United States Patent [19]
`Luckman
`
`I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US005520695A
`[11] Patent Number:
`[ 45] Date of Patent:
`
`5,520,695
`May 28, 1996
`
`INSTRUMENTS FOR USE IN KNEE
`REPLACEMENT SURGERY
`
`Zimmer Intramedullary Knee Instrumentation for the Miller/
`Galante Total Knee System, Zimmer Inc.
`
`[54]
`
`[75]
`
`Inventor: Thomas Luckman, East Falmouth,
`Mass.
`
`[73] Assignee: Johnson & Johnson Professional, Inc.,
`Raynham, Mass.
`
`[21] Appl. No.: 242,945
`
`[22] Filed:
`
`May 16, 1994
`
`Related U.S. Application Data
`
`[62] Division of Ser. No. 837,306, Feb. 14, 1992, abandoned.
`Int. Cl.6
`..................................................... A61B 17156
`[51]
`[52] U.S. CI . ................................. 606/88; 606179; 606/82;
`606196
`[58] Field of Search ........................... 606179, 82, 86-90,
`606196; 128/898
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,787,383 11/1988 Kenna ....................................... 606/88
`5/1992 Poggie et al .............................. 606190
`5,116,338
`6/1992 Bert et al .............................. 606/87 X
`5,122,144
`4/1994 Caspari et al ......................... 606/88 X
`5,304,181
`5/1994 Goodfellow et al .................. 606/88 X
`5,314,482
`
`FOREIGN PATENT DOCUMENTS
`
`0104732
`
`4/1984 European Pat. Off .................. 606/88
`
`OTHER PUBLICATIONS
`
`New Jersey Tricompartmental Total Knee System, Surgical
`Procedure by Frederick Buechel, DePuy, 606/88 1984 .
`Knee Replacement Using the Insall/Burstein Total Knee
`Condyla Knee System, Insall & Burstein, N. Y. Society for
`RRC.
`
`Primary Examiner-Mickey Yu
`Assistant Examiner-Brian E. Hanlon
`Attorney, Agent, or Firm-Joseph F. Shirtz
`
`[57]
`
`ABSTRACT
`
`The present invention relates to an instrument and method
`for performing a partial knee replacement and, in particular,
`a single condyle replacement method. The instrument
`includes a tibial mounted platform which has formed
`thereon a keyed slot for receiving a spacer which spacer is
`positioned between the femur and tibia of the knee joint
`being replaced. The spacer receives thereon a positioning
`element which positioning element includes guides for guid(cid:173)
`ing a drill to drill mounting holes for mounting further
`instruments used in the knee operation. In particular, the
`mounting holes are drilled when the femur and tibia are in
`a predetermined angular relationship with the spacer pro(cid:173)
`viding a predetermined spacial relationship. In this way, the
`mounting holes are properly determined and positioned with
`respect to the relationship between the femur and tibia. A
`saw guide is mounted to the mounting holes and used to
`guide a saw when cutting the anterior chamfer, the posterior
`chamfer and the posterior femoral cut. A further drill guide
`is then mounted to the mounting holes after removal of the
`saw guide for drilling holes for receiving the lugs of the
`condyle prosthesis.
`
`3 Claims, 7 Drawing Sheets
`
`-1-
`
`Smith & Nephew Ex. 1089
`IPR Petition - USP 7,534,263
`
`

`
`May 28, 1996
`
`U.S. Patent
`FIG. 1
`
`Sheet 1of7
`
`5,520,695
`
`I
`
`3
`
`5
`
`6
`' I
`
`-2-
`
`

`
`U.S. Patent
`
`May 28, 1996
`
`Sheet 2 of 7
`
`5,520,695
`
`FIG. 2
`
`2
`
`4
`
`FIG. 3
`
`13
`
`2
`
`-3-
`
`

`
`U.S. Patent
`
`May 28, 1996
`
`Sheet 3 of 7
`
`5,520,695
`
`FIG. 4
`
`8
`
`4
`
`FIG. 5
`
`2
`
`-4-
`
`

`
`U.S. Patent
`U.S. Patent
`
`May 28, 1996
`May 28, 1996
`
`Sheet 4 of 7
`Sheet 4 of 7
`
`(
`
`5,520,695
`5,520,695
`
`FIG. 6
`FIG. 6
`
`27
`
`4
`
`23
`23
`
`4”?’
