throbber
United-States Patent [19]
`Woolson
`
`[11] Patent Number:
`[45] Date of Patent:
`
`4,841,975
`Jun. 27, 1989
`
`[54] PREOPERATIVE PLANNING OF BONE
`CUTS AND JOINT REPLACEMENT USING
`RADIANT ENERGY SCAN IMAGING
`[75] Inventor:
`Steven T. Woolson, Los Altos, Calif.
`[73] Assignee: Cemax, Inc., Santa Clara, Calif.
`[21] Appl. No.: 38,515
`[22] Filed:
`Apr. 15, 1987
`
`[51] Int. Clx‘ .............................................. .. A61B 6/00
`[52] US. Cl. .................................. .. 128/653; 378/205;
`128/303 B
`[58] Field of Search .......... .. 378/205; 128/630, 303 B,
`128/653, 659
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`3,941,127 3/1976 Froning ......................... .. 128/303 B
`4,058,114 11/1977 Soldner .... ..
`.. 128/303 B
`4,360,028 7/1982 Barbier et a1. .
`.... .. 128/659
`
`4,436,684 3/1984 White . . . . . . . . .
`
`. . . . .. 264/138
`
`4,440,168
`4,583,538
`
`128/303 B
`4/1984 Warren
`4/1986 Onik .............................. .. 128/303 B
`
`OTHER PUBLICATIONS
`Rutkow et al., “Orthopaedic Operations in The United
`States”, The Journal of Bone and Joint Surgery, ,vol.
`68-A, #5, 6/86, pp. 716-719.
`Insall et al., “The Total Condylar Knee Prosthesis in
`Gonarthrosis”, The Journal of Bone and Joint Surgery,
`vol. 64-A, #5, 6/83, pp. 619-628.
`Lotke et al., “In?uence of Positioning of Prosthesis in
`Total Knee Replacement”, The Journal of Bone and
`Joint Surgery, vol. 59-A, #1, l/77, pp. 77-79.
`Johnson et al., “The Distribution of Load Across the
`Knee, A Comparison of Static and Dynamic Measure
`ments”, The Journal of Bone and Joint Surgery, vol.
`62-B, #3, 8/80, pp. 346-349.
`
`Corcoran, “Medical Electronics”, IEEE Spectrum,
`1/87, pp. 66-68.
`McDonnell Douglas advertisement, “Breadthrough:
`Computer Graphics that Create Model Patients for
`Surgeons”, Businessweek, 6/ 18/ 84.
`“Machine-Made Body Joints”, Science Digest, 6/ 83.
`Love, “Better Bones”, Forbes, 11/21/83, pp. 314, 316.
`“Hospital for Special Surgery Computer Designs Cus
`tomized Joint Replacements”, Orthopedics Today, vol.
`2, No. 12, 12/83, Pp- 3 & 16.
`Primary Examiner-Ruth S. Smith
`Attorney, Agent, or Firm-Cushman, Darby & Cushman
`[57]
`ABSTRACT
`A method is disclosed for the preoperative planning of
`a total knee replacement. Guide tools having guide
`members which are adjustable for placement on se
`lected positions of the femur and tibia are used for locat
`ing the position of desired bone cuts de?ned by a cut
`ting guide surface existing on the guide member. Se
`lected regions of the femur and tibia are scanned by
`computed tomographic techniques to provide images of
`these regions. The respective centers of the femur head,
`distal femur, proximal tibia and distal tibia, or ankle
`joint are determined. The center points are then used to
`de?ne a mechanical axis relative to which selected cuts
`are to be made corresponding to selected prostheses to
`be implanted. The CT scan representations are used to
`measure the desired location of the guide member cut
`ting surface and the respective locations of guide mem
`bers adjacent selected bone positions. These guide
`members are adjusted relative to the cutting surface
`prior to surgery. This provides for precise placement of
`the guide tools during surgery and the making of accu
`rate and precise bone cuts conforming to the selected
`prostheses.
