throbber
,
`
`"
`
`PATENT NUMBER
`
`8241734
`\ \\\~\ \~\ ~\~ \~\\\\\~ \\\\\ ~\\ \~\ \\l
`
`&241734
`
`./
`
`/[J
`(
`~ Available C6p~::;:;::'
`.
`u.s. UTILITY PATENT APPLlCXION
`~'pu) Q.~
`
`O.I.P.E.
`
`. JUN 05 zaoi
`
`SECTOR CLASS b
`00
`
`SUBCLASS
`
`q9
`
`-
`
`ART UNIT
`
`3131
`
`EXAMINER ' '-/-L~'
`,\ f t<
`. ) . ..,.
`i V ~o _ .. -/
`FILED WITH: 0 DISK (CRF) 0 FICHE·
`
`(Attached In pocl<et on right In.lde flap)
`
`PREPARED AND APPROVED FOR ISSUE
`
`ISSUING CLASSIFICATION
`
`O TERMINAL
`
`DISCLAIMER
`
`DRAWINGS
`
`CLAIMS ALLOWED
`
`Sheets Drwg.
`
`Print Fig.
`I
`
`Total Claims
`
`o a) The term of this patent
`
`subsequent to
`has been dlsc)aimed.
`
`'date)
`
`o b) The t~rm'of this patent shall
`
`not extend beyond the expiration date
`of U.S Patent. No. ____ _
`
`o c) The terminal _months of
`this patent have been di~claimed.
`
`SUI)enlisoi"9'Fl11teiOt Examiner
`J ~
`Group3700
`(Zit ~(D~e~
`
`(Primary Examinsr)
`
`......... -
`.~, t ~.
`\)
`(Legal Instruments
`
`WARNING:
`The Information disclosed herein may be restricted. Unauthorized disclosure may be prohibited by the United States Code Title 35. Sections 122. 181 and 368.
`Possession outside the U.S. Patent & Trademark Office Is restricted to authorized employees and contractors only.
`
`Fonn PTO·436A
`(Rev. 10197)
`
`(FACE)
`
`STRYKER EXHIBIT 1027, pg. 1
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01433
`
`

`

`..
`
`..
`
`-- I ~ j •
`
`-
`
`1
`
`-
`
`Patent
`Docket No. 1759.15100
`
`SYSTEMS AND METHODS
`FOR PLACING MATERIALS INTO BONE
`FIELD OF THE INVENTION
`The
`invention generally relates to the
`treatment of bone conditions in humans and other
`animals.
`BACKGROUND OF THE INVENTION
`Injection devices similar to a household
`caulking gun are used to inject bone cement into
`bone. A typical bone cement injection device has a
`pistol-shaped body, which supports
`a cartridge
`containing bone cement. A trigger actuates a spring(cid:173)
`loaded ram, which forces a volume of bone cement in
`a viscous condition through a suitable nozzle ~nd
`into the interior of a bone targeted for treatment.
`According to the teachings of U. S. Patent Nos.
`4,969,888 and 5,108,404,
`a cavity can be first
`formed by compacting cancellous bone
`inside the
`bone,
`into which
`the bone cement
`is
`injected.
`Conventional cement injection devices provide no
`opportunity
`to override
`the spring action and
`quickly terminate the flow of cement, should the
`cavity fill before the spring-actuated load cycle is
`completed. Furthermore, once
`the spring-actuated
`mechanism
`is
`triggered,
`conventional
`cement
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`5
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`15
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`20
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`25
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`STRYKER EXHIBIT 1027, pg. 2
`
`