`
`-
`
`25
`
`
`
`1.,-
`
`2
`
`‘
`
`-+-
`24---
`20
`». K
`K
`23 21
`210
`22 21
` ' 1
`a.=:::::::::::::=:=9 2______________+_+__H_
`\ \ \\\\
`
`18
`r
`\\\\\\\\\\
`’5““" Q
`//
`~l
`\
`\
`
`19
`
`17
`17
`
`14
`14
`
`12
`
`5
`
`\
`1
`1\
`
`'
`
`“
`
`‘
`
`13
`13
`
`\\\‘
`
`1.
`
`I
`
`I
`
`-5-
`
`

`
`U.S. Patent
`U.S. Patent
`
`May 28, 1996
`May 28, 1996
`
`Sheet 5 of 7
`Sheet 5 of 7
`
`5,520,695
`5,520,695
`
`FIG. 7
`FIG. 7
`
`1
`
`I
`I
`
`I
`
`....--..-.. / (/
`
`2
`
`-6-
`
`

`
`U.S. Patent
`
`May 28, 1996
`
`Sheet 6 of 7
`
`5,520,695
`
`FIG. 8
`
`33-, I y
`
`I
`
`4
`
`1
`
`FIG. 9
`
`28
`
`34 __ >-.,"'·
`
`-7-
`
`

`
`U.S. Patent
`
`May 28, 1996
`
`Sheet 7 of 7
`,
`
`5,520,695
`
`FIG. 10
`
`2
`
`FIG. 11
`
`38
`
`39
`
`I
`I
`I
`I
`
`I ' 40
`
`-8-
`
`

`
`5,520,695
`
`1
`INSTRUMENTS FOR USE IN KNEE
`REPLACEMENT SURGERY
`
`This is a division of application Ser. No. 07/837,306 filed
`Feb. 14, 1992, now abandoned which is hereby incorporated 5
`by reference.
`
`2
`U.S. Pat. No. 4,722,330 entitled, "Femoral Surface Shap(cid:173)
`ing Guide for Knee Implants" describes a guide for mount(cid:173)
`ing on an intermedullary alignment guide which references
`the central long axis of the femur in shaping the distal
`femoral surface and a method for shaping the distal femur
`using the shaping guide.
`U.S. Pat. No. 4,892,093 entitled, "Femoral Cutting
`Guide" describes a cutting guide which is used for guiding
`a saw blade during the preparation of a femur for the implant
`of the femoral component of a knee prosthesis. The guide
`includes guide surfaces for enabling the cutting of all four of
`the anterial femoral cut, the posterial femoral cut, the
`anterior chamfer and the posterior chamfer, while the cutting
`guide remains located and secured to the femur in a single
`15 position.
`U.S. Pat. No. 4,926,847 entitled, "Surgical Cutting
`Block" issued previously to the present inventor. That device
`provided a significant advance in the development of cut
`saw guides for knee surgery and provided a cutting guide to
`20 position a bone cutting device. The cutting guide has at least
`one fixed or stationary surface and a movable surface to
`create a slot or gap between the fixed surface and the
`movable surface. The cutting device is positioned and held
`in the slot to make accurate bone cuts.
`While the above-described devices have provided mixed
`results in the advancement of the surgical technique in total
`knee prostheses replacement, it has been found that when
`doing Jess radical single condyle replacement that the inter-
`30 relationship between the two surfaces, that is the proximal
`tibial surface and the distal femur surfaces, is difficult to
`align. That is, in a single condyle replacement, the remaining
`healthy condyle is left in tact as well as the receiving tibial
`tray on the proximal tibia. Only the diseased portion of the
`single condyle is removed. Thus the new condyle prosthesis
`must be aligned not only with the reference to the mechani(cid:173)
`cal axis of the patient but also with respect to the condyle
`which remains in tact and unchanged by the surgery.
`SUMMARY OF THE INVENTION
`
`35
`
`FIELD OF THE INVENTION
`
`This invention relates to surgical instruments and, in 10
`particular, to instruments for use in preparing the bones of a
`joint for receiving prosthesis.