`
`18 Claims, 4 Drawing Sheets
`
`-1-
`
`Smith & Nephew Ex. 1031
`IPR Petition - USP 7,534,263
`
`

`
`US. Patent Jun. 27, 1989
`
`Sheet 1 of 4
`
`4,841,975
`
`FIG. 2A
`
`FIG. 2B
`
`FIG. 5
`
`-2-
`
`

`
`US. Patent
`Jun. 27, 1989‘
`US. Patent Jun. 27, 1989‘
`
`Sheet 2 of4
`Sheet 2 01'4
`
`4,841,975
`4,841,975
`
`.26
`
`)~44
`
`R
`
`FIG. 3B
`FIG. 3B
`
`28
`
`-3-
`
`
`

`
`US. Patent Jun. 27, 1989
`
`Sheet 3 of 4
`
`4,841,975
`
`58
`
`66
`
`58
`
`,’0 JP 0
`
`{It "3"
`
`.' [64
`
`4B5
`66
`68
`
`FIG. 6B
`
`62
`
`FIG. 6A
`
`-4-
`
`

`
`US. Patent Jun. 27, 1989 '
`
`Sheet 4 0f 4
`
`4,841,975
`
`w
`
`2 Q .
`
`/¢D Jv U|\\.\
`
`C 7% 8 v v 1\
`
`
`
`2.: \ U . .M F v 6 ‘In 1 n .Iwl-
`
`4 8 / 9 9 l/
`
`T 4 6 \ > a 3 7 6
`
`4 UK
`
`¢ 1 B
`
`4 _ .
`
`8 1 b ~U4IJU
`6 I y K v
`
`8 _
`
`4 6 ‘
`_ m 3 A. 7 »%
`
`-‘O| Jl |\
`
`
`
`b !|.I.\\.\ \/
`
`+ 7
`
`\n- ‘l
`
`. | O
`
`FIG. 8A
`
`FIG. 88
`
`-5-
`
`

`
`1
`
`PREOPERATIVE PLANNING OF BONE CUTS
`AND JOINT REPLACEMENT USING RADIANT
`ENERGY SCAN IMAGING
`
`O
`
`4,841,975
`2
`intramedullary system of femoral component align
`ment;
`2. localization of the center of the femoral head by
`external markers after operative radiographs are
`taken, and correct estimation of the center of the
`distal femur for the external alignment system of
`femoral alignment;
`3. visual estimation of the centers of the proximal tibia
`and of the ankle joint in both the coronal and sagittal
`planes for correct tibial component alignment.
`These alignment techniques may produce error from
`the fact that the surgeon must estimate the correct posi
`tion of all bone landmarks and from inaccuracies in the
`preoperative radiographs of the knee joint. Flexion
`contractures of the knee will cause signi?cant errors in
`the tibiofemoral angle (the angle between the femoral
`anatomical and mechanical axes). Medullary systems
`require accurate placement of the entrance hole for the
`alignment rods since the rod does not tightly fit into the
`medullary canal and may be angled into it if the drill
`hole is placed too far medially or laterally. A consider
`able amount of the operative time in total knee replace
`ment surgery is expended in positioning and attaching
`the alignment instruments and in double-checking their
`placement, which is essential since any system may fail
`and have to be overruled by the experienced eye of the
`surgeon.
`The present invention overcomes the inherent inac
`curateness of the presently used systems by combining
`several steps. Selected regions of the body adjacent a
`bone to be resectioned are scanned with radiant energy
`to obtain representations of the regions for de?ning the
`structure of the speci?c bone and adjacent body re
`gions. From the representations, desired positions of a
`cutting guide relative to the bone are determined. Thus.
`by having these specific features of bone structure iden
`ti?ed and used for determining speci?c placement of the
`cutting guide, accurate and precise placement during
`the surgical procedure is provided.
