United States Patent [19]
`Stone
`
`US006008433A
`[11] Patent Number:
`[45] Date of Patent:
`
`6,008,433
`Dec. 28, 1999
`
`[54] OSTEOTOMY WEDGE DEVICE, KIT AND
`METHODS FOR REALIGNMENT OF A
`VARUS ANGULATED KNEE
`
`[76] Inventor: Kevin R. Stone, 1 Throckmorton La.,
`Mill Valley, Calif. 94941
`
`[21] Appl. No.: 09/064,958
`[22]
`Filed:
`Apr. 23, 1998
`
`[51] Int. Cl.6 ...................................................... .. A61F 2/28
`[52] US. Cl. ................................ .. 623/16; 606/61; 623/20
`[58] Field of Search ................................ .. 623/16, 17, 18,
`623/20; 433/175; 606/60, 61, 70, 74, 88
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4/1980 Ashman ................................ .. 433/175
`4,199,864
`4,484,570 11/1984 Sutter et al. ..
`128/92
`4,746,532
`5/1988 Suzuki et al.
`427/2
`5,047,058
`9/1991 Roberts et al.
`.. 623/20
`5,108,399
`4/1992 Eitenmuller et al. .
`606/77
`
`5,129,904
`
`7/1992 Illi . . . . . . . . . . . . . . . . . . . . .
`
`. . . . .. 606/72
`
`5,192,327
`
`3/1993 Brantigan . . . . . .
`
`. . . . .. 623/17
`
`623/17
`4/1994 Senter et al. ..
`5,306,307
`4/1994 Wagner et al. ......................... .. 623/17
`5,306,309
`5,364,400 11/1994 Rego, Jr. et al. ....................... .. 606/72
`5,716,415
`2/1998 Steffee
`..
`
`
`
`5,766,251 5,865,847
`
`
`
`6/1998 Koshino 2/1999 Kohrs et al. ............................ .. 623/17
`
`FOREIGN PATENT DOCUMENTS
`
`60-150756 8/1985 Japan ..................................... .. 623/16
`4-055266
`5/1993 Japan ..................................... .. 623/16
`1107854 8/1984 U.S.S.R. ................................ .. 623/17
`
`OTHER PUBLICATIONS
`
`Frank R. Noyes et al., High Tibial Osteotomy in Knees With
`Associated Chronic Ligament De?ciencies, Master Tech
`niques in Orthopaedic Surgery, Reconstructive Knee Sur
`gery, 185—210, (1995).
`A. Miniaci et al., Proximal Tibial Osteotomy, A NeW Fixa
`tion Device, No. 246, Clinical Orthopaedics and Related
`Research, 250—259, (Sep. 1989).
`
`James J. Elting, MD. et al., Unilateral Frame Distraction:
`Proximal Tibial Valgus Osteotomy for Medical Gonarthritis,
`vol. 27, No. 5, Contemporary Orthopaedics, 435—440, (Nov.
`1993).
`Dr. Ch. Mansat, The Mansat Staple Blade, Sales brochure
`from Societe De Protheses Othopedie Reeducation Trauma
`tologie, Saint—Jean 31240 France.
`
`Primary Examiner—Bruce E. SnoW
`Attorney, Agent, or Firm—Lappin & Kusmer LLP
`
`[57]
`
`ABSTRACT
`
`The invention provides an osteotomy device, and kit and
`methods for realigning varus angulated knees. The device
`involves a substantially Wedge-shaped body having tWo
`intersecting principal surfaces angularly offset. These prin
`cipal surfaces extend in a direction of a drive axis about a
`principal plane from an insertion end to a drive surface at a
`drive end. At least one of the principal surfaces is adapted to
`engage mechanically a surface adjacent thereto. The drive
`surface is also adapted to receive a force in the direction of
`the drive axis toWard the insertion end. The kit of the present
`invention includes substantially such an osteotomy device
`having cannular opening along its drive axis and an
`osteotomy pin. A method of the invention involves making
`a transverse incision partially into the tibia; realigning tibial
`portions above and beloW the incision With respect to each
`other to create a predetermined angle A betWeen opposing
`faces of the incision, thereby creating a Wedge-shaped
`opening; providing a substantially Wedge-shaped body hav
`ing tWo angularly offset intersecting principal surfaces,
`Wherein at least one of the surfaces is adapted to engage
`mechanically a surface adjacent thereto; and driving the
`body into the opening. Another invention method involves
`making the incision and realigning the tibia substantially as
`described above folloWed by positioning an osteotomy pin
`Within the Wedge-shaped opening; and placing the substan
`tially Wedge-shaped body having a cannular opening along
`a drive axis Within the Wedge-shaped opening such that the
`pin is positioned in the cannular opening of the body.
