(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2018/0153587 A1
`van der Walt et al.
`Jun. 7, 2018
`(43) Pub. Date:
`
`US 20180153587A1
`
`(54)
`
`(71)
`
`(72)
`
`SYSTEMS AND METHODS FOR JOINT
`REPLACEMENT
`
`Applicant: OrthAlign, lnc.. Aliso Viejo. CA (US)
`
`Inventors: Nicholas van der Walt. Laguna Hills.
`CA (US): Santiago P. Borja. Tucson.
`AZ (US)
`
`(21)
`
`App]. No.: 15/794,351
`
`(22)
`
`Filed:
`
`Oct. 26, 2017
`
`Related U.S. Application Data
`
`(60)
`
`Continuation of application No. 15/402.574. filed on
`Jan. 10. 2017. now Pat. No. 9.855.075. which is a
`division oi‘application No. 14/949525. filed on Nov.
`23. 2015. now Pat. No. 9.572.586. which is a contin-
`
`uation of application No. 141570.889. filed on Dec.
`15. 2014. now Pat. No. 9.192.392. which is a contin-
`uation of application No. 12/626162. filed on Nov.
`25. 2009. now Pat. No. 8.911.447. which is a contin-
`uation ofapplication No. 121509.414. filed on Jul. 24.
`2009. now abandoned.
`
`(52)
`
`(57)
`
`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. 611187.632. filed on Jun. 16. 2009.
`provisional application No. 611173.159. filed on Apr.
`27. 2009.
`
`Publication Classification
`
`(51)
`
`Int. (fl.
`
`A613 17/70
`A613 I7/I7
`A613 17/15
`A613 34/20
`A613 34/00
`A613 90/00
`U.S. Cl.
`
`(2006.01)
`(2006.01 )
`(2006.01)
`(2016.01)
`(2016.01)
`(2016.01)
`
`CPC ...... A613 17/7017 (2013.01): A613 [7/] 764
`(2013.01); A613 [7/157 (2013.01); .4613
`2090/067 (2016.02); A613 3400 (2016.02):
`A613 3405 (2016.02); A613 203412048
`(2016.02); A613 17/155 (2013.01)
`
`ABSTRACT
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`(60)
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`Provisional application No. 61/ 102.754. filed on Oct.
`3. 2008. provisional application No. 611135.863. filed
`on Jul. 24. 2008. provisional application No. 611102.
`767. filed on Oct. 3. 2008. provisional application No.
`611155.093. filed on Feb. 24. 2009. provisional appli-
`cation No. 611104.644. filed on Oct. 10. 2008. pro-
`visional application No. 611153.268. filed on Feb. 17.
`2009. provisional application No. 611153.257. 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 of a cutting plane or planes along a bony surface.
`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
`
`
`
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`[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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`is a divisional of U.S. patent application Ser. No. 14/949,
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`525, filed Nov. 23, 2015, which is a continuation from U.S.
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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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`12/626,162, filed Nov. 25, 2009, which is a continuation
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`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
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`U.S. 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
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`
`
`Application No. 61/102,767, filed Oct. 3, 2008, U.S. Pro-
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`
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`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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`filed Apr. 27, 2009, U.S. Provisional Patent Application No.
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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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`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
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`[0002] The present application is directed to systems and
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`methods for joint replacement, in particular to systems and
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`methods for knee joint replacement which utilize a surgical
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`orientation device or devices.
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`Description of the Related Art
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`Joint replacement procedures, including knee joint
`[0003]
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`‘eplacement procedures, are commonly used to replace a
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`oatient’s joint with a prosthetic joint component or compo-
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`1ents. Such procedures often use a system or systems of
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`surgical
`tools and devices,
`including but not limited to
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`cutting guides (e.g. cutting blocks) and surgical guides, to
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`nake surgical cuts along a portion or portions of the
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`oatient’s bone.
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`[0004] Current systems and methods often use expensive,
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`complex, bulky, and/or massive computer navigation sys-
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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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`novement of a surgical
`instrument or landmark in the
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`iuman 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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`Jsed, simple methods are used, such “eyeballing” the align-
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`nent of rods with anatomical features, such as leg bones.
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`These simple methods are not sufi‘iciently 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
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`[0006] Accordingly, there is a lack of devices, systems and
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`methods that can be used to accurately position components
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`of prosthetic joints without overly complicating the proce-
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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.
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`
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`least one embodiment, a
`In accordance with at
`[0007]
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`surgical orientation device for use in a total knee arthro-
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`plasty procedure having an associated three-dimensional
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`coordinate reference system can comprise a portable hous-
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`ing configured to connect to a knee bone by way of one or
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`more orthopedic fixtures, a sensor located within the hous-
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`ing, the sensor configured to monitor the orientation of the
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`housing in the three-dimensional coordinate reference sys-
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`tem, the sensor further configured to generate orientation
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`data corresponding to the monitored orientation of the
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`surgical orientation device, and wherein the sensor com-
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`prises a multi-axis accelerometer. The surgical orientation
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`device can further comprise a display module configured to
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`display one or more angle measurements corresponding to
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`an olfset from a fiexion-extension angle or a varus-valgus
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`angle of a mechanical axis 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 maximize the 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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`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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`ciated three-dimensional coordinate reference system. The
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`device can comprise a portable housing configured to con-
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`nect to a knee bone by way of the orthopedic fixtures, and
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`a sensor located within the housing, the sensor configured to
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`monitor the orientation of the housing in the three-dimen-
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`sional coordinate reference system, the sensor further con-
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`figured to generate orientation data corresponding to the
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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 user of 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 member attach-
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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 at least one probe for referencing a plurality of
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`anatomical landmarks, the anatomical landmarks referenc-
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`ing a mechanical axis of the leg. The at least one adjustment
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`device can be moveable in at least one degree of freedom so
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`as to orient a cutting guide relative 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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`

