0 PIC
`
`OFFICE- DE. LA PROPRrlrrt~
`
`lNTELLECTlHH.LE DU CANADA
`
`C I P 0
`
`CANADIAN INTE!.LECTlJA!.
`
`PROPERTY OFFICE
`
`Onawa Hull KIA OC9
`
`(21)
`
`(A1)
`
`2,121,001
`
`(22}
`
`( 43)
`
`1994/04/11
`
`1994/10/22
`
`5
`(51) INTL.CL. A61F-002/44
`
`(19) (CA) APPLICATION FOR CANADIAN PATENT (12)
`
`(54) Intervertebral Prosthesis and a Process for Implanting
`Such a Prosthesis
`
`(72) Baumgartner, Walter - Switzerland ;
`
`(71) Sulzer Medizinaltechnik AG - switzerland ;
`
`(30)
`
`(EP) 93810291.0 1993/04/21
`
`(57) 18 Claims
`
`(11
`
`..
`0 m
`..
`N
`~
`w
`
`(11
`
`Notice:
`
`This application is as filed and may therefore contain an
`incomplete specification.
`
`1+1
`
`Industria Canada
`
`Industry Canada
`
`3488
`
`Canada
`
`,''I
`
`STRYKER EXHIBIT 1008, pg. 1
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01433
`
`
`
`OFFICE- DE. LA PROPRrlrrt~
`
`lNTELLECTlHH.LE DU CANADA
`
`C I P 0
`
`CANADIAN INTE!.LECTlJA!.
`
`PROPERTY OFFICE
`
`Onawa Hull KIA OC9
`
`(21)
`
`(A1)
`
`2,121,001
`
`(22}
`
`( 43)
`
`1994/04/11
`
`1994/10/22
`
`5
`(51) INTL.CL. A61F-002/44
`
`(19) (CA) APPLICATION FOR CANADIAN PATENT (12)
`
`(54) Intervertebral Prosthesis and a Process for Implanting
`Such a Prosthesis
`
`(72) Baumgartner, Walter - Switzerland ;
`
`(71) Sulzer Medizinaltechnik AG - switzerland ;
`
`(30)
`
`(EP) 93810291.0 1993/04/21
`
`(57) 18 Claims
`
`(11
`
`..
`0 m
`..
`N
`~
`w
`
`(11
`
`Notice:
`
`This application is as filed and may therefore contain an
`incomplete specification.
`
`1+1
`
`Industria Canada
`
`Industry Canada
`
`3488
`
`Canada
`
`,''I
`
`STRYKER EXHIBIT 1008, pg. 1
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01433
`
`
`
`Abstract
`
`2121001
`
`An implant consisting of several support members (7), which
`are produced from an elastic plastic, is provided as a
`replacement for a part, which is no
`longer capable of
`bearing loads, of the core region of an intervertebral disk
`(3)~ The support members (7) are inserted one after the
`other into a central cavity (5) constructed in the core
`region by means of a
`tube (6) passing through an outer
`annular region (4) of the intervertebral disk (3) until said
`cavity is filled. When the cavity (5) becomes clogged with
`the filling members (7),
`they become deposited on the
`boundary walls of the annular region (4) and against one
`another
`and are elastically deformed under stress.
`Accordingly a universal implant which can be adapted to
`cavities (5) of any shape, and which forms a relatively
`compact, elastic support structure, can be achieved.
`
`(Fig. l)
`
`5
`
`10
`
`15
`
`20
`
`STRYKER EXHIBIT 1008, pg. 2
`
`
`
`1
`
`2121001
`
`P.6568/Tg/IS
`
`SULZER Medizinaltechnik AG. CH-8404 Winterthur. Switzerland
`
`An interY9rtebral prosthesis and a process
`for implanting such a prQsthes~
`
`The invention relates to an intervertebral prosthesis as
`specified in the precharacterising clause of Claim 1 and
`also to a process for implanting such a prosthesis.