`
`19 Claims, 4 Drawing Sheets
`
`2/5
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`2/2
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`2/0
`
`200
`/
`220
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`234
`
`262
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1005
`1 of 11
`
`

`
`U.S. Patent
`
`Dec. 28, 1999
`
`Sheet 1 of4
`
`6,008,433
`
`“7/ FIG. 2B
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1005
`2 of 11
`
`

`
`U.S. Patent
`
`Dec. 28, 1999
`
`Sheet 2 of4
`
`6,008,433
`
`A34
`
`F]. c
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1005
`3 of 11
`
`

`
`U.S. Patent
`
`Dec. 28, 1999
`
`Sheet 3 of4
`
`6,008,433
`
`/
`
`2/2
`
`2/0
`
`220
`
`.254
`
`FIG. 4B
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1005
`4 of 11
`
`

`
`U.S. Patent
`
`Dec. 28, 1999
`
`Sheet 4 of4
`
`6,008,433
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1005
`5 of 11
`
`

`
`1
`OSTEOTOMY WEDGE DEVICE, KIT AND
`METHODS FOR REALIGNMENT OF A
`VARUS ANGULATED KNEE
`
`FIELD OF THE INVENTION
`
`The present invention relates to a device, a kit and
`methods for tibial realignment, and in particular, to a device,
`a kit and methods for the correction of varus angulated knees
`including the genu varus and genus valgus conditions.
`
`BACKGROUND OF THE INVENTION
`
`Varus angulated knees are deformities Which are charac
`teriZed by abnormal angulations of the leg in relation to the
`thigh. Stedman’s Medical Dictionary, Williams & Wilkins,
`Baltimore, Md. (1995). For example, the genu varus angu
`lated knee condition is characteriZed by an outWard boWing
`of the legs and is commonly referred to as boWleg. Another
`example, the genu valgus angulated knee condition, is
`characteriZed by a lateral angulation of the leg in relation to
`the thigh and is commonly referred to as knock-knee. Either
`of these conditions may result in abnormal loads on the
`femurtibial joint. Further, such loads may cause tensile
`forces to develop in the collateral ligaments and other soft
`tissue structures. Persons With varus angulated knee condi
`tions may experience knee pain, sWelling, recurrent loss of
`stability related to activity, functional limitations, and sub
`luxation. Both the genu varus and genu valgus angulated
`knee conditions may require reconstruction of the surround
`ing ligaments as Well as correction of the abnormal angu
`lation.
`High Tibial Osteotomies (HTO) are surgical methods
`used to correct the abnormal angulations of varus angulated
`knees. Frank R. Noyes, et al., High Tibial Osteotomy in
`Knees with Associated Chronic Ligament De?ciencies in
`Master Techniques in Orthopaedic Surgery, Reconstructive
`Knee Surgery, 185, 185—187 (1995). In accordance With
`such methods, the desired angle of correction is ?rst deter
`mined. Transverse and oblique incisions are then made into
`a lateral portion of the upper tibia forming a triangular
`shaped opening. The opening is closed by rotating the loWer
`portion of the tibia relative to the upper portion of the tibia
`so that the long axes of the loWer and upper portions of the
`tibia are substantially aligned or slightly (e.g., 5—13 degrees
`valgus) over-corrected relative to the desired correction
`angle. A. Miniaci et al., Proximal Tibial Osteotom. A New
`Fixation Device, 246 Clinical Orthopaedics and Related
`Research 250, 250—259 (September 1989). The closure is
`secured With an L-shaped bracket or buttress that is screWed
`into the tibia on each side of the closure.
