as) United States
`a2) Patent Application Publication (0) Pub. No.: US 2018/0153587 Al
`(43) Pub. Date:
`Jun. 7, 2018
`van der Walt et al.
`
`US 20180153587A1
`
`(54)
`
`SYSTEMS AND METHODS FOR JOINT
`REPLACEMENT
`
`(71)
`
`Applicant: OrthAlign, Inc., Aliso Viejo, CA (US)
`
`(72)
`
`Inventors: Nicholas van der Walt, Laguna Hills,
`CA (US); Santiago P. Borja, Tucson,
`AZ (US)
`
`(21)
`
`Appl. No.: 15/794,351
`
`(22)
`
`Filed:
`
`Oct. 26, 2017
`
`on Feb. 17, 2009,provisional application No. 61/153,
`255, filed on Feb. 17, 2009, provisional application
`No. 61/173,158, filed on Apr. 27, 2009, provisional
`application No. 61/187,632, filed on Jun. 16, 2009,
`provisional application No. 61/173,159, filed on Apr.
`27, 2009.
`
`Publication Classification
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2016.01)
`(2016.01)
`(2016.01)
`
`Int. Cl.
`A6IB 17/70
`A6IB 17/17
`A6IB 17/15
`A6IB 34/20
`A61B 34/00
`A61B 90/00
`US. Cl.
`CPC ...... A6IB 17/7017 (2013.01); A6IB 17/1764
`(2013.01); A6IB 17/157 (2013.01); A6IB
`2090/067 (2016.02); A6IB 34/20 (2016.02);
`AG61B 34/25 (2016.02); A61B 2034/2048
`(2016.02); A6IB 17/155 (2013.01)
`
`ABSTRACT
`
`(51)
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`(52)
`
`(57)
`
`Related U.S. Application Data
`
`Continuation ofapplication No. 15/402,574, filed on
`Jan. 10, 2017, now Pat. No. 9.855.075, which is a
`division ofapplication No. 14/949,525, filed on Nov.
`23, 2015, now Pat. No. 9,572,586, whichis a contin-
`uation of application No. 14/570,889, filed on Dec.
`15, 2014, now Pat. No. 9.192.392, whichis a contin-
`uation of application No. 12/626,162, filed on Nov.
`25, 2009, now Pat. No. 8,911,447, whichis a contin-
`uationofapplication No. 12/509,414,filed on Jul. 24,
`2009, now abandoned.
`
`(60)
`
`(60)
`
`Provisional application No. 61/102,754,filed on Oct.
`3, 2008,provisional application No. 61/135,863, filed
`on Jul. 24, 2008, provisional application No. 61/102,
`767, filed on Oct. 3, 2008, provisional application No.
`61/155,093,filed on Feb. 24, 2009, provisional appli-
`cation No. 61/104,644, filed on Oct. 10, 2008, pro-
`visional application No. 61/153,268,filed on Feb. 17,
`2009, provisional application No. 61/153,257, filed
`
`Systems and methods for joint replacement are provided.
`The systems and methods include a surgical orientation
`device and at
`least one orthopedic fixture. The surgical
`orientation device and orthopedic fixtures can be used to
`locate the orientation of an axis in the body,
`to adjust an
`orientation ofa cutting plane or planes along a bonysurface,
`to distract a joint, or to otherwise assist in an orthopedic
`procedure or procedures.
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`

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`SYSTEMS AND METHODS FOR JOINT
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`REPLACEMENT
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`CROSS-REFERENCE TO RELATED
`
`
`
`APPLICATIONS
`
`
`[0001] This application is a continuation from U'S. patent
`
`
`
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`
`
`
`
`
`application Ser. No. 15/402,574, filed Jan. 10, 2017, which
`
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`
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`is a divisional of U.S. patent application Ser. No. 14/949,
`
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`
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`525, filed Nov. 23, 2015, which is a continuation from USS.
`
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`
`
`patent application Ser. No. 14/570,889, filed Dec. 15, 2014,
`
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`
`
`
`
`
`which is a continuation from U.S. patent application Ser. No.
`
`
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`
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`
`
`
`12/626,162, filed Nov. 25, 2009, which is a continuation
`
`
`
`
`
`
`
`
`
`from U.S. patent application Ser. No. 12/509,414, filed Jul.
`
`
`
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`
`
`
`
`24, 2009, which claims benefit under 35 U.S.C. § 119(e) to
`
`
`
`
`
`
`
`
`
`
`
`USS. Provisional Patent Application No. 61/102,754, filed
`
`
`
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`
`
`
`Oct. 3, 2008, U.S. Provisional Patent Application No.