`

`-
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`2
`
`-
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`injection devices do not permit the injection volume
`or inject rate to be adjusted or controlled in real
`time,
`in reaction to cancellous bone volume and
`density conditions encountered inside bone.
`called
`In
`a
`clinical
`procedure
`vertebroplasty, bone cement is injected at high
`pressure
`(typically,
`about 700 psi)
`into
`the
`interior of a vertebral body, without the prior
`formation of a cavity. Because high pressure is
`used, there is little opportunity to quickly and
`accurately adjust cement flow in reaction to bone
`volume and density conditions encountered. Momentum
`generated by high pressure-induced cement
`flow
`continues to propel cement into the targeted bone
`site even after termination of the high pressure.
`As a result of the relatively high pressure
`that conventional procedures rely upon, coupled with
`the effective lack of a short response time, the
`targeted bone
`interior can
`suddenly overfill.
`Excess filling material can be forced outside the
`bone interior, and into adjoining tissue regions,
`where
`the presence of filling material
`is not
`required or desired.
`For these and other reasons, there is a
`for new
`systems and methods
`for placing
`need
`material into bones, with greater rate and volume
`control,
`a
`faster
`response
`time,
`and without
`requiring the use of high pressure.
`SUMMARY OF THE INVENTION
`instruments,
`provides
`The
`invention
`systems, and methods, .which, in use, enable greater
`control over the placement of materials into bone.
`One aspect of the invention provides an
`instrument for tamping material into bone through a
`subcutaneous path. The instrument comprises a body
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`5
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`30
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`35
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`STRYKER EXHIBIT 1027, pg. 3
`
`

`

`•
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`-
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`3
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`-
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`•
`
`having a length and a terminus. The body includes
`markings located along the length at increments from
`the terminus. The markings allow the physician to
`gauge
`the position of
`the
`instrument
`in
`the
`subcutaneous path, as material is being tamped into
`bone.
`In particular,
`the markers allow
`the
`physician to tell at a glance the location of the
`terminus, in terms of how far beyond or short of the
`end of the subcutaneous path it is.
`In one embodiment, the instrument is used
`by deploying a cannut~ to establish a subcutaneous
`path into bone. A material is introduced into bone
`through the cannula. The terminus of the instrument
`is advanced through the cannula to urge material
`residing in the cannula into bone.
`Another aspect of the invention provides an
`apparatus for introducing material into bone through
`a subcutaneous cannula. The apparatus includes a
`delivery device to convey the material at a
`low
`delivery pressure. As used herein, a "low delivery
`pressure" is equivalent to the pressure at which
`liquid is expressed
`from
`1 cc syringe by
`the
`application of moderate force to the syringe piston,
`which amounts to a pressure that is no greater than
`about 360 psi.
`According to this aspect of the invention,
`the apparatus also
`includes a nozzle
`instrument
`capable of advancement
`through
`the subcutaneous
`cannula into bone. The nozzle comprises a proximal
`fitting to couple the nozzle
`instrument to the
`delivery device.
`The nozzle further comprises a
`nozzle terminus through which the material conveyed
`by the delivery device enters bone at the delivery
`pressure.
`In one embodiment,
`
`the delivery device
`
`...
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`5
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`20
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`25
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`STRYKER EXHIBIT 1027, pg. 4
`
`

`

`•
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`-
`
`4
`
`-
`
`comprises a syringe.
`In one embodiment, the apparatus further
`includes a tamping instrument, which is capable of
`advancement through the subcutaneous cannula. The
`tamping instrument has a
`tamping terminus which,
`during the advancement, urges material residing in
`the subcutaneous cannula into bone.
`In one embodiment, the tamping instrument
`includes markings to visually gauge the advancement
`of the tamping terminus through the subcutaneous
`cannula.
`
`In one embodiment, the apparatus is used by
`deploying a cannula to establish a subcutaneous path
`into bone.
`The del i very device is actuated to
`convey material at the delivery pressure through the
`nozzle terminus into bone.
`Another aspect of the invention provides a
`tool for deployment into bone. The tool comprises
`a catheter tube having a distal region and an
`expandable structure carried by the distal region
`for compacting cancellous bone.
`The
`tool also
`includes an introducer sleeve slidably carried by
`the catheter tube for movement between a retracted
`position spaced from the expandable structure and an
`advanced
`position
`overlying
`the
`expandable
`structure. The introducer sleeve includes a tubular
`main body dimensioned to compress the expandable
`structure when
`the
`introducer sleeve is in the
`advanced position.
`A collar extends beyond the
`distal
`region of
`the catheter
`tube when
`the
`introducer sleeve is in the advanced position. The
`collar is dimensioned larger than the tubular main
`body to releasably engage an end of a cannula.
`Thus, the introducer sleeve both sizes and aligns
`the expandable structure
`for passage
`into
`the
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`5
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`STRYKER EXHIBIT 1027, pg. 5
`
`