`Control of the guide surface of a cutting guide which
`de?nes the contour of a desired bone cut is assured
`where the cutting guide includes one or more gauge
`members positionable adjacent a selected position on
`the bone and adjustable relative to the guide surface for
`positioning the guide relative to the bone. These spe
`ci?c settings of the gauge members relative to the guide
`surface are determined from the representations of the
`selected body regions adjacent and including the bone
`having a section to be replaced. In the preferred method
`of the present invention, a joint is replaced and the
`replacing prostheses are aligned relative to axes associ
`ated with each joint-forming bone so that the resulting
`prostheses will have a speci?c alignment relative to
`those axes. By determining the position of the gauge
`member relative to the axis, the position of the cutting
`guide surface is established prior to the surgical proce
`dure, with corresponding precise placement of the
`guide during the procedure.
`It should be noted that CT scan information has been
`used in the past relative to prostheses. For example, in
`an article in Volume 97 (June 1979) of Fortschritte der
`Medizin on page 781-784 entitled “Ein neues Verfahren
`zur Herstellung Alloplastischer Spezilimplantate fur
`den Becken-Teilersatz”, a method of preparing alloplas
`tic implants is described in which a three-dimensional
`model of a patient’s pelvis is constructed by assembling
`Styrofoam sheets made from computer tomography
`
`35
`
`BACKGROUND AND SUMMARY OF THE
`INVENTION
`This invention relates to a method for preoperative
`planning of surgery. More particularly, it pertains to a
`method of preoperative planning of a bone cut and joint
`replacement using radiant energy scan imaging to deter
`mine the position of a bone-cut-de?ning guide relative
`to the bone to be cut.
`The preferred method of the present invention is for
`the replacement of a total knee. This includes the re
`moval of bone sections from the distal femur and proxi
`mal tibia for replacement by a knee joint prosthesis
`associated with each of these bones.
`Total knee replacement is a common orthopaedic
`surgical procedure currently performed over 150,000
`times each year in the US The clinical results of many
`operations are excellent with complete relief of pain,
`improvement in function, restoration of motion, and
`correction of deformity in over 90% of the cases. How
`ever, there are a number of cases in which failures occur
`following the knee replacement. One of the most impor
`tant causes for failure of the procedure is from prosthe
`sis component loosening because of unbalanced loading
`of the tibial component caused by improper knee joint
`alignment. Because of this fact, all total knee implanta
`tion systems attempt to align the reconstructed knee
`joint in the mechanical axis in both the coronal and the
`sagittal planes. If achieved, this results in the placement
`of the total knee prostheses in a common mechanical
`axis which correspondingly is highly likely to produce
`a successful long-term result.
`Reproducing the mechanical axis at surgery is pres
`ently done by one of two different techniques, which
`use either the external bone landmarks at the hip and
`ankle joints or the medullary canal of the femur or a
`combination of these two systems for alignment. Knee
`systems which use the center of the femoral head as a
`landmark for orienting the femoral component require
`an operative radiograph of the hip joint to position an
`external marker for alignment of the femoral cutting
`guide. Intramedullary knee systems require a preopera
`tive radiograph of the femur in order to determine the
`angle between the anatomical and the mechanical axes
`of the femur for proper orientation of the femoral cut
`ting guide. These intramedullary systems require the
`surgeon to estimate the placement of a drill hole into the
`distal femur at a central location in the bone for intro
`duction of a small diameter rod into the medullary canal
`to produce the correct component alignment. The prox
`imal tibia is cut perpendicular to the mechanical axis of
`the tibia by adjusting the tibial cutting guide in relation
`to the knee and ankle joints. Both of these techniques
`necessitate intraoperative visual estimation of the loca
`tion of the midpoints of the distal femur, the proximal
`tibia and the ankle joint by the surgeon. The alignment
`of the components in the sagittal plane is also done by
`visual means or the “eyeball” method.
`In summary, with the present total knee instrument
`systems, correct knee alignment involves the following:
`1. preoperative determination of the angle between the
`anatomical and mechanical axes of the femur from
`the radiographs, and appropriate placement of the
`medullary rod entrance hole in the femur for the
`
`45
`
`55
`
`-6-
`
`

`
`3
`?lms. U.S. Pat. No. 4,436,684 assigned to the same as
`signee as this application, describes using information
`obtained from CT scans to drive a sculpting tool to
`make a corporeal model.