`
`
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`
`
`
`
`
`61/135,863, filed Jul. 24, 2008, U.S. Provisional Patent
`
`
`
`
`
`
`
`
`Application No. 61/102,767, filed Oct. 3, 2008, U.S. Pro-
`
`
`
`
`
`
`
`
`visional Patent Application No. 61/155,093, filed Feb. 24,
`
`
`
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`
`
`2009, U.S. Provisional Patent Application No. 61/104,644,
`
`
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`
`
`filed Oct. 10, 2008, U.S. Provisional Patent Application No.
`
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`61/153,268, filed Feb. 17, 2009, U.S. Provisional Patent
`
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`
`
`
`Application No. 61/153,257, filed Feb. 17, 2009, U.S. Pro-
`
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`
`
`
`visional Patent Application No. 61/153,255, filed Feb. 17,
`
`
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`
`2009, U.S. Provisional Patent Application No. 61/173,158,
`
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`
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`
`
`filed Apr. 27, 2009, U.S. Provisional Patent Application No.
`
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`
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`61/187,632, filed Jun. 16, 2009, and U.S. Provisional Patent
`
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`
`
`
`
`
`Application No. 61/173,159, filed Apr. 27, 2009, each of
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`
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`
`
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`which is incorporated in its entirety by reference herein.
`
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`
`
`BACKGROUND OF THE INVENTIONS
`
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`
`
`Field of the Inventions
`
`
`
`
`[0002] The present application is directed to systems and
`
`
`
`
`
`
`
`
`
`methods for joint replacement, in particular to systems and
`
`
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`
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`
`
`
`
`methods for knee joint replacement which utilize a surgical
`
`
`
`
`
`
`
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`orientation device or devices.
`
`
`
`
`
`
`
`Description of the Related Art
`
`
`
`
`
`Joint replacement procedures, including knee joint
`[0003]
`
`
`
`
`
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`replacement procedures, are commonly used to replace a
`
`
`
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`
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`patient’s joint with a prosthetic joint component or compo-
`
`
`
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`
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`nents. Such procedures often use a system or systems of
`
`
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`
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`surgical
`tools and devices,
`including but not limited to
`
`
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`
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`cutting guides (e.g. cutting blocks) and surgical guides, to
`
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`make surgical cuts along a portion or portions of the
`
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`patient’s bone.
`
`
`[0004] Current systems and methods often use expensive,
`
`
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`
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`
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`complex, bulky, and/or massive computer navigation sys-
`
`
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`
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`ems which require a computer or computers, as well as
`
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`hree dimensional imaging,to track a spatial location and/or
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`movement of a surgical
`instrument or landmark in the
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`human body. These systems are used generally to assist a
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`user to determine where in space a tool or landmark is
`
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`ocated, and often require extensive training, cost, and room.
`
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`[0005] Where such complex and costly system are not
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`
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`used, simple methods are used, such “eyeballing”the align-
`
`
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`
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`ment of rods with anatomical features, such as leg bones.
`
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`These simple methods are not sufficiently accurate to reli-
`
`
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`ably align and place implant components and the bones to
`
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`which such components are attached.
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`SUMMARY OF THE INVENTIONS
`
`
`
`
`[0006] Accordingly, there is a lack of devices, systems and
`
`
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`
`
`
`methods that can be used to accurately position components
`
`
`
`
`
`
`
`
`
`of prosthetic joints without overly complicating the proce-
`
`
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`
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`dures, crowding the medical personnel, and/or burdening the
`
`
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`
`
`
`
`
`physician of health-care facility with the great cost of
`
`
`
`
`
`
`
`
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`complex navigation systems.
`
`
`
`least one embodiment, a
`In accordance with at
`[0007]
`
`
`
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`
`
`
`
`surgical orientation device for use in a total knee arthro-
`
`
`
`
`
`
`
`
`
`plasty procedure having an associated three-dimensional
`
`
`
`
`
`coordinate reference system can comprise a portable hous-
`
`
`
`
`
`
`
`ing configured to connect to a knee bone by wayof one or
`
`
`
`
`
`
`
`
`
`
`
`
`more orthopedic fixtures, a sensor located within the hous-
`
`
`
`
`
`
`
`
`ing, the sensor configured to monitor the orientation of the
`
`
`
`
`
`
`
`
`
`
`housing in the three-dimensional coordinate reference sys-
`
`
`
`
`
`
`tem, the sensor further configured to generate orientation
`
`
`
`
`
`
`
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`data corresponding to the monitored orientation of the
`
`
`
`
`
`
`
`
`surgical orientation device, and wherein the sensor com-
`
`
`
`
`
`
`
`prises a multi-axis accelerometer. The surgical orientation
`
`
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`
`
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`device can further comprise a display module configured to
`
`
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`
`
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`display one or more angle measurements corresponding to
`
`
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`
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`an offset from a flexion-extension angle or a varus-valgus
`
`
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`
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`angle of a mechanicalaxis of the knee joint, and wherein the
`
`
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`sensor can be oriented relative to the housing at an acute
`
`
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`angle to maximizethe sensitivity of the sensor when coupled
`
`
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`to a tibia or a femur.