`Accordingly, the HTO procedure requires shortening of
`the tibia and the ?bula. Such shortening may lead to ankle
`pain. Additional incisions may also be necessary because it
`may be dif?cult to determine the amount of bone removal
`required.
`Unilateral frame distraction procedures are alternative
`surgical methods for the correction of abnormal angulation
`of varus angulated knees. In accordance With such methods,
`the medial cortex of the tibia is divided leaving the medul
`lary bone, the lateral aspect of the joint, the tibia and the
`peroneal nerve intact. James J. Elting, MD. et al., Unilateral
`Frame Distraction: Proximal Tibial Valgus Osteotomy for
`Medial Gonarthritis. Vol. 27 No. 5 Contemporary Ortho
`paedics 435, 436 (1993). Pins or screWs are placed,
`respectively, transversely into the proximal tibia epiphysis
`and into the mid-shaft region of the tibia, and used to attach
`the axial ?xator. The purpose of the ?xator is to distract the
`
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`6,008,433
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`2
`bone in order to position the tibia in the proper alignment.
`After surgery, the patient distracts the ?xator approximately
`1 millimeter per day (0.25 mm, 3 to 4 times per day) until
`the tibia is in the proper alignment and knee pain is relieved.
`Once callus formation occurs, the ?xator is dynamiZed to
`encourage ?lm bone consolidation. When the neWly-formed
`medially based bone Wedge appears mature and fully
`consolidated, the ?xator is removed.
`In contrast to one-time surgeries, the above-identi?ed
`procedure may require approximately an additional three
`month post-surgery distraction period to complete the
`correction, as Well as removal of the ?xator after that period.
`Further, during the post-surgery distraction period, the pro
`cedure may require active patient participation Which may or
`may not be reliable. Moreover, the patient’s Wearing of the
`externally attached ?xator may be cumbersome and embar
`rassing for the patient. In addition, Whether the tibial realign
`ment remains stable over time is not yet knoWn.
`Another surgical method for the correction of varus
`angulated knees involves a spacer attached to a blade plate.
`Dr. Ch. Mansat, The Mansat Staple Blade, Sales brochure
`from Societe De Protheses Othopedie Reeducation
`Traumatologie, Saint-Jean 31240 France. In accordance
`With this method, a transverse incision is made in the medial
`to lateral direction in the upper, medial portion of the tibia
`leaving the lateral cortex portion of the tibia intact. The
`loWer portion of the tibia beloW the incision is positioned at
`a pre-determined angle to correct the varus deformity, With
`the intact lateral cortex of the tibia acting as a hinge.
`Angularly positioning the loWer tibia portion separately
`from the upper portion of the tibia above the incision forms
`a triangular-shaped opening at the incision point. A square
`shaped spacer attached to a blade plate is positioned in the
`mouth of the opening and secured With screWs through the
`blade plate into the tibia.
`In the above-identi?ed method, a signi?cant amount of
`bone groWth is required to ?ll the opening, since the spacer
`has a different shape from the triangular-shaped opening
`formed by the surgical incisions. Further, once the spacer is
`properly positioned, the surgical method requires the addi
`tional step of ?xing the screWs of the blade plate into the
`tibia to secure the spacer to the bone.
`Thus, there is a need for devices, kits and methods to
`correct varus angulated knee deformities Which avoid short
`ening the tibia and ?bula causing ankle pain. Further there
`is a need for devices, kits and methods Which do not require
`the Wearing of external devices and lengthy post-surgery
`correction periods involving potentially unreliable active
`patient participation. In addition, there is a need for devices
`and kits and methods that both promote bone groWth and
`minimiZe the amount of bone groWth required for correction
`and strengthening. Further, there is a need for varus angu
`lated knee correction devices Which are secured in the
`desired positions Without the need for additional securing
`structures.