`
`BACKGROUND OF THE INVENTION
`
`In total knee replacement surgery, it is known to use
`instrumentation to guide the cuts made to the proximal tibia
`and the distal femur in order to properly align the cuts with
`the bone.
`For example, U.S. Pat. No. 4,524,766 describes a system
`of precision instruments for utilization in knee surgery. The
`instrumentation provides a series of alignment and cutting
`guides which function to align the various necessary cuts of
`the bone structure with respect to the various body parts.
`FIG. 7 of that reference as well as FIG. 15 shows certain 25
`interrelational instrumentation used in aligning the cuts, in
`particular, the distal femur cut and the proximal tibia cut.
`U.S. Pat. No. 4,938,762 refers to a reference system for
`implantation of condylar total knee prostheses. This device
`involves a cumbersome set of reference systems used for
`total knee prostheses which comprises a measuring rod
`which is parallel to the longitudinal axis of the tibia which
`has a pair of attachment arms for attachment to the tibia. A
`guide rail is connected to the measuring rod having a scale
`thereon and an adjustable measuring carriage to which a
`cutting block for performing the necessary osteotomies is
`affixed for movement in two directions. Of particular interest
`with respect to the present application is FIG. 2 of that
`reference and the accompanying text.
`U.S. Pat. No. 4,574,794 is entitled, "Orthopaedic Bone 40
`Cutting Jig and Alignment Device". This device constitutes
`a large cumbersome frame which attaches to the lower
`extremity of the leg and adjusts for the alignment of the
`various bone cuts.
`U.S. Pat. No. 4,421,112 describes a tibial osteotomy guide
`assembly and method. That reference is described as having
`a method and guide assembly for use in tibial osteotomy
`wherein two pairs of guide pins are inserted into the tibia at
`predetermined angles with respect to each other through a 50
`guide block. The adjacent surfaces of the pairs of pins are
`then used to precisely guide a saw by which a wedged shape
`segment of the tibia is removed.
`U.S. Pat. No. 4,487,203 entitled, "Tri-Planer Knee Resec(cid:173)
`tion Method" describes as apparatus for use in a tri-planer 55
`knee system which includes a single guide member for use
`in resecting the distal femur condyles, the proximal tibia and
`the distal femur. The instrumentation includes femur and
`tibia guide rods, a tibia adapter, a tibia bar and a femur bar
`for establishing equal flexion and extension gaps in tri- 60
`planer resection.
`U.S. Pat. No. 4,567,885 entitled, "Tri-Planer Knee Resec(cid:173)
`tion System" describes a tri-planer knee resection system
`which is provided for preparing a knee joint for a prosthesis.
`This patent matured from an application which was a 65
`division of the application which matured into the '203
`patent above.
`
`The present invention, therefore, provides a unique set of
`instruments which provide an interrelationship between the
`femur and the tibia such that the cut on the proximal tibia is
`related to the cuts made on the femur for the reception of the
`45 prosthesis. Thus, the alignment between the two bones is
`established by the instrumentation in order to more closely
`match the operation of the condy le which has been removed.
`The invention provides for an instrument for use in
`surgical joint replacement for replacing an articulating joint
`between a first skeletal member and a second skeletal
`member. The instrument comprises a first skeletal member
`mountable platform which is positioned in a predetermined
`position relative to the first skeletal member. A skeletal
`member positioner which has a face is mounted to the
`platform for medial-lateral and posterior-anterior adjustment
`and positionable in relative mating position between the face
`of the positioner and the first skeletal member. In this way,
`the face which is angularly fixed with respect to the platform
`is used to position the second skeletal member in a prede(cid:173)
`termined angular relationship to the first skeletal member.
`This relationship includes both rotational and angular posi-
`tioning.
`The positioner may include a spacer which is received by
`the platform in order to fix the relative displacement
`between the two skeletal members. The spacer may be
`positionable along a surface of one of the skeletal members
`and used to physically place the second skeletal member.
