United States Patent [19]
`Bonutti
`
`US006099531A
`[11] Patent Number:
`[45] Date of Patent:
`
`6,099,531
`Aug. 8,2000
`
`[54] CHANGING RELATIONSHIP BETWEEN
`BONES
`
`[76] Inventor: Peter M. Bonutti, 1303 W. Evergreen
`PlZ., Effingham, Ill. 62401
`
`[21] Appl. No.: 09/137,443
`[22]
`Filed:
`Aug. 20, 1998
`
`[51] Int. Cl.7 ...................................................... .. A61F 5/00
`[52] US. Cl. ............................... .. 606/87; 606/88; 623/17;
`623/19
`[58] Field of Search ................................ .. 606/87, 86, 88,
`606/89, 75, 76, 77, 60, 61, 62; 623/17,
`19
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5/1985 Mittelmeier et a1. .
`4,516,276
`5/1991 Kuslich.
`5,015,255
`6/1991 Ray et 211..
`5,026,373
`5,258,031 11/1993 Salib et a1. .............................. .. 606/61
`5,360,450 11/1994 Giannini .................................. .. 606/77
`5,601,565
`2/1997 Huebner.
`5,609,635
`3/1997 Michelson ............................... .. 623/17
`5,620,448
`4/1997 Puddu .
`5,669,909
`9/1997 Zdeblick et a1. .
`5,766,251
`6/1998 Koshino .
`5,906,616
`3/1999 Pavlov et a1. ........................... .. 606/61
`
`Primary Examiner—Michael BuiZ
`Assistant Examiner—Lien Ngo
`Attorney, Agent, or Firm—Tarolli, Sundheim, Covell,
`Tummino & SZabo L.L.P.
`
`[57]
`
`ABSTRACT
`
`To change a spatial relationship between two or more bones
`in a patient’s body, a wedge member is moved into a joint
`between the bones. As the wedge member enters the joint,
`pivotal movement occurs between the bones to change the
`orientation of the bones relative to each other. The wedge
`member may have a circular cross sectional con?guration
`and be moved into the joint by rotating the wedge member
`about an axis which extends between a thin leading edge
`portion and a thick trailing edge portion of the wedge
`member. Alternatively, the wedge member may have a
`cam-shaped con?guration and be rotated through less than a
`revolution to apply force against the bones. The wedge
`member may have a porous construction which enables bone
`to grow through the wedge member and immobilize the
`joint. The wedge member may be coated with and/or contain
`bone growth promoting material. The wedge member may
`be connected to only one of the bones or may be connected
`to two adjacent bones. If the wedge member is connected to
`only one bone, the joint may be capable of being ?exed after
`the wedge member is inserted into the joint.
`
`129 Claims, 9 Drawing Sheets
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`1 of 29
`
`

`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`2 of 29
`
`

`
`U.S. Patent
`
`Aug. 8,2000
`
`Sheet 2 of9
`
`6,099,531
`
`64
`
`44
`
`I)
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`3 of 29
`
`

`
`U.S. Patent
`
`Aug. 8,2000
`
`Sheet 3 of9
`
`6,099,531
`
`76
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`4 of 29
`
`

`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`5 of 29
`
`

`
`U.S. Patent
`
`Aug. 8,2000
`
`Sheet 5 of9
`
`6,099,531
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`6 of 29
`
`

`
`U.S. Patent
`
`Aug. 8,2000
`
`Sheet 6 of9
`
`6,099,531
`
`126
`
`d 6 7
`
`34d
`
`d 8 7
`
`Iii)
`
`-
`
`,
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`7 of 29
`
`

`
`U.S. Patent
`
`Aug. 8,2000
`
`Sheet 7 of9
`
`6,099,531
`
`2e
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`8 of 29
`
`

`
`U.S. Patent
`
`Aug. 8,2000
`
`Sheet 8 of9
`
`6,099,531
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`9 of 29
`
`

`
`U.S. Patent
`
`Aug. 8,2000
`
`Sheet 9 of9
`
`6,099,531
`
`30h
`
`30h
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`10 of 29
`
`

`
`6,099,531
`
`1
`CHANGING RELATIONSHIP BETWEEN
`BONES
`
`BACKGROUND OF THE INVENTION
`
`2
`One embodiment of the Wedge member has major side
`surfaces extending betWeen thick and thin end portions of
`the Wedge member. The Wedge member is moved into the
`joint With the thin end portion leading. As the Wedge
`member is moved into the joint, the thick trailing end portion
`of the Wedge member expands the joint.