`As will be more apparent hereinafter, with the pres
`ent invention a surgeon’s need to do preoperative plan
`ning from plain radiographs is eliminated. Because there
`is no need to determine the placement or adjustment of
`cutting guides at the time of surgery, fewer instruments
`are necessary and the surgical procedure is simpli?ed
`and shortened. Accurate sizing of the prosthesis compo
`nents is possible by measurement of the axial CT scan
`slices at the level of component placement for each
`bone. The vast majority of all important intraoperative
`decisions are decided preoperatively by this intensive
`and precise planning method. The surgeon has to make
`fewer critical judgment calls during surgery and is able
`to eliminate the constant visual monitoring of the align
`ment instrument. Elimination of these steps markedly
`reduces the operative time of the procedure.
`
`5
`
`25
`
`30
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`Referring now to the accompanying four sheets of
`drawings:
`FIG. 1 is a silhouette view of a femur as viewed in the
`coronal plane;
`FIGS. 2A. 2B are silhouette views of a tibia in coro
`nal and sagittal planes, respectively;
`FIGS. 3A, 3B are silhouette views of a femur and a
`tibia, respectively, identifying bone regions scanned for
`obtaining representations of the bones;
`FIG. 4 is a perspective view of an anterior femoral
`cutting guide in place on a distal femur;
`FIG. 5 is a distal end view of the cutting guide of
`FIG. 4;
`35
`FIGS. 6A, 6B are anterior and lateral views, respec
`tively, of-a femur with a distal femoral cutting guide in
`place;
`FIGS. 7A, 7B are a lateral view and a perspective of
`another cutting guide for making ?nal femoral cuts; and
`40
`FIGS. 8A, 8B show anterior and lateral views, re
`spectively, of a proximal tibial cutting guide in position
`adjacent a tibia showing adjustments and placement of
`the cutting guide for use during a knee replacement
`operation performed according to the present inven
`tion.
`
`4,841,975
`4
`patient has not been moved. Thus, it will be appreciated
`that the points, lines and dimensions discussed herein
`may be obtained either in a manual process using repro
`duced selected 2D images, or by identifying those
`points on an appropriate computer system which then
`can relate the speci?c points selected.
`Referring initially to FIGS. 1, 2A and 2B, selected
`positions on the bones of interest, in this case the femur
`and tibia, are identi?ed. In this instance it is important
`that the knee prostheses be positioned on, and for rela
`tive rotation about, an axis perpendicular to the me
`chanical axis of a femur 10 and a'corresponding tibia 12.
`A mechanical axis 14 extends through the midpoint 16
`of the femur head. Axis 14 also extends through mid
`point 18 of the distal femur. During the knee replace
`ment surgical procedure, it will be necessary to resec
`tion the medial and lateral condyles of the distal femur
`by cutting along a line 20 which is perpendicular to axis
`14.
`The proximal end of tibia 12 will be resectioned along
`a cut plane identi?ed by the dashed line 22 in FIG. 2B.
`The line of this cut must be perpendicular, or slightly
`angled as will be discussed subsequently, relative to a
`mechanical axis 24 of the tibia. Axis 24 is de?ned by the
`midpoint 26 of the proximal tibia and the midpoint 28 of
`the ankle joint.
`The mechanical axes of the femur and tibia in two
`planes can be graphically determined by identi?cation
`of the 3D coordinates derived from the CT image data
`by identi?cation of the positions of the midpoints of the
`femoral head, the distal femur, the proximal tibia and
`the ankle joint in the coronal and sagittal planes. Fur
`ther, the 3D spatial location of the most distal projec
`tions of the medial and lateral femoral condyles 30, 32,
`respectively, are found in the coronal plane image, as
`shown in FIG. 1. The distance from each of these points
`to distal femoral out line 20 is also determined. These
`are represented, respectively, by distances A and B.