`
`-9-
`
`

`
`5,520,695
`
`3
`The positioner may be movable in two linear directions
`both posterior-anterior and medial-lateral. In this way, the
`positioner can be adjusted relative to the first cut so that it
`places the other skeletal member in the proper position. This
`permits minor adjustment of the positioner relative to the 5
`actual physical make-up of the joint being replaced.
`Once the two skeletal members are in appropriate rela(cid:173)
`tionship, both spacially and angularly, the positioner pro(cid:173)
`vides a guide for boring mounting holes in the first skeletal
`member. These mounting holes are later used for mounting 10
`a saw guide for making one or more remaining cuts to the
`first skeletal member. This fixes the position of the one or
`more later cuts relative to the second skeletal member such
`that the cuts are made in a predetermined position on the first
`skeletal member and in known relationship to the second
`skeletal member. Thus, when the prosthesis is eventually
`added to the space formed by the cuts, the prosthesis is in a
`precise known location relative to the other skeletal member.
`The same mounting holes provided for the guide to make
`the cuts to the skeletal member may also be used to mount
`a guide for drilling bore holes for mounting the prosthesis.
`In this way, a prosthesis having lugs depending from the
`back thereof is precisely positioned for mounting. By using
`the same mounting holes to drill the lug holes, the lug holes
`are placed in precise locations in order to mount the pros(cid:173)
`thesis relative to the joint in a precise known position.
`The invention further includes the novel spacing mecha(cid:173)
`nism which physically displaces the bones relative to one
`another in order to place them in the appropriate spacial
`relationship. This spacer may include means for attaching
`the positioner described above thus providing a single unit
`which has both the spacial, rotational and angular position of
`the skeletal members fixed.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`15
`
`25
`
`35
`
`30
`
`4
`In FIG. 1, there is shown a femur 1 of a knee joint between
`that femur and the adjacent tibia 2. The femur has formed
`thereon naturally occurring condyles 3 and 4. Condyle 4 has
`already been prepared for reception of a prosthesis element
`5. The prosthesis element is mounted on the femur through
`a frictional fit of lugs 6 and lug holes 7 formed in the distal
`portion of the femur after certain femoral cuts have been
`made. The femur has been shaped by providing a distal
`femoral cut 8 forming a substantially planer surface perpen(cid:173)
`dicular to the mechanical axis of the femur. That is, perpen(cid:173)
`dicular to the alignment along the central axis of the femur
`to the ball of the hip. There is provided an anterior chamfer
`9 and a posterior chamfer 10 for reception of the prosthesis
`element 5 and the articulation of that prosthesis element
`relative to the tibia. The tibia has implanted thereon a tibial
`tray 11 which frictionally rides against the prosthesis ele(cid:173)
`. ment 5 after the replacement surgery has been performed.
`In order to provide appropriate cuts to the distal femur, the
`instrumentation of the present invention is used. Initially, as
`20 shown in FIG. 2, the diseased condyle is measured using a
`unique measuring device. This device is correlated in a
`known manner to a set of prostheses components of various
`sizes which correlate to the size measured by the instrumen(cid:173)
`tation. That is, the distal femur is measured in order to find
`the appropriate prosthesis to replace the removed bone. As
`seen in FIG. 3, a tibial guide element 12 having an extended
`down rod 13 and a platform 14 is mounted to the tibia. The
`surgeon determines the appropriate depth of cut for the tibial
`osteotomy and mounts the tibial element by driving tapered
`pins 12a into the tibia at the appropriate height. The instru(cid:173)
`ment is aligned with the tibia by extending the down rod 13
`along the length of the tibia and aligning the end of the down
`rod with the ankle in an appropriate manner. This manner is
`easily determined by those of ordinary skill in the art. The
`platform 14 of the tibial guide acts as a saw guide for the saw
`blade 17 which is used to cut away the necessary bone on the
`proximal tibia. In a similar manner, a similar guide device to
`the tibial platform is mounted to the femur with the down
`rod aligned with the ball of the hip in order to provide the
`40 proper plane. This device guides a saw to make the appro(cid:173)
`priate distal femur cut 8 which cut is shown in FIG. 4. The
`tibial guide is formed of a sufficiently hard metal material
`such as stainless steel. The instrumentation is provided to
`mate specifically with either the medial or lateral portion of
`each of the left or right legs.