`In another embodiment of the invention, the Wedge mem
`ber is rotated relative to the joint to expand the joint. The
`Wedge member may have a circular cross sectional con?gu
`ration and an external thread convolution Which extends
`from a thin leading end of the Wedge member to a thick
`trailing end of the Wedge member. The Wedge member is
`pressed into the joint and rotated to cause the Wedge member
`to expand the joint.
`In another embodiment of the invention, the Wedge mem
`ber has surface areas Which are relatively close together and
`other surface areas Which are relatively far apart. The Wedge
`member is moved into the joint With the surface areas Which
`are close together engaging the adjacent bones. The Wedge
`member is then rotated to apply force against the adjacent
`bones to expand the joint. The Wedge member may be
`rotated about its central axis to apply forced against the
`bones and expand the joint. Alternatively, the Wedge mem
`ber may be rotated about a location Where the Wedge
`member engages one of the bones.
`Regardless of Which embodiment of the Wedge member is
`selected, the Wedge member may be used With any one of the
`many different bones and joints in a patient’s body. The
`Wedge member may be utiliZed at joints in a patient’s Wrist,
`ankle, hand, foot, back or other portions of the patient’s
`body. The Wedge member may be particularly advantageous
`When a joint betWeen vertebrae in patient’s back is to be
`immobiliZed. One or more Wedge members may be used to
`expand a joint and transmit force betWeen bones.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`The foregoing and other features of the present invention
`Will become more apparent from the folloWing description
`taken in connection With the accompanying draWings
`Wherein:
`FIG. 1 is a schematic illustration depicting the spatial
`relationship betWeen bones at a joint in a patient’s body;
`FIG. 2 is a schematic illustration depicting the manner in
`Which a Wedge member is inserted into the joint betWeen the
`bones of FIG. 1 to expand a portion of the joint and change
`the spatial relationship betWeen the bones;
`FIG. 3 is a schematic illustration of another embodiment
`of the invention in Which the joint of FIG. 1 is ?exed after
`the Wedge member has been inserted into the joint and
`connected With only one of the bones;
`FIG. 4 is a schematic illustration depicting an alternative
`manner of inserting the Wedge member into the joint
`betWeen the bones of FIG. 1;
`FIG. 5 is a schematic pictorial illustration of the Wedge
`member of FIGS. 2 and 3;
`FIG. 6 is a plan vieW further illustrating the construction
`of the Wedge member of FIG. 5;
`FIG. 7 is a side vieW, taken generally along the line 7—7
`of FIG. 6, of the Wedge member of FIG. 5;
`FIG. 8 is an enlarged fragmentary schematic sectional
`vieW depicting the manner in Which the Wedge member of
`FIGS. 5—7 is positioned, as shoWn in FIG. 2, in a joint
`betWeen bones;
`FIG. 9 is a fragmentary schematic sectional vieW, gener
`ally similar to FIG. 8, but on a reduced scale, illustrating an
`embodiment of the invention in Which the Wedge member is
`porous;
`
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`The present invention relates to a neW and improved
`method of changing a spatial relationship betWeen bones
`Which are interconnected at a joint in a patient’s body.
`It has previously been suggested that joints betWeen bones
`be fused, that is, surgically immobilized, to promote patient
`comfort. Thus, US. Pat. No. 5,026,373 suggests that a
`fusion cage be positioned betWeen adjacent vertebrae. Per
`forations are formed in the cage. The cage is packed With a
`bone-inducing substance. A method for immobiliZing ver
`tebrae is also disclosed in US. Pat. No. 5,015,255.
`It has previously been suggested that the spatial relation
`ship betWeen portions of a bone in a patient’s body be
`changed to correct deformities. This may be done by remov
`ing a Wedge-shaped piece of bone in the manner disclosed
`in US. Pat. No. 5,601,565.
`Another method of changing the spatial relationship
`betWeen portions of a bone in a patient’s body includes
`forming a slot in the bone. A forked Wedge tool is inserted
`into the slot. Aplate is then placed in a central opening in the
`forked Wedge tool and positioned against the bone. The plate
`is secured to the bone. The forked Wedge tool is then
`removed from the opening. This method of changing the
`spatial relationship betWeen portions of a bone in a patient’s
`body is disclosed in US. Pat. No. 5,620,448.
`A method and apparatus for use in changing a spatial
`relationship betWeen portions of a bone in a patient’s body
`is also disclosed in co-pending US. patent application Ser.
`No. 09/109,126, ?led Jun. 30, 1998 by Peter M. Bonutti and
`entitled Method And Apparatus For Use In Operating On A
`Bone. This application discloses the use of a Wedge member
`35
`to expand a slot formed in a bone. The Wedge member is
`porous and may be coated With and/or contain bone groWth
`promoting material. The Wedge member may have a con
`?guration Which corresponds to a con?guration of a portion
`of the bone Which is engaged by the Wedge member.
`Alternatively, the Wedge member disclosed in the aforemen
`tioned application Ser. No. 09/109,126 may have a circular
`cross sectional con?guration With an external thread convo
`lution to enable the Wedge member to be moved into an
`opening in a bone by rotating the Wedge member.
`
`40
`
`45
`
`SUMMARY OF THE INVENTION
`AneW and improved method and apparatus is provided to
`change a spatial relationship betWeen bones Which are
`interconnected at a joint in a patient’s body. When this is to
`be done, an opening is formed in a portion of the patient’s
`body to expose the joint interconnecting the bones. One of
`the bones is moved relative to the other by expanding at least
`a portion of the joint With a Wedge member. The Wedge
`member is moved into the joint and applies force against the
`bones. The opening is closed With the Wedge member still
`disposed in the joint betWeen the bones. Force is then
`transmitted betWeen the bones through the Wedge member to
`maintain the joint in an expanded condition.
`If the joint is to be ?exed after being expanded by the
`Wedge member, the Wedge member may be connected With
`only one of the bones. Alternatively, if the joint is to be
`immobiliZed (fused) after inserting the Wedge member, the
`Wedge member may be ?xedly connected With the bones
`interconnected at the joint. The Wedge member may be
`porous and may be coated With and/or contain bone groWth
`promoting material.
`
`55
`
`60
`
`65
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`11 of 29
`
`

`
`3
`FIG. 10 is a fragmentary schematic sectional vieW, gen
`erally similar to FIG. 9, illustrating an embodiment of the
`Wedge member Which is porous and has a chamber Which
`holds bone groWth promoting material;
`FIG. 11 is a fragmentary schematic sectional vieW, gen
`erally similar to FIGS. 8—10, illustrating the manner in
`Which the Wedge member of FIG. 3 is connected With only
`one bone to enable the joint betWeen bones to be ?exed;
`FIG. 12 is a schematic illustration depicting the manner in
`Which a rotatable Wedge member is moved into a joint
`betWeen bones;
`FIG. 13 is a schematic illustration depicting the Wedge
`member of FIG. 12 after the Wedge member has been rotated
`to expand a portion of the joint betWeen the bones;
`FIG. 14 is an enlarged fragmentary schematic sectional
`vieW, taken generally along the line 14—14 of FIG. 12,
`illustrating the relationship of the rotatable Wedge member
`to the bones prior to rotation of the Wedge member;
`FIG. 15 is an enlarged fragmentary schematic sectional
`vieW, taken generally along the line 15—15 of FIG. 13,
`illustrating the relationship of the rotatable Wedge member
`of FIG. 14 to the bones after rotation of the Wedge member;
`FIG. 16 is a fragmentary schematic sectional vieW, taken
`generally along the line 16—16 of FIG. 15, illustrating the
`manner in Which the rotatable Wedge member is connected
`With the bones;
`FIG. 17 is a fragmentary schematic sectional vieW, gen
`erally similar to FIG. 16, illustrating an embodiment of the
`rotatable Wedge member Which is porous;
`FIG. 18 is a fragmentary sectional vieW, generally similar
`to FIG. 14, illustrating the relationship betWeen the bones at
`a joint When another embodiment of the rotatable Wedge
`member is in the initial orientation illustrated in FIG. 12
`relative to the bones;
`FIG. 19 is a fragmentary schematic sectional vieW, gen
`erally similar to FIG. 15, illustrating the relationship of the
`rotatable Wedge member of FIG. 18 to the bones after the
`Wedge member has been rotated;
`FIG. 20 is a fragmentary schematic sectional vieW, taken
`generally along the line 20—20 of FIG. 19, further illus
`trating the construction of the rotatable Wedge member;
`FIG. 21 is a schematic illustration, generally similar to
`FIG. 2, depicting the manner in Which another embodiment
`of the rotatable Wedge member is moved into a joint betWeen
`bones in a patient’s body;
`FIG. 22 is an enlarged schematic pictorial illustration of
`the rotatable Wedge member of FIG. 21;
`FIG. 23 is a fragmentary schematic illustration, generally
`similar to FIG. 2, depicting the manner in Which another
`embodiment of the Wedge member is moved into a joint
`betWeen bones in a patient’s body; and
`FIG. 24 is an enlarged fragmentary schematic sectional
`vieW, taken generally along the line 24—24 of FIG. 23,
`further illustrating the relationship of the Wedge member to
`the bones.
`
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`15
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`45
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`55
`
`DESCRIPTION OF SPECIFIC PREFERRED
`EMBODIMENTS OF THE INVENTION
`
`General Description
`An upper or ?rst bone 30 in a patient’s body is illustrated
`schematically in FIG. 1. A loWer or second bone 32 is
`connected With the upper bone 30 at a joint 34. The bones
`30 and 32 and joint 34 have been illustrated schematically to
`
`65
`
`6,099,531
`
`4
`represent any one of many bones and joints in a patient’s
`body. Thus, the bones 30 and 32 and joint 34 may be
`disposed in a patient’s hand, foot, back, or other portion of
`the patient’s body. It should be understood that the bones 30
`and 32 and joint 34 have been illustrated schematically in
`FIG. 1 as being representative of any one of the many joints
`in a human patient’s body and it is not intended to limit the
`present invention to any particular joint.
`In order to correct deformities, improve patient comfort or
`other reasons, it may be desired to change the spatial
`relationship betWeen the upper and loWer bones 30 and 32.
`Thus, it may be desired to change the angular relationship
`betWeen longitudinal central axes 38 and 40 from the
`relationship illustrated schematically in FIG. 1 to the rela
`tionship illustrated schematically in FIG. 2.
`In order to change the spatial relationship betWeen the
`longitudinal central axes 38 and 40 of the bones 30 and 32,
`an opening is formed in a portion of the patient’s body to
`expose the joint 34. AWedge member 44 (FIG. 2) is moved
`into the exposed joint 34 betWeen the bones 30 and 32. The
`Wedge member 44 applies force against the outer side
`surfaces of the bones 30 and 32 at the joint 34 to expand a
`portion of the joint.
`As the Wedge member 44 is moved into the joint 34, in the
`manner illustrated schematically in FIG. 2, the loWer bone
`32 is pivoted relative to the upper bone 30 about an axis
`extending through the joint 34. This changes the angular
`orientation of the loWer bone 32 relative to the upper bone
`30. Thus, the spatial relationship betWeen the upper and
`loWer bones 30 and 32 is changed from the spatial relation
`ship illustrated in FIG. 1 to the spatial relationship illustrated
`in FIG. 2 by the Wedge member 44.
`In FIG. 2, the Wedge member 44 has been illustrated
`schematically as having an extent Which corresponds to
`approximately one-half of the extent of the joint 34.
`HoWever, it is contemplated that the Wedge member 44
`could have an extent Which is either smaller than or greater
`than the extent illustrated in FIG. 2. Thus, the distance
`betWeen the thick and thin end portions of the tapered Wedge
`member 44 may be less than one-half of the Width of the
`joint 34. Similarly, the distance betWeen the thin leading end
`portion and thick trailing end portion of the Wedge member
`44 may be greater than one-half of the Width of the joint 34.
`The Wedge member 44 may be relatively narroW, as
`measured along the thin end portion of the Wedge member.
`This Would enable a plurality of narroW Wedge members 44
`to be used to expand a single joint 34. If the Wedge member
`44 is relatively Wide, only a single Wedge member may be
`required to expand a joint 34, as shoWn in FIG. 2.
`In the embodiment of the invention illustrated in FIG. 2,
`the joint 34 is fused after the joint has been expanded by the
`Wedge member 44 to change the spatial relationship betWeen
`the bones 30 and 32. Thus, after the joint 34 has been
`expanded by the Wedge member 34, the joint is immobiliZed
`With the upper and loWer bones 30 and 32 in the spatial
`relationship illustrated in FIG. 2. When the Wedge member
`44 is utiliZed in association With joints betWeen vertebrae in
`a patient’s back, it is believed that it may be particularly
`advantageous to immobiliZe the joint 34.
`ImmobiliZation of the joint 34 may be accomplished by
`connecting the Wedge member 44 With both the upper bone
`30 and the loWer bone 32. ImmobiliZation of the joint 34
`may also be accomplished by the groWth of bone and/or
`other body tissue betWeen the tWo bones 30 and 32 at the
`joint 34. KnoWn bone groWth promoting materials may be
`provided at the joint 34 if desired. The bone groWth pro
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`12 of 29
`
`

`
`6,099,531
`
`5
`moting materials may include bone morphogenic proteins
`and/or other osteoinductive materials.
`In the embodiment of the invention illustrated in FIG. 3,
`the joint 34 is capable of being ?exed after the Wedge
`member 44 has been utiliZed to expand a portion of the joint.
`Thus, once the Wedge member 44 has been inserted into the
`joint 34, in the manner illustrated in FIG. 2, the patient may
`?ex the joint under the in?uence of force transmitted to the
`bones 32 and 30 from muscle tissue in the patient’s body.
`When the joint 34 is ?exed, as illustrated schematically in
`FIG. 3, the bone 32 moves aWay from the Wedge member 44.
`The Wedge member 44 is ?xedly connected to only the bone
`30. This alloWs the bone 32 to move aWay from the Wedge
`member. It is believed that it Will be particularly advanta
`geous to enable the joint 34 to be ?exed When the Wedge
`member is utiliZed to correct deformities occurring in hands,
`feet, Wrists or ankles of a patient. HoWever, it should be
`understood that the Wedge member could be attached to a
`single bone at any joint in a patient’s body Which is to be
`?exed after the Wedge member has been used to expand the
`joint.
`In the embodiment of the invention illustrated in FIGS.
`1—3, the Wedge member 44 has been shoWn as being moved
`into the joint 34 in a direction Which is perpendicular to an
`axis about Which the joint is ?exed. Thus, the Wedge
`member 44 is moved into the joint 34 (FIG. 2) in a direction
`perpendicular to the axis about Which the joint 34 is sche
`matically illustrated in FIG. 3 as being ?exed.
`In the embodiment of the invention illustrated in FIG. 4,
`the Wedge member 44 is inserted into the joint 34 in a
`direction parallel to the axis about Which the joint is nor
`mally ?exed. Thus, the Wedge member 44 is illustrated in
`FIG. 4 as being inserted into the joint 34 in a direction
`perpendicular to the plane of the draWing of the joint 34 in
`FIGS. 1 and 3. It should be understood that the Wedge
`member 44 could be inserted into a joint, such as the joint
`34, in any desired direction in order to obtain a desired
`expansion of the joint. Thus, the Wedge member 44 could be
`moved into the joint 34 along a path Which is neither
`perpendicular to or parallel to the axis about Which the joint
`is ?exed.
`After one or more Wedge members 44 have been posi
`tioned in a joint 34, in the manner previously explained, the
`opening in the patient’s body is closed. When the opening in
`the patient’s body is closed, the Wedge member 44 remains
`in the joint 34 betWeen the bones 30 and 32. The Wedge
`member 44 is formed of a rigid material Which is capable of
`transmitting force betWeen the bones 30 and 32 immediately
`after being positioned in the joint 34. Therefore, the Wedge
`member 44 is effective to maintain the changed spatial
`relationship, such as the spatial relationship illustrated in
`FIG. 2, betWeen the bones 30 and 32 during loading of the
`joint 34 immediately after positioning of the Wedge member
`in the joint.
`
`Wedge Member
`The Wedge member 44 (FIGS. 5—7) tapers from a thick
`end portion 50 to a thin end portion 52. The Wedge member
`44 has ?at upper and loWer major side surfaces 54 and 56
`(FIG. 7) Which slope toWard each other from the thick end
`portion 50 to the thin end portion 52. The major side surfaces
`54 and 56 intersect at the thin end portion 52. The pointed
`thin end portion 52 of the Wedge member 44 facilitates
`moving the Wedge member into the joint 34 betWeen the
`bones 30 and 32 (FIG. 2).
`In the illustrated embodiment of the Wedge member 44
`(FIGS. 5—7), the thick end portion 50 has an outer side
`
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`surface 60 Which forms a portion of a cylinder. The thin end
`portion 52 extends diametrically across the cylinder (FIG.
`6). Therefore, the Wedge member 44 has a semi-circular
`con?guration. HoWever, it should be understood that the
`con?guration of the upper and loWer major side surfaces 54
`and 56 of the Wedge member 44 corresponds to the con
`?guration of the joint With Which the Wedge member is to be
`associated.
`The semi-circular outer side surface 60 Will, for many
`joints at least, have an irregular con?guration other than the
`semi-circular con?guration illustrated in FIGS. 5 and 6. This
`enables the outer side surface 60 to be aligned With the outer
`side surfaces of the bones 30 and 32 at the joint 34. Since
`most bones do not have outer side surfaces Which form
`portions of a semi-circular, it is believed that in all
`probability, the Wedge member 44 Will have an outer side
`surface 60 With an irregular con?guration rather than the
`semi-circular con?guration illustrated in FIG. 5.
`The extent of the thin end portion 52 of the Wedge
`member 44 may be substantially less than shoWn in FIG. 6.
`Thus, the extent of the thin end portion 52 of the Wedge
`member 44 may be less than one-half of the extent shoWn in
`FIG. 6. This Would result in the major side surfaces 54 and
`56 of the Wedge member 44 having a generally U-shaped
`con?guration. Parallel triangular side surfaces Would extend
`betWeen the outer side surface 50 of the Wedge member 44
`and opposite ends of the thin end portion 52. These trian
`gular side surfaces Would be spaced from opposite sides of
`the joint 34 When the Wedge member 44 is inserted into the
`joint.
`When the Wedge member 44 has a relatively narroW,
`generally U-shaped con?guration, a plurality of the Wedge
`members may be inserted into a single joint 34 (FIG. 1).
`When a plurality of narroW Wedge members 44 are used at
`one joint 34, the Wedge members may have different con
`?gurations. Thus, the Wedge members 44 may have different
`lengths and/or different angles betWeen the upper and loWer
`major side surfaces 54 and 56 of the Wedge members.
`The upper and loWer major side surfaces 54 and 56 of the
`Wedge member 44 slope toWard each other from the thick
`end portion 50 to the thin end portion 52 of the Wedge
`member. It is contemplated that a plurality of Wedge mem
`bers 44 having different acute angles betWeen the upper and
`loWer major side surfaces 54 and 56 may be provided. This
`Would enable a surgeon to select the Wedge member 44
`having a desired thickness at the thick end portion 50. Thus,
`if a surgeon determines that a joint should be expanded to
`either a lesser or greater amount than Would be accom
`plished by a Wedge member having one angle, the surgeon
`may select a Wedge member having a different angle and
`thickness to effect the desired expansion of the joint 34. It is
`also contemplated that a plurality of Wedge members 44
`having different Widths, as measured along the thin end
`portion 52, may be provided.
`The acute angle betWeen the ?at upper and loWer major
`side surfaces 54 and 56 is determined by the extent to Which
`the joint 34 is to be expanded, that is, the extent to Which the
`spatial relationship betWeen the bones 30 and 32 is to be
`changed by insertion of the Wedge member 44. Of course,
`the speci?c angle provided betWeen the upper and loWer
`major side surfaces 54 and 56 of the Wedge member 44 Will
`vary depending upon the siZe of the joint With Which the
`Wedge member is used and the extent to Which the spatial
`relationship betWeen the bones 30 and 32 is to be changed
`by use of the Wedge member. In addition, the length and
`Width of the Wedge member 44 inserted into a particular
`
`DePuy Synthes Sales, Inc. & Depuy Synthes Products, Inc.
`Exhibit 1001
`13 of 29
`
`

`
`6,099,531
`
`7
`joint Will be determined by the extent to Which the joint is
`to be expanded and the total number of Wedge members to
`be inserted into the joint.
`It is believed that it may be desired to have the acute angle
`betWeen the upper and loWer major side surfaces 54 and 56
`(FIG. 6) of the Wedge member 44 Within a range betWeen
`one and thirty degrees. Although it is difficult to be certain,
`it is believed that it may be preferred to have the acute angle
`betWeen the upper and loWer major side surfaces 54 and 56
`of the Wedge member 44 vary Within a range of ?ve degrees
`to tWenty degrees. It should be understood that the foregoing
`speci?c ranges of siZes for the angle betWeen the upper and
`loWer major side surfaces 54 and 56 of the Wedge member
`44 have been set forth herein for purposes of clarity of
`description and it is contemplated that the angle betWeen the
`upper and loWer major side surfaces 54 and 56 may be any
`one of many angles other than these speci?c angles.
`The siZe of the Wedge member relative to a speci?c joint
`34 may vary depending upon the deformity to be corrected.
`Thus, a narroW Wedge member 44 may have a thin end
`portion 52 (FIG. 6) With a length Which is relatively small
`compared to the Width of a joint. The thin end portion 52 of
`the narroW Wedge member 44 could have a length of less
`than one fourth the distance across the joint. This Would
`result in opposite ends of the thin end portion 52 being
`spaced from the periphery of the joint. It is contemplated
`that a plurality of narroW Wedge members 44 could be used
`to expand a single joint.
`The Wedge member 44 may be formed of any one of many
`different knoWn materials Which are compatible With a
`patient’s body. For example, the Wedge member may be
`formed of human or animal bone, stainless steel, tantalum,
`a porous ceramic, or a polymeric material. If desired, the
`Wedge member may be formed of a biodegradable material.
`HoWever, it is preferred to have the Wedge member 44
`formed of a rigid material Which is capable of enabling force
`to be transmitted through the joint 34 betWeen the bones 30
`and 32 immediately after installation of the Wedge member
`in the joint.
`In the embodiment of the invention illustrated in FIG. 2,
`the joint 34 is immobiliZed. To facilitate immobiliZation of
`the joint 34, the Wedge member 44 is ?xedly connected With
`the bone 30 and With the bone 32. To facilitate ?xedly
`connecting the Wedge member 44 With the bones 30 and 32,
`a pair of passages 64 and 66 are formed in the Wedge
`member 44 (FIGS. 6 and 7). When the Wedge member 44 is
`positioned in the joint 34 (FIG. 2), suitable fasteners, that is
`screWs 70 and 72 extend through the passages 64 and 66 into
`the bones 30 and 32 in the manner indicated schematically
`in FIG. 8. The screWs 70 and 72 engage hard cortical outer
`layers 76 and 78 of the bones 30 and 32. If desired, the
`screWs 70 and 72 could extend into the relatively soft
`cancellous bone 80 and 82.
`Although the Wedge member 44 has been illustrated in
`FIG. 8 as being connected With the bones 30 and 32 by a pair
`of screWs 70 and 72, it should be understood that the Wedge
`member 44 may be connected With only one of the bones 30
`or 32 by only one of the screWs 70 or 72 if desired. For
`example, if the Wedge member 44 is connected With the
`bone 30 by the screW 70, the joint 34 could be ?exed in the
`manner illustrated schematically in FIG. 3, after the Wedge
`member 44 has been moved into the joint.
`
`15
`
`25
`
`35
`
`45
`
`55
`
`Positioning of Wedge Member
`When the Wedge member 44 is to be inserted in to the
`joint 34 to change the spatial relationship betWeen the bones
`
`65
`
`8
`30 and 32 in the manner illustrated schematically in FIG. 2,
`a location for insertion of the Wedge member into the joint
`34 is selected by a surgeon. The speci?c location at Which
`the Wedge member 44 is inserted into the joint 34 to expand
`the joint Will be selected by the surgeon as a function of the
`desired result from a particular operation. In addition, the
`siZe of the Wedge member 44 Will be selected by the surgeon
`as a function of the joint and the result to be obtained from
`a particular operation.
`The con?guration of the Wedge member 44 Will be
`selected by the surgeon as a function of the location Where
`the Wedge member is to be inserted into the joint 34. The
`Wedge member 44 may be relatively Wide and have a long
`thin end portion 52, as shoWn in FIG. 6, to enable the thin
`end portion to extend betWeen opposite sides of the joint.
`Alternatively, the Wedge member 44 may be relatively
`narroW and have a thin end portion 52 Which is short. If this
`is done, the thin end portion 52 Would not extend betWeen
`opposite sides of the joint 34. A plurality of the narroW
`Wedge members 44 may be inserted into a single joint 34 to
`expand the joint and transmit force betWeen the bones 30
`and 32.
`The surgeon makes an incision in soft body tissue sur
`rounding the joint 34 to expose the joint. Once the joint 34
`has been exposed, the thin end portion 52 (FIGS. 5 and 6)
`of the Wedge member 44 is moved into the joint 34. When
`the Wedge member 44 is to be inserted into a joint in the
`manner illustrated schematically in FIG. 2, the longitudinal
`central axis of the thin end portion 52 of the Wedge member
`is aligned With an axis about Which the joint pivots. The
`Wedge member is then moved into the joint 34 along a linear
`path Which extends perpendicular to the axis about Which
`the joint pivots. The Wedge member 44 is moved into the
`joint 34 by applying force against the trailing thick end
`portion 50 of the Wedge member.
`As the Wedge member 44 is moved into the joint 34, the
`upper major side surface 54 (FIGS. 5 and 7) of the Wedge
`member slides along an outer side surface 88 (FIG. 8) of the
`outer layer 76 of hard cortical bone. The loWer major side
`surface 56 of the Wedge member 44 slides along an outer
`side surface 90 of the outer layer 78 of hard cortical bone.
`The outer side surfaces 88 and 90 of the bones 30 and 32
`are in their naturally occurring conditions. Thus, the outer
`side surfaces 88 and 90 of the bones 30 and 32 are not cut
`aWay to prepare for insertion of the Wedge member 44 into
`the joint 34. HoWever, it should be understood that under
`certain circumstances that it may be necessary to abrade or
`otherWise cut the outer side surfaces 88 and 90 of the outer
`layers 76 and 78 of hard cortical bone to prepare the joint 34
`for insertion of the Wedge member 44.
`As the thin leading end portion 52 (FIG. 8) of the Wedge
`member 44 moves into the joint 34, the upper and loWer
`major side surfaces 54 and 56 apply force against the outer
`side surfaces 88 and 90 on the bones 30 and 32. As this
`occurs, the joint 34 is expanded. As the joint 34 is expanded,
`the bone 32 is pivoted, relative to the bone 30, from the
`initial orientation, shoWn in FIG. 1, to the improved orien
`tation shoWn in FIG. 2. As this occurs, the longitudinal
`central axis 40 of the bone 32 moves relative to the longi
`tudinal central axis 38 of the bone 30. Therefore, the angular
`relationship betWeen the bones 30 and 32 is changed by
`expansion of a portion of the joint 34 by insertion of