`This gives the proportions of bone from the medial and
`lateral condyles which are to be resected to produce a
`distal femoral cut along line 20. As will be seen, the
`plane represented by line 20 in FIG. 1 is also perpendic
`ular to the anterior femoral cortex which, in the sagittal
`plane, is parallel with mechanical axis 14. The remain
`der of the femoral bone cuts, as will be described, are
`customized to the speci?c prosthesis, and ligamentous
`balancing of the new knee joint is done in a routine
`manner.
`As will be seen, the tibial cutting guide includes
`gauge members positioned to contact opposite sides of
`the proximal tibia and, with an allowance for skin
`depth, the lateral and medial ankle protusions. More
`speci?cally, tibial mechanical axis 24 in the coronal and
`sagittal planes, as seen in FIGS. 2A, 2B, is graphically
`depicted and the distances from this line are found to
`the medial cortex (distance C) and to the lateral cortex
`(distance D) of the proximal tibia. Also the distance
`from mechanical axis 24 to the skin surface over the
`medial malleolus (distance E) and to the skin surface
`over the lateral malleoulus (distance F) are determined
`for alignment in the coronal plane. Further, from a
`representation of the tibia in the sagittal plane, the dis
`tance from the axis to the anterior cortex of the proxi
`mal tibia where the tibial cutting guide 34 contacts it
`(distance G) and the distance from the axis to the skin
`surface over the anterior aspect of the distal tibia (dis
`tance H) is determined. Further, the distance along axis
`24 from cut line 22 to the position where distance H is
`
`45
`
`DETAILED DESCRIPTION OF THE
`PREFERRED METHOD
`The preferred method of practicing the present in
`vention is based on exact three-dimensional (3D) data of
`the bone anatomy obtained from computed tomography
`(CT) scans of the knee, hip and ankle joints for a total
`knee replacement. Any point on a CT scan slice can be
`located on the x or horizontal axis (coronal plane) and
`on the y or vertical axis (sagittal plane) as seen on a
`two-dimensional (2D) CT image. Speci?c points may
`be located by scaling or measuring relative to a refer
`ence point on the 2D image. Alternatively, such points
`may be simply identified on a CT scan imaging system,
`such as a CEMAX-IOOO or CEMAX-lSOO system avail
`able from CEMAX, Inc. of Santa Clara, Calif. In such
`system, the image generated from CT scan information
`is identi?ed by movement of a cursor to the speci?c
`point of interest. The system then determines the spatial
`or 3D coordinates associated with that point which then
`may be related to any other point selected which re
`sulted from the same scan procedure, so long as the
`
`55
`
`65
`
`-7-
`
`

`
`5
`measured, is also determined. This distance is shown as
`distance I.
`Finally, as will be further described subsequently, the
`position of the base of tibial cutting guide 34 from the
`skin surface over the anterior aspect of the distal tibia
`can be varied to control the angle of cut line 22 with
`respect to axis 24. Thus, a distance J must be determined
`for producing the corresponding selected angle.
`In order to obtain the necessary representations or
`images of the regions of the femur and tibia, and associ
`ated body portions, such as the skin around the ankle,
`suitable CT scans are made. Further, since only selected
`regions need be measured, only those regions need to be
`scanned. The CT scan protocol involves independent
`scans of the femur and of the tibia with the patient
`supine and with the knee joint in extension. The femoral
`scan includes a single centimeter-thick scan through the
`center of the femoral head as identi?ed by region 36 of
`FIG. 3A. With the femur held in position, a single 1
`centimeter-thick scan is made through the distal femur,
`in region 38, through the femoral condyles at the mid
`point of the patella. Then 1.5- or Z-milIimeter-thick
`scans are performed through the distal projections of
`both femoral condyles, shown as region 40, so that the
`most detailed information is of the articular surface of
`25
`the femur.