`

`•
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`-
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`5
`
`-
`
`•
`
`cannula through the end of the cannula.
`Another aspect of the invention provides
`apparatus for introducing material into bone through
`a subcutaneous cannula.
`The apparatus includes a
`delivery device to convey the material at a
`low
`delivery pressure, i.e., a pressure no greater than
`about 360 psi. The apparatus also includes a nozzle
`instrument capable of
`advancement
`through
`the
`subcutaneous cannula
`into bone and comprising a
`proximal fitting to couple the nozzle instrument to
`the delivery device.
`The nozzle also includes a
`nozzle bore, through which the material conveyed by
`the delivery device enters bone at the delivery
`pressure. The apparatus further includes a stylet
`capable of advancement into the nozzle bore through
`the proximal fitting to close the nozzle bore and,
`with the nozzle instrument. Together, the nozzle
`and the stylet form a tamping instrument capable of
`advancement through the subcutaneous cannula to urge
`residual material from the subcutaneous cannula.
`Another aspect of the invention provides a
`method for delivering material
`into bone.
`The
`method deploys a cannula through soft tissue to
`establish a subcutaneous path into bone. The method
`introduces a material into bone through the cannula.
`The method advances a tamping instrument through the
`cannula to urge material residing in the cannula
`into bone.
`the method
`In one embodiment,
`material at a
`low delivery pressure,
`pressure no greater than about 360 psi.
`In one embodiment,
`the introducing step
`uses a manual syringe.
`The material can comprise medication or a
`material that sets to a hardened condition e.g.,
`
`delivers
`i.e.,
`a
`
`5
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`10
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`15
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`20
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`25
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`30
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`35
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`STRYKER EXHIBIT 1027, pg. 6
`
`

`

`•
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`-
`
`6
`
`-
`
`•
`
`bone cement, or autograft
`tissue, or allograft
`tissue,
`or
`synthetic
`bone
`substitute,
`or
`combinations thereof.
`further
`the method
`In one embodiment,
`includes the step of deploying a cavity forming
`instrument
`through
`the
`cannula
`to
`compress
`cancellous bone and
`form
`a cavity.
`In
`this
`embodiment,
`the
`introducing and advancing steps
`convey material into the cavity.
`Features and advantages of the inventions
`are set forth
`in the following Description and
`Drawings, as well as in the appended Claims.
`BRIEF DESCRIPTION OF THE DRAWINGS
`Fig. 1 is a plane view of a kit housing a
`system of functional instruments, which,
`in use,
`gain subcutaneous access to the inside of a bone to
`compact cancellous bone and
`form
`a cavity ·for
`therapeutic purposes;
`Fig. 2 is an exploded perspective view of
`the kit shown in Fig. 1;
`the
`Fig.
`3
`is a perspective view of
`subcutaneous access instrument group that forms a
`part of the system shown in Fig. 1;
`Fig. 4A is a perspective view of the cavity
`forming instrument that forms a part of the system
`shown in Fig. 1;
`Fig. 4B is a section view of the catheter
`taken
`the cavity
`forming
`instrument,
`tube of
`generally along line 4B-4B in Fig. 1;
`Fig. 4C is an end view of an alternative
`embodiment of the cavity forming instrument shown in
`Fig. 4A, having a prebent stylet;
`the
`Fig.
`5
`is
`a perspective view of
`material introducing instrument group that forms a
`part of the system shown in Fig. 1;
`
`5
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`10
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`15
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`20
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`25
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`30
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`35
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`STRYKER EXHIBIT 1027, pg. 7
`
`