`
`type
`the mentioned
`intervertebral prostheses of
`Known
`contain implants for intervertebral disks, which via a tube
`can be introduced through the outer ring (anulus fibrosus)
`.of the intervertebral disk into its core region (nucleus
`pulposus), in order to achieve a bearing action in the
`direction of the main load. Thus EP-A-0 453 393 shows a
`hollow member which can be introduced into the core region
`of the intervertebral disk, and which can be coiled in the
`shape of a spiral and which can be filled in the coiled
`state with an incompressible fluid. Before the insertion of
`such an implant, the core region of the intervertebral disk,
`which is no longer capable of bearing loads, has to be
`cleared out with au~iliary tools through the hollow tube, in
`order to replace the no longer load-bearing material by the
`implant. As the surgeon has to work with determined implant
`sizes, he is forced to produce a matching cavity in the core
`region of the intervertebral disk.
`The known
`implant
`requires a relatively expensive design of the hollow member,
`in order to guarantee a permanent tightness against the
`egress of fluid, which is required if the implant is to work
`optimally.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1008, pg. 3
`
`
`
`2121001
`
`2
`
`The invention is intended to counteract these disadvantages.
`
`The object of the invention is to create a universal, simple
`to apply implant, which can be used as a support member for
`very varied cavities formed at random.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`This object is achieved in accordance with the invention in
`that the
`implant contains at least three elastically
`deformable support members which can be inserted into the
`central cavity and can be positioned therein.
`
`One advantage of the invention lies in that when creating
`the cavity, the surgeon only has to remove the material of
`the nucleus which is no longer capable of load bearing and
`that the quantity of support members to be inserted is
`necessarily established when
`the support members are
`inserted. The implant, which consists of support members
`which can be positioned spaced apart or touching one another
`and which can be made from an optional elastic material well
`tolerated by the body, is consequently suitable for every
`intervertebral disk. When
`the central cavity becomes
`clogged with the support members, they abut the boundary
`walls, so that a universal transfer of compressive forces
`and an optimal distribution in the central cavity can be
`achieved.
`During
`loading
`the
`support members are
`elastically deformed, and the compressive forces acting in
`the direction of the member axis are converted into edge
`stresses in the anulus fibrosus.
`
`30
`
`A process according to the invention for implanting such an
`intervertebral prosthesis is the subject matter of Claim 15.
`
`Refinements of the subject matter of the invention are given
`in the dependent claims.
`
`35
`
`to the
`According to a preferred embodiment according
`invention, the support members can be made from an elastic
`
`STRYKER EXHIBIT 1008, pg. 4
`
`
`
`2121001
`
`3
`
`from a sui table
`implant made
`plastic. Accordingly an
`plastic material which can be well tolerated by the body,
`which can be manufactured with
`low expenditure and is
`permanently dimensionally stable, can be simply obtained.
`
`The support members may preferably be designed in the form
`of rotational solids, which enable an optimal, uniform
`transfer of the compressive forces.
`In this respect
`spherical designs are particularly advantageous.
`
`The packing density can be increased by the use of support
`members having different dimensions. By providing ducts in
`the support members, cavities can be produced, which in
`contrast to solid members permit a defined, greater elastic
`deformation.
`In order to control the rigidity of the
`implant, a mixture of solid members and hollow members can
`be inserted. For the support members themselves there is a
`plurality of shapes, which ranges from the non-oriented
`spherical shape via lenticular and bean-shaped members to
`oblong, cylindrical, sausage-shaped members.
`
`Several support members can be connected in chains to form
`a string-like, flexible support, whereby
`the distance
`between two support members advantageously corresponds at
`least ·to the diameter of one of the support members, in
`order to enable deviations of 180" when inserting the
`support members. Single-piece chains made from the same
`material are also possible,
`in which
`the
`flexible
`intermediate pieces are designed with a correspondingly thin
`shape.
`It is also possible to space support members with
`flexible tubing. The chain shape of the support members has
`firstly the advantage that a support member in a chain can
`not easily leave the central cavity through an aperture and
`secondly that during fillinq the operation can not be
`reversed without great time loss by withdrawing the chain.