`The distal femur cut and proximal tibial cut are made
`specifically with reference to the mechanical axis of the leg.
`However, the femur requires certain chamfer cuts and a
`posterior cut in order to fit the prostheses thereon. These cuts
`50 must be closely related to the position of the tibia and must
`take into account the thickness of the tibial tray to be
`implanted and the prostheses to be implanted.
`The tibial platform now provides a second function
`through the key slot 15 defined therein. A spacer element 16
`having a handle 17 is inserted into the key slot via a tongue
`18 formed thereon. The femur and tibia are placed in fiexion
`and the spacer is positioned between the femur and tibia as
`shown in FIG. 6. This spacer is sized to provide appropriate
`tension to the ligaments of the knee joint and thus determine
`the size of the tibial tray and thickness of the prostheses
`necessary. This also places the femur and tibia in an appro(cid:173)
`priate separation for the next several steps of the surgical
`procedure. The spacer receives thereon a carriage 19 having
`a key slot 20 formed therein. The carriage 19 is received on
`the spacer via a dove-tail key 21 which fits in a dove-tail
`formed slot 22 in the spacer. As can be seen from the
`drawings, the dove-tail slot 22 runs perpendicular to the slot
`
`FIG. 1 shows the prepared distal femur and proximal tibia
`receiving the femoral portion of the knee prosthesis;
`FIG. 2 shows a unique measuring device of the invention
`used to measure the distal femur prior to making the cuts in
`order to size the necessary prosthesis;
`FIG. 3 shows the.alignment device of the present inven(cid:173)
`tion attached to the proximal tibia while making the proxi(cid:173)
`mal tibial cut;
`FIG. 4 shows the proximal tibial cut and the distal femoral
`cut already made;
`FIG. 5 shows the insertion of the mounting portion of the
`instrumentation of the present device onto the tibial portion
`of the instrumentation;
`FIG. 6 is a side view showing the interrelationship
`between the femoral guide drill and the tibial portion of the
`instrumentation;
`FIG. 7 is a perspective view of the operation being shown
`in FIG. 6;
`FIG. 8 is a perspective view showing the femoral saw 55
`guide mounted to the distal femur in the holes prepared in
`the operation depicted in FIGS. 6 and 7;
`FIG. 9 is a side view of the instrumentation of FIG. 8;
`FIG. 10 shows a drill guide block mounted to the distal
`femur; and
`FIG. 11 shows the side view of the guide block in FIG.10.
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`45
`
`60
`
`65
`
`The invention will now be described in connection with
`the accompanying drawings.
`
`-10-
`
`

`
`5,520,695
`
`5
`
`5
`15 defined in the platform. Thus, the spacer can be inserted
`from the anterior to the posterior direction of the tibia and
`force the femur into its separated position. The platform then
`moves in either from the medial or lateral side providing a
`positionable apparatus which can be moved forward and
`back by movement of the spacer and to the left or right via
`the interaction of the dove-tail 21 and the slot 22 defined by
`the spacer. The carriage 19 initially receives thereon a drill
`guide 23. The drill guide 23 has defined therein a pair of
`guide openings 24 which guide a drill 25 while making a 10
`mounting hole 26 in the distal end of the femur.
`In use, the drill guide 23 has a face 27 at a known and
`predetermined angle to the platform 14. Actually, the known
`predetermined angle is with respect to the spacer 16 which
`is held in face-to-face alignment with the top of the platform. 15
`This face 27 is then placed adjacent the distal end of the
`femur, and the femur is positioned such that the original
`distal femur cut is in face-to-face engagement with the face
`27 of the drill guide 23. Thus, prior to drilling, the femur and
`tibia are placed in spacial relationship by the spacer 16 and 20
`in angular relationship by the drill guide 23 through its
`face-to-face engagement between the surface 27 and the
`distal cut 8. Once the femur is positioned, the drill 25 is used
`to drill the mounting holes 26 in the distal cut of the femur.
`Having thus established the particular relationship between 25
`the mounting holes 26 and the distal femur cut 8 and the
`proximal tibia cut, the drill guide and spacer may be
`removed.