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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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`images related 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 performing the first 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 images related 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 and an on-screen graphic, displayed in the
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`window and representing one or more orientation measure-
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`ments corresponding to 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
`least one embodiment, a
`[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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`device to orient the orthopedic fixture relative to a mechani-
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`cal axis of the 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 of a 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 orthopedic fixture, 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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`aortable surgical orientation device to orient a cutting guide
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`at an intended orientation relative to a mechanical axis of the
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`eg, and resecting the proximal tibia along the cutting guide
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`0 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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`'mplant, 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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`emur and the tibia in response to a prompt from the portable
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`surgical orientation device to align the femur with the
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`nechanical 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 perpendicular to 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 infomration 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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`FIG. 2A is a perspective view of a tibial preparation
`[0016]
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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 embodiment that 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. 3A is a perspective view of a 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. 3B is a perspective view of a second arrange-
`[0019]
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`ment of the tibial preparation system of FIG. 3A;
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`[0020]
`FIG. 4A is a perspective view of a 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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`ment of the tibial preparation system of FIG. 4A;
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`[0022]
`FIG. Sis 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 view of the surgical orien-
`[0028]
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`tation device of FIG. 7;
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`[0029]
`FIG. 11 is a block diagram of an electrical system
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`of the surgical orientation device of FIG. 7;
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`[0030]
`FIGS. 12A-12C illustrate 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 of interior 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
`
`073
`
`

`

`
`
`US 2018/0153587 Al
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`
`
`
`Jun. 7, 2018
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`FIG. 46 is a top view of the distraction device of
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`F G. 12F is a side view of a left leg of a patient
`[0033]
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`illustrating an orientation reference frame;
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`F G. 13 is a perspective view of a surgical orien-
`[0034]
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`tation device according to another embodiment;
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`[0035]
`F-G. 14 is a perspective view of a coupling device
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`according to one embodiment that can be used to connect the
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`surgical orientation device of FIG. 7 to other components;
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`F-G. 15 is a perspective view an outer housing of
`[0036]
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`the coupling device of FIG. 14;
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`[0037] F'G. 16 is a perspective view of interior compo-
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