`The patient is repositioned for the scans of the tibia. A
`single centimeter thick scan through the ankle joint
`(region 42) is made and again, without any patient mo
`tion, the proximal articular surface of the tibia is simi
`larly scanned (region 44).
`When an enhanced computerized imaging system is
`used, a magnetic tape copy of the CT image data is
`made for transfer of the data to the imaging system for
`producing the representations of the selected bones.
`From the spatial coordinates in the coronal plane
`derived from the scans of the femoral head and the
`distal femur, a femoral coronal mechanical axis line 14 is
`mapped out on graph paper as illustrated in FIG. 1.
`Distal femoral out line 20 is drawn perpendicular to
`mechanical axis line 14. Measurements of the distances
`from line 20 to the most distal points 30, 32 on the me
`dial and lateral femoral condyles, respectively, are
`taken from the graph. The relative distances for medial
`and lateral condylar bone resection to create a distal
`femoral cut along line 20 are thus known. This bone cut
`is also made perpendicular to the anterior femoral cor
`tex, and therefore, the distal femoral cut need only be
`planned in the coronal plane.
`Planning of the proximal tibial cut is more complex,
`since the reference points for it must be determined in
`two planes preoperatively. The tibial mechanical axis 24
`in the coronal and sagittal planes is determined from the
`coordinates of the centers of the ankle joint (point 28)
`and of the proximal tibia (point 26). The distances from
`this axis to the medial (distance C) and lateral (distance
`D) cortexes of the proximal tibia and to the skin over
`the medial (distance E) and lateral (distance F) malleo
`lus are used for appropriate positioning of the tibial jig
`or cutting guide 34 in the coronal plane. It will be ap
`preciated that any two of these distances are suf?cient
`to align the tibial jig relative to the axis.
`The direction of the proximal tibial cut in the sagittal
`plane will be dependent upon the particular total knee
`prostheses chosen. This cut may be made perpendicular
`to the sagittal mechanical axis, as is shown in FIG. 2B,
`or inclined posteriorly up to 5 or 10 degrees. The dis
`tance from the skin surface over the distal tibial plafond
`
`4,841,975
`6
`to the distal portion of the tibial cutting guide (distance
`J) determines the amount of posterior inclination of the
`tibial cut.
`Using this preoperative planning method, the surgeon
`is able to determine mechanical axes 14, 24 and dis
`tances A-J. These speci?c bone landmarks and dis
`tances correspond for presetting the cutting guides illus
`trated in FIGS. 4»8, which now will be discussed. It
`will be appreciated that the various cutting guide ad
`justments which need to be made are precisely deter
`mined. The gauge members of the guides are adjusted
`corresponding to the determined distances. Thus. when
`these cutting guides are placed in position adjacent the
`bone to be resectioned, precise positioning and align
`ment are achieved.
`In particular, during a surgical procedure, the ?rst
`femoral bone cut is flush with and parallel to the ante
`rior cortex of the femur as illustrated in FIGS. 4 and 5.
`In these ?gures, the position of an anterior cortex cut
`ting guide 46 is shown positioned on the distal end of a
`femur 10. Guide 46 includes a block member 48 which
`is tacked into position against the distal condyles as
`shown in the ?gures. A cutting-surface-de?ning mem
`ber 50 has a slit 52 which is planar and aligned with the
`underside of a foot 54 positionable on the anterior tibial
`cortex. Thus, a saw 56 cutting through slit 52 makes an
`initial anterior femoral cut flush with the anterior femo
`ral cortex, as shown by the dashed lines in FIG. 4. This
`results in a bone surface which is parallel with the ante
`rior femoral cortex which, as discussed previously, is
`parallel with the mechanical axis of the femur.