`A similar retention action can be achieved on individual
`support members having elastically deformable expansion
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1008, pg. 5
`
`
`
`2121001
`
`4
`
`tube are
`the
`through
`elements, which during insertion
`deformed in the longitudinal direction and during entry into
`the central cavity spring back and assume a larger cross
`section.
`
`in a
`A further method of depositing support members
`determined orientation lies in adapting the cross section of
`the
`tube
`to guide faces of
`the support members and
`depositing the support members purposefully -
`roughly like
`an insect laying its eggs - on determined sites of the
`central cavity, by the support member being guided in the
`tube and being ejected with a plunger. A lenticular member
`may be deposited so that, for example, its flat sides are
`directed against the adjacent vertebrae.
`
`If the support members comprise a positional indicator,
`roughly in the form of an inclusion made from a material
`which is visible under X-ray examination, such as tantalum,
`for example, their depositing and subsequent changes in
`position can be controlled.
`
`Polyurethane, for example, is suitable as the plastic for
`such support members. The support members may also be made
`from another material# e.g. a hydrogel.
`Corresponding
`support members may also ·be made from a suitable foam ..
`Another design, in which each support member is formed by a
`cocoon-type coil consisting of a plastic thread or a metal
`thread, is also conceivable.
`
`In order to increase the safety for the insertion and
`retention the support members, before the insertion of the
`suppor't .members a bag made from a synthetic woven fabric or
`plastic film can be introduced through the tube into the
`central cavity, whereby the aperture of the bag remains
`outside the tube.
`The support members are now inserted
`through
`the aperture of
`this hag, which aperture is
`supported on the tube. When the central cavity and the bag
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`j
`~~i
`
`..
`
`STRYKER EXHIBIT 1008, pg. 6
`
`
`
`2121001
`
`5
`
`is filled with support members, the bag can be tied off with
`a clamp or wire, in order to prevent support members coming
`out.
`
`5
`
`Further features and. details can be gathered from the
`following description of exemplified 'embodiments of the
`in conjunction with the claims, represented
`invention,
`diagrammatically in the drawings.
`
`10
`
`Fig •. 1
`
`15
`
`Fig. 2
`
`20
`
`Fig. 3
`
`shows a body of a vertebra in a plan view
`with
`a
`cross
`section
`through
`an
`intervertebral disk 1 which contains an
`implant of support members, which can be
`supplied via a tube;
`
`a
`in
`intervertebral disk
`the
`shows
`longitudinal section along line II-II in
`Fig. l;
`
`a
`an
`through
`section
`cross
`shows
`intervertebral disk, having an implant in
`a modified embodiment;
`
`Fig. 3a
`
`shows a cross section through a bag with
`support members:
`
`Fig. 4a - 4e
`
`support
`embodiments of
`show various
`members cons·tructed in accordance with the
`invention:
`
`Fig. 5
`
`shows the support member shown in Fig. 4e
`in a position during insertion through a
`tube represented in a partial longitudinal
`section;
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1008, pg. 7
`
`
`
`2121001
`
`6
`
`Fig. 6, 7 and 8
`
`several
`implants consisting of
`show
`support members connected to one another,
`in different embodiments.
`
`10
`
`15
`
`5 According to the representation in Figures 1 and 2, an
`intervertebral disk 3 positioned between
`two vertebral
`bodies 1 comprises an intact outer annular region 4 of
`natural tissue, which surrounds a central core region.
`In
`the core region is formed a cavity 5, which was previously
`created by
`the
`removal of
`the core of
`the damaged
`intervertebral disk which is no longer load bearing - or a
`part thereof - and if necessary damaged parts of the outer
`annular region 4. The formation of the cavity 5 and the
`removal of the tissue parts which are no longer capable of
`load-bearing is performed in a known manner by a tubular
`guide part, as represented in the form of a tube 6, which,
`as for example in EP-A-0 453 393 mentioned at the beginning,
`is inserted, passing through an aperture 30 in the outer
`annular region 4, into the core region of the intervertebral
`disk 3 by a relatively slight engagement from the dorsal
`side between the vertebral bodies 1 and 2. A gouge is
`inserted into the core region through the inserted tube 6,
`by which the cavity 5 is created and the cut out tissue
`parts are removed.