`The femur has now been supplied with the mounting
`holes 26. These mounting holes receive a femoral saw guide 30
`28 which is mounted therein through a frictional fit via lugs
`29 projecting from the bottom side of the guide. The guide
`defines an anterior chamfer slot 30, a posterior chamfer slot
`31 and a posterior femoral cut slot 32. These guides are used
`to position and orient the saw when making the anterior 35
`chamfer, the posterior chamfer and the posterior femoral
`cuts to the distal ends of the femur.
`The anterior femoral cut is made along a plane 33 defined
`by the slot 30 and the posterior chamfer is made along a 40
`plane 34 defined by the slot 31. Finally, the posterior cut is
`made along a plane 35 which is defined by the slot 32.
`After the anterior and posterior chamfers and the posterial
`femoral cut have been made, the saw guide 28 is removed
`and a prostheses lug hole drill guide 36 is mounted in the 45
`same mounting holes 26 via lugs 37 extending from the
`bottom of the drill guide. The drill guide has formed thereon
`a series of angular surfaces which mate with the posterior
`chamfer 38, the anterior chamfer 39 and the original distal
`. femoral cut 8. Thus, the guide is placed in the proper 50
`position to make the openings for receiving the mounting
`lugs of the prosthesis. The drill guide defines a pair of
`openings 40 which are positioned and oriented to make
`openings specific to the prosthesis to be used. A drill 41 is
`used to drill out the openings and, in practice, the guide may 55
`be at an angle 42 to the actual mechanical axis of the femur.
`The drill defines the prosthesis mounting holes 7 and then
`the drill guide 36 is removed from its position adjacent the
`distal femur.
`A prosthesis similar to that shown in FIG. 1 is then 60
`mounted on the distal femur by a frictional fit between the
`lugs 6 and the openings 7 formed by the drill. A tibial tray
`
`6
`11 is mounted in the cut formed on the proximal tibia and the
`surgical site is closed. The condyle prostheses and tibial tray
`may be mounted in any known manner. Therefore, the lugs
`6 and openings 7 may merely provide an orientation func-
`tion while the prostheses is held in place by other means.
`It can easily be seen by one of ordinary skill in the art that
`minor departures from the specific function features and
`structures shown in this application can be made without
`escaping the spirit and scope of the invention which I have
`made.
`What is claimed is:
`1. A method of replacing a portion of a knee joint in an
`animal with an implanted prosthesis comprising:
`a. positioning a first guide relative the distal end of a
`femur and making a distal femoral cut using said guide;
`b. positioning a second guide adjacent a proximal end of
`a tibia and making a proximal tibial cut using said
`guide;
`c. attaching a spacer element to said second guide and
`positioning said spacer between said proximal tibia end
`and distal femur end to provide a spacing between said
`distal femur end and proximal tibial end when said
`femur and tibia are in fiexion which correlates to the
`operative thickness of the implanted prosthesis;
`d. attaching a guide block having at least two guide bores
`to said spacer to form a predetermined angle between
`a guide face of said guide block and the proximal tibial
`cut;
`e. positioning said femur with said distal femoral cut
`adjacent to said guide face and matching said guide
`face with said spacer in place;
`f. boring at least two mounting bores in the distal femur
`using said guide bores in said guide block to position
`said mounting bores;
`g. mounting a chamfer cut guide to the distal end of the
`femur using said mounting bores to position the cham(cid:173)
`fer cut guide on the femur;
`h. cutting at least one femur chamfer cut using said
`chamfer cut guide to position said cut;
`i. attaching a femoral prostheses component along said at
`least one femur chamfer cut; and
`j. attaching a tibial prostheses component along said
`proximal tibia cut.
`2. The method according to claim 1 further comprising
`mounting a lug bore guide to the distal end of the femur
`using said mounting bores to position the lug bore guide and
`boring at least one lug bore in the distal end of the femur
`using the lug bore guide to position the lug bore and
`positioning the said femoral prosthesis component on said
`femur at least in part by positioning a lug depending from
`said femoral prosthesis component within said lug bore.
`3. The method according to claim 2 wherein three cuts are
`made to the distal end of the femur using said chamfer cut
`guide to guide each of the three cuts without removal or
`repositioning of the chamfer cut guide between cuts.
`
`* * * * *
`
`-11-