`
`
`
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`
`[0008]
`In accordance with another embodiment, an ortho-
`
`
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`
`
`
`pedic orientation system for use in a joint procedure can
`
`
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`comprise an orthopedic fixture adapted to be coupled with a
`
`
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`
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`knee bone and to be adjustable in multiple degrees of
`
`
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`freedom, and a surgical orientation device having an asso-
`
`
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`
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`ciated three-dimensional coordinate reference system. The
`
`
`
`
`
`device can comprise a portable housing configured to con-
`
`
`
`
`
`
`
`
`nect to a knee bone by wayofthe orthopedic fixtures, and
`
`
`
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`
`
`a sensor located within the housing, the sensor configuredto
`
`
`
`
`
`
`
`
`
`
`monitor the orientation of the housing in the three-dimen-
`
`
`
`
`
`
`
`
`sional coordinate reference system, the sensor further con-
`
`
`
`
`
`
`
`figured to generate orientation data corresponding to the
`
`
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`
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`monitored orientation of the surgical orientation device. The
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`surgical orientation device can further comprise an output
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`device configured to inform a userof the orientation of the
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`device relative to a reference plane corresponding to a
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`mechanical axis of the joint, and wherein the sensor can be
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`configured for optimum sensitivity in the range of motion of
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`the orthopedic fixture.
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`[0009]
`In accordance with at least one embodiment, an
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`orthopedic system for orienting a cutting plane during a joint
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`replacement procedure can comprise a base memberattach-
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`able to an anterior face of a tibia, at least one adjustment
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`device connected to and moveable relative to the base
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`member, and atleast one probe for referencing a plurality of
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`anatomical landmarks, the anatomical landmarks referenc-
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`ing a mechanicalaxis of the leg. The at least one adjustment
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`device can be moveablein at least one degree of freedom so
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`as to orient a cutting guiderelative to a proximal feature of
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`the tibia, such that the cutting guide is oriented at a selected
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`angle relative to the mechanical axis.
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`[0010]
`In accordance with at least one embodiment, an
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`interactive user interface for aiding a user in performing an
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`orthopedic procedure can be provided, wherein the user
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`interface is displayed on a display associated with a surgical
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`orientation device configured to monitor the orientation of
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`the surgical orientation device in a three-dimensional coor-
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`dinate reference system and wherein the user interface is
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`072
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`072
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`US 2018/0153587 Al
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`Jun. 7, 2018
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`configured to perform acts comprising showing the user
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`steps to be performed in the identified orthopedic procedure
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`and guiding the user in performance of the steps. Guiding
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`the user can comprise displaying one or more instructive
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`imagesrelated to a first step to be performed in the identified
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`orthopedic procedure, prompting the user to press a user
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`input after performingthefirst step of the identified ortho-
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`pedic procedure, receiving a confirmation from the user that
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`the first step of the identified procedure has been performed,
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`and displaying one or more instructive imagesrelated to the
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`second step to be performed in the identified orthopedic
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`procedure.
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`In accordance with another embodiment, a moni-
`(0011]
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`toring system can be provided for monitoring an orientation
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`of a surgical orientation device having an associated three-
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`dimensional coordinate reference system during an ortho-
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`pedic procedure,the orientation system comprising a display
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`having a window andan on-screen graphic, displayed in the
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`window and representing one or more orientation measure-
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`ments correspondingto an orientation of the surgical orien-
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`tation device about one or more axes of the three-dimen-
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`sional coordinate reference system,
`the one or more
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`orientation measurements generated by a processor.
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`In accordance with at
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`[0012]
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`method for preparing a proximal portion of a tibia for
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`receiving a knee implant can comprise coupling an ortho-
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`pedic fixture with a proximal feature of the patient’s leg,
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`connecting a portable surgical orientation device to an
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`adjustment device that is connected to the orthopedic fixture
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`and moveable relative to the leg, moving the adjustment
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`device to move the portable surgical orientation device in
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`response to a prompt from the portable surgical orientation
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`deviceto orient the orthopedic fixture relative to a mechani-
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`cal axis ofthe leg.
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`[0013]
`In accordance with another embodiment, a method
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`for performing total knee arthroplasty on a knee joint of a
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`patient can comprise preparing a proximal portion ofa tibia
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`for receiving a knee implant, including coupling an ortho-
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`pedic fixture with a proximal portion of the patient’s tibia,
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`connecting a portable surgical orientation device to a move-
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`able portion of the orthopedicfixture, moving the moveable
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`portion of the orthopedic fixture to move the portable
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`surgical orientation device in response to a prompt from the
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`portable surgical orientation device to orient a cutting guide
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`at an intendedorientation relative to a mechanicalaxis of the
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`eg, and resecting the proximal tibia along the cutting guide
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`o define a tibial plateau. The method can further comprise
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`preparing a distal portion of a femur for receiving a knee
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`implant, including coupling an orthopedic fixture and the
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`portable surgical orientation device with an anterior surface
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`of a distal portion of the femur, moving at least one of the
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`emurandthetibia in response to a promptfromthe portable
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`surgical orientation device to align the femur with the
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`mechanical axis of the leg, securing a cutting guide with an
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`anterior feature of the femur such that the guide is substan-
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`ially perpendicularto the mechanical axis, and resecting the
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`distal femur.