`
`20
`
`25
`
`30
`
`35
`
`An intervertebral prosthesis in the form of an implant
`consisting of several support members 7, which can be
`inserted one after the other into the cavity 5, and which
`are made from an elastic plastic well tolerated by the body,
`e.g. polyurethane, is provided as a replacement for at least
`one part of the core region removed. The support members 7
`are constructed as rotational solids, and in the example
`represented in the form of balls, the dimensions of which
`are chosen so that they can be inserted through the tube 6
`into the cavity 5. The support members 7 are packed into
`the cavity 5, if necessary by means of a plunger 8, until
`the cavity is substantially filled by the support members 7
`
`STRYKER EXHIBIT 1008, pg. 8
`
`
`
`2121001
`
`7
`
`5
`
`resting against one another and the support members 5 form
`a new core region of the intervertebral disk 3 capable of
`the
`transfer of compressive forces.
`The number and
`dimensions of the support members 7 can be varied at random
`according to the dimensions given and the shape of the
`cavity 5 to be filled and the cross section of the tube 6.
`Thus for example a design is possible which requires fewer
`support members 7 than the design shown, e.g. three support
`members 7 designed in appropriate sizes 4
`The support
`10 members 7 can be designed with varying dimensions or, as
`represented, with the same diameters.
`A design is also
`possible with support members 7 disposed in a single layer,
`for example, which can be disposed at a distance or at
`varying distances from one another.
`
`15
`
`20
`
`25
`
`30
`
`35
`
`When the cavity is completely full, which can be monitored,
`for example, by a second tubular guide part, as represented
`in the form of a tube 6', which can be inserted from the
`right hand side in Figure 1 dorsally through an aperture 30'
`into the cavity 5, the tube 6 is or both tubes 6, 6' are
`withdrawn in a known manner from the annular region 4,
`whereby the through-duct - aperture 30 and 30' respectively
`-
`for the tube 6 and 6' respectively is closed accordingly
`in front of the last support member 7 inserted. This may be
`provided, in a manner still to be described, with retention
`means which make it difficult for support members to leave
`through the through-channel.
`
`An observation instrument 9 can be inserted through the tube
`6' to monitor the clearing of the cavity 5 and/or the
`implantation operation or an auxiliary instrument (not
`represented) can be inserted to assist the clearing and
`implantation process.
`It is obvious that instead of the
`tubes 6, 6' represented, other suitable protective and/or
`guide elements of any shape and design can also be used.
`
`STRYKER EXHIBIT 1008, pg. 9
`
`
`
`2121001
`
`8
`
`In Figure 3 the corresponding parts are provided with the
`same reference numbers. According to this embodiment the
`support members 7 can be disposed in a covering surrounding
`them, and in the representation in a bag 10, which is
`inserted in the empty state through the tube 6
`into the
`cavity 5 and is then filled with the support members 7
`through the aperture remaining outside the tube 6. The bag
`10 may be made from a woven fabric, a knitted fabric or a
`film made from an elastic plastic well tolerated by the
`body, e.g. also from polyethylene. When the bag 10 is
`filled and is connected to the support members 7 to form a
`compact,
`elastic
`implant
`sui table
`for
`transmitting
`compressive forces between the vertebral bodies l and 2, the
`bag 10 can be tied off by a sealing part 11, e.g. in the
`form of a clamp or, as shown in the drawings, a previously
`inserted wire loop, in order to keep the support members 7
`together. After this the end of the bag 10 is cut off and
`withdrawn together with the tube 6.