`As illustrated in FIGS. 6A and 6B, the distal femur
`condylar cuts are then made using a distal femoral cut
`ting guide 58 placed flat on the anterior femur surface
`just cut and pinned into place. The proportion of the
`medial and lateral femoral condylar bone to be resected
`which was determined by the preoperative planning
`system is used to set this instrument. If, for example, this
`proportion is 2:1, or removal of twice the amount of
`medial femoral condylar bone as lateral femoral condy
`lar bone, and the distal thickness of the femoral prosthe
`sis is 8 mm, then the distal femoral cutting guide gauge
`member 60 is correspondingly adjustably positioned on
`an adjustment post 62 relative to a slit 64 de?ning a cut
`surface contour (corresponding to out line 20). Corre
`spondingly, the lateral femoral condyle cut is deter
`mined by positioning a gauge member 66, which ex
`tends down across the face of the condyle, a distance B
`from slit 64, by adjustment along an adjustment post 68.
`With the bottom surface of cutting guide 58 being pla
`nar and perpendicular to slit 64, a cut, identi?ed by line
`70 in FIG. 6B, results which is perpendicular to me
`chanical axis 14.
`The ?nal anterior, posterior and chamfer cuts on the
`femur are made after the proximal tibial cut has been
`made and a trial test of adequate bone resection has been
`made with the knee in extension using trial spacers, as is
`conventionally done. The ?nal distal femoral cuts are
`made with a single conventional cutting guide 72 which
`is ?xed in position on femur 10 by pins which are placed
`in holes drilled in the end of the femur which corre
`spond to the pegs in the actual femoral prosthesis, as
`represented by the use of a drill 74. The resulting cuts
`by saw 56 are illustrated in FIG. 7A.
`FIGS. 8A, 8B illustrate the positioning of tibial cut
`ting guide 34 relative to tibia 12. Cutting guide 34 in
`cludes a telescoping shaft, parallel with axis 24 as
`viewed in FIG. 8A, consisting of a base member 76, an
`
`55
`
`65
`
`35
`
`45
`
`-8-
`
`

`
`4,841,975
`
`0
`
`7
`intermediate shaft member 78, and a cut-positioning
`member 80. Each of these three members are adjustable
`relative to the other, as shown. Intermediate member 78
`includes a brace 82 which contacts the anterior cortex
`of the proximal tibia. This position corresponds with the
`location for measuring distance G described with refer
`ence to FIG. 2B. Further, cut-positioning member 80
`has a cross-arm 84 with a slit 86 de?ning the proximal
`tibial cut. Cross-arm 84 includes laterally extending
`adjustment bars 88, 90 to which are adjustably attached
`corresponding gauge members 92 and 94, respectively.
`These gauge members are positioned relative to shaft
`member 80 in accordance with dimensions C and D, as
`described previously. At the end of base shaft member
`76 opposite from intermediate shaft member 78 is a plate
`96 which is adjustable relative to shaft member 76 for
`varying the distance of the associated end 760 of the
`base shaft member from the skin surface over the ante
`rior aspect of the distal tibia, as discussed previously.
`End 76a is also referred to herein as a gauge member.
`Thus, plate 96 is adjustable for positioning the end 760
`a distance J from the skin surface.
`Mounted on base shaft member 76 adjacent end 760 is
`a lateral adjustment bar 98 which extends to each side of
`shaft member 76, as shown in FIG. 8A. Each end of bar
`98 has an ankle‘ joint gauge member. A gauge member
`100 is positioned a distance E for placement on the skin
`over the medial malleolus. The other gauge member 102
`is positioned a distance F from the longitudinal axis of
`shaft member 76 for placement on the skin over the
`lateral malleolus. Thus, the adjustments of the various
`gauge members as well as the length of the shaft mem
`bers result in cutting slit 86 being aligned perpendicular
`to mechanical axis 24. Thus, cutting guide 34 is aligned
`precisely relative to the tibia.
`The p_osterior inclination of the tibial bone cut is
`determined by the design requirements of the particular
`prosthesis. Adjustable plate 96 on shaft end 76a, as has
`been discussed, is set at a distance which will result in
`the desired posterior inclination of the angle of proximal
`tibial bone cut de?ned by slit 86. It is suf?cient, to align
`tibial out line 22 below the most de?cient tibial plateau
`as determined by the CT scan representations. Cutting
`guide 34 is then stabilized in the proximal tibia by pins
`45
`shown in dashed lines in brace 82. The bone cut is made
`along out line 22 by passing a saw 56 through slit 86.
