040. As shown in FIG. In this embodiment, the central tibia engaging portion 15030 may include a flat surface capable of contacting the central cancellous surface of the resected proximal portion of the patient's tibia. In other embodiments, the central tibia engaging portion may have an undulating surface as described above.

A single lower circumferential wall or fin 15040 may include an inner wall surface 15051 and an outer wall surface 15055 . For example, the wall may have a cross-sectional kidney shape similar to the top 15024 . The upper portion 15024 may have a constant thickness, varying thickness, varying thickness, or other suitable thickness. The inner wall surface 15051 may be disposed at right angles or 90 degrees to the upper surface 15025, or at any suitable angle or angles. The outer wall surface 15055 may be positioned at right angles or 90 degrees to the top surface 15025 . In other embodiments, the outer wall surface may be angled with respect to the upper surface, such as parallel to and spaced from the inner surface of the cortical bone, as shown in FIG. good. In other embodiments, the outer wall surface 15055 may be configured to rest on the inner surface of the underlying cortical bone.

Referring again to FIG. 47, in this illustrated embodiment, the wall or fin 15040 may be circumferential and positioned a full circle near the periphery of the implant or tibial tray inferior surface or inferior surface 15030 . The outer surface of the circumferential wall or fins should be taken from pre-operative images of the patient's inner cortical wall, especially in order to design the implant or tibial tray such that the outer fin wall is a fixed and constant distance from the mapped inner surface of the cortical wall. May be based on data.

An implant ledge width W9 from the mapped inner cortical wall position and the outer fin wall position can be determined. Referring to FIG. 50, for example, the outer fin wall can be defined to have a distance X from the inner cortical wall. A width Y based on accepted preoperative patient sample data for cortical wall thickness may allow designing an implant ledge W9 such that the width of the ledge is characterized by the following equation:

W9=X+Y

For example, the distance X from the inner cortical wall to the outer fin wall may be defined to be 3 mm from the inner cortical wall at all points. Cortical wall thickness may be based on the patient's age. For example, the thickness Y of the cortical wall can be determined, for example, by Gosman et al., "Development of Cortical Bone Geometry in the Human Femoral and Tibial Diap," published in The Anatomical Record, 2013, 296(5), pp. 774-787. hysis" According to the article entitled, it may be 2.2 mm for some predetermined age. Accordingly, the tibial tray may be designed and constructed to have a ledge width W9 of, for example, 5.2 mm from the outer surface of the fin at all points along the periphery. Width Y may be variable based on anatomical observations or further studies. For example, further studies may reveal that the average thickness of the cut walls is not uniform. For example, if the medial wall thickness is generally a different value than the lateral thickness, that information can be incorporated into the design of the tibial tray. In other embodiments of the present disclosure, the patient-specific design may employ cortical medial wall mapping to design a patient-specific tibial tray with matched walls or fins. An implant ledge width W9 may then be determined based on the mapped cortical wall thickness and the known distance of the wall or fin from the inner cortical wall.

With further reference to FIG. 50, in a total knee arthroplasty as indicated by the arrows in FIG. , the tibial tray and the cutting portion of the patient's proximal tibia may be resisted by the at least one downwardly extending wall and the cut periphery of the proximal tibia. . In some embodiments, the greater portion is greater than 50 percent, greater than 60 percent, greater than 70 percent, greater than 80 percent, greater than 90 percent, between 50 percent and 60 percent, 50 percent and 70 percent between 50 and 80 percent, between 50 and 90 percent, between 60 and 70 percent, between 70 and 80 percent, between 80 and 90 percent, It may be between 60 percent and 80 percent, about 60 percent, 70 percent, about 80 percent, about 90 percent or any other suitable percentage or range of percentages. In other described and illustrated embodiments of tibial trays in the present disclosure, such shear forces may be counteracted in total knee arthroplasty as well. Such embodiments may include no central keel, or may include a central keel, such as a shallow keel, wherein such shear forces are applied to the periphery of the resected proximal portion of the patient's tibia. mainly canceled by

51-56 illustrate a bi-cruciate tibial tray 16000 according to one embodiment of the present disclosure. For example, both the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL) may be preserved in a bilateral cruciate ligament retaining knee replacement. For example, this may be provided by bone cutting and implant geometry that avoids these ligaments. The bilateral cruciate tibial tray 16000 may include circumferential or partially circumferential walls or fins. The lateral, anterior and medial fin walls are designed to abut or be close to the cortical medial wall. The posterior portion of the implant lower surface may have no rim or may have a rim designed to generally inset from and match the periphery of the posterior implant surface. The posterior implant surface is curved to retain the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL). In this illustrated embodiment, the tibial tray 16000 includes a U-shaped body 16022 having a U-shaped upper portion 16024 and a C-shaped lower tibial engaging portion 16026 (best shown in FIGS. 52 and 55). may include U-shaped top portion 16024 (FIGS. 51 and 54) may define portions (outer portion and inner portion) defining cavity 16021 therebetween. Top 16024 may include a generally planar upper surface 16025 (best shown in FIGS. 51 and 54) for supporting plastic bearing spacers (not shown). Tops 16024 may include raised lands or raised portions 16023 (best shown in FIG. 51) disposed between outer portions of tops 16024 . In some embodiments, the planar upper surface 16025 may include a peripheral upwardly extending lip (not shown) for mounting and constraining plastic bearing spacers via snap-fit connections.

The lower tibia engaging portion 16026 is a C-shaped member that extends into the cancellous bone of the resected tibia when operably attached to the resected proximal portion of the tibia (not shown in FIGS. 51-56). Walls or fins 16040 may also be included. The wall or fin 16040 may be designed to be offset or spaced from the periphery of the underlying tibial cortical bone of the proximal portion of the tibia.

A single downwardly extending C-shaped wall or fin 16040 may include an inner wall surface 16051 and an outer wall surface 16055 . For example, the wall may have a cross-sectional shape similar to U-shaped cross-sectional upper portion 16024 along its perimeter. Also, the upper portion 16024 may have a constant thickness, different thicknesses, varying thicknesses, or other suitable thicknesses. Inner wall surface 16051 may be disposed at right angles or 90 degrees to top surface 16025, or at any suitable angle or angles. The outer wall surface 16055 may be positioned at right angles or 90 degrees to the top surface 16025 . In other embodiments, the outer wall surface is angled with respect to the upper surface, such as parallel to and spaced from the inner surface of the cortical bone (not shown in FIGS. 51-56). good too. In other embodiments, the outer wall surface 15055 may be configured to rest on the inner surface of the underlying cortical bone. The outer surface of the peripheral wall or fins 15055 may be based on pre-operative imaging data of the patient's inner cortical wall, specifically placing the implant such that the outer fin wall is a fixed and constant distance from the mapped inner surface of the inner cortical wall. It is for design.

57-61 illustrate a bilateral cruciate tibial tray 17000 according to one embodiment of the present disclosure. For example, both the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL) may be preserved in a bilateral cruciate ligament retaining knee replacement. For example, this can be provided by bone cutting that avoids these ligaments and implant geometry. The bilateral cruciate tibial tray 17000 may include circumferential or partially circumferential walls or fins. The lateral, anterior and medial fin walls are designed to abut or be close to the cortical medial wall. The posterior portion of the implant lower surface may a) have no rim, or b) may have a rim designed to generally inset from and conform to the periphery of the posterior surface of the implant. The posterior surface of the implant is curved to retain the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL).

In this illustrated embodiment, the tibial tray 17000 includes both cruciate ligaments, except that the wall 17040 is disposed obliquely with respect to the upper surface 17025 and is spaced from a plurality of inferior extension processes or pins 17300 . It may be essentially identical to tibial tray 16000 (FIGS. 51-56). Wall 17040 and pin 17300 may be positioned at an angle S that is non-perpendicular to top surface 17000 and to the medial-lateral direction. For example, angle S may be between about 70 and 80 degrees, may be about 75 degrees, or may be any other suitable non-orthogonal angle.

During insertion of a conventional style tibial baseplate with posts and fins, the tibia is greatly subluxed anteriorly so that the post and fins can be prepared with a punch used from above. In order for the tibial implant to sit directly on the resected tibial surface and seated straight down, the tibia must remain anteriorly subluxed. In embodiments of the tibial tray 17000, the walls and pegs are angled generally posteriorly to allow the implant to be inserted obliquely from the front rather than straight down from above. This would allow the surgeon to sublux the tibia anteriorly less than some conventional systems to insert the tibial baseplate, resulting in less soft tissue damage due to extreme subluxation of the tibia.

FIG. 62 shows a patient-specific jig or tibial cavity with a series of openings 18050 to accommodate a non-robotic burr or milling tool 12000 (FIG. 44) so that the surgeon can manually drill the cavity as described above. A cutting guide 18000 is illustrated. For example, cutting guide 18000 can be used by a surgeon to form at least one cavity, such as a continuous cavity, in a resected proximal portion of a patient's tibia for knee replacement surgery. The resected proximal portion of the tibia includes a central cancellous bone surface and a peripheral cortical bone surface, as described above. The cutting guide 18000 may include a planar member 18020 having a first planar surface 18022 and a second planar surface (not shown in FIG. 62).

The planar member 18020 may include a peripheral outer edge 18023 corresponding to the peripheral cortical bone along the resected proximal portion of the patient's tibia. A series of curved openings 18050 extend through the planar member from the first planar surface 18022 to the second planar surface (not shown) and are spaced from the peripheral outer edge. Each of the openings 18050 defines an axis 18060 and the openings have a constant width W10 perpendicular to the axis. This width desirably corresponds to the width of the inferior extension of the corresponding patient-specific tibial tray. Each opening has an inner edge 18061 and an outer edge 18062 . The outer edge 18062 may be arranged parallel to the peripheral outer edge 18023 . The cutting guide 18000 may include one or more fixation holes 18070 to accommodate temporary fixation of the cutting guide to the resected tibia, eg, via screws. The circumference of the cutting guide may be sized to match the circumference of the cut tibia to facilitate visual alignment and proper placement on the cut tibia.

Cutting guide 18000 can be, for example, a patient-specific cutting guide, and can be effected using system 700 of FIG. 7 and system 800 of FIG. For example, suitable algorithms and programming code stored in memory 730 (FIG. 7) along with patient tibia data 702 (FIG. 7) and surgeon inputs 704 (FIG. 7) are operatively processed in processor 710 (FIG. 7). A patient-specific cutting guide may be generated, which may be produced or manufactured using the 3D printer 795 (FIG. 7).

Cutting guide 18000 may be operable with a milling tool, such as milling tool 12000 (FIG. 44). As such, the patient-specific tibial cavity cutting guide 18000 having an opening 18050 into which the milling tool 12000 fits constrains the motion of the milling tool 1200 to a fixed shape. Manual drilling of at least one cavity for inferior extension of the tibial tray may be performed to the appropriate depth. For example, the cutting portion for the milling guide 12000 (Fig. 44) extends a length L (Fig. 44) corresponding to the depth of the inferior extension of the tibial tray so that the tibial tray is cut proximal to the patient's tibia. It may be sized to receive the inferior extension of the tibial tray when placed on the portion. As will be appreciated, the cutting guide 18000 may be removed and the remainder between the series of cavities removed by the surgeon to complete the continuous cavities of the resected portion of the proximal portion of the patient's tibia. may be

FIG. 63 is a block diagram of a method 19000 for use in total knee arthroplasty. The method 19000, for example, at 19100 cuts a proximal portion of the patient's tibia, wherein the cut proximal portion of the tibia comprises a laterally cut cancellous bone surface, a laterally cut peripheral cortical bone surface. and at least one cavity formed around the resected cancellous bone and at 19200 at least medially spaced from the peripheral edge of the tibial tray and extending around at least a portion of the central inferior surface. providing a tibial tray having one inferior extensor wall, at 19300 inserting at least one inferior extensor wall into at least one cavity formed around the cut cancellous bone surface; Placing the rim on the laterally cut peripheral cortical bone surface and the medial inferior surface on the laterally cut cancellous bone surface, in total knee arthroplasty, the tibial tray and the cut cancellous bone A greater portion of the shear force acting laterally on the tibial tray and cutting portion of the patient's proximal tibia is located along at least one lower surface compared to the portion of shear force resisted along the central inferior surface of the surface. It is resisted by the extensor wall and the milled perimeter of the proximal tibia.

64-71 show a tibial tray system 20001 (FIGS. 64-67) and a tibial tray system 30001 (FIGS. 68-71) according to embodiments of the present disclosure. In these embodiments, the tibial tray system includes a tibial tray and one, two, or more screws. The walls or fins of the tibial tray may require sufficient depth or minimal depth to operate in response to both shear and pull-off or lift-off forces, as compared to tibial trays with simple walls. or multiple screws may be of short size to support shear forces by minimizing or inhibiting lift-off of the tibial tray from the resected proximal portion of the patient's tibia; is described below.

For example, as shown in FIGS. 64 and 67, the tibial tray system 20001 is tibial tray 15000 with the addition of being operable to receive screws 20500 (FIGS. 64 and 67) according to embodiments of the present disclosure. A tibial tray 20000 configured similarly to (FIGS. 47-50) may be included. In this illustrated embodiment. The tibial tray 20000 has a peripheral wall or fins 20040 positioned within cancellous bone 20011 and underlying cortical bone 20012 (FIG. 67) of a resected portion of the patient's tibia 20010 (FIG. 67) for use in total knee arthroplasty. 20013 (FIG. 67) of the proximal portion of the tibia. The screws 20500 can minimize or inhibit lift-off of the tibial tray 20000 once the tibial tray assembly 20001 is placed in a cut portion of the patient's tibia 20010 (FIG. 67).

As shown in FIGS. 65 and 66, the tibial tray 20000 may include a body 20022 having an upper portion 20024 and a lower tibial engagement portion 20026. As shown in FIGS. Top 20024 may include a generally planar upper surface 20025 (best shown in FIG. 65) for supporting a plastic bearing spacer (not shown). In some embodiments, the planar upper surface 20025 may include a peripheral upwardly extending lip (not shown) for attachment via snap-fit connections, for example, to constrain plastic bearing spacers.

The lower tibia engaging portion 20026 may include a peripheral wall or fin 20040 that extends into the cancellous bone 20011 of the resected tibia when operably attached to the resected proximal portion of the tibia 20010 (FIG. 67). The peripheral wall or fin 20040 may be designed to be offset or spaced from the periphery of the underlying tibial cortical bone 20012 of the proximal portion of the patient's tibia 20010 .

As shown in FIG. 66, the tibia engaging portion 20026 may include a central tibia engaging portion 20030 and a single inferior circumferential wall or fin 20040. As shown in FIG. In this embodiment, the central tibia engaging portion 20030 may include a flat surface capable of contacting the resected central cancellous bone surface 20011 (FIG. 67) of the resected proximal portion of the patient's tibia 20010 . In other embodiments, the central tibia engaging portion may have an undulating (ie, convex or concave) surface as described above.

A single lower peripheral wall or fin 20040 may include an inner wall surface 20051 and an outer wall surface 20055 . For example, the wall may have a cross-sectional kidney shape similar to that of top 20024 or may be a mirror image of the outer contour of top 20024 . Top 20024 may have a constant thickness, different thickness, varying thickness, or other suitable thickness. The inner wall surface 20051 may be arranged at a right angle or about 90 degrees to the upper surface 20025, or may be arranged at any suitable angle or angles. The outer wall surface 20055 may be positioned at right angles or approximately 90 degrees to the top surface 20025 . In other embodiments, the outer wall surface is parallel to the inner surface of the cortical bone (eg, as shown in FIG. 67) and angled with respect to the superior surface so as to be spaced from the inner surface of the cortical bone. may In other embodiments, the outer wall surface 20055 may be configured to rest on the inner surface of the underlying cortical bone.

In this illustrated embodiment, the walls or fins 20040 may be circumferential, extending completely around the implant or tibial tray inferior surface or inferior surface 20030 and disposed towards the periphery. The outer surface of the circumferential wall or fins is used to preoperatively measure the inner cortical wall of the patient, particularly for designing implants or tibial trays such that the outer fin outer surface is a fixed and constant distance from the mapped inner surface of the cortical wall. It may be based on image data.

As shown in Figures 65 and 66, the upper portion 20024 may include holes or passageways 20060 extending from the upper surface 20025 (Figure 65) to the lower surface 20033 (Figure 66). Passageway 20060 may be configured to be countersunk.

64 and 66, the illustrated tibial tray system 20001 includes a tibial tray 20000 having a peripheral wall 20040 and releasably attachable (modular) screws 20060 located toward the center of the tibial tray 20000. Including combinations with

As will be understood from this description, the peripheral rim or wall is operable to account for lift-off or pull-out forces while the rim or wall 20040 should account for shear forces, while the screw 20500 may It may be of reduced or minimal height or depth. For example, screw 20500 may comprise body 20510 having proximal or head portion 20520 and threaded shank portion 20540 . In other embodiments, screw 20500 may include a head, an unthreaded shank portion, a threaded shank, and a tip. The head portion 20520 may be positioned below or flush with the upper surface 20025 (FIG. 67) of the tibial tray 20000 . Proximal or head portion 20520 may have a recess or driver configuration for engaging a tool such as, for example, a hex driver for inserting or removing screw 20500 .

Referring to Drawing 67, in some embodiments, wall 20040 is about 1 millimeter, about 2 millimeters, about 3 millimeters, about 4 millimeters, about 5 millimeters, about 6 millimeters, about 7 millimeters, about 8 millimeters, about 9 millimeters, about 10 millimeters, between about 1 millimeter and about 10 millimeters, between about 1 millimeter and about 7 millimeters, between about 1 millimeter and about 5 millimeters, between about 1 millimeter and about 3 millimeters, or other may be a continuous surrounding perimeter wall having a depth D8 that is the appropriate size of the

Screw 20500 may have a diameter D9 of about 10 millimeters, about 12 millimeters, about 15 millimeters, between about 10 millimeters and about 15 millimeters, or other suitable size.

The screw 20500 has a height or depth D10 extending from the inferior surface of the tibial tray between about 5 millimeters, about 7 millimeters, about 10 millimeters, about 15 millimeters, about 20 millimeters, about 25 millimeters, between about 5 millimeters and about 25 millimeters. Between millimeters, between about 5 millimeters and about 20 millimeters, between about 5 millimeters and about 15 millimeters, or between about 10 millimeters and about 20 millimeters.

68 and 69, tibial tray system 30001 may include a tibial tray 30000 configured similar to tibial tray 15000 (FIGS. 47-50), but additionally, according to an embodiment of the present disclosure: It is operable to receive a plurality of screws 30501 and 30502 (Figs. 68 and 71). In this illustrated embodiment, the tibial tray 30000 can be placed on a resected portion of the tibia 30010 (Fig. 71) and the peripheral wall or fins 30040 can be placed into cancellous bone 30011 for total knee arthroplasty. closely abuts the inner surface 30013 (Fig. 71) of the underlying cortical bone 30012 (Fig. 71) of the resected portion of the patient's tibia 30010 (Fig. 71) for use in . Screws 35001 and 30502 can minimize or inhibit lift-off of tibial tray 30000 once tibial tray assembly 30001 is placed in a cut portion of a patient's tibia 30010 (FIG. 71).

As shown in FIGS. 69 and 70, the tibial tray 30000 may include a body 30022 having an upper portion 30024 and a lower tibial engaging portion 30026. As shown in FIGS. Top 30024 may include a generally planar upper surface 30025 (best shown in FIG. 69) for supporting a plastic bearing spacer (not shown). In some embodiments, the planar upper surface 30025 may include a peripheral upwardly extending lip (not shown) for attaching a plastic bearing spacer, eg, via a snap-fit connection.

The lower tibia engaging portion 30026 may include a peripheral wall or fin 30040 that extends into the cancellous bone 30011 of the resected tibia when operably attached to the resected proximal portion of the tibia 30010 (FIG. 71). The peripheral wall or fin 30040 may be designed to be offset or spaced from the periphery of the underlying tibial cortical bone 30012 of the proximal portion of the patient's tibia 30010 .

As shown in FIG. 70, the tibia engaging portion 30026 may include a central tibia engaging portion 30030 and a single inferior circumferential wall or fin 30040. As shown in FIG. In this embodiment, the central tibia engaging portion 30030 may include a flat surface capable of contacting the resected central cancellous bone surface 30011 (FIG. 71) of the resected proximal portion of the patient's tibia 30010 . In other embodiments, the central tibia engaging portion may have an undulating surface as described above.

A single lower circumferential wall or fin 30040 may include an inner wall surface 30051 and an outer wall surface 30055 . For example, the wall may have a cross-sectional kidney shape similar to the top 30024 or may be a mirror image of the outer contour of the top 30024 . The upper portion 30024 may have a constant thickness, varying thickness, varying thickness, or other suitable thickness. The inner wall surface 30051 may be arranged at a right angle or about 90 degrees to the upper surface 30025, or may be arranged at any suitable angle or angles. The outer wall surface 30055 may be positioned at right angles or approximately 90 degrees to the top surface 30025 . In other embodiments, the outer wall surface is parallel to the inner surface of the cortical bone (eg, as shown in FIG. 71) and angled with respect to the superior surface so as to be spaced from the inner surface of the cortical bone. may In other embodiments, the outer wall surface 30055 may be configured to rest on the inner surface of the underlying cortical bone.

In this illustrated embodiment, the walls or fins 30040 are circumferential and extend completely around the implant or tibial tray inferior surface or inferior surface 30030 and may be positioned towards the periphery. The outer surface of the circumferential wall or fins is used to preoperatively measure the inner cortical wall of the patient, particularly for designing implants or tibial trays such that the outer fin outer surface is a fixed and constant distance from the mapped inner surface of the cortical wall. It may be based on image data.

69 and 70, the upper portion 30024 may include a plurality of holes or passages 30061, 30062 extending from the upper surface 30025 (FIG. 69) to the lower surface 30033 (FIG. 70). Passages 30061, 30062 may be configured to be countersunk.

68 and 70, this exemplary tibial tray system 30001 includes a tibial tray 30000 having a peripheral wall 30040 and removably attachable screws 30501 each located in a different compartment of the tibial tray 30000. and 30502.

As will be understood from this specification, the peripheral rims or walls operate such that screws 30501 and 30502 account for lift-off or pull-out forces, while rim or wall 30040 may need to account for shear forces. As is possible, it may have a reduced or minimal height or depth. For example, screws 30501 and 30502 may be essentially the same as screw 20500 (FIGS. 64 and 67) having a body with a proximal or head portion and a threaded shank portion. In other embodiments, screws 30501 and 30502 may include a head, an unthreaded shank portion, a threaded shank, and a tip. The head portion may be positioned below or flush with the upper surface 30025 (FIG. 71) of the tibial tray 30000 . The proximal or head portions of the screws 30501 and 30502 may have recesses or driver formations for engaging tools such as hex drivers for inserting or removing the screws 30501 and 30502, for example.

71, in some embodiments the wall 30040 is about 1 millimeter, about 2 millimeters, about 3 millimeters, about 4 millimeters, about 5 millimeters, about 6 millimeters, about 7 millimeters, about 8 millimeters, about 9 millimeters, about 10 millimeters, between about 1 millimeter and about 10 millimeters, between about 1 millimeter and about 7 millimeters, between about 1 millimeter and about 5 millimeters, between about 1 millimeter and about 3 millimeters, or other may be a continuous surrounding perimeter wall having a depth D11 that is the appropriate size of .

Screws 30501 and 30502 may have a diameter D12 of about 10 millimeters, about 12 millimeters, about 15 millimeters, between about 10 millimeters and about 15 millimeters, or other suitable size.

The screws 30501 and 30502 extend from the lower surface of the tibial tray to a height or depth D13 of about 5 millimeters, about 7 millimeters, about 10 millimeters, about 15 millimeters, about 20 millimeters, about 25 millimeters, about 5 millimeters and about 25 millimeters. Between millimeters, between about 5 millimeters and about 20 millimeters, between about 5 millimeters and about 15 millimeters, or between about 10 millimeters and about 20 millimeters.

FIG. 72 illustrates a tibial tray system 40001 having a tibial tray 40000 and at least one locking screw 40500 that may interface with at least one screw hole 40060 in the tibial tray 40000, according to one embodiment of the present disclosure. For example, a locking screw may include a tapered head portion 40505 with external threads. The tibial tray 40000 may have a tapered passageway 40060 with internal threads of corresponding size and configuration. When the tibial tray system 40001 is attached to the resected proximal portion of the patient's tibia, the screw 40500 is rotated and secured within the passageway 40060 in the tibial tray 40000 so that the head 40505 tapers with internal threads. It will be seated and locked in the shaped passageway 40060 . The locking screw 40500 may reduce the risk of screw toggling and generally constrain the screw to an axis perpendicular to the screw hole 40060 and the top surface of the tibial tray. A locking screw 40500 may be locked into the threaded hole 40060 to resist lateral forces and provide additional stability.

FIG. 73 illustrates a conical screw 40700, which can be a locking or non-locking conical screw usable in the tibial tray systems described above, according to embodiments of the present disclosure. In this illustrated embodiment, the conical threads 40700 may taper toward the distal end 40703 . In other embodiments, the screw may have a corkscrew configuration. Such a configuration may provide increased surface contact area of the screw with the underlying bone while being minimally invasive as the screw 40700 extends further into cancellous bone.

In some embodiments, one or more of the screws 20500, 30061, 30062, 40700 are non-growth therein, i.e., to promote osteointegration so that the screws can be removable during revision. may not be designed for As noted above, the one or more screws 20500, 30061, 30062, 40700 are operable to promote shorter walls or fins by providing initial stability while bone growth occurs. you can For example, the wall or fin height may be reduced to a height of 1 mm to 3 mm, defined above. Shorter walls or fins are minimally invasive and may preserve bone. Additionally, shorter walls or fins may facilitate easier modification. If the walls or fins are short enough, a correction can be made by directly undercutting the implant. In this case, strong walls and fins can be used to increase the stiffness of the implant, as no incisions are required for revision.

One, two or more screws 20500, 30061, 30062, 40700 contact the inner cortical bone, e.g. It will be appreciated that it may be employed with any of the tibial trays described herein having a possible peripheral extension wall or a peripheral extension wall spaced therefrom. The screws may be locking or non-locking.

In still other embodiments, a tibial tray system employing one or more screws may include one or more walls, such as the walls described above, wherein the one or more walls are about 1 millimeter or less, about 2 millimeters or less. less than or equal to about 3 millimeters, less than or equal to about 4 millimeters, less than or equal to about 5 millimeters, greater than about 5 millimeters, less than or equal to about 6 millimeters, less than or equal to about 7 millimeters, less than or equal to about 8 millimeters, less than or equal to about 9 millimeters, less than or equal to about 10 millimeters, or other may have an appropriately sized depth of

In still other embodiments, a tibial tray system employing one or more screws may include one or more walls, such as the walls described above, wherein the one or more walls are between about 1 millimeter and about 10 millimeters. between about 1 millimeter and about 7 millimeters, between about 1 millimeter and about 5 millimeters, between about 1 millimeter and about 3 millimeters, or any other suitable range of sizes. may

In still other embodiments, a tibial tray system that employs one or more walls may include one or more screws, such as those described above, the one or more screws extending from the lower surface of the tibial tray. or a depth of about 5 millimeters or less, about 7 millimeters or less, about 10 millimeters or less, about 15 millimeters or less, about 15 millimeters or less, about 20 millimeters or less, about 25 millimeters or less, between about 5 millimeters and about 25 millimeters; It may be between about 5 millimeters and about 20 millimeters, between about 5 millimeters and about 15 millimeters, between about 10 millimeters and about 20 millimeters, or any other suitable height or range of heights.

In still other embodiments, a tibial tray system employing one or more walls and one or more screws, such as the walls and screws described above, wherein the one or more screws are about 3 millimeters or less, about 4 mm or less, about 5 mm or less, about 6 mm or less, about 7 mm or less, about 8 mm or less, about 9 mm or less, about 10 mm, about 12 mm, about 15 mm, between about 3 mm and about 5 mm , between about 3 millimeters and about 10 millimeters, between about 5 millimeters and about 10 millimeters, between about 10 millimeters and about 15 millimeters, or other suitable size diameters.

In some embodiments, the tibial tray may be configured for cutting the proximal medial or lateral portion of a patient's tibia for knee replacement surgery according to embodiments of the present disclosure. Such a tibial tray may include the features of the tibial trays described above and employ one or more screws to inhibit lift-off of the partial tibial tray.

FIG. 74 is a block diagram of a method 50000 for use in total knee replacement surgery. The method 50000, for example, at 50100, cuts a proximal portion of the patient's tibia, wherein the cut proximal portion of the tibia comprises a laterally cut cancellous bone surface, a laterally cut peripheral cortical bone surface. , and at least one cavity formed around the resected cancellous bone, and at 50200 at least one cavity medially spaced from the periphery of the tibial tray and extending around at least a portion of the central inferior surface. providing a tibial tray having four inferior extensor walls, at 53000 inserting at least one inferior extensor wall into at least one cavity formed in the periphery of the resected cancellous bone surface, and at 50400 the periphery of the tibial tray; on the laterally cut peripheral cortical bone surface and the medial inferior surface on the laterally cut cancellous bone surface, and at 50500 insert at least one screw through the tibial tray and into the cancellous bone. In fixation and total knee arthroplasty, the screw inhibits lift-off of the tibial tray, compared to the portion of the shear force resisted along the medial inferior surface of the tibial tray and the cut cancellous bone surface. A greater portion of the shear force acting laterally on the cut portion of the patient's proximal tibia is resisted by the at least one inferior extensor wall and the cut periphery of the proximal tibia.

From the techniques of the present disclosure regarding the tibial tray and the milled proximal portion of the tibia, such designs and techniques are designed to rest on a flat cutting surface that minimizes surface contact area and maximizes shear forces. It will be appreciated that the problems of conventional non-patient-specific tibial trays that lack overlapping modes of support and provide poor implant surface area coverage that impacts the risk of subsidence can be overcome. Patient-specific tibial trays and patient-specific cut tibial proximal portions overcome the problems associated with conventional tibial trays, which are manually segmented from large image databases and Designed as a geometric approximation of multiple bone models that are proportionally constrained and scaled to accept implants of various sizes, the cutting of the proximal tibia is often flattened using a sagittal saw. being cut.

Techniques of the present disclosure may result in increased surface contact area and/or decreased shear forces along the cutting surface of the implant-bone interface, resulting in poor alignment and natural lateral loading of the joint. Less breakage or slack.

Algorithms of the present disclosure are designed to generate patient-specific tibial trays and proximal tibia robotic cutting paths that address the primary failure modes of press-fit knee implants by restoring pre-operative anatomy. Specifically, 1) maximize contact area to enhance osseointegration, 2) reduce shear forces and concentrate forces on both sides of the intercondylar process, 3) It is characterized by maximizing cortical bone contact around the implant, 4) minimizing subsidence and increasing stability with patient-specific support members.

A1.
A tibial tray for a resected proximal portion of a patient's tibia for total knee replacement surgery. The resected proximal portion of the tibia comprises a central cancellous bone surface, a peripheral cortical bone surface, and at least one formed around the cancellous bone spaced from the cortical bone and exposing an underlying portion of the cancellous bone of the tibia. and a cavity. The tibial tray may include a body having an upper portion with an upper surface and a lower tibial engaging portion. The body was formed on the cancellous surface such that the lower tibia engaging portion had a central portion contactable with the central cancellous bone surface and the peripheral inferior extension was spaced from the inner surface of the underlying cortical bone of the patient's tibia. and a peripheral underextension received in the at least one cavity.

A2.
According to A1, the inferior tibia engaging portion comprises a peripheral edge having a lower surface capable of resting against the peripheral cortical bone surface of the patient's tibia, and the peripheral inferior extension is positioned medially from the peripheral edge. tibia tray.
A3.
The tibial tray of A1 or A2, wherein the medial surface of the inferior tibial engagement portion includes a non-planar surface.
A4.
The tibial tray of any of A1-A3, wherein the inferior extension of the inferior tibia engaging portion can extend around at least 10% of the peripheral inner surface of the underlying cortical bone of the patient's tibia.
A5.
The tibial tray of any of A1-A4, wherein the inferior tibial engagement portion includes an inferior convex surface, an inferior concave surface, and/or an inferior convex and an inferior concave surface.
A6.
according to any of A1-A5, wherein the inferior tibia engaging portion includes a pair of spaced inferior convex surfaces corresponding to the size of the medial and lateral condyles of the patient's proximal tibia. tibia tray.
A7.
The tibial tray of any of A1-A6, wherein the peripheral inferior extension includes a wall spaced from the inner surface of the cortical bone.
A8.
the wall comprising a surface configured to be spaced from the inner surface of the underlying cortical bone and having an angle of about 35 degrees with respect to the upper upper surface of the body; The tibial tray of A7, extending about 7 mm down from the .
A9.
The tibial tray of any of A7 or A8, wherein the wall extends along at least 30 percent of the circumference of the underlying peripheral cancellous bone of the patient's tibia.
A10.
The tibial tray of any of A7-A9, wherein the wall extends along the entire perimeter of the body.
A11.
The tibial tray of any of A1-A10, wherein the inferior extension includes a pair of curved walls configured to space away from the inner surface of the cortical bone.
A12.
The inferior extension includes a pair of curved walls configured to be spaced apart from the medial surface of the cortical bone, the medial surface sized to the medial and lateral condyles of the proximal portion of the patient's tibia. includes a pair of correspondingly spaced inferior convex surfaces.
A13.
The tibial tray of any of A1-A12, wherein the peripheral inferior extension defines a gap between the peripheral inferior extension and the inner surface of the cortical bone.
A14.
The tibial tray of any of A1-A13, wherein the central portion of the body includes a inferior extensor keel.
A15.
The tibial tray of any of A1-A14, wherein the body comprises a unitary body.

B1.
A method for forming a patient-specific tibial tray for total knee replacement surgery in a patient, the method comprising:
determining a patient-specific resected proximal portion of the patient's tibia, wherein the resected proximal portion of the patient's tibia is spaced from the central cancellous bone surface, the peripheral cortical bone surface, and the cortical bone; at least one cavity formed around the cancellous bone at the tibia exposing the underlying portion of the cancellous bone of the tibia;
forming a patient-specific tibial tray including a body having upper and lower tibial engaging portions having an upper surface, the lower tibial engaging portion having a central portion contactable with a central cancellous bone surface and a peripheral portion; having a peripheral inferior extension received within the at least one cavity such that the inferior extension is spaced away from the inner surface of the underlying cortical bone of the patient's tibia.

B2.
obtaining, via a processor, first data representing a proximal portion of the patient's tibia; and via the processor, a patient-specific cut proximal portion of the patient's tibia based on the first data; and wherein forming via the processor comprises 3D printing, forging, casting based on the second data.
B2.
Obtaining the first data includes obtaining CT scan data and/or X-rays, and determining a patient-specific resection of the patient's tibia based on the obtained first data. The method of B1, comprising determining the proximal portion.
B3.
The method of B1 or B2, further comprising maximizing the size and shape of the underlying tibia engagement portion based on the depth and amount of circumferential extension of the underlying cancellous bone.
B20.
The method of one of B17-B19, further comprising reducing shear forces and local forces based on the interface between the implant and the bone based on the formula Fx=Fcos(θ).

C1.
A tibial tray for a resected proximal portion of a patient's tibia for total knee arthroplasty, the resected proximal portion of the tibia comprising a central cancellous bone surface, a peripheral cortical bone surface and a cancellous bone. and at least one cavity formed around the bone. The tibial tray includes a body including an upper portion having an upper surface and a lower tibial engaging portion. The inferior tibia engaging portion has a central portion having a central surface contactable with the central cancellous bone surface, and a peripheral inferoextensive outer surface portion that rests against the cancellous bone surface so as to correspond to the undulations of the inner surface of the underlying cortical bone of the patient's tibia. and a peripheral inferior extension receivable within the at least one cavity formed.

C2.
The tibial tray of C1, wherein the peripheral inferior extension includes at least a portion of the peripheral inferior extension surface extending from a proximal portion of the peripheral inferior extension to a distal portion of the peripheral inferior extension; At least a portion is contoured to correspond to the undulations of the upper marginal portion of the cortical bone along the cutting surface so as to be positioned adjacent the underlying concave inner surface of the cortical bone.
C3.
The tibial tray of C2, wherein at least a portion of the peripheral inferior extensor surface from the proximal portion to the distal portion is contoured perpendicular to the cutting surface.
C4.
The tibial tray of C1, wherein the peripheral inferior extension includes at least a portion of a peripheral inferior extension surface extending from a proximal portion of the peripheral inferior extension to a distal portion of the peripheral inferior extension, wherein the inferior extension includes a cutting A proximal portion contoured to correspond to the contour of the upper edge portion of the cortical bone along the plane, and a proximal portion contoured to lie medially from the contour of the upper edge portion of the cortical bone along the cutting surface. and a distal portion.

D1.
A tibial tray for a resected proximal portion of a patient's tibia for knee replacement surgery, the resected proximal portion of the tibia comprising a central cancellous bone surface, a peripheral cortical bone surface, and an underlying cortex. and at least one cavity formed in cancellous bone to expose at least a portion of the inner surface of the bone. The tibial tray includes a body including an upper portion having an upper surface and a lower tibial engagement portion. The inferior tibia engaging portion includes a central portion having a central surface contactable with the central cancellous bone surface and a peripheral inferior extension received in at least one cavity formed in the cancellous bone surface; is contactable with the exposed underlying inner surface of the patient's tibia cortical bone.

D2.
The tibial tray of D1, wherein the inferior tibia engaging portion includes a peripheral edge having a lower surface capable of resting against the peripheral cortical bone surface of the patient's tibia, and the peripheral inferior extension is medial of the peripheral edge. placed towards.
D3.
The tibial tray of D1, wherein the medial surface of the inferior tibial engagement portion includes a non-planar surface.
D4.
The tibial tray of D1, wherein the inferior extension surface of the inferior tibia engaging portion is capable of contacting at least 10 percent of the peripheral inner surface of the underlying cortical bone of the patient's tibia.
D5.
The tibial tray of D1, wherein the inferior tibial engagement portion includes an inferior convex surface, an inferior concave surface, and/or an inferior convex and an inferior concave surface.
D6.
The tibial tray of D1, wherein the inferior tibial engaging portion includes a pair of spaced apart inferior convex surfaces corresponding in size to the medial and lateral condyles of the proximal portion of the patient's tibia. .
D7.
The tibial tray of D1, wherein the peripheral inferior extension includes a wall contactable against the exposed inner surface of the cortical bone.
D8.
The tibial tray of D7, wherein the wall includes a surface contactable to the exposed inner surface of the underlying cortical bone and has an angle of about 35 degrees to the upper surface of the upper portion of the body and the upper portion of the body. extends about 7 mm below the top surface of the
D9.
The tibial tray of D7, wherein the wall extends around at least 30% of the peripheral inner surface of the underlying cortical bone of the patient's tibia.
D10.
The tibial tray of D7, wherein the wall extends along the entire central portion of the body.
D11.
The tibial tray of D1, wherein the inferior extension includes a pair of curved walls contactable against spaced apart portions of the inner surface of the cortical bone.
D12.
The tibial tray of D1, wherein the inferior extension includes a pair of curved walls contactable against spaced portions of the cortical bone of the medial surface and the medial surface is the proximal portion of the patient's tibia. a pair of spaced inferior convex surfaces corresponding in size to the medial and lateral condyles of the .
D13.
The tibial tray of D1, wherein the inferior extension includes at least one inferior extension pin extending through an opening in the medial cortical bone and having a rim compliant with the outer surface of the cortical bone.
D14.
The tibial tray of D1, wherein the central portion of the body includes the inferior extensor keel.
D15.
The tibial tray of D1, wherein the body comprises a unitary body.

E1.
A method for forming a patient-specific tibial tray for a patient's knee replacement, comprising:
The method is
determining a patient-specific resected proximal portion of the patient's tibia;
The resected proximal portion of the patient's tibia has one or more cavities and/or cavities in the cancellous bone exposing at least a portion of the upper central cancellous bone surface, the peripheral cortical bone surface, and the inner surface of the underlying cortical bone of the tibia. or an opening,
The method also
forming a patient-specific tibial tray including a body having an upper portion having an upper surface and a lower tibial engagement portion;
The inferior tibia engaging portion includes a central portion contactable with a cancellous bone surface and a peripheral inferior extension received in one or more cavities and/or openings to expose exposed cortical bone of the patient's tibia. It has one or more surfaces that are contactable with the underlying inner surface.

E2.
obtaining, via a processor, first data representing a proximal portion of the patient's tibia; and via the processor, a patient-specific cut proximal portion of the patient's tibia based on the first data; and wherein forming via the processor includes 3D printing, forging, casting based on the second data.
E3.
The step of obtaining first data includes obtaining CT scan data and/or X-rays, and the step of determining is a patient-specific resection of the patient's tibia based on the obtained first data. The method of E2, comprising determining the proximal portion.
E4.
The method of E2, further comprising maximizing one or more surfaces of the inferior tibia engaging portion based on the depth and amount of surface extending along the perimeter of the inner surface portion of the underlying cortical bone.
E5.
The method of E2, further comprising reducing shear and local forces based on the implant-to-bone interface based on the formula Fx=Fcos(θ).

Numerous changes and modifications can be made to the above-described and other embodiments of the invention without departing from the scope of the invention, as would be appreciated by those skilled in the art based on the teachings herein. can be done. Implants and other components of the devices and/or apparatus disclosed herein, including the accompanying abstracts and drawings, are known to those skilled in the art to serve similar functions for their intended purposes. As such, it may be replaced by an alternative component or configuration, such as those disclosed in other embodiments, serving the same, equivalent or similar purpose. Additionally, devices and apparatus may include more or fewer components or configurations than the embodiments as described and illustrated herein. Accordingly, this detailed description of the presently preferred embodiments should be taken as illustrative rather than limiting of the invention.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular terms are intended to include the plural unless the context clearly indicates otherwise. It will be further understood that the terms "comprise," "have," "include," or "include" are open-ended linking verbs. As a result, a method or apparatus that "comprises," "has," "includes," or "encompasses" one or more steps or elements retains one or more of those steps or elements but does not include one of them. It is not limited to having only one or more steps or elements. Similarly, a method step or apparatus element that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features but does not have one or more of those features. It is not limited to possessing only one or more characteristics. Further, a device or structure configured in a certain way may be configured in at least that way, but may also be configured in ways not described.

The invention has been described with reference to preferred embodiments. It will be appreciated that the architectural and operational embodiments described herein are exemplary of multiple possible arrangements for providing the same general features, properties, and general device operation. . Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the invention be construed as including all such alterations and modifications.

Claims (111)

A tibial tray system for a resected portion extending laterally through a proximal portion of a patient's tibia for use in total knee arthroplasty, comprising:
the resected proximal portion of the tibia having a resected cancellous bone surface, a resected peripheral cortical bone surface, and at least one cavity formed around an underlying layer of the resected cancellous bone;
The tibial tray system includes a tibial tray,
The tibial tray includes a body including upper and lower tibial engagement portions;
the top includes a top surface and a rim;
The lower tibia engaging portion is
a peripheral inferior surface that can be supported on the cut peripheral cortical bone surface;
a central lower surface positionable on the resected central cancellous bone surface;
at least one inferior extension wall extending about at least a portion of the central inferior surface spaced inwardly from the peripheral inferior surface;
at least one inferior extensor wall is receivable within at least one cavity formed around the resected cancellous bone surface;
The tibial tray system further includes at least one screw extendable through at least one passage extending from the upper surface to the lower central surface of the tibial tray;
in total knee arthroplasty, at least one screw extends through the tibial tray and into cancellous bone to inhibit lift-off of the tibial tray;
The amount of shear force acting laterally to the tibial tray and the cut portion of the patient's proximal tibia compared to the portion of the shear force resisted along the medial inferior surface of the tibial tray and the cut cancellous bone surface. , a greater portion of which is resisted by at least one inferior extensor wall and the milled circumference of the proximal tibia;
Tibia tray system. at least one passage comprises a single passage;
at least one screw comprises a single screw;
The tibial tray system of claim 1. at least one passageway including a single passageway disposed through the central inferior surface of the tibial tray to receive the single screw;
3. The tibial tray system of claim 2. at least one passage comprises a plurality of passages;
the at least one screw comprises a plurality of screws;
The tibial tray system of claim 1. at least one passage includes a pair of passages;
at least one screw includes a pair of screws;
the tibial tray including one of a pair of passageways disposed in a medial portion of the tibial tray to receive one of the pair of screws;
the tibial tray including the other one of a pair of passageways disposed in the outer portion of the tibial tray to receive the other one of the pair of screws;
The tibial tray system of claim 1. at least one passage includes a through hole that is countersunk;
The tibial tray system of claim 1. at least one screw includes a head that can be positioned flush with or below the top surface of the tibial tray;
The tibial tray system of claim 1. at least one passage comprises a tapered passage having threads;
at least one screw comprises a locking screw having a tapered head with threads;
The tibial tray system of claim 1. at least one screw includes a conical shape that tapers toward the distal end;
The tibial tray system of claim 1. the walls include a depth that is less than about 3 millimeters;
The tibial tray system of claim 1. the walls include a depth that is less than about 5 millimeters;
The tibial tray system of claim 1. the wall includes a depth that is less than about 10 millimeters;
The tibial tray system of claim 1. the screws including a depth extending from the inferior surface of the tibial tray of less than about 25 millimeters;
The tibial tray system of claim 1. the screws including a depth extending from the inferior surface of the tibial tray of less than about 15 millimeters;
The tibial tray system of claim 1. the screw comprises a diameter of less than about 15 millimeters;
The tibial tray system of claim 1. the screw comprises a diameter of less than about 5 millimeters;
The tibial tray system of claim 1. the body including the thickness from the top surface to the center bottom surface,
at least one inferior extension wall has a depth from the central inferior surface;
its depth is greater than its thickness,
The tibial tray system of claim 1. at least one inferior extension wall comprises a continuous surrounding wall;
The tibial tray system of claim 1. the at least one inferior extension wall includes a first U-shaped wall and a spaced apart second U-shaped wall;
The tibial tray system of claim 1. the at least one inferior extension wall includes a third wall disposed between the first U-shaped wall and the spaced apart second U-shaped wall;
the depth of the third wall is less than the depth of the first U-shaped wall and the second U-shaped wall;
20. The tibial tray system of claim 19. at least one inferior extension wall comprises a C-shaped wall;
The tibial tray system of claim 1. the inferior tibia engaging portion includes a medial surface including a plane extending entirely over the medial medial surface from the at least one inferior extensor wall;
The tibial tray system of claim 1. the inferior tibia engagement portion does not include a keel;
The tibial tray system of claim 1. at least one inferior extension wall includes a depth greater than 5 millimeters;
The tibial tray system of claim 1. at least one inferior extension wall includes a depth of between 5 millimeters and 10 millimeters from the median plane;
The tibial tray system of claim 1. at least one inferior extension wall positioned between 2 millimeters and 5 millimeters inward from the periphery;
The tibial tray system of claim 1. at least one inferior extension wall comprises a constant thickness;
The tibial tray system of claim 1. at least one inferior extension wall comprises a thickness between 2 millimeters and 10 millimeters;
The tibial tray system of claim 1. at least one inferior extension wall comprises a constant thickness of 3 millimeters;
The tibial tray system of claim 1. at least one inferior extensor wall includes a thickness greater than 25 percent of the width between the medial and lateral portions of the tibial tray;
The tibial tray system of claim 1. at least one inferior extension wall includes a constant depth;
The tibial tray system of claim 1. at least one inferior extension wall includes a tapered depth;
The tibial tray system of claim 1. at least one inferior extension wall includes parallel inferior inferior extension surfaces and inferior inferior extension surfaces;
The tibial tray system of claim 1. at least one inferior extension wall includes parallel inferior inferior extension surfaces and inferior inferior extension surfaces arranged perpendicular to the upper surface;
34. The tibial tray system of claim 33. at least one inferior extension wall includes parallel inferior inferior extension surfaces and inferior inferior extension surfaces disposed non-perpendicular to the upper surface;
34. The tibial tray system of claim 33. at least one inferior extension wall includes an inferior extension outer surface disposed at an angle between 10 and 30 degrees from normal to the upper surface;
The tibial tray system of claim 1. at least one inferior wall includes an inferior outer surface disposed non-perpendicular to the upper surface and an inferior inner surface disposed perpendicular to the upper surface;
The tibial tray system of claim 1. at least one inferior extension wall includes an inferior inferior extension surface and an inferior extension inner surface terminating at an acute angle;
The tibial tray system of claim 1. the inferior tibia engaging portion includes a central portion including an undulating surface;
The tibial tray system of claim 1. the inferior tibia engaging portion includes at least one of an inferior convex surface, an inferior concave surface, and/or an inferior convex and an inferior concave surface;
40. The tibial tray system of Claim 39. the contoured surfaces correspond to the articular surface of the medial condyle and the articular surface of the lateral condyle of the proximal portion of the patient's tibia;
41. The tibial tray system of claim 40. the at least one inferior extensor wall is sized and configured such that the outer surface of the at least one inferior extensor wall is spaced from the inner surface of the underlying cortical bone;
The tibial tray system of claim 1. the at least one inferior extensor wall is sized and configured such that the outer surface of the at least one inferior extensor wall defines a gap from the inner surface of the cortical bone of between 1 and 3 millimeters;
43. The tibial tray system of claim 42. the at least one inferior extensor wall is sized and configured such that the outer surface of the at least one inferior extensor wall defines a gap of 2 millimeters from the inner surface of the cortical bone;
43. The tibial tray system of claim 42. at least one inferior extensor wall is sized and configured to be engageable with an inner surface of the underlying cortical bone;
The tibial tray system of claim 1. at least one inferior extensor wall includes an outer surface that conforms to corresponding adjacent inner surface undulations of the underlying cortical bone along the depth of the at least one inferior extensor wall;
The tibial tray system of claim 1. the inferior tibia engaging portion is received in the second at least one cavity of the resected tibia of the patient and includes a second at least one inferior extension engageable with the opening in the underlying cortical bone;
The tibial tray system of claim 1. the second at least one inferior extension includes at least one inferior extension post;
48. The tibial tray system of claim 47. the inferior extension post includes an edge alignable with the outer surface of the cortical bone;
49. The tibial tray system of claim 48. A tibial tray includes a body having an inner portion and a spaced apart outer portion defining a cavity therebetween;
The tibial tray system of claim 1. A lower tibia engaging portion was positioned on the medial portion, spaced apart from the at least one inferior extensor wall, and a first inferior extensor post, spaced from the at least one inferior extensor wall, on the lateral portion. including a second downward extension post;
51. The tibial tray system of claim 50. a tibial tray comprising a monolithic structure and material;
The tibial tray system of claim 1. further comprising a cutting guide having at least one opening for forming at least one cavity in the proximal portion of the tibia to be cut;
The tibial tray system of claim 1. further comprising a milling tool having a proximal diameter sized larger than the opening and a distal diameter sized to pass through the opening;
38. The tibial tray system of claim 37. Cutting a proximal portion of the patient's tibia, the cut proximal portion of the tibia comprising a laterally cut cancellous bone surface, a laterally cut peripheral cortical bone surface, and a cut laterally cut peripheral cortical bone surface. having at least one cavity formed around cancellous bone;
Providing a tibial tray having at least one inferior extensor wall spaced medially from the periphery of the tibial tray and extending around at least a portion of the central inferior surface and at least one passageway extending from the superior surface to the inferior central surface. and,
inserting at least one inferior extensor wall into at least one cavity formed around the resected cancellous bone surface;
placing the peripheral edge of the tibial tray on the laterally cut peripheral cortical bone surface and placing the central inferior surface on the laterally cut cancellous bone surface;
securing at least one screw within the at least one passageway and within the cancellous bone;
a method comprising
In a total knee arthroplasty, the at least one screw inhibits lift-off of the tibial tray compared to a portion of the shear forces resisted along the medial inferior surface of the tibial tray and the cut cancellous bone surface. and a greater portion of the shear force acting laterally on the cut portion of the patient's proximal tibia is resisted by the at least one inferior extensor wall and the cut proximal tibia circumference;
Method. at least one cavity comprises a continuous cavity along the perimeter of the underside of the cancellous bone to be cut;
at least one inferior extension wall comprises a continuous surrounding wall;
56. The method of claim 55. the at least one cavity includes a first U-shaped cavity and a second spaced apart U-shaped cavity;
the at least one inferior extension wall includes a first U-shaped wall and a spaced apart second U-shaped wall;
56. The method of claim 55. at least one cavity comprises a C-shaped cavity;
at least one inferior extension wall comprises a C-shaped wall;
56. The method of claim 55. the tibial tray does not include a keel;
56. The method of claim 55. In a total knee arthroplasty, the medial inferior surface of the inferior tibial engagement portion includes a plane extending over the resected cancellous bone.
56. The method of claim 55. In a total knee arthroplasty, the central inferior surface of the inferior tibial engagement portion includes an undulating surface extending over the resected cancellous bone.
56. The method of claim 55. in a total knee arthroplasty, the entirety of at least one inferior extensor wall is spaced from the inner surface of the cortical bone;
56. The method of claim 55. In total knee arthroplasty, at least one inferior extensor wall is in contact with the inner surface of the cortical bone.
56. The method of claim 55. in a total knee arthroplasty, the at least one inferior extensor wall includes an outer surface that conforms to the medial contours of the corresponding adjacent medial surface of the cortical bone along the depth of the at least one inferior extensor wall;
56. The method of claim 55. The cutting step includes using a cutting guide having at least one opening for forming at least one cavity in the cut proximal portion of the tibia.
56. The method of claim 55. The cutting step uses a milling tool having a proximal diameter sized larger than the opening and a distal diameter sized to pass through the opening to form at least one cavity in the cut proximal portion of the tibia. including to
66. A tibial tray according to claim 65. A method of forming a patient-specific tibial tray for total knee replacement surgery in a patient, comprising:
The method is
Acquiring, via at least one processor, first data representing a proximal portion of the patient's tibia, the first data indicating that the proximal portion of the patient's tibia is the medial cancellous bone and the lateral and medial surfaces. corresponding to having peripheral cortical bone with
The method also
determining, via at least one processor, second data representing a patient-specific resected proximal portion of the patient's tibia based on the first data;
The resected proximal portion of the patient's tibia has a central cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed around the underside of the resected cancellous bone; the cavity has an outer contoured surface portion corresponding to an adjacent inner surface portion of the cortical bone to be cut;
The method also
forming, via at least one processor, a patient-specific tibial tray based on the second data;
A patient-specific tibial tray includes a body having upper and lower tibial engaging portions including an upper surface, the lower tibial engaging portion having a central portion contactable with a cut central cancellous bone surface, and at least a downward extending wall is received in the at least one cavity, the at least one passageway extending from the upper surface to the central lower surface;
In a total knee arthroplasty, the at least one screw inhibits lift-off of the tibial tray, compared to the portion of the shear force that can be resisted along the medial inferior surface of the tibial tray and the cut cancellous bone surface. a greater portion of the shear forces acting laterally on the cut portion of the patient's proximal tibia can be resisted by the at least one inferior extensor wall and the perimeter of the cut proximal tibia;
Method. Determining second data via at least one processor comprises:
Employing the formula Fx=Fcos(θ) to reduce the shear and local forces based on the interface between the implant and the bone;
68. The method of claim 67. Determining, via the at least one processor, second data representing a patient-specific resected proximal portion of the patient's tibia is performed in a total knee arthroplasty on an upper portion and a resected portion of the patient's tibia. optimizing the size and position of at least one cavity to support shear forces between the proximal portion;
68. The method of claim 67. forming via at least one processor comprises 3D printing, forging, or casting;
68. The method of claim 67. acquiring the first data comprises acquiring CT scan data and/or X-ray data;
68. The method of claim 67. Determining, via the at least one processor, the second data determines that the at least one cavity extends into cancellous bone including a first U-shaped cavity and a second spaced apart U-shaped cavity. including
Forming a patient-specific tibial tray based on the second data, via the at least one processor, includes forming the at least one inferior extensor wall into a first U-shaped cavity and spaced apart second U-shaped cavities. including a first U-shaped wall and a spaced apart second U-shaped wall, each received in a cavity of the
68. The method of claim 67. Determining, via the at least one processor, the second data comprises the step of determining, via the at least one processor, the at least one cavity located between the first U-shaped cavity and the spaced apart second U-shaped cavity; extending into cancellous bone comprising 3 cavities;
the depth of the third cavity is less than the depth of the first U-shaped cavity and the second U-shaped cavity;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, includes forming the at least one inferior extensor wall into a first U-shaped wall and a spaced apart second U-shaped wall. including a third wall positioned between the glyph wall;
73. The method of claim 72. determining, via the at least one processor, the second data including the at least one cavity extending into cancellous bone including the C-shaped cavity;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, wherein the at least one inferior extensor wall includes a C-shaped wall received in the C-shaped cavity. including,
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific proximal portion to be cut of the patient's tibia includes at least one cavity along at least 10% of the circumference of cancellous bone. ,
Forming a patient-specific tibial tray based on the second data, via the at least one processor, includes: forming a patient-specific tibial tray including at least one inferior extensor wall extending along at least 10% of the circumference of the body; including tray
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific proximal portion to be cut of the patient's tibia includes at least one cavity along at least 30% of the circumference of cancellous bone. ,
Forming a patient-specific tibial tray based on the second data, via the at least one processor, includes: forming a patient-specific tibial tray including at least one inferior extensor wall extending along at least 30% of the circumference of the body; including tray
68. The method of claim 67. Determining the second data, via the at least one processor, is performed in cancellous bone, wherein the at least one cavity comprises a cavity extending continuously around the central cancellous bone surface and adjacent the inner surface of the underlying cortical bone. including extending to
Forming a patient-specific tibial tray based on the second data, via the at least one processor, includes forming the at least one inferior extensor wall adjacent the central cancellous bone surface and the underlying cortical bone inner surface. comprising a continuous inferior extension wall received in a cavity extending into the cancellous bone comprising a cavity extending continuously through the cancellous bone;
68. The method of claim 67. forming a patient-specific tibial tray based on the second data via the at least one processor includes at least one inferior extensor wall without a keel;
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific proximal portion to be cut of the patient's tibia includes the at least one cavity having a constant thickness;
forming a patient-specific tibial tray based on the second data, via the at least one processor, the patient-specific tibial tray including at least one inferior extensor wall having a constant thickness;
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific proximal portion to be cut of the patient's tibia includes: including having a thickness;
Forming the patient-specific tibial tray based on the second data, via the at least one processor, includes forming the patient-specific tibial tray with at least one thickness having a constant thickness between 2 millimeters and 10 millimeters. including two inferior extension walls,
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific proximal resected portion of the patient's tibia comprises: determining, via at least one processor, the at least one cavity in a medial portion of the proximal portion of the tibia to be resected; having a thickness greater than 25 percent of the width between and the outer portion;
Forming the patient-specific tibial tray based on the second data, via the at least one processor, wherein the patient-specific tibial tray is greater than 25 percent of the width between the medial portion and the lateral portion of the body. at least one inferior extension wall having a thickness greater than
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific proximal portion to be cut of the patient's tibia includes the at least one cavity having a constant depth;
forming the patient-specific tibial tray based on the second data, via the at least one processor, wherein the patient-specific tibial tray includes at least one inferior extensor wall having a constant depth;
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific proximal portion of the patient's tibia to be resected, wherein the at least one cavity has a constant depth greater than 5 millimeters. including
Forming a patient-specific tibial tray based on the second data, via the at least one processor, wherein the patient-specific tibial tray includes at least one inferior extensor wall having a constant depth greater than 5 millimeters. including,
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific proximal portion of the patient's tibia to be resected, wherein the at least one cavity has a constant depth greater than 10 millimeters. including
Forming a patient-specific tibial tray based on the second data, via the at least one processor, wherein the patient-specific tibial tray includes at least one inferior extensor wall having a constant depth greater than 10 millimeters. including,
68. The method of claim 67. determining, via at least one processor, second data representing a patient-specific proximal portion to be cut of the patient's tibia includes the at least one cavity having a tapered depth;
forming a patient-specific tibial tray based on the second data, via the at least one processor, wherein the patient-specific tibial tray includes at least one inferior extensor wall having a tapered depth;
68. The method of claim 67. determining, via the at least one processor, the second data comprising the midcancellous bone surface to be resected having an undulating surface;
forming a patient-specific tibial tray based on the second data, via the at least one processor, including the inferior tibial engaging portion having a central portion having an undulating surface;
68. The method of claim 67. determining, via the at least one processor, the second data comprising the central cancellous bone surface to be resected having a convex surface, a concave surface, and/or at least one of a convex surface and a concave surface;
forming the patient-specific tibial tray based on the second data, via the at least one processor, wherein the inferior tibial engagement portion has a convex surface, a concave surface, and/or a convex and a concave surface; having at least one of the central portions having
68. The method of claim 67. Determining, via the at least one processor, second data is the undulations in which the cut midcancellous bone surface corresponds to the articular surface of the medial condyle and the articular surface of the lateral condyle of the proximal portion of the patient's tibia. including having an aspect of
Forming the patient-specific tibial tray based on the second data, via the at least one processor, comprises: the lower tibial engaging portion aligning with the articular surface of the medial condyle of the proximal portion of the patient's tibia; having a central portion with an undulating surface corresponding to the articular surface of the condyle;
88. The method of claim 87. determining, via the at least one processor, the second data including that the cut central cancellous bone surface has a planar surface;
forming a patient-specific tibial tray based on the second data, via the at least one processor, including the inferior tibial engaging portion having a central portion having a planar surface;
68. The method of claim 67. determining, via the at least one processor, the second data including the at least one cavity extending away from an inner surface of the underlying cortical bone;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, may include at least one inferior extensor spaced apart from an inner surface of the underlying cortical bone and positioned within the cancellous bone. including walls
68. The method of claim 67. Determining second data, via the at least one processor, determines that the at least one cavity extends and is spaced apart from the inner surface of the underlying cortical bone to define a gap of between 1 millimeter and 3 millimeters. including
Forming the patient-specific tibial tray based on the second data, via the at least one processor, can be positioned within the cancellous bone and spaced from the inner surface of the underlying cortical bone by a distance of 1 millimeter and more. at least one inferior extension wall defining a gap of between 3 millimeters;
91. The method of claim 90. determining, via the at least one processor, the second data including the at least one cavity extending and spaced apart from an inner surface of the underlying cortical bone to define a gap of 2 millimeters;
Forming the patient-specific tibial tray based on the second data, via the at least one processor, can be positioned within the cancellous bone and separated from the inner surface of the underlying cortical bone by two millimeters. including at least one inferior extension wall defining a gap;
91. The method of claim 90. determining, via the at least one processor, the second data including the at least one cavity extending into the cancellous bone exposing an inner surface of the underlying cortical bone;
Based on the second data, via the at least one processor, forming the patient-specific tibial tray includes at least one inferior extensor wall engagable with an inner surface of the underlying cortical bone. ,
68. The method of claim 67. determining, via the at least one processor, the second data including at least one cavity extending into cancellous bone having parallel inner and outer surfaces;
forming the patient-specific tibial tray based on the second data, via the at least one processor, including the at least one inferior extension wall having parallel medial and lateral inferior extension surfaces;
68. The method of claim 67. Determining, via the at least one processor, the second data determines that the at least one cavity extends into the cancellous bone having parallel inner and outer surfaces arranged perpendicular to the cancellous bone to be cut. including
Forming a patient-specific tibial tray based on the second data, via at least one processor, comprises parallel medial and lateral inferior medial and lateral inferior extensor walls in which at least one inferior extensor wall is positioned perpendicular to the upper surface of the body. including having a stretched surface,
95. The method of claim 94. Determining, via the at least one processor, the second data determines that the at least one cavity extends into cancellous bone having parallel inner and outer surfaces arranged non-perpendicular to the cancellous bone to be cut. including
Forming a patient-specific tibial tray based on the second data, via the at least one processor, comprises parallel medial and lateral at least one inferior extensor wall disposed non-perpendicularly on the upper surface of the body. including having a hypotension surface;
95. The method of claim 94. Determining second data, via the at least one processor, defines an outer surface in which the at least one cavity is positioned at an angle of between 10 and 30 degrees with respect to cancellous bone to be cut. extending into cancellous bone having
Forming the patient-specific tibial tray based on the second data, via the at least one processor, comprises: forming the at least one inferior extensor wall at an angle between 10 degrees and 30 degrees from normal to the upper surface of the body; having a lateral inferior extension surface positioned at an angle between
68. The method of claim 67. Determining, via the at least one processor, the second data determines that the at least one cavity extends into the cancellous bone having a lateral inferior extension surface positioned non-perpendicular to the cancellous bone being cut. including
The medial inferior extension surface is positioned perpendicular to the cancellous bone to be cut,
Forming a patient-specific tibial tray based on the second data, via the at least one processor, includes forming a lateral tibial tray in which the at least one inferior extensor wall is positioned at a non-perpendicular angle to the upper surface of the body. including having a hypotension surface;
the medial indentation surface is disposed perpendicular to the upper surface of the body;
68. The method of claim 67. Determining, via the at least one processor, the second data is within cancellous bone in which the at least one cavity has lateral and medial inferior extension surfaces that terminate at an acute angle to the cancellous bone being cut. including extending to
Forming a patient-specific tibial tray based on the second data, via the at least one processor, wherein the at least one inferior extension wall has a lateral inferior extension surface and a medial inferior extension surface terminating at an acute angle. including
68. The method of claim 67. Determining, via the at least one processor, the second data determines that the at least one cavity extends completely into the cancellous bone having a lateral inferior extension surface into the medial contours of the corresponding adjacent medial surface of the underlying cortical bone. including extending along the corresponding depth;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, includes: forming the patient-specific tibial tray so that the at least one inferior extensor wall completely conforms to the medial contours of the corresponding adjacent medial surface of the underlying cortical bone; having a corresponding lateral inferior extension surface;
68. The method of claim 67. determining the second data, via the at least one processor, including the second at least one cavity extending into the cancellous bone and through the underlying cortical bone;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, is received within a second at least one cavity of the resected tibia of the patient and of the underlying cortical bone. including a second at least one downward extension engageable with the opening;
68. The method of claim 67. the second at least one inferior extension includes at least one inferior extension post;
102. The method of claim 101. determining the second data, via the at least one processor, including the second at least one cavity extending into the cancellous bone and through the underlying cortical bone;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, is received within a second at least one cavity of the resected tibia of the patient and of the underlying cortical bone. a second at least one inferior extension having an edge engageable with the opening and alignable with the outer surface of the cortical bone;
68. The method of claim 67. determining, via the at least one processor, the second data including the second at least one cavity extending into the center of the cancellous bone;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, is received within a second at least one cavity of the resected tibia of the patient to define a keel. a second at least one inferior extension;
68. The method of claim 67. Determining, via at least one processor, second data representing a patient-specific cut proximal portion of the patient's tibia based on the first data includes: has at least one cavity extending into the cancellous bone adjacent to the central cancellous bone to which the anterior and posterior cruciate ligaments attach, the surrounding cortical bone surface, and the inner surface of the underlying cortical bone;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, wherein the patient-specific tibial tray has an upper surface having a lateral portion and a spaced apart medial portion; A body having a lateral tibia engaging portion, the inferior tibia engaging portion having a central portion contactable with the cut central cancellous bone surface and at least one inferior extensor wall received in the at least one cavity. ,
68. The method of claim 67. determining, via the at least one processor, the second data including third and fourth cavities extending into cancellous bone;
Forming a patient-specific tibial tray based on the second data, via the at least one processor, comprises third and fourth cavities received in third and fourth cavities of the resected patient's tibia. including post
106. The method of claim 105. forming a patient-specific tibial tray based on the second data, via the at least one processor, comprising forming a positionable peripheral edge on the cut peripheral cortical bone surface;
68. The method of claim 67. Based on the second data, via the at least one processor, forming a patient-specific tibial tray comprises forming a body sized to be locatable between the generally cut peripheral cortical bone surfaces. include,
68. The method of claim 67. Based on the second data, via the at least one processor, forming a patient-specific tibial tray comprises forming a body sized to be locatable between the generally cut peripheral cortical bone surfaces. include,
68. The method of claim 67. A tibial tray system for a cut medial or lateral proximal portion of a patient's tibia for partial knee replacement surgery, comprising:
The resected medial or lateral proximal portion of the tibia comprises at least one formed around a central cancellous bone surface, a partial peripheral cortical bone surface, and cancellous bone of the resected medial or lateral proximal portion of the tibia. having two cavities,
The tibial tray includes a partial tibial tray including a body;
the body includes an upper portion with an upper surface and a lower tibia engagement portion;
The lower tibia engaging portion is
a central portion having a central surface contactable with a cut lateral or lateral central cancellous bone surface;
A perimeter received in at least one cavity formed around cancellous bone of the medial or lateral proximal portion that has been resected so that the peripheral inferior lateral surface portion corresponds to the undulations of the underlying inner surface of the cortical bone of the patient's tibia. a lower extension;
at least one screw can extend through the at least one passageway from the superior surface to the medial surface of the tibia;
Tibia tray system. the inferior extension comprises a curved wall of the inferior extension;
111. The tibial tray of claim 110.

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