`
`As can.be seen in particular from Figure 3a, the bag 10 can
`be adapted to any desired shape of the cavity 5 to be filled
`according to the anatomical conditions prevailing.
`
`Numerous embodiments of support member 7 are possible.
`Thus, for example, ins·tead of rotational solids, designs
`with polyhedral support members 7 are possible. As shown in
`Figure 4a the spherical · support members 7 in the design
`represented - or at least one or some of the support members
`7 - may be designed with a closed cavity 12, which contain
`an insert 13 in the form of a spherical inclusion made from
`a material which is visible under X-ray examination, e.g6
`tantalum, as a positional indicator for the respective
`position of the support mel'nbers 7.. Designs without an
`insert 13 are possible, in which case a correspondin9ly
`greater elastic deformation of the support member can be
`achieved by the cavity 12.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1008, pg. 10
`
`
`
`As shown in Figure 4b, the or at least some of the support
`members 7 have different diameters D or Dl andjor are
`designed with a duct 14 passing through them, which is open, ·
`or as represented can be provided with a rod-shaped insert
`15 as a positional
`indicator, whereby
`the respective
`orientation of the insert 15 can be seen.
`
`As shown in Figure 4c, support members 7 can be designed
`with substantially cylindrical shapes rounded off at the
`ends, which can also be provided with a duct 14 andjor with
`a
`rod-shaped
`inclusion 15
`or for example with
`two
`corresponding inclusions, offset against one another in the
`axial direction of the support member 7.
`These support
`members 7 may also have different diameters D or 01 and/or
`different lengths L or Ll.
`
`As shown in Figure 4d, the or at least some of the support
`members 7 can be lenticular, and in the example represented
`in the shape of an ellipsoid, and can be accordingly
`designed with defined support:. surfaces 16, which permit the
`support members 7 to be deposited purposefully with the
`support faces 16 directed against the adjacent vertebral
`bodies l, 2. As can also be seen from Figure 4d, the tube
`6 can be designed with a corresponding cross section, which
`as represented is oval, and which forms guideways 17 for the
`support faces 16.
`
`As shown in Figure 4e, at least one of the support members,
`e. 9. the last support member 7 to be inserted into the
`cavity 5, can be provided with at least one, and as shown
`four elastically deformable expansion elements 18, which in
`the expanded state protrude laterally from the support
`member 7 and which, as represented in Figure 5, are deformed
`when
`inserted
`through the tube 6
`in the
`longitudinal
`direction into stressed positions 18' and spring back, on
`leaving the tube 6, inside the cavity 5 in the expanded
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1008, pg. 11
`
`
`
`2121001
`
`10
`
`state, and thus prevent the support members from leaving the
`cavity 5 through the through-aperture for the tube 6.
`
`5
`
`As can be seen from Figure 6, several support members can be
`disposed in the manner of pearls on a pearl necklace on a
`flexible, ribbon-like or string-like support 20 and be
`connected thereto to form a cohesive implant. The support
`20 may preferably be provided with stop parts 21 disposed
`between the support members 7, as represented in the form of
`knots constructed on the support 20, which are disposed so
`that between the support members 7 a predetermined minimum
`distance A
`is observed, which corresponds at
`least
`approximately to the diameter of one of the support members
`7 or -
`in designs in which the dimensions of the support
`15 members 7 vary -
`the sum of the radii of the adjacent
`support members 7.
`
`10
`
`20
`
`25
`
`As shown in Figure 7, the support members 7 and the support
`20 are manufactured from the same material and are connected
`to form a single-piece implant, whereby the support 20 acts
`as a spacer. According to the representation shown in
`Figure 8, a number of support members 7 can be disposed in
`a covering in the form of tubing 22 tightly surrounding the
`support members 7 and can be connected thereto to form a
`cohesive implant. The tubing 22, just like the bag 10, may
`be formed from a corresponding woven fabric, a knitted
`fabric or a film.