`The posterior cruciate ligament may be removed or
`spared according to the surgeon‘s preference. After
`making the tibial and the distal femoral bone cuts, a trial
`tibial component and trial femoral spacer is inserted into
`the joint space to test the adequacy of bone resection
`with the knee in extension, as is conventionally done. If
`this space is inadequate, further resection of the distal
`femur is possible before the remaining femoral bone cuts
`are made.
`The remainder of the surgical procedure is carried
`out as usual. The patella is prepared, trial components
`are inserted, and soft-tissue balancing is done by varying
`the thickness of the tibial component or by ligamentous
`release procedures. The actual prostheses are selected
`and implanted.
`It is seen that this preoperative CT planning method
`produces distal femoral and proximal tibial bone cuts
`which are perpendicular to the coronal mechanical axis
`without intraoperative localization of the femoral head
`or other external bone landmarks. Positioning of align
`ment instruments in relation to the-hip joint or femoral
`
`40
`
`8
`medullary canal at surgery is not needed, since all land
`marks for these bone cuts are at the knee and ankle joint.
`The above discussion is directed speci?cally to a
`preferred method of practicing the invention. However,
`it will be appreciated that the method has general appli
`cability to any bone resectioning in which the bone cuts
`are de?ned by a cutting guide surface of a guide mem
`ber placeable adjacent the bone for guiding the resec
`tioning. Thus, while a preferred method of practicing
`the invention has been described, it will be understood
`by those skilled in the art that various changes may be
`made without departing from the spirit and scope of the
`invention as de?ned by the claims and their equivalents.
`What is claimed is:
`1. A method of preoperative planning of surgical cuts
`of a selected bone in a body using a cutting guide having
`a guide surface de?ning the contour of a desired bone
`cut and a gauge member having a predetermined posi
`tion relative to the guide surface and positionable adja
`cent a selected postion on the bone, comprising:
`selecting regions of the body in which the selected
`bone is located to be used in determining a desired
`positioning of the cutting guide relative to the bone
`during cutting;
`subjecting the selected body regions to radiant en~
`ergy to produce radiant energy responses that are
`characteristic of the body and the selected bone
`and are detectable externally of the body;
`detecting produced radiant energy responses to ob
`tain representations of the selected body regions,
`including representations of the corresponding
`regions of the individual bone; and
`determining from the representations a selected posi
`tion of the gauge member relative to the bone so
`that when the gauge member is placed adjacent the
`selected position on the bone, the guide surface is in
`the selected position relative to the bone.
`2. A method according to claim 1 wherein the gauge
`member is adjustable relative to the guide surface for
`positioning the guide surface relative to the bone, said
`determining from the representations further including
`adjusting the gauge member relative to the bone so that
`when the gauge member is placed adjacent the selected
`position on the bone, the guide surface is in the selected
`position relative to the bone;
`said method further including adjusting the position
`of the gauge member relative to the guide surface
`corresponding to the determined position so that
`the guide surface is in the selected position when
`the cutting guide is placed adjacent the bone.
`3. A method according to claim 2 usable when a
`surgical cut is desired having a selected orientation
`relative to a de?nable axis associated with the bone and
`the cutting guide has a plurality of gauge members;
`said selecting including selecting regions of the bone
`relative to which the position of the axis can be
`determined;
`said determining further including determining the
`desired positions of the gauge members relative to
`the bone appropriate for positioning the guide sur
`face in the desired position relative to the axis; and
`said adjusting including adjusting the position of the
`gauge members relative to the guide surfaces cor
`responding to the determined positions so that the
`guide surfaces are positioned relative to the axis
`when positioned with the gauge members adjacent
`the bone.
`
`-9-
`
`

`
`4,841,975
`4. A method according to claim 3 which further in
`cludes producing three-dimensional coordinates corre
`sponding to portions of th

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket