Patent Application
20230088873
The present disclosure relates generally to surgical implants, methods, and systems for use in repairing knee joints, and more particularly to patient specific surgical procedures and customized tibial trays for use in the replacement of knee joints.
Typically, the most common indication for revision surgery of Total Knee Arthroplasties is aseptic loosening (29.8%) and subsidence. Aseptic loosening is also a major cause of post-operative pain. These failures are tied to poor osseointegration, imperfect implant coverage, limited support and shear forces introduced by a flat resection plane.
Shortcomings of the prior art are overcome and additional advantages are provided through the provision, in one embodiment, of a tibial tray system for a resected portion extending transversely across a proximal portion of a tibia of a patient for use in a total knee replacement, 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 in the underlying periphery of the resected cancellous bone, the tibial tray system includes for example, a tibial tray an at least one screw. The tibial tray includes a body comprising a superior portion and an inferior tibia-engaging portion. The superior portion comprising a superior surface and a peripheral edge, and at least one passageway extending therethrough. The inferior tibia-engaging portion includes a peripheral inferior surface supportable on the resected peripheral cortical bone surface, a center inferior surface disposable on the resected center cancellous bone surface, and at least one inferiorly-extending wall spaced inwardly from the peripheral inferior surface and extending around at least a portion of the center inferior surface, the at least one inferiorly-extending wall being receivable in the at least one cavity formed in the periphery of the resected cancellous bone surface. The at least one screw is extendable through the at least one passageway of the tibial tray. In the total knee replacement, the at least one screw extends through the tibial tray and into the cancellous bone to inhibit lift-off of the tibial tray, and a greater portion of a shearing force acting transversely to the tibial tray and the resected portion of the proximal portion of the tibia of the patient is resisted by the at least one inferiorly-extending wall and the periphery of the resected proximal portion of the tibia compared to a portion of the shearing force being resisted along the center inferior surface of the tibial tray and the resected cancellous bone surface.
In another embodiment, a method includes, for example, resecting a proximal portion of a tibia of a patient, the resected proximal portion of the tibia having a transverse resected cancellous bone surface, a transverse resected peripheral cortical bone surface, and at least one cavity formed in the periphery of the resected cancellous bone, providing a tibial tray having at least one inferiorly-extending wall spaced inwardly from a peripheral edge of the tibial tray and extending around at least a portion of a center inferior surface, and at least one passageway extending therethrough, inserting the at least one inferiorly-extending wall in the at least one cavity formed in the periphery of the resected cancellous bone surface, disposing the peripheral edge of the tibial tray on the transverse resected peripheral cortical bone surface, and the center inferior surface on the transverse resected cancellous bone surface, securing at least one screw in the at least one passageway and into the cancellous bone, and wherein, in the total knee replacement, the at least one screw inhibits lift-off of the tibial tray, and a greater portion of a shearing force acting transversely on the tibial tray and the resected portion of the proximal portion of the tibia of the patient is resisted by the at least one inferiorly-extending wall and the periphery of the resected proximal portion of the tibia compared to a portion of the shearing force being resisted along the center inferior surface of the tibial tray and the resected cancellous bone surface.
In another embodiment, a method for forming a patient specific tibial tray for a total knee replacement of a patient includes, for example, obtaining first data, via at least one processor, representing a proximal portion of the tibia of the patient, the first data corresponding to the proximal portion of the tibia of the patient having an inner cancellous bone, and a peripheral cortical bone having an outer surface and an inner surface, determining, via the at least one processor, second data representing a patient specific resected proximal portion of the tibia of the patient based on the first data, the resected proximal portion of the tibia of the patient having a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the underlying periphery of the resected cancellous bone, the at least one cavity having in outer contoured surface portion corresponding to an adjacent inner surface portion of the resected cortical bone, forming, via the at least one processor, the patient specific tibial tray based on the second data, the patient specific tibial tray comprising a body having a superior portion including a superior surface and an inferior tibia-engaging portion, the inferior tibia engaging portion having a center portion contactable with the resected center cancellous bone surface, at least one inferiorly-extending wall receivable in the at least one cavity, and at least one passageway extending from the superior surface to the inferior surface, and wherein, in the total knee replacement, the at least one screw inhibits lift-off of the tibial tray, and a greater portion of a shearing force acting transversely on the patient specific tibial tray and the resected portion of the proximal portion of the tibia of the patient is resistible by the at least one inferiorly-extending wall and the periphery of the resected proximal portion of the tibia compared to a portion of the shearing force being resistible along the center inferior surface of the tibial tray and the resected cancellous bone surface.
Shortcomings of the prior art are overcome and additional advantages are provided through the provision, in one embodiment, of a tibial tray for a resection extending transversely across a proximal portion of a tibia of a patient for use in a total knee replacement. 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 in the underlying periphery of the resected cancellous bone. The tibial tray includes a body comprising a superior portion and an inferior tibia-engaging portion. The superior portion includes a superior surface and a peripheral edge. The inferior tibia-engaging portion includes a peripheral inferior surface supportable on the resected peripheral cortical bone surface, a center inferior surface disposable on the resected center cancellous bone surface, and at least one inferiorly-extending wall spaced inwardly from the peripheral inferior surface and extending around at least a portion of the center inferior surface. The at least one inferiorly-extending wall is receivable in the at least one cavity formed in the periphery of the resected cancellous bone surface. The body includes a thickness between the superior surface and the center inferior surface, the at least one inferiorly-extending wall has a depth from the center inferior surface, and the depth being greater than the thickness. In the total knee replacement, a greater portion of a shearing force acting transversely on the tibial tray and the resected portion of the proximal portion of the tibia of the patient is resisted by the at least one inferiorly-extending wall and the periphery of the resected proximal portion of the tibia compared a portion of the shearing force being resisted along the center inferior surface of the tibial tray and the resected cancellous bone surface.
In another embodiment, a method including, for example, resecting a proximal portion of a tibia of a patient, the resected proximal portion of the tibia having a transverse resected cancellous bone surface, a transverse resected peripheral cortical bone surface, and at least one cavity formed in the underlying periphery of the resected cancellous bone, providing a tibial tray having at least one inferiorly-extending wall spaced inwardly from a peripheral edge of the tibial tray and extending around at least a portion of a center inferior surface, inserting the at least one inferiorly-extending wall in the at least one cavity formed in the underlying periphery of the resected cancellous bone surface, and disposing the center inferior surface against the transverse resected cancellous bone surface, wherein in a total knee replacement, a greater portion of a shearing force acting transversely on the tibial tray and the resected portion of the proximal portion of the tibia of the patient is resisted by the at least one inferiorly-extending wall and the periphery of the resected proximal portion of the tibia compared to a portion of the shearing force being resisted along the center inferior surface of the tibial tray and the resected cancellous bone surface.
In another embodiment, a method for forming a patient specific tibial tray for a total knee replacement of the patient, includes for example, obtaining first data, via at least one processor, representing a proximal portion of the tibia of the patient, the first data corresponding to the proximal portion of the tibia of the patient having an inner cancellous bone, and a peripheral cortical bone having an outer surface and an inner surface, determining, via the at least one processor, second data representing a patient specific resected proximal portion of the tibia of the patient based on the first data, the resected proximal portion of the tibia of the patient having a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the underlying periphery of the resected cancellous bone, the at least one cavity having in outer contoured surface portion corresponding to an adjacent inner surface portion of the resected cortical bone, forming, via the at least one processor, the patient specific tibial tray based on the second data, the patient specific tibial tray comprising a body having a superior portion having a superior surface and an inferior tibia-engaging portion, the inferior tibia engaging portion having a center portion contactable with the resected center cancellous bone surface, and at least one inferiorly-extending wall receivable in the at least one cavity, and wherein, in the total knee replacement, a greater portion of a shearing force acting transversely on the patient specific tibial tray and the resected portion of the proximal portion of the tibia of the patient is resistible by the at least one inferiorly-extending wall and the periphery of the resected proximal portion of the tibia compared to a portion of the shearing force being resistible along the center inferior surface of the tibial tray and the resected cancellous bone surface.
Shortcomings of the prior art are overcome and additional advantages are provided through the provision, in one embodiment, of a tibial tray for a resected proximal portion of a tibia of a patient for a knee replacement. The resected proximal portion of the tibia includes a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the cancellous bone exposing at least a portion of an underlying inner surface of the cortical bone. The tibial tray includes a body having a superior portion with a superior surface, and an inferior tibia-engaging portion. The inferior tibia-engaging portion includes a center portion having a center surface contactable with the center cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity formed in the cancellous bone. A surface of the peripheral inferiorly-extending portion is contactable with the exposed underlying inner surface of the cortical bone of the tibia of the patient.
In another embodiment, a method for forming a patient specific tibial tray for a knee replacement for the patient includes, for example, determining a patient specific resected proximal portion of a tibia of the patient, the resected proximal portion of the tibia of the patient having a superior center cancellous bone surface, a peripheral cortical bone surface, and one or more cavities and/or openings in the cancellous bone exposing at least a portion of an underlying inner surface of the cortical bone of the tibia, and forming the patient specific tibial tray comprising a body having an superior portion with a superior surface and an inferior tibia-engaging portion, the inferior tibia engaging portion having a center portion contactable with the cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the one or more cavities and/or openings and having one or more surfaces contactable with the exposed underlying inner surface of the cortical bone of the tibia of the patient.
In another embodiment, a robotic method for resecting a proximal portion of a tibia of a patient for a knee replacement includes, for example, obtaining, via a processor, first data representing a proximal portion of the tibia of the patient comprising centralized cancellous bone and peripheral cortical bone, determining, via the processor, second data of a patient specific resected proximal portion of the tibia of the patient having a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the cancellous bone exposing at least a portion of an underlying inner surface of the cortical bone based on the first data, and forming, via the processor, the tibia of the patent based on the second data of the patient specific resected proximal portion of the tibia, the resected proximal portion of the tibia of the patient having the center cancellous bone surface, a peripheral cortical bone surface, and the at least one cavity exposing the inner surface of the cortical bone of the tibia.
Shortcomings of the prior art are also overcome and additional advantages are provided through the provision, in one embodiment, of a tibial tray for a resected proximal portion of a tibia of a patient for a total knee replacement. The resected proximal portion of the tibia includes a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone which is spaced apart from the cortical bone exposing an underlying portion of the cancellous bone of the tibia. The tibial tray includes a body having a superior portion with a superior surface, and an inferior tibia-engaging portion. The inferior tibia-engaging portion includes a center portion having a center surface contactable with the center cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity formed in the cancellous bone surface so that the peripheral inferiorly-extending portion is spaced apart from the underlying inner surface of the cortical bone of the tibia of the patient.
In another embodiment, a method for forming a patient specific tibial tray for a total knee replacement for the patient includes, for example, determining a patient specific resected proximal portion of a tibia of the patient, the resected proximal portion of the tibia of the patient having a superior center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone exposing an underlying portion of the cancellous bone of the tibia, and forming the patient specific tibial tray comprising a body having a superior portion with a superior surface and an inferior tibia-engaging portion, the inferior tibia engaging portion having a center portion contactable with the center cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity so that the peripheral inferiorly-extending portion is spaced apart from the exposed underlying inner surface of the cortical bone of the tibia of the patient.
In another embodiment, a robotic method for resecting a proximal portion of a tibia of a patient for a total knee replacement includes, for example, obtaining, via a processor, first data representing a proximal portion of the tibia of the patient comprising centralized cancellous bone and peripheral cortical bone, determining, via the processor, second data of a patient specific resected proximal portion of the tibia of the patient having a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone spaced apart from the cortical bone exposing an underlying portion of the cancellous bone based on the first data, and forming, via the processor, the tibia of the patent based on the second data representing the patient specific resected proximal portion of the tibia, the resected proximal portion of the tibia of the patient having a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone spaced apart from the cortical bone exposing an underlying portion of the cancellous bone of the tibia.
Shortcomings of the prior art are also overcome and additional advantages are provided through the provision, in one embodiment, of a tibial tray for a resected proximal portion of a tibia of a patient for a total knee replacement. The resected proximal portion of the tibia includes a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone which is spaced apart from the cortical bone exposing an underlying portion of the cancellous bone of the tibia. The tibial tray includes a body having a superior portion with a superior surface, and an inferior tibia-engaging portion. The inferior tibia-engaging portion includes a center portion having a center surface contactable with the center cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity formed in the cancellous bone surface so that the peripheral inferiorly-extending outer surface portion corresponds to the contour of the underlying inner surface of the cortical bone of the tibia of the patient. In other embodiments, the peripheral, inferiorly-extending portion includes at least a portion of the peripheral inferiorly-extending outer surface portion extending from a proximal portion of the peripheral, inferiorly-extending portion to a distal portion of the peripheral, inferiorly-extending portion contoured to correspond to a contour of a superior edge portion of the cortical bone along the resection plane so that the at least the portion of the peripheral inferiorly-extending outer surface portion is disposable adjacent to a underlying concave inner surface of the cortical bone.
Shortcomings of the prior art are also overcome and additional advantages are provided through the provision, in one embodiment, of a tibial tray for a resected medial or lateral proximal portion of a tibia of a patient for a partial knee replacement, The resected medial or lateral proximal portion of the tibia has a central cancellous bone surface, a partial peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone in the resected medial or lateral proximal portion of the tibia. The tibial tray includes a body having a superior portion with a superior surface, and an inferior tibia-engaging portion. The inferior tibia-engaging portion includes a center portion having a center surface contactable with the resected central cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity formed in the resected cancellous bone surface so that the peripheral inferiorly-extending outer surface portion corresponds to the contour of the underlying inner surface of the cortical bone of the tibia of the patient.
Shortcomings of the prior art are also overcome and additional advantages are provided through the provision, in one embodiment, of a cutting guide for forming at least one cavity in a resected proximal portion of a tibia of a patient for knee replacement. The resected proximal portion of the tibia has a center 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 corresponding to at least a portion of an outer peripheral cortical bone along the resection of the proximal portion of the tibial of the patient, and at least one U-shaped opening extending through the planar member from the first planar surface to the second planar surface 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 normal to the U-shape axis. The U-shaped opening has an inner edge and an outer edge, and the outer edge being parallel to the peripheral outer edge. The cutting guide can further include a milling tool having a proximal diameter sized larger than the width of the opening, and a distal diameter sized for passing through the opening.
Shortcomings of the prior art are also overcome and additional advantages are provided through the provision, in one embodiment, a cutting guide for forming a pair of cavities in a resected proximal portion of a tibia of a patient for total knee replacement, the resected proximal portion of the tibia having a center 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 a peripheral outer edge corresponding to an outer peripheral cortical bone along the resection of the proximal portion of the tibial of the patient. A pair of U-shaped openings extend through the planar member from the first planar surface to the second planar surface and spaced from the peripheral outer edge. Each of the pair of U-shaped openings define a U-shaped axis, and the U-shaped opening has a constant width normal to the U-shape axis. Each of the pair of the U-shaped openings having an inner edge and an outer edge, and the outer edge is parallel to the peripheral outer edge. The cutting guide can further include a milling tool having a proximal diameter sized larger than the width of opening, and a distal diameter sized for passing through the opening.
The subject matter which is regarded as the disclosure is particularly pointed out and distinctly claimed in the concluding portion of the specification. The disclosure, however, may best be understood by reference to the following detailed description of various embodiments and the accompanying drawings in which:
Generally stated, disclosed herein are resected proximal portions of tibias, tibial trays, and methods and robotic systems for forming the same.
In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior, and inferior are defined by their standard usage for indicating a particular part of a bone or implant according to the relative disposition of the natural bone or directional terms of reference.
Positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current devices and methods are described herein with reference to use with the bones of the knee, the bones of the knee may be used to describe the surfaces, positions, directions or orientations of the tibial trays, tibial tray installation, and surgical methods. Further, the devices and surgical methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the devices and surgical methods, and the aspects, components, features and the like thereof, described and/or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the spirit and scope of the disclosure. For example, the apparatus and surgical methods, and the aspects, components, features and the like thereof, described herein with respect to a left knee may be mirrored so that they likewise function with a right knee and vice versa.
Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference to, for example,
In some embodiments, for example, a patient specific tibial tray design may mitigate aseptic loosening and subsidence through a combination of high peripheral surface area contact, underside surface geometry, and patient matched pegs that interface with cortical metaphyseal bone. The present disclosure may solve and/or overcome a primary cause for knee implant failure, namely, aseptic loosening of the tibial component and subsidence.
In some embodiments, the present disclosure is directed to methods for generating a three-dimensional model of a tibia and generating a cut plan for excavating a portion of the tibia with a robot or robotic excavator according to the cut plan to allow for the insertion of a custom tibial tray designed to increase or maximize cortical contact with the periphery of the inner tibial wall.
In some embodiments, a technique of the present disclosure is directed to maximizing cortical contact of a tibial tray along the underlying inner surface of the cortical wall of the tibia. A virtual model of the proximal portion of a tibia bone may be used to determine an improved implant that is designed to achieve a higher level of cortical contact. A processor may be employed and configured to generate an excavation protocol for excavating bone from the tibia such that the amount of bone contact between the bone and the implant is increased, such as 10 percent or greater, compared to convention tibial trays.
For example, the tibial tray 20 may include a body 22 having a superior portion 24 and an inferior tibia-engaging portion 26. The superior portion 24 may include a generally planar superior surface 25 for supporting a plastic bearing spacer (not shown in
The tibia engaging portion 26 may include a center tibia engaging portion 30 and a peripheral tibia engaging portion 40. In this embodiment, the center tibia engaging portion 30 may include a planar surface contactable with the center cancellous bone surface of the resected proximal portion of the tibia of the patient.
The peripheral tibia-engaging portion 40 may include at least one inferiorly-extending wall 50. The inferiorly-extending wall 50 may include an inner wall surface 52 and an outer wall surface 54. The inner wall surface 52 may be disposed normal or at 90 degrees to the superior surface 25, or at any suitable angle or angles. The outer wall surface 54 may be able to be aligned with and abutting or contacting an inner surface 13 of the cortical bone 12.
For example, the outer wall surface 54 may be disposed at an angle A1, which may be angled at about 25 degrees to about 45 degrees, about 30 degrees to about 40 degrees, about 35 degrees, or other suitable angles relative to the superior surface 25 of the tibial tray 20. The wall 50 is received in a cavity formed in the resected proximal portion of the tibia 10. The cavity may be formed in the cancellous bone, trabecular bone, spongy bone, or light porous bone of the tibia. The wall may increase the contact area with the inner surface 13 of the cortical bone 12. A depth D1 of the wall 50 may extend 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, exceed 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 5 mm, about 7 mm, or other suitable depths. In some embodiments, the inferiorly-extending wall 50 may extend along at least 25 percent of the periphery of the body 22, along at least 50 percent of the periphery of the body 22, extend along the entire periphery of the body 22, or extend along another suitable amount along the periphery of the body 22. The width W1 of the wall 50 may be about 5 mm to 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 a lower surface 28 that extends over the superior cut cortical bone 19, e.g., edge 18. In some embodiments, the tibial tray 20 may feature a keel 32 (shown in dashed lines in
The tibial tray 320 may include a body 322 having a superior portion 324 and an inferior tibia-engaging portion 326. A superior surface 325 of the superior portion 324 may be a generally planar surface for supporting a plastic bearing spacer (not shown in
The tibia engaging portion 326 may include a tibia engaging center portion 330 defining a recess 340 relative to a peripheral tibia-engaging portion 350. The peripheral tibia-engaging portion 350 may be a wall or a flat portion disposed around some or all of the tibia engaging center portion 330 and at an elevation different than the tibia engaging center portion 330. The peripheral tibia-engaging portion 350 may be disposed in a cavity formed in the cancellous bone, trabecular bone, spongy bone, or light porous bone of the proximal portion of the tibia adjacent to the inner surface of the cortical bone of the proximal portion of the tibia. 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 disposed normal or at 90 degrees to the superior surface 325 of the superior portion 324. The outer wall surface 354 may be able to be aligned with and abutting to an inner side surface 213 of the inner surface of the cortical bone 212. A depth D2 of the peripheral tibia-engaging portion 350 may exceed 0.5 mm and may not exceed 75 mm. The geometric resurfacing of the proximal portion of the tibia may result in the superior and inferior portions along a resection plane (excluding a keel and pins) having a depth D3 greater than about 0.5 mm and less than about 15 mm. In some embodiments, a tibial tray may feature a keel and support pins. As described in greater detail below, the proximal portion of the tibia 210 may be resected manually or robotically to receive the corresponding manually or robotically formed tibial tray 320.
For example, a typical proximal portion of the tibia bone may feature a concave minimum near the lateral condyle, a convex maximum near the intercondyle eminence, and a concave minimum near the medial condyle. The resected proximal portion of the tibia 410 for a knee replacement of the present disclosure may remove the damaged bone from the proximal portion of the tibia while shaping the bone to include a similar general contour of a typical tibia bone. The resurfaced proximal portion of the tibia bone 410 may feature a concave minimum 416 near the lateral condyle, a convex maximum 417 near the intercondyle eminence, and a concave minimum 418 near the medial condyle. The concave minimum 416, the convex maximum 417, and/or the concave minimum 418 may extend into the cancellous bone, trabecular bone, spongy bone, or light porous bone of the proximal portion of the tibia, which lateral portions of the concave minimum 416, the convex maximum 417, and the concave minimum 418 may be disposed adjacent to and/or in contact with the underlying inner surface of the cortical bone 412 of the proximal portion of the tibia 410. The tibial tray 420 may include an inferior tibia-engaging 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 surfaces and the radius of the convex surface may be constant radiuses or have varying curvature. The outer edges of the convex surfaces, when viewed from below, may have an oval or a generally egg-shaped configuration.
The tibial tray 420 may include one or more pins 490 designed to interface with the underlying cortical bone 412. For example, as shown in
The presently disclosed tibial trays may be operable with conventional plastic spacers and femoral components. For example, the superior surface of the presently disclosed tribal trays may include a surface having a general symmetrical or kidney bean shape designed for engagement with a standard plastic spacer component such as in a snap fit manner. A tibial tray with a variable thickness (by way of nonlimiting example, a rim) may exist at the periphery of the tibial tray such that tibial tray coverage is maximized along the resection plane, but such that engagement of a plastic spacer component is not compromised. The thickness of the tibial rim may be about 4 mm. In other embodiment the rim may exceed about 0.5 mm and be less than about 25 mm.
The tibial trays of the present disclosures may include a one-piece, monolithic, or integral body, or may be formed from two or more components. The tibial tray may be made out of a standard metallic implant material, such as titanium, cobalt chrome, or other acceptable stainless steels. In other embodiments, the tibial tray may of the present disclosure may be made out of a plastic or polymeric material.
The method 600 may include, for example, at 610 obtaining first data representing a proximal portion of the tibia of the patient. At 620, second data of a patient specific resected proximal portion of the tibia of the patient is determined based on the first data. The resected proximal portion of the tibia of the patient has a superior surface and one or more cavities or openings exposing an inferior portion of an underlying inner surface of the 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, the tibial tray is formed based on the second data, and at 660, the formed tibial tray is secured onto the formed resected proximal portion of the tibia so that an inferior portion of the tibial tray extends into the one or more cavities and/or openings and contacts the underlying inner surface of the cortical bone of the tibia.
For example, tibia data 702 such as first data representing a proximal portion of a tibia of the patient (block 610 in
The memory 730 may include various modules for processing the input data. For example, the memory 730 may include a tibia cut generator 740, a robotic tibia cut plan generator 750, and a tibial tray generator 760.
The tibia cut generator 740 may be operable for determining the second data representative of the patient specific resected proximal portion of the tibia of the patient based on the first data (block 620,
The cut generator 740 may include various modules such as a resection surface generator 742, a cavity generator 744, and an optimizing generator 746. The resection generator 742 may allow for a surgeon to indicate, for example, a resection plane or such plane may be automatically generated provided, e.g., by input by a surgeon, or based on or utilizing predetermined data. For example, the resection plane may be determined as disclosed in U.S. patent application Ser. No. 16/153,334, entitled, “Apparatus, Method and System for Providing Customizable Bone Implants”, the entire subject matter of which is incorporated herein by reference. The cavity generator 744 may include receiving initial inputs from a surgeon such as locations, widths, lengths, depths, or may be based on or utilizing predetermined data. Optimizing generator 746 may take the inputted or generated configuration of the tibial tray, and virtually test or compare such tibial tray installed in the resected tibia based on forces likely to be experienced. Automatically varying of the dimensions may allow for comparison to previous developed configurations to optimize the configuration of the patient specific resected tibia and the tibial tray. In some embodiments, optimizing generator 746 may optimize the depth of the walls, the thickness of the walls, and the amount and location of the walls that extend around the tibial tray to result in a reduce removal amount needed of the cancellous bone, thereby causing less trauma to the tibial of the patient. In some embodiments, a suitable module in the memory 730 may have suitable programming or algorithms for virtually testing a resultant patient specific proximal portion of the tibia and corresponding tibial tray, or for comparison the resultant patient specific proximal portion of the tibia and corresponding tibial tray against exemplary acceptable configurations. Such optimizing techniques are described below.
The robotic tibia cut plan generator 750 may be operable to determine data or instructions for operating a surgical robot 790 or other automated device for forming the patient's tibia based on the second data (block 640,
The tibial tray generator 760 may be operable to determine a configuration of a patient specific tibial tray having, for example, an inferior surface based on the second data (block 630,
The technique of the present disclosure may solve the problem by more closely matching the native anatomy of the joint and thereby increasing the surface area contact for osseointegration and reducing shear forces along the implant to bone interface plane. Osseointegration (organic fixation) may occur from cortical contact. For example, the system may introduce patient specific wall, supports, or pegs that interface with the underlying cortical metaphyseal bone to add stability and resist subsidence. By mapping the contours of the metaphyseal bone (the transitional zone at which the diaphysis and epiphysis of a bone come together) such that a tibial tray can be formed and readily inserted.
Programming code or algorithms, such as in the tibia cut generator 750, may include the introduction of non-planar shapes to the bottom of the tibial tray that may increase the surface area contact of the resected tibia significantly. By way of example, the surface area of a circle in a plane is characterized by the equation (Area of Circle=πr2). The surface area of a semi-spherical shape approximated by a half-sphere is characterized by the equation (Area of a half-sphere=2πr2). Thus, the introduction of semi-spherical shapes can increase the surface area contact significantly. By way of nonlimiting example, a half-sphere has twice the surface area of a circle of equal radius. The configuration of a normal proximal portion of the tibia is not a flat plane, but the anatomy is characterized by concave and convex geometries, and the tibia cut generator 750 in determining the resected proximal portion of the tibia may be based on the surface area being non-parallel.
An approximation of these concave and convex surface features 900 is illustrated in
In other embodiments, auto-segmentation and implant generation algorithms may be utilized with a surgical robot to introduce pre-planned semi-oblong irregular shapes and cavities into the proximal tibial surface that are designed for engagement with a conforming patient specific tibial tray generated by the algorithms. For example, a pre-operative anatomy of the tibia is characterized by segmentation and implant generation algorithms, which are designed to output a robotic surgical plan and a corresponding patient specific implant. The algorithm outputs may be designed to loosely reconstruct the pre-operative curvature of the native anatomy (geometric approximations of the proximal surface of the tibia, specifically the medial and lateral condyles, intercondyle eminence and medial and lateral curved plateaus) as well as may introduce cavities for pegs of variable length and with high conformity to the underlying bone. The algorithm may map the contours of the metaphy seal bone such that a high conformity implant can be inserted. The surgical robot may prepare these surface features with tissue ablation tooling (for example a burrs, sagittal saws, drills, etc.) and the implant may be 3D printed, forged or cast.
The tibial tray may be aligned at the surgeon's discretion and input or by system 700. The total knee arthroplasties (TKA) of the present disclosure may be aligned with the tibial component, which is positioned perpendicular to the anatomic axis of the tibia similar to conventional TKAs. For example, the anatomic axis may be colinear with the mechanical axis unless there is some unusual deformity. Alternatively, a so-called kinematic or anatomic technique may be employed in which the goal is to recreate the native sagittal and coronal orientation of the tibial joint surface (e.g., restore the joint surface to where it was before arthritis set in). There is variation in the native alignment of the tibia. The coronal alignment typically averages 3 degrees of varus and the sagittal (posterior slope) averages 7 degrees or so but ranges widely between 0 and 15+. The algorithms in the tibia cut generator may be able to apply either technique.
With reference to
In some embodiments, for example, a patient specific tibial tray design may mitigate aseptic loosening and subsidence through a combination of high underlying peripheral surface area contact and underside surface geometry that interfaces more closely with peripheral cancellous bone adjacent to the cortical bone. The present disclosure may solve and/or overcome a primary cause for knee implant failure, namely, aseptic loosening of the tibial component and subsidence.
In some embodiments, the present disclosure is directed to methods for generating a three-dimensional model of a tibia and generating a cut plan for excavating a portion of the tibia with a robot or robotic excavator according to the cut plan to allow for the insertion of a custom tibial tray designed with one or more peripheral inferiorly-extending portions designed to be spaced from the periphery of the underlying tibial cortical bone.
In some embodiments, a technique of the present disclosure is directed to increasing stability of the tibial tray relative to the resected proximal portion of the tibia by employing one or more peripheral inferiorly-extending portions designed to be spaced from the periphery of the underlying tibial cortical bone. A virtual model of the proximal portion of a tibia bone may be used to determine an improved implant that is designed to achieve a higher level of stability. A processor may be employed and configured to generate an excavation protocol for resecting the proximal tibia and excavating cancellous bone from the tibia such that the amount of contact between the tibia and the implant is increased, by, for example, an amount of 10 percent or greater contact compared to convention tibial trays.
For example, as shown in
With reference still to
The peripheral tibia-engaging portion 2040 may include at least one inferiorly-extending wall, and may include a first inferiorly-extending wall 2050 and a spaced apart second inferiorly-extending wall 2051. The first inferiorly-extending wall 2050 may include an inner wall surface 2052 and an outer wall surface 2054. For example, the walls 2052 and 2054 may be U-shaped walls facing each other. The second inferiorly-extending wall 2051 may include an inner wall surface 2053 and an outer wall surface 2055. The walls 2050 and 2051 may be a mirror image of wall 2050 and may have constant thicknesses, different thickness, varying thickness, or other suitable thicknesses. The inner wall surfaces 2052 and 2053 may be disposed normal or at 90 degrees to the superior surface 2025, or at any suitable angle or angles. The outer wall surfaces 2054 and 2055 may be disposed normal or at 90 degrees to the superior surface 2025. In other embodiments, the outer wall surface may be angled relative to the superior surface such as parallel with and spaced from an inner surface 2013 (
The inner wall surface 2052 of the first wall 2050 may be disposed adjacent to or abut the inner surface 2125 of the first U-shaped cavity 2115, the outer wall surface 2054 of the first wall 2050 may be disposed adjacent to or abut the outer surface 2126 of the first U-shaped cavity 2115, the inner wall surface 2053 of the second wall 2051 may be disposed adjacent to or abut the inner surface 2127 of the second U-shaped cavity 2117, and the outer wall surface 2055 of the second wall 2051 may be disposed adjacent to or abut the outer surface 2128 of the second U-shaped cavity 2117.
With reference again to
With reference again to
For example, as shown in
The tibia engaging portion 3026 may include a center tibia engaging portion 3030 and a peripheral tibia engaging portion 3040. In this embodiment, the center tibia engaging portion 3030 may include a contoured surface contactable with the center cancellous bone surface of the resected proximal portion of the tibia of the patient. For example, the center tibia engaging portion may include one or more concave, convex, or planar surfaces contactable with the center cancellous bone surface of the resected proximal portion of the tibia of the patient as similarly described above.
The peripheral tibia-engaging portion 3040 may include at least one inferiorly-extending wall having portions disposed at different depths. Peripheral tibia-engaging portion 3040 may include, for example, a first inferiorly-extending wall 3050 and a spaced apart second inferiorly-extending wall 3051. Peripheral tibia-engaging portion 3040 may further include a connecting inferiorly-extending wall 3070, a first inwardly-extending wall 3080, and a second inwardly-extending wall 3090. The connecting inferiorly-extending wall 3080 may extend between the first inferiorly-extending wall 3050 and the spaced apart second inferiorly-extending wall 3051. The inwardly facing ends 3081 and 3091 of first inwardly-extending wall 3080 and a second inwardly-extending wall 3090, respectively, may define a gap G disposed along the posterior side of the tibial tray 3020. The gap G may inhibit the need to sacrifice tendons and ligaments at the posterior side of the proximal tibia.
The first inferiorly-extending wall 3050 may include an inner wall surface 3052 and an outer wall surface 3054. The second inferiorly-extending wall 3051 may include an inner wall surface 3053 and an outer wall surface 3055. The walls 3050 and 3051 may have generally constant thicknesses being rounded at the inferiormost end.
The inner wall surfaces 3052 and 3053 may be disposed normal or at 90 degrees to the superior 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 (
With reference again to
With reference again to
With reference again to
As illustrated in
In the various embodiments, desirably, the cavities and walls do not penetrate the outer cortical bone. In other embodiments, a portion of the cavities or walls such as the lower portions thereof may contact or extend into the cortical bone.
In further embodiments, a patient matched or customized tibial tray may include, for example, inferiorly-extending pegs, flanges, fins, etc. that are positioned at or near the peripheral edge of the tibial tray and which, when installed, is received in one or more cavities or holes in the cancellous bone spaced apart from and in close proximity with the underlying inner surface of the cortical bone in the resected proximal portion of the patient's tibia. An alternative embodiment of the tibial tray may have, for example, asymmetrical convex elements extending from the undersurface of the tray to enhance force distribution over the medial and lateral compartments and a rim that extends around all, almost the entire, or a portion of the peripheral superior surface of the resected cortical bone.
The present disclosure is also directed to methods and systems for generating a three dimensional cut plan for excavating portions of the proximal tibia for a total knee replacement using a robot or robotic excavator according to the cut plan to create cavities that allow for the insertion of the custom tibial trays shown and described in connection with
As described above, the tibial trays according to the present disclosure for use in a total knee replacement may include one or more inferiorly-extending walls with an outer wall surface and an inner wall surface. The outer wall surface may be configured to correspond and contact an underlying inner surface of the cortical bone or be spaced from and disposed closely adjacent to an underlying inner surface of the cortical bone. It will be appreciated that a tibial tray having an inferiorly-extending wall corresponding to the location of the lateral cortical bone having an inner concave surface 7016 below a resection plane RP1 may result in the one or more inferiorly-extending walls of the tibial tray not being insertable in the resected proximal tibia with one or more cavities for receiving the one or more inferiorly-extending walls.
As shown in
With reference to
As shown in
In some embodiments, for example, for clinical reasons a resection plane may not be flat, but instead need to be disposed on an angle. If the implant was designed assuming a flat resection plane, but inserted onto an angled resection plane, clinical problems may be introduced. For example, the inferiorly-extending wall may not accurately correspond to the inner surface of a cortical wall and/or may even contact and/or penetrate the cortical bone.
With reference to
For example, as shown in
The superior portion 10024 may include a generally planar superior surface 10025 (
With reference again to
The peripheral tibia-engaging portion 10040 may include an inferiorly-extending wall 10050. The inferiorly-extending wall 10050 may include an inner wall surface 10052 (
As described above, various surgical robot methods may be employed for excavating the one or more cavities in the cancellous bone in the resected proximal portion of the tibia for insertion of the various tibial components as described above.
Planar member 11020 may include a peripheral outer edge 11023, which corresponds to an outer peripheral cortical bone along the resected proximal portion of the tibial of the patient. A pair of U-shaped openings 11050 extends through the planar member from the first planar surface 11022 to the second planar surface (not shown) and is spaced from the peripheral outer edge. Each of the pair of U-shaped openings 11050 defines a U-shaped axis 11060, and the U-shaped opening has a constant width W8 normal to the U-shape axis. Width W8 desirably corresponds to the width of the inferiorly-extending portions of corresponding patient specific tibial tray. Each of the pair of U-shaped openings have an inner edge 11061 and an outer edge 11062. The outer edge 11062 may be disposed parallel to the peripheral outer edge 11023. Cutting guide 11000 may be, for example, a patient specific cutting guide and which may be effected using the system 700 of
With reference to
With reference again to
In this illustrated embodiment, the tibial tray 15000 may include a body 15022 having a superior portion 15024 and an inferior tibia-engaging portion 15026. The superior portion 15024 may include a generally planar superior surface 15025 (best shown in
The inferior tibia-engaging portion 15026 may include the circumferential wall or fin 15040, which when operably attached to the resected proximal portion of a tibia 10 (
As shown in
The single inferiorly-extending 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 superior portion 15024. The superior portion 15024 may have constant thicknesses, different thickness, varying thickness, or other suitable thicknesses. The inner wall surface 15051 may be disposed normal or at 90 degrees to the superior surface 15025, or at any suitable angle or angles. The outer wall surface 15055 may be disposed normal or at 90 degrees to the superior surface 15025. In other embodiments, the outer wall surface may be angled relative to the superior surface such as parallel with and spaced from an inner surface of the cortical bone as shown in
With reference again to
An implant ledge width W9 from the location of the mapped inner cortical wall and the location of the outer fin wall can be determined. With reference to
W9=X+Y
For example, a distance X from the inner cortical wall to an outer fin wall may be defined as being 3 mm from the inner cortical wall at every point. The thickness of the cortical wall may be based on a patient's age. For example, a cortical wall thickness Y may be 2.2 mm for a certain age as predetermined based on, e.g., Gosman et al. “Development of Cortical Bone Geometry in the Human Femoral and Tibial Diaphysis”, The Anatomical Record, 296(5), 774-787, 2013. Thus, a tibial tray may be designed and configured having a ledge width W9 of 5.2 mm for example, from the exterior surface of the fin at every point along the periphery. The width Y may be variable based on anatomical observation or further study. For example, further research may find the average resected wall thickness is not uniform. For example, if the medial wall thickness is generally a value different from the lateral thickness, that information may be incorporated into the design of the tibial tray. In other embodiments of the present disclosure, a patient specific design may employ a mapping of the inner cortical wall to design a patient specific tibial tray having a matched wall or fin. An implant ledge width W9 may then be determined based on the mapped cortical wall thicknesses and a known distance of the wall or fin from the inner cortical wall.
With reference still to
The inferior tibia-engaging portion 16026 may include the C-shaped wall or fin 16040, which when operably attached to the resected proximal portion of a tibia (not shown in
The single inferiorly-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 the cross-sectional U-shaped superior portion 16024 along with periphery thereof. The superior portion 16024 may have constant thicknesses, different thickness, varying thickness, or other suitable thicknesses. The inner wall surface 16051 may be disposed normal or at 90 degrees to the superior surface 16025, or at any suitable angle or angles. The outer wall surface 16055 may be disposed normal or at 90 degrees to the superior surface 16025. In other embodiments, the outer wall surface may be angled relative to the superior surface such as parallel with and spaced from an inner surface of the cortical bone (not shown in
In this illustrated embodiment, the tibial tray 17000 may be essentially the same the bi-cruciate tibial tray 16000 (
During the insertion of a traditional style tibial baseplate with a post and fins, the tibia is subluxed in the anterior direction to a great extent to allow the post and fins to be prepared with a punch used from the superior direction. The tibia must remain subluxed anteriorly in order to place the tibial implant directly onto the resected tibia surface and seated in a directly inferior direction. In the embodiment of the tibial tray 17000, the wall and pegs are angled generally in the posterior direction to allow the implant to be inserted from the anterior side on an angle rather than directly down from the superior direction. This may allow the surgeon to sublux the tibia anteriorly less than in some traditional systems in order to insert the tibial baseplate, which may cause less soft tissue damage due to extreme subluxation of the tibia.
Planar member 18020 may include a peripheral outer edge 18023, which corresponds to an outer peripheral cortical bone along the resected proximal portion of the tibial of the patient. A series curved openings 18050 extends through the planar member from the first planar surface 18022 to the second planar surface (not shown) and is spaced from the peripheral outer edge. Each of the openings 18050 defines an axis 18060, and the opening has a constant width W10 normal to the axis. The width desirably corresponds to the width of the inferiorly-extending portions of corresponding patient specific tibial tray. Each of the openings have an inner edge 18061 and an outer edge 18062. The outer edge 18062 may be disposed parallel to the peripheral outer edge 18023. The cutting guide 18000 may include one or more fixing holes 18070 to accommodate temporary fixation, e.g., via screws, of the cutting guide to the resected tibia. The periphery of the cutting guide may be sized to match the outer periphery of the resected tibia such that visual alignment and proper placement on the resected tibia is readily performed.
Cutting guide 18000 may be, for example, a patient specific cutting guide and which may be effected using the system 700 of
The cutting guide 18000 may be operable with a milling tool such as the milling tool 12000 (
For example, as shown in
As shown in
The inferior tibia-engaging portion 20026 may include the circumferential wall or fin 20040, which when operably attached to the resected proximal portion of a tibia 20010 (
As shown in
The single inferiorly-extending circumferential 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 the superior portion 20024, or mirror the outer contour of the superior portion 20024. The superior portion 20024 may have constant thicknesses, different thickness, varying thickness, or other suitable thicknesses. The inner wall surface 20051 may be disposed normal or at about 90 degrees to the superior surface 20025, or at any suitable angle or angles. The outer wall surface 20055 may be disposed normal or at about 90 degrees to the superior surface 20025. In other embodiments, the outer wall surface may be angled relative to the superior surface such as parallel with and spaced from an inner surface of the cortical bone (for example, as shown in
In this illustrated embodiment, the wall or fin 20040 may be circumferential and extend completely around and located towards a periphery of the implant or tibial tray undersurface or inferior surface 20030. The outer surface of the circumferential wall or fin may be based on pre-operative imaging data of the inner cortical wall of a patient, specifically to design the implant or tibial tray such that the fin outer wall is a fixed and a constant distance from the mapped inner surface of the cortical wall.
As shown in
With reference again to
As will be appreciated from the present description, the peripheral rim or wall may be of a reduced or minimum height or depth because the rim or wall 20040 may need to account for shear forces, while the screw 20500 is operable to account for lift-off or pull out forces. For example, the screw 20500 may have a body 20510 having a proximal or head portion 20520 and a threaded shank portion 20540. In other embodiments, the screw 20500 may include a head; a non-threaded shank portion, a threaded shank, and a tip. The head portion 20520 may be disposed below or flush with the superior surface 20025 (
With reference to
The screw 20500 may have a diameter D9 of about 10 millimeters, about 12 millimeters, about 15 millimeters, between about 10 millimeters to about 15 millimeters, or other suitable sized diameter.
The screw 20500 may have a height or depth D10 extending from the inferior surface of the tibial tray of 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 about 5 millimeters and about 25 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.
With reference to
As shown in
The inferior tibia-engaging portion 30026 may include the circumferential wall or fin 30040, which when operably attached to the resected proximal portion of a tibia 30010 (
As shown in
The single inferiorly-extending 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 superior portion 30024 or mirror the outer contour of the superior portion 30024. The superior portion 30024 may have constant thicknesses, different thickness, varying thickness, or other suitable thicknesses. The inner wall surface 30051 may be disposed normal or at about 90 degrees to the superior surface 30025, or at any suitable angle or angles. The outer wall surface 30055 may be disposed normal or at about 90 degrees to the superior surface 30025. In other embodiments, the outer wall surface may be angled relative to the superior surface such as parallel with and spaced from an inner surface of the cortical bone (for example, as shown in
In this illustrated embodiment, the wall or fin 30040 may be circumferential and extend completely around and be positioned towards a periphery of the implant or tibial tray undersurface or inferior surface 30030. The outer surface of the circumferential wall or fin may be based on pre-operative imaging data of the inner cortical wall of a patient, specifically to design the implant or tibial tray such that the fin outer wall is a fixed and a constant distance from the mapped inner surface of the cortical wall.
As shown in
With reference again to
As will be appreciated from the present description, the peripheral rim or wall may be of a reduced or minimum height or depth because the rim or wall 30040 may need to account for shear forces, while the screws 30501 and 30502 are operable to account for lift-off or pull out forces. For example, the screws 30501 and 30502 may be essentially the same as the screw 20500 (
With reference to
The screws 30501 and 30502 may have a diameter D12 of about 10 millimeters, about 12 millimeters, about 15 millimeters, between about 10 millimeters to about 15 millimeters, or other suitable sized diameter.
The screws 30501 and 30502 may have a height or depth D13 extending from the inferior surface of the tibial tray of 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 about 5 millimeters and about 25 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.
In some embodiments, the one or more screws 20500, 30061, 30062, 40700 may be non-ingrowth, i.e., not designed to facilitate osseointegration so that the screws may be removable during a revision. As described above, the one or more screws 20500, 30061, 30062, 40700 may be operable to facilitate a shorter wall or fin by providing initial stability while bone growth occurs. For example, the wall or fin height could be reduced to 1 mm to 3 mm in height, and defined above. Shorter walls or fins may be minimally invasive and preserve bone. Furthermore, a shorter wall or fin may facilitate an easier revision. If a wall or fin is short enough the revision could be made by directly undercutting the implant. This would allow for solid walls or fins that can add to the rigidity of the implant because they would not need to be cut through for a revision.
It will be appreciated that one, two, or more screws 20500, 30061, 30062, 40700 may be employed with any of the tibial trays described herein, for example, having a continuous surrounding peripherally-extending wall, spaced apart U-shaped peripherally-extending walls, peripherally-extending wall contactable with the inner cortical bone or spaced therefrom. The screws may be locking or non-locking.
In still other embodiments, tibial trays systems employing one or more screws may include one or more walls, such as the walls described above, and in which the one or more walls may have a depth of about or less than about 1 millimeter, about or less than about 2 millimeters, about or less than about 3 millimeters, about or less than about 4 millimeters, about or less than about 5 millimeters, greater than about 5 millimeters, about or less than about 6 millimeters, about or less than about 7 millimeters, about or less than about 8 millimeters, about or less than about 9 millimeters, about or less than about 10 millimeters, or other suitable sized depths.
In still other embodiments, tibial trays systems employing one or more screws may include one or more walls, such as the walls described above and in which the one or more walls may have a depth of between about 1 millimeters and about 10 millimeters, between about 1 millimeters and about 7 millimeters, between about 1 millimeters and about 5 millimeters, between about 1 millimeters and about 3 millimeters, or other suitable range of sized depths.
In still other embodiments, tibial trays systems employing one or more walls may include one or more screws, such as the screws described above, and in which the one or more screws may have a height or depth extending from the inferior surface of the tibial tray of about or less than about 5 millimeters, about or less than about 7 millimeters, about or less than about 10 millimeters, about 15 or less than about millimeters, about or less than about 20 millimeters, about or less than about 25 millimeters, between about 5 millimeters and about 25 millimeters, between about 5 millimeters and about 25 millimeters, 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 other suitable heights or ranges of heights.
In still other embodiments, tibial trays systems employing one or more walls and one or more screws, such as the walls and screws described above, and in which the one or more screws may have a diameter of about or less than about 3 millimeters, about or less than about 4 millimeters, about or less than about 5 millimeters, about or less than about 6 millimeters, about or less than about 7 millimeters, about or less than about 8 millimeters, about or less than about 9 millimeters, about 10 millimeters, about 12 millimeters, about 15 millimeters, between about 3 millimeters to about 5 millimeters, between about 3 millimeters to about 10 millimeters, between about 5 millimeters to about 10 millimeters, between about 10 millimeters to about 15 millimeters, or other suitable sized diameter.
In some embodiments, tibial trays may be configured for a resected medial or lateral proximal portion of a tibia of a patient for a partial knee replacement, according to embodiments of the present disclosure. Such tibial trays may include features for the above described tibial trays and employ one or more screws to inhibit lift off of the partial tibial tray.
It will be appreciated from the technique of the present disclosure for the tibial trays and the resected proximal portion of the tibia that such designs and techniques may overcome the problems of conventional non-patient specific tibial trays that are designed to rest on a flat resection plane that minimizes surface area contact and maximizes shear forces, lack redundant modes of support, provide poor implant surface area coverage influencing the risk of subsidence. The patient specific tibial trays and the patent specific resected proximal portion of the tibia overcome the problems associated with conventional tibial trays, which conventional tibial trays are designed as geometric approximations of multiple bone models that are manually segmented from large image databases and proportionally constrained and scaled to accommodate a range of implant sizes and resecting of the proximal portion of the tibia being flat cut often using a sagittal saw.
The technique of the present disclosure may provide increased surface area contact and/or reduced shear forces along the resection plane of the implant-to-bone interface resulting in less failures or loosening by poor alignment and natural lateral loading of the joint.
The algorithms of the present disclosure may be operable to generate a patient specific tibial tray and robotic cut path of the proximal portion of the tibia that solves the primary failures modes of press-fit tibial knee implants by restoring the pre-operative anatomy and specifically: 1) maximizing the surface area contact for increased osseointegration; 2) reducing shear forces and localizing forces to either side of the intercondylar eminence; 3) maximizing cortical contact at the periphery of the implant; and 4) minimizing subsidence and increasing stability with patient specific support members.
A1. A tibial tray for a resected proximal portion of a tibia of a patient for a total knee replacement. The resected proximal portion of the tibia has a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone spaced apart from the cortical bone exposing an underlying portion of the cancellous bone of the tibia. The tibial tray may include a body having a superior portion with a superior surface, and an inferior tibia-engaging portion. The body may include an inferior tibia-engaging portion having a center portion having a center surface contactable with the center cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity formed in the cancellous bone surface so that the peripheral inferiorly-extending portion is spaced apart from the underlying inner surface of the cortical bone of the tibia of the patient.
A2. The tibial tray of A1, wherein the inferior tibia-engaging portion comprises a peripheral edge portion having an inferior surface supportable on the peripheral cortical bone surface of the tibia of the patient, and the peripheral, inferiorly-extending portion being disposed inwardly of the peripheral edge portion. A3. The tibial tray of A1 or A2, wherein the center surface of the inferior tibia-engaging portion comprises a non-planar surface. A4. The tibial tray of any of A1 through A3, wherein the inferiorly-extending portion of the inferior tibia-engaging portion is extendable around at least 10 percent of a perimeter of the underlying peripheral inner surface of the cortical bone of the tibia of the patient. A5. The tibial tray of any of A1 through A4, wherein the inferior tibia-engaging portion comprises an inferior convex surface, an inferior concave surface, and/or an inferior convex surface and an inferior concave surface. A6. The tibial tray of any of A1 through A5, wherein the inferior tibia-engaging portion comprises a pair of spaced-apart inferior convex surfaces corresponding in size to a medial condyle and a lateral condyle of the proximal portion of the tibia of the patient. A7. The tibial tray of any of A1 through A6, wherein the peripheral, inferiorly-extending portion comprises a wall spaced apart from the inner surface of the cortical bone. A8. The tibial tray of A7, wherein the wall comprises a surface configured to be spaced apart from the underlying inner surface of the cortical bone, is angled at about 35 degrees relative to the superior surface of the superior portion of the body, and extends about 7 mm below the superior surface of the superior portion of the body. A9. The tibial tray of any of A7 or A8, wherein the wall extends along at least 30 percent of a perimeter of the underlying peripheral cancellous bone of the tibia of the patient. A10. The tibial tray of any of A7 through A9, wherein the wall extends along the entire peripheral portion of the body. A11. The tibial tray of any of A1 through A10, wherein the inferiorly-extending portion comprises a pair of curved walls configured to be spaced apart from the inner surface the cortical bone. A12. The tibial tray of any of A1 through A11, wherein the inferiorly-extending portion comprises a pair of curved walls configured to be spaced apart from the inner surface the cortical bone, and the center surface comprises a pair of spaced-apart inferior convex surfaces corresponding in size to a medial condyle and a lateral condyle of the proximal portion of the tibia of the patient. A13. The tibial tray of any of A1 through A12, wherein the peripheral inferiorly-extending portion defines a constant gap between the peripheral inferiorly-extending portion and an inner surface of the cortical bone. A14. The tibial tray of any of A1 through A13, wherein the center portion of the body comprises an inferiorly-extending keel. A15. The tibial tray of any of A1 through A14, wherein the body comprises a one-piece body.
B1. A method for forming a patient specific tibial tray for a total knee replacement of the patient, the method comprising: determining a patient specific resected proximal portion of a tibia of the patient, the resected proximal portion of the tibia of the patient having a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone spaced apart from the cortical bone exposing an underlying portion of the cancellous bone of the tibia; and forming the patient specific tibial tray comprising a body having a superior portion having a superior surface and an inferior tibia-engaging portion, the inferior tibia engaging portion having a center portion contactable with the center cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity so that the peripheral inferiorly-extending portion is spaced apart from the underlying inner surface of the cortical bone of the tibia of the patient.
B2. The method of B1 further comprising, obtaining first data, via a processor, representing a proximal portion of the tibia of the patient, and determining, via the processor, second data corresponding the patient specific resected proximal portion of the tibia of the patient based on the first data, and the forming, via the processor, comprises 3D printing, forging, casting based on the second data. B2. The method of B1, wherein the obtaining first data comprises obtaining CT scan data and/or X-rays, and the determining comprises determining the patient specific resected proximal portion of the tibia of the patient based on the obtained first data. B3. The method of B1 or B2 further comprising, maximizing the size and shape of the inferior tibia-engaging portion based on a depth and an amount extending along the periphery of the underlying cancellous bone. B20. The method of and of B17 through B19 further comprising, reducing shear forces and localized forces based on the implant to bone contact plane based on the equation Fx=F cos(theta).
C1. A tibial tray for a resected proximal portion of a tibia of a patient for a total knee replacement, the resected proximal portion of the tibia having a central cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the periphery of the cancellous bone. The tibial tray comprising a body the body comprising a superior portion with a superior surface; and an inferior tibia-engaging portion. The inferior tibia-engaging portion comprises a center portion having a center surface contactable with the central cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity formed in the cancellous bone surface so that the peripheral inferiorly-extending outer surface portion corresponds to the contour of the underlying inner surface of the cortical bone of the tibia of the patient.
C2. The tibial tray of C1, wherein the peripheral, inferiorly-extending portion comprises at least a portion of the peripheral inferiorly-extending outer surface portion extending from a proximal portion of the peripheral, inferiorly-extending portion to a distal portion of the peripheral, inferiorly-extending portion contoured to correspond to a contour of a superior edge portion of the cortical bone along the resection plane so that the at least the portion of the peripheral inferiorly-extending outer surface portion is disposable adjacent to a underlying concave inner surface of the cortical bone. C3. The tibial tray of C2, wherein the contour of the at least the portion of the peripheral inferiorly-extending outer surface portion from the proximal portion to the distal portion of the peripheral, inferiorly-extending portion is perpendicular to the resection plane. C4. The tibial tray of C1, wherein the peripheral, inferiorly-extending portion comprises at least a portion of the peripheral inferiorly-extending outer surface portion extending from a proximal portion of the peripheral, inferiorly-extending portion to a distal portion of the peripheral, inferiorly-extending portion having a proximal portion contoured to correspond to a contour of a superior edge portion of the cortical bone along the resection plane, and a distal portion contoured to being disposable inwardly from the contour of the superior edge portion of the cortical bone along the resection plane.
D1. A tibial tray for a resected proximal portion of a tibia of a patient for a knee replacement, the resected proximal portion of the tibia having a center cancellous bone surface, a peripheral cortical bone surface, and at least one cavity formed in the cancellous bone exposing at least a portion of an underlying inner surface of the cortical bone. The tibial tray includes a body comprising a superior portion with a superior surface; and an inferior tibia-engaging portion. The inferior tibia-engaging portion comprises a center portion having a center surface contactable with the center cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the at least one cavity formed in the cancellous bone surface, a surface of the peripheral inferiorly-extending portion contactable with the exposed underlying inner surface of the cortical bone of the tibia of the patient.
D2. The tibial tray of D1 wherein the inferior tibia-engaging portion comprises: a peripheral edge portion having an inferior surface supportable on the peripheral cortical bone surface of the tibia of the patient, and the peripheral, inferiorly-extending portion being disposed inwardly of the peripheral edge portion. D3. The tibial tray of D1 wherein the center surface of the inferior tibia-engaging portion comprises a non-planar surface. D4. The tibial tray of D1 wherein the surface of the inferiorly-extending portion of the inferior tibia-engaging portion is contactable with at least 10 percent of a perimeter of the underlying peripheral inner surface of the cortical bone of the tibia of the patient. D5. The tibial tray of D1 wherein the inferior tibia-engaging portion comprises an inferior convex surface, an inferior concave surface, and/or an inferior convex surface and an inferior concave surface. D6. The tibial tray of D1 wherein the inferior tibia-engaging portion comprises a pair of spaced-apart inferior convex surfaces corresponding in size to a medial condyle and a lateral condyle of the proximal portion of the tibia of the patient. D7. The tibial tray of D1 wherein the peripheral, inferiorly-extending portion comprises a wall contactable against the exposed inner surface of the cortical bone. D8. The tibial tray of D7 wherein the wall comprises the surface contactable with the exposed underlying inner surface of the cortical bone and is angled at about 35 degrees relative to the superior surface of the superior portion of the body and extending about 7 mm below the superior surface of the superior portion of the body. D9. The tibial tray of D7 wherein the wall extends along at least 30 percent of a perimeter of the underlying peripheral inner surface of the cortical bone of the tibia of the patient. D10. The tibial tray of D7 wherein the wall extends along the entire center portion of the body. D11. The tibial tray of D1 wherein the inferiorly-extending portion comprises a pair of curved walls contactable against spaced apart portions of the inner surface the cortical bone. D12. The tibial tray of D1 wherein the inferiorly-extending portion comprises a pair of curved walls contactable against spaced apart portions of the inner surface the cortical bone, and the center surface comprises a pair of spaced-apart inferior convex surfaces corresponding in size to a medial condyle and a lateral condyle of the proximal portion of the tibia of the patient. D13. The tibial tray of D1 wherein the inferiorly-extending portion comprises at least one inferiorly-extending pin extendable through an aperture in the inner cortical bone and having an edge alignable with an outer surface of the cortical bone. D14. The tibial tray of D1 wherein the center portion of the body comprises an inferiorly-extending keel. D15. The tibial tray of D1 wherein the body comprises a one-piece body.
E1. A method for forming a patient specific tibial tray for a knee replacement of the patient, the method comprising: determining a patient specific resected proximal portion of a tibia of the patient, the resected proximal portion of the tibia of the patient having a superior center cancellous bone surface, a peripheral cortical bone surface, and one or more cavities and/or openings in the cancellous bone exposing at least a portion of an underlying inner surface of the cortical bone of the tibia; and forming the patient specific tibial tray comprising a body having an superior portion having a superior surface and an inferior tibia-engaging portion, the inferior tibia engaging portion having a center portion contactable with the cancellous bone surface, and a peripheral, inferiorly-extending portion receivable in the one or more cavities and/or openings and having one or more surfaces contactable with the exposed underlying inner surface of the cortical bone of the tibia of the patient.
E2. The method of E1 further comprising obtaining first data, via a processor, representing a proximal portion of the tibia of the patient, and determining, via the processor, second data corresponding the patient specific resected proximal portion of the tibia of the patient based on the first data, and the forming, via the processor, comprises 3D printing, forging, casting based on the second data. E3. The method of E2 wherein the obtaining first data comprises obtaining CT scan data and/or X-rays, and the determining comprises determining the patient specific resected proximal portion of the tibia of the patient based on the obtained first data. E4. The method of E2 further comprising maximizing the one or more surfaces of the inferior tibia-engaging portion based on a depth and an amount of the surface extending along the perimeter of the underlying inner surface portion of the cortical bone. E5. The method of E2 further comprising reducing shear forces and localized forces based on the implant to bone contact plane based on the equation Fx=F cos(theta).
As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present invention without departing from the scope of the invention. The implants and other components of the devices and/or apparatus as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the devices and apparatus may include more or fewer components or features than the embodiments as described and illustrated herein. Accordingly, this detailed description of the currently-preferred embodiments is to be taken as illustrative, as opposed to limiting 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 forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.
The invention has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general apparatus operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.
This application is a bypass continuation of PCT/US2021/033102 (atty. dock. no. 5247.004BWO) filed May 19, 2021, entitled “Customized Tibial Trays, Methods, And Systems For Knee Replacement,” which claims the priority benefit of U.S. Provisional Patent Application No. 63/027,098 (atty. dock. no. 5247.004P3), filed May 19, 2020, entitled “Customized Tibial Trays, Methods, And Systems For Knee Replacement,” which application is hereby incorporated herein by reference in its entirety. This application is a bypass continuation of PCT/US2021/033102 (atty. dock. no. 5247.004BWO) filed May 19, 2021, entitled “Customized Tibial Trays, Methods, And Systems For Knee Replacement,” which was a continuation-in-part application of International Patent Application No. PCT/US2020/020279 filed Feb. 28, 2020, entitled “Customized Tibial Trays, Methods, And Systems For Knee Replacement” and published under the PCT Articles in English as WO 2020/176824 on Sep. 3, 2020 (atty. dock. no. 5247.004AWO), which International application perfects and claims priority benefit of U.S. Provisional Patent Application No. 62/811,855, filed Feb. 28, 2019, entitled “Customized Tibial Trays Contactable With An Underlying Cortical Bone, Methods, And Systems For Knee Replacement” (atty. dock. no. 5247.004P), and which International application perfects and claims priority benefit of U.S. Provisional Patent Application No. 62/879,800, filed Jul. 29, 2019, entitled “Customized Tibial Trays, Methods, And Systems For Knee Replacement” (atty. dock. no. 5247.004P2), and which applications are hereby incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63027098 | May 2020 | US | |
| 62811855 | Feb 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2021/033102 | May 2021 | US |
| Child | 18057404 | US | |
| Parent | PCT/US2020/033102 | May 2021 | US |
| Child | PCT/US2021/033102 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2020/020279 | Feb 2020 | US |
| Child | PCT/US2020/033102 | US |