`
`To sum up, the invention can consequently be described as
`follows:
`
`30
`
`An implant consisting of several support members 7, which
`are produced from an elastic plastic, is provided as a
`replacement
`for
`a part of
`the core
`region of an
`intervertebral disk 3 which is no longer capable of load
`bearing. The support members 7 are inserted one after the
`other into a central cavity 5 constructed in the core region
`
`35
`
`STRYKER EXHIBIT 1008, pg. 12
`
`
`
`212J001
`by means of a tube 6 passing though an outer annular region
`4 of the intervertebral disk 3, until said cavity is filled.
`When the cavity 5 is clogged with the filling members 7,
`they become deposited at the boundary walls of the annular
`region 4 and against one another and are elastically
`deformed under stress. Accordingly a universal implant
`which can be adapted to cavities 5 of any shape, and which
`forms a relatively compact, elastic support structure, can
`be achieved.
`
`5
`
`STRYKER EXHIBIT 1008, pg. 13
`
`
`
`2121001
`
`12
`
`Claims
`
`1.
`
`5
`
`10
`
`implant,
`intervertebral prosthesis having an
`An
`which can be inserted into a central cavity (5) of
`a core region of the intervertebral disk (3) and
`which is suitable for the transfer of compressive
`forces, as a replacement for a part of this core
`region,
`characterised in that the implant contains at least
`three elastically deformable support members (7),
`which can be inserted into the central cavity (5)
`and can be positioned therein.
`
`15
`
`2.
`
`A prosthesis according to Claim 1,
`characterised in that the support members (7) are
`made from an elastic plastic.
`
`20
`
`25
`
`4.
`
`5.
`
`30
`
`A prosthesis according to Claim 1 or 2,
`characterised in that the support members (7) are
`designed in the form of rotational solids.
`
`A prosthesis according to one of the preceding
`Claims,
`characterised in that the inserted support members
`(7) are designed with varying dimensions (D, Dl, L,
`Ll).
`
`A prosthesis according to one of the preceding
`Claims,
`characterised in that at least one of the support
`members (7) is desi9ned with a duct (14) passing
`through it •
`
`.} ..
`
`'
`
`STRYKER EXHIBIT 1008, pg. 14
`
`
`
`6.
`
`7.
`
`5
`
`10
`
`8.
`
`15
`
`20
`
`25
`
`9.
`
`10.
`
`30
`
`2121001
`13
`
`A prosthesis according to one of the preceding
`Claims,
`characterised in that at least one of the support
`members (7) is designed with a closed cavity (12).
`
`A prosthesis according to one of the preceding
`Claims,
`characterised in that at least one of the support
`members ( 7) is designed wi·th at least one insert
`(13, 15) made from a material which is visible under
`X-ray examination, e.g. tantalum.
`
`A prosthesis according to one of the preceding
`Claims,
`characterised in that the support members (7) are
`disposed in the manner of a pearl necklace on a
`flexible, e.g. string-like, support (20), which
`comprises
`observing
`retention means
`for
`a
`predetermined minimum distance
`(A) between
`the
`support members (7).
`
`A prosthesis according to Claim 8,
`characterised in that the minimum distance
`(A)
`between the support members (7) corresponds at least
`roughly to the diameter (0) of one of the support
`members (7).
`
`A prosthesis according to Claim 8 or 9,
`characterised in that the retention means contain at
`least one stop part ( 21) mounted between the support
`members (7), e.q. in the form of a knot constructed
`in the flexible support (20).
`
`35
`
`ll.
`
`A prosthesis according to Claim 8 or 9,
`characterised in that the support members (7) and
`the flexible support ( 20) are produced from the same
`
`. -~:::::~/
`. '
`
`'.· ,·
`
`:.··· ....
`
`STRYKER EXHIBIT 1008, pg. 15
`
`
`
`2121001
`
`14
`
`material and are connected to form a single-piece
`implant.
`
`A prosthesis according to one of the preceding
`Claims,
`characterised in that the support members {7) are
`disposed in a covering (10, 22) surrounding them.
`
`A prosthesis according to one of the preceding
`Claims,
`characterised in that at least one of the.support
`is provided with at
`members
`least one
`(7)
`elastically deformable
`expansion element
`(18)
`laterally protruding from a main part of the support
`member.
`
`A prosthesis according to one of the preceding
`Claims,
`characterised in that at least one of the support
`members (7) comprises a defined support face (16),
`which is intended to interact with a guideway (17)
`constructed in a guide part (tube 6) and by which
`the support member
`(7) can be positioned in a
`defined position in the central cavity (5).
`
`for
`intervertebral
`an
`implanting
`process
`A
`prosthesis, which contains an implant having at
`least three elastically deformable support members
`( 7) , which
`i:mplant can be inserted into a core
`re;ion of an intervertebral disk (3),
`characterised in that
`
`in a first step in an outer annular region (4)
`of the intervertebral disk ( 3) there is mounted ~
`an aperture passing through said annular region
`towards the core region,
`
`12.
`
`5
`
`13.
`
`10
`
`14.
`
`15
`
`20
`
`25
`
`15.
`
`30
`
`35
`
`STRYKER EXHIBIT 1008, pg. 16
`
`
`
`2121001
`
`15
`
`in a following step a gouge is inserted through
`the aperture (30) towards the core region and
`therein by cutting out tissue parts of the core
`of the intervertebral disk which are no longer
`load-bearing is created a central cavity (5)
`and the tissue parts cut out are removed
`through the aperture (30),
`
`in a further step the support nternbers ( 7) are
`introduced through the aperture (30) into the
`cavity (5), whereby the cavity is substantially
`filled and the support members
`( 7)
`form a
`pressure-resistant support structure, and
`
`in a following step, after the introduction of
`the last support member the aperture (30) is
`closed.
`
`16.
`
`17.
`
`A process according to Claim 15,
`characterised in that into the aperture (30) passinq
`through the outer annular region (4) is inserted a
`tubular protective and/or guide part (tube 6) ,
`through which the gouge and the support members ( 7)
`are inserted into the core region.
`
`A process according to Claim 15 or 16,
`characterised in·that in the outer annular region
`(4) is mounted a second aperture (30'),
`and in that through it is inserted a second guide
`part (tube 6') towards the core region, by which the
`clearing out of
`the cavity
`(5)
`and/or
`the
`introduction of the support members
`( 7) can be
`monitored or influenced respectively.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`STRYKER EXHIBIT 1008, pg. 17
`
`
`
`21:21001
`16
`
`18.
`
`5
`
`A process according to one of Claims 15 to 17,
`characterised in that after clearing out the central
`cavity {5) a covering (10) for the support members
`(7) subsequently to be inserted is introduced into
`the cavity (5), whereby a filling aperture remains
`outside the outer annular region (4).
`
`STRYKER EXHIBIT 1008, pg. 18
`
`
`
`2121001
`
`··.~
`
`Fig.1
`
`Fig.2
`
`5
`7 ===Ft:Hft~...;;; -~~ "'
`7~ry~~~~F7
`
`2
`
`4
`1
`
`STRYKER EXHIBIT 1008, pg. 19
`
`
`
`2121001
`
`Fig. 3
`
`7
`
`11
`
`13
`
`10
`Fig.4a
`~2
`~7
`
`Fig.4b
`15~714 7
`
`0~14~1
`
`Fig. 4c
`
`15
`
`7
`14 14
`
`7
`
`L
`
`L1
`
`Fig. 3a
`
`18
`
`18
`
`' 18
`
`Fig.5
`18'
`7
`
`18'
`
`·-···
`
`.:·.:
`
`STRYKER EXHIBIT 1008, pg. 20
`
`
`
`2121oe1
`
`Fig.6
`
`14
`
`7
`
`7
`
`Fig.7
`
`Fig.8
`
`21.
`
`'
`(}owfinff, Stmlfu! & JJe.rulwMm',
`
`. ··.
`
`STRYKER EXHIBIT 1008, pg. 21
`
`
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