`
`SUMMARY OF THE INVENTION
`The foregoing and other objects are achieved by the
`invention Which is directed to an osteotomy device, and kit
`and methods for realigning varus angulated knees, but also
`may be used for realigning any malaligned bone. In
`particular, the osteotomy devices and kits of the invention
`involve substantially Wedge-shaped bodies having, inter
`alia, principal surfaces adapted to engage mechanically
`surfaces such as bone, thereby promoting contiguous bone
`formation and groWth of bone cells around and attaching to
`the osteotomy devices.
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1005
`6 of 11
`
`

`
`6,008,433
`
`3
`The methods of the invention involve, inter alia, realign
`ing portions of the tibia at a predetermined angle A to create
`a Wedge-shaped opening; providing a substantially Wedge
`shaped body having tWo principal surfaces angularly offset
`by an angle A and extending to form vertex, Wherein at least
`one of the surfaces is adapted to engage mechanically a
`surface adjacent thereto; and driving the body into the
`Wedge-shaped opening. Alternatively, the methods of the
`invention involve, inter alia, additionally positioning an
`osteotomy pin Within the Wedge-shaped opening along a
`drive axis such that the pin extends radially outWard from
`the tibia and placing the substantially Wedge-shaped body
`having a cannular opening into the Wedge-shaped opening
`along the drive axis such that the pin is positioned in the
`cannular opening of the body.
`Accordingly, the device, kit and methods of the invention
`avoid shortening of the tibia and the ?bula, the need for
`external correction devices and lengthy post-surgery correc
`tion procedures requiring active patient participation.
`In one embodiment, the osteotomy device of the present
`invention involves a substantially Wedge-shaped body hav
`ing tWo principal surfaces Which are angularly offset by an
`angle A and intersect to form a vertex. These surfaces extend
`at least in part about a principal plane from the vertex at an
`insertion end to a drive surface at a drive end. The principal
`plane contains a drive axis extending from the vertex toWard
`the drive surface. The drive surface extends at least in part
`transversely to the principal plane. At least one of the
`principal surfaces is adapted to engage mechanically an
`adjacent surface, such as bone material. The drive surface is
`adapted to receive a force in the direction of the drive axis
`toWard the insertion end.
`In another embodiment, the invention provides a kit
`having substantially the above-identi?ed osteotomy device,
`Wherein the substantially Wedge-shaped body has a portion
`de?ning a cannular opening along a drive axis extending
`from the vertex in the principal plane, and an osteotomy pin
`for placement Within the cannular opening.
`In yet another embodiment, the invention provides a
`method for realigning a varus angulated knee. The method
`involves making a transverse incision into the medial upper
`tibia, thereby creating a loWer portion of the tibia capable of
`being realigned and leaving intact the lateral portion of the
`tibia; realigning the loWer portion of the tibia at a predeter
`mined angle A, thereby creating a Wedge-shaped opening
`capable of receiving a substantially Wedge-shaped body
`having tWo principal surfaces angularly offset by the pre
`determined angle A and intersecting to form a vertex,
`Wherein at least one of the surfaces is adapted to engage
`mechanically a surface adjacent thereto; and driving the
`body into the Wedge-shaped opening.
`In still another embodiment, the invention provides a
`method for realigning a varus angulated knee. The method
`involves making a transverse incision into the medial upper
`tibia, thereby creating a loWer portion of the tibia capable of
`being realigned and leaving intact the lateral portion of the
`tibia; realigning the loWer portion of the tibia to a predeter
`mined angle A, thereby creating a Wedge-shaped opening
`capable of receiving a substantially Wedge-shaped body
`having a portion de?ning a cannular opening betWeen tWo
`principal surfaces angularly offset by the predetermined
`angle A and intersecting to form a vertex, Wherein at least
`one of the surfaces is adapted to engage mechanically a
`surface adjacent thereto; positioning an osteotomy pin
`Within the Wedge-shaped opening along a drive axis such
`that the osteotomy pin extends radially outWard from the
`
`4
`intact tibial portion; and placing the substantially Wedge
`shaped body Within the Wedge-shaped opening along the
`drive axis such that the osteotomy pin is positioned in the
`cannular opening of the portion of the substantially Wedge
`shaped body.
`
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`BRIEF DESCRIPTION THE DRAWINGS
`
`The foregoing and other objects of this invention, the
`various features thereof, as Well as the invention itself, may
`be more fully understood from the folloWing description,
`When read together With the accompanying draWings in
`Which:
`FIG. 1A illustrates a perspective vieW of an osteotomy
`device having a substantially Wedge-shaped body, according
`to an embodiment of the invention;
`FIG. 1B illustrates in section, the device of FIG. 1A, along
`lines 1A—1A;
`FIG. 2A illustrates the surface texture of the principal
`surface of a substantially Wedge-shaped body of an
`osteotomy device having a saW-tooth contour on the prin
`cipal surfaces, according to an embodiment of the invention;
`FIG. 2B illustrates an osteotomy device according to an
`embodiment of the invention, including a plate and screW
`system for securing the substantially Wedge-shaped body of
`the osteotomy device to cortical and cancellous bone;
`FIG. 3A illustrates a transverse incision into the medial
`upper tibia, according to an embodiment of the invention;
`FIG. 3B illustrates the portion of the tibia beloW the
`transverse incision illustrated in FIG. 3A realigned at a
`predetermined angle, thereby creating an opening capable of
`receiving a substantially Wedge-shaped body, according to
`an embodiment of the invention;
`FIG. 3C illustrates a substantially Wedge-shaped body
`driven into the opening illustrated in FIG. 3B, according to
`an embodiment of the invention;
`FIG. 4A illustrates a kit for realigning a varus angulated
`knee having, inter alia, a substantially Wedge-shaped body
`having a cannular opening along a drive axis, according to
`an embodiment of the invention;
`FIG. 4B illustrates a kit for realigning a varus angulated
`knee having, inter alia, an osteotomy pin for positioning
`Within the cannular opening of the substantially Wedge
`shaped body illustrated in FIG. 3A, according to an embodi
`ment of the invention;
`FIG. 5A illustrates a transverse incision into the medial
`upper tibia, according to an embodiment of the invention;
`FIG. 5B illustrates the portion of the tibia beloW the
`transverse incision illustrated in FIG. 5A realigned at a
`predetermined angle, thereby creating an opening capable of
`receiving a substantially Wedge-shaped body, according to
`an embodiment of the invention;
`FIG. 5C illustrates an osteotomy pin positioned Within the
`opening illustrated in FIG. 5B, according to an embodiment
`of the invention; and
`FIG. 5D illustrates a substantially Wedge-shaped body
`having a cannular opening along a drive axis being placed
`Within the opening along the drive axis illustrated in FIGS.
`5B and 5C such that the osteotomy pin is positioned in the
`cannular opening of the substantially Wedge-shaped body,
`according to an embodiment of the invention.
`
`65
`
`DETAILED DESCRIPTION THE INVENTION
`The present invention provides an osteotomy device, kit
`and methods for realigning varus angulated knees. The
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1005
`7 of 11
`
`

`
`6,008,433
`
`25
`
`35
`
`15
`
`5
`osteotomy device of the present invention involves a sub
`stantially Wedge-shaped body having, inter alia, a principal
`surface adapted to engage mechanically a surface, such as
`bone. The kit of the present invention includes such a
`substantially Wedge-shaped body having a cannular opening
`along a drive axis, and an osteotomy pin for placement
`Within the body’s cannular opening. The method of the
`invention includes the steps of, inter alia, making a trans
`verse incision partially into the tibia; realigning the portion
`of the tibia beloW the incision at a predetermined angle A
`10
`betWeen opposing faces of the incision thereby creating a
`Wedge-shaped opening; providing a correspondingly sub
`stantially Wedge-shaped body having tWo angularly offset
`intersecting principal surfaces, Wherein at least one of the
`surfaces is adapted, at least in part, to engage mechanically
`a surface adjacent thereto; and driving the body into the
`Wedge-shaped opening such that the body is mechanically
`held in place betWeen the opposing faces and ?lls at least a
`part of a region betWeen the opposing faces. Another method
`of the invention substantially includes the ?rst tWo steps
`described above folloWed by the steps of, inter alia, posi
`tioning an osteotomy pin Within the Wedge-shaped opening
`and placing the substantially Wedge-shaped body having a
`cannular opening along a drive axis Within the opening
`along the body’s drive axis such that the osteotomy pin is
`positioned in the body’s cannular opening.
`In one embodiment, the invention provides an osteotomy
`device 100, as shoWn in FIGS. 1A, 1B, 2A, 2B and 3A—3C.
`The device has a substantially Wedge-shaped body 110
`having tWo angularly offset intersecting principal surfaces
`112, 114. The principal surfaces 112,114 intersect at a vertex
`121 at insertion end 120 and in the illustrated embodiment,
`extend about a principal plane 122 extending midWay
`betWeen surfaces 112, 114 from the vertex 121 at the
`insertion end 120 to a drive surface 126 at a drive end 118.
`The principal plane 122 contains a drive axis 116. The drive
`surface 126 extends, at least in part, in a direction transverse
`to the principal plane 122. The drive surface 126 is adapted
`to receive a force in the direction of the drive axis 116
`toWards the insertion end 120. In the embodiment of FIGS.
`1A—1B, the principal surfaces 112, 114 are planar and
`smooth. In other embodiments, different forms and surface
`textures of the principal surfaces 112, 114 can be used, as,
`for example, to assist in maintaining placement of the device
`110 betWeen tWo bone portions. For example, the osteotomy
`device of the present invention can be, at least in part, curved
`instead of planar. Alternative surface textures Which can be
`used for surfaces 112, 114 are described in detail beloW. By
`Way of example, the osteotomy devices of the present
`invention can be formed of materials manufactured by
`Bionix Implants, Inc., Blue Bell, Pa.
`The dimensions of the osteotomy device 100 illustrated in
`FIG. 1A are shoWn in FIG. 1B. Preferably, the length (L) of
`the substantially Wedge-shaped body 110 ranges from about
`20 mm to about 100 mm, and more preferably ranges from
`about 30 mm to about 90 mm, most preferably ranges from
`about 40 mm to about 80 mm. The height
`of the drive
`surface 126 of the substantially Wedge-shaped body 110
`ranges from about 4 mm to about 20 mm, and more
`preferably ranges from about 8 mm to about 15 mm. The
`angle (A) betWeen surfaces 112, 114 of the substantially
`Wedge-shaped body 110 ranges from about 5 degrees to
`about 25 degrees, and more preferably ranges from about 10
`degrees to about 20 degrees.
`At a minimum, at least one of the principal surfaces 112,
`114 is adapted, at least in part, to engage mechanically a
`surface or surfaces thereto. The entire body 110 as a whole
`
`6
`can be similarly adapted, hoWever. For exemplary purposes,
`such adaptations are explained beloW in the context of
`principal surfaces 112, 114. Preferably, both surfaces 112,
`114 are adapted, at least in part, to engage mechanically
`surfaces adjacent thereto. Thus, bone cells groW at the
`boundary of the exposed bone and the principal surfaces
`112, 114 of the osteotomy device of the present invention.
`Such bone cells attach to the principal surfaces 112, 114 and
`secure the device’s substantially Wedge-shaped body to the
`osteotomy site.
`In particular, the shapes, surface textures and/or materials
`of the principal surfaces 112, 114 are adapted to mechani
`cally engage adjacent surface materials such as bone. For
`example, the substantially Wedge-like shapes of the princi
`pal surfaces 112, 114 are designed to conform to the shape
`of an opening in the tibia Where the body 110 is inserted.
`Thus, the principal surfaces 112, 114 substantially engage
`the Walls of the tibial opening promoting bone groWth to the
`principal surfaces 112, 114 and minimiZing void space
`betWeen the body 110 and the Walls of the tibial opening.
`In another exemplary embodiment, as shoWn in FIG. 2A,
`the saW-tooth surface textures of the principal surfaces 112
`and 114 are adapted to mechanically engage surfaces adja
`cent to body 110. The saW-tooth contour of the surface
`textures de?nes uneven gradations 152 Which increase the
`surface area available for bone adhesion. Preferably, the
`height (h) of each of the saW-tooth graduations ranges from
`about 1 mm to about 2 mm and more preferably, h is about
`1.5 mm.
`In still other exemplary embodiments, one or both of the
`principal surfaces 112, 114 are formed of a material selected
`to engage mechanically surfaces adjacent to body 110. By
`Way of example, the principal surface 112 can be formed of
`a porous material Which alloWs bone cells to groW Within
`and throughout the pores. The diameters of such pores can
`range in siZe from about 50 micrometers to about 500
`micrometers. Nonlimiting examples of such a porous mate
`rial include polylactic acid (PLA), polyglycolic acid (PGA)
`and collagen.
`In alternative embodiments, the material of one or both of
`the principal surfaces 112, 114 includes roughened non
`porous material Which has properties Which facilitate the
`binding of bone to the principal surfaces 112, 114. Non
`limiting examples of such a non-porous material include
`titanium, graphite, and steel. Other non-porous materials
`knoWn to those of ordinary skill in the art to facilitate the
`binding of bone to the material can also be used to form the
`body 110 of the present invention.
`In a further embodiment, the material of one or both of the
`principal surfaces 112, 114 is a resorbable material, such as
`lactides and collagen. Such resorbable material is absorbed
`into the recipient body as the bone cells develop throughout
`the osteotomy site. The resorbable material can be selected
`such that the substantially Wedge-shaped body is absorbed
`into the recipient body over a predetermined time period.
`This predetermined time period can range from about 3
`months to about 48 months. Non-limiting examples of a
`resorbable material Which can be used to form the body 110
`of the present invention include PLA, PGA, collagen and
`hydroxy apetite. Other resorbable materials knoWn to those
`of ordinary skill in the art can also be used to form the body
`110 of the present invention.
`In still a further embodiment, the substantially Wedge
`shaped body 110 can be further secured With a screW and
`plate system 170, as illustrated in FIG. 2B. ScreWs 172 can
`be screWed through plate 174 and into the body 110.
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`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1005
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`6,008,433
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`Additional screws 176 can be screwed through the plate 174
`and through the cortical bone into the cancellous bone.
`ScreWs 172 have suf?cient length to reach opposite cortex.
`Preferably, screWs 172, 176 have diameters ranging from
`about 4.5 mm to about 6.5 mm and lengths ranging from
`about 20 mm to about 100 mm, and more preferably from
`about 30 mm to about 90 mm, most preferably from about
`40 mm to about 80 mm.
`In yet another embodiment, the body 110 of the osteotomy
`device of the present invention can be holloW. Accordingly,
`materials such as ground cancellous bone can be packed
`Within the body 110. Further, such a body 110 include a
`plurality of holes on the principal surface Which can facili
`tate packing of material Within the body 110.
`FIGS. 3A—3C illustrate the steps of a method of the
`present invention for realigning a varus angulated knee. In
`accordance With this method, a transverse incision 132 is
`partially made into the tibia 136, as shoWn in FIG. 3A.
`Upper 136 and loWer 138 portions of the tibia are created
`leaving the lateral portion 134 of the tibia intact. The upper
`132 and loWer 138 portions of the tibia are realigned With
`respect to each other to create predetermined angle 140
`betWeen opposing faces 144, 146 of the incision, thereby
`creating a substantially Wedge-shaped opening 142, as
`shoWn in FIG. 3B. A correspondingly substantially Wedge
`shaped body having tWo principal surfaces angularly offset
`by the predetermined angle 140 and intersecting to form a
`vertex is provided. At least one of the principal surfaces is
`adapted, at least in part, to engage mechanically a surface
`adjacent thereto. Axial force is applied to the substantially
`Wedge-shaped body to drive the body into the Wedged
`shaped opening 142.
`In an embodiment of this method of the invention, the
`substantially Wedge-shaped body consists of the substan
`tially Wedge-shaped body 110 of osteotomy device 100
`described above, as illustrated in FIG. 3C. At least one of the
`principal surfaces 112, 114 of the osteotomy device 100
`mechanically engages adjacent bone material facilitating
`adherence of the osteotomy device 100 to the osteotomy site.
`The substantially Wedge-shaped form of the body 110 con
`forms substantially to the Wedge-shaped surgical opening
`142 in the tibia and thus minimiZes the void space betWeen
`the body 110 and the opposing faces 144, 146 de?ning the
`opening 142. Accordingly, the bone groWth needed to ?ll
`such void space to secure the body 110 to the insertion site
`and to strengthen the realigned knee is minimiZed.
`In still other embodiments of this method of the invention,
`cancellous bone is packed into betWeen the body and the
`region betWeen the opposing faces of the incision. Further,
`additional cancellous bone can be packed inside the body
`Where the body is holloW. Such packing is facilitated Where
`the body includes holes on its principal surface. Preferably
`the diameters of such holes can range from about 2 mm to
`about 10 mm.
`The invention further provides another osteotomy device
`200 for realigning a varus angulated knee, as illustrated in
`FIG. 4A. The osteotomy device 200 includes a substantially
`Wedge-shaped body 210 having tWo principal surfaces 212,
`214 angularly offset and intersecting to form a vertex 221.
`The principal surfaces 212, 214 extend in the direction of a
`drive axis 216 about a principal plane 222 from the vertex
`221 at an insertion end 220 to a drive surface 226 at a drive
`end 218. The principal plane 222 contains the drive axis 216.
`The drive surface 226 extends at least in part in a direction
`transverse to the principal plane 222. The drive surface 226
`is adapted to receive a force in the direction of the drive axis
`216 toWard the insertion end 220.
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`At a minimum, at least one of the principal surfaces 212,
`214 or at a maximum, the body 210 as a Whole is adapted,
`at least in part, to engage mechanically a surface adjacent
`thereto. For example, the shapes, surface textures or mate
`rials of the principal surfaces 212, 214 or the body 210 as a
`Whole are adapted, at least in part, to engage mechanically
`adjacent surface materials such as bone, as described above
`in relation to the osteotomy device 100. Preferably, both
`surfaces 212, 214 are adapted, at least in part, to engage
`mechanically surfaces adjacent thereto. Further, in the illus
`trated embodiment of FIG. 4A, the surfaces 212, 214 are
`planar. In other embodiments, other forms of the principal
`surfaces 212, 214 are possible. For example, the principal
`surfaces 212, 214 can be, at least in part, curved.
`The substantially Wedge-shaped body 210 also has a
`cannular opening 252 extending along drive axis 216.
`Preferably, the cannular opening 252 has a diameter (Do)
`ranging from about 1 mm to about 4 mm, and more
`preferably from about 2 mm to about 3 mm.
`The height and length and angle of the substantially
`Wedge-shaped body 210 of the osteotomy device 200 are
`substantially the same as the corresponding dimensions of
`the substantially Wedge-shaped body 110 of the osteotomy
`device 100 described above and illustrated in FIG. 1B.
`The diameter and length and angle of the body 210 of the
`osteotomy device 200 are substantially the same as the
`corresponding dimensions of the body 110 of the osteotomy
`device 100 described above and illustrated in FIG. 1B.
`Moreover, like the body 110 described above, the body 210
`can be holloW and further, can include holes on the pri