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`[0014]
`In accordance with another embodiment, a method
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`of performing an orthopedic procedure can comprise cou-
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`pling an orthopedic fixture and the portable surgical orien-
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`tation device with a distal portion of a limb that comprises
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`a portion of a ball-and-socket joint, the portable surgical
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`orientation device including a housing enclosing a sensor
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`and a microprocessor. The method can further comprise
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`activating the sensor within the portable surgical orientation
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`device, such that the sensor outputs a signal indicative of
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`orientation, collecting positional information of the portable
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`surgical orientation device; and determining the location of
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`the mechanical axis of the limb based on the positional
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`information collected.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`FIG. 1 shows a representation of a human leg,
`[0015]
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`identifying the femoral head, knee joint, femur, tibia, and
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`ankle;
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`[0016] FIG.2A isa perspective view ofa tibial preparation
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`system according to one embodiment that can be used in
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`connection with preparation of an aspect of a knee joint
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`during a knee joint replacement procedure;
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`FIG. 2B is a perspective view of another tibial
`[0017]
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`preparation system according to one embodimentthat can be
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`used in connection with preparation of an aspect of a knee
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`joint during a knee joint replacement procedure;
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`[0018]
`FIG. 3Aisa perspective view ofa first arrangement
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`of another tibial preparation system according to one
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`embodimentthat can be used in connection with preparation
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`of an aspect of a knee joint during a knee joint replacement
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`procedure;
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`FIG. 3B is a perspective view of a second arrange-
`[0019]
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`ment of the tibial preparation system of FIG. 3.A;
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`[0020]
`FIG. 4A is a perspective view ofa first arrangement
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`of another tibial preparation system according to one
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`embodiment that can be used in connection with preparation
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`of an aspect of a knee joint during a knee joint replacement
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`procedure;
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`FIG. 4B is a perspective view of a second arrange-
`[0021]
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`mentofthe tibial preparation system of FIG. 4A;
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`[0022]
`FIG. 51s a perspective view of femoral preparation
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`system according to one embodiment that can be used in
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`connection with preparation of an aspect of a knee joint
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`during a knee joint replacement procedure;
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`FIG. 6 is a perspective view of a femoral prepara-
`[0023]
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`tion and knee distraction system according to one embodi-
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`ment that can be used in connection with preparation of an
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`aspect of a knee joint during a knee joint replacement
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`procedure;
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`FIG. 7 is a perspective view of a surgical orienta-
`[0024]
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`tion device according to one embodiment that can be used
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`for orienting a resection plane or planes;
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`[0025]
`FIG. 8 is a back view of the surgical orientation
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`device of FIG.7;
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`FIG. 9 is a perspective view of the surgical orien-
`[0026]
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`tation device of FIG, 7;
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`[0027]
`FIG. 10A is a top view of the surgical orientation
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`device of FIG.7;
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`FIG. 10B is a bottom viewof the surgical orien-
`[0028]
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`tation device of FIG. 7;
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`[0029]
`FIG. 11 is a block diagram ofan electrical system
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`of the surgical orientation device of FIG. 7;
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`[0030]
`FIGS. 12A-12Cillustrate operation of accelerom-
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`eters according to embodiments that can be used as sensors
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`in the electrical system of FIG. 11;
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`[0031]
`FIG. 12D is a perspective view ofinterior compo-
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`nents of the surgical orientation device of FIG. 7;
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`[0032]
`FIG. 12E is a flow chart of an embodiment of an
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`orientation measurement process performed by the surgical
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`orientation device of FIG. 7;
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`073
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`073
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`

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`US 2018/0153587 Al
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`Jun. 7, 2018
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`074
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`[0033] FIG. 12F is a side view ofaleft leg of a patient [0057] FIG. 38 is a perspective view of the tibial prepa-
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`illustrating an orientation reference frame;
`ration system of FIG. 4B during a knee joint replacement
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`procedure;
`FIG. 13 is a perspective view of a surgical orien-
`[0034]
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`tation device according to another embodiment;
`FIG. 39 is a perspective view of a the second
`[0058]
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`[0035]
`FIG. 14 is a perspective viewof a coupling device
`arrangement of the tibial preparation system of FIG. 4B
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`according to one embodimentthat can