`

`•
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`-
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`7 -
`
`.
`
`•
`
`Figs. 6 and 7 are, respectively, top and
`side views of a human vertebral body;
`Fig. 8 is a top view of a vertebral body
`during insertion of a spinal needle instrument to
`begin a bone access procedure;
`showing
`top views
`Figs.
`9
`to 11 are
`-subsequent steps, after insertion of the spinal
`needle instrument shown in Fig. 8, of inserting a
`guide pin instrument into the vertebral body;
`Fig. 12 is a perspective view showing a
`subsequent step, after insertion of the guide pin
`instrument shown in Figs. 9 to 11, which deploys an
`obturator instrument deployed over the guide pin
`·instrument with aid of a handle;
`Fig. 13 is a
`top view of the vertebral
`body, with the obturator instrument shown in Fig. 12
`deployed;
`Fig. 14 is a perspective view showing a
`subsequent step, after insertion of the obturator
`instrument shown in Fig.
`12, which uses the handle
`in the deployment of a
`shown
`in Fig. 12 to aid
`cannula instrument over the obturator instrument;
`Fig. 15 is a
`top view of the vertebral
`body, with the cannula instrument shown in Fig. 14
`deployed;
`Fig. 16 is a perspective view showing a
`subsequent step, after insertion of the cannula
`instrument shown
`in Fig. 14, which
`removes
`the
`obturator instrument from the cannula instrument, to
`instrument
`and guide pin
`the
`cannula
`leave
`instrument in place;
`top view of the vertebral
`Fig. 17 is a
`body, after the obturator removal step shown in Fig.
`16,
`leaving the cannula instrument and guide pin
`instrument in place;
`
`5
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`10
`
`= =
`
`15
`
`= w.
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`20
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`25
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`30
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`35
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`STRYKER EXHIBIT 1027, pg. 8
`
`

`

`•
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`-
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`8
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`-
`
`•
`
`Fig. 18 is a perspective view showing a
`subsequent step, after removal of the obturator
`instrument shown in Fig. 16, which uses the handle
`shown in Fig. 14 to aid in the deployment of a drill
`bit instrument through the cannula instrument along
`the guide pin instrument;
`Fig. 19 is a
`top view of the vertebral
`body, as the drill bit instrument shown in Fig. 18
`is deployed with aid of the handle to open a passage
`into the interior volume of the vertebral bodYi
`Fig. 20 is a perspective view showing a
`subsequent step, after removal of the drill bit
`instrument and guide pin instrument shown in Fig.
`18, of deploying the cavity forming instrument into
`the vertebral body;
`top view of the vertebral
`Fig. 21 is a
`body, as the expandable structure carried by the
`cavity
`forming
`instrument shown
`in Fig. 20
`is
`deployed into the interior volume of the vertebral
`body;
`
`top view of the vertebral
`Fig. 22 is a
`as
`the expandable structure
`shown
`in ~
`body,
`collapsed condition
`in Fig. 21
`is expanded
`to
`compact cancellous bone and form a cavitYi
`Fig. 23 is a
`top view of the vertebral
`body, after removal of the expandable structure,
`showing the cavity formed by compacting cancellous
`bone;
`
`the
`is a perspective view of
`24
`Fig.
`syringe of
`the material
`introducing
`instrument
`group, shown in Fig. 5, being filled with a material
`selected for introduction into the cavity shown in
`Fig. 23;
`
`the
`is a perspective view of
`Fig. 25
`syringe shown in Fig. 24 being joined to a nozzle,
`
`5
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`10
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`15
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`20
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`25
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`STRYKER EXHIBIT 1027, pg. 9
`
`

`

`•
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`-
`
`9
`
`-
`
`•
`
`which also forms a part of the material introducing
`instrument group shown in Fig. 5;
`Fig. 26 is a perspective view showing the
`syringe and attached nozzle shown in Fig. 25 being
`deployed
`through
`the
`cannula
`instrument
`in
`preparation of introducing material into the cavity;
`Figs. 27 and 28 are perspective and top
`respectively,
`showing
`the
`syringe
`and
`views,
`attached nozzle shown in Fig. 26 in use to inject
`material into the cannula instrument for passage
`into the cavitYi
`Fig. 29 is a top view of the vertebral body
`a measured volume of material has been
`after
`injected and
`the syringe and attached nozzle
`withdrawn from the cannula instrument;
`the
`showing
`Fig.
`30
`is
`a
`top view
`deployment of a
`tamping instrument, which forms a
`part of the material introducing instrument group
`shown
`in Fig. 5, being deployed
`in the cannula
`instrumenti
`Fig. 31 is a top view showing advancement
`of the tamping instrument in the cannula instrument
`to displace and distribute material from the cannula
`instrument into the cavity;
`Fig. 32 is a top view of the vertebral body
`after removal of the tamping instrument and cannula
`instrument, showing the cavity, now filled with the
`material;
`Fig. 33 is a perspective view of a reduced
`diameter cannula instrument and associated reduced
`diameter material
`introducing
`instruments, which
`embody features of the invention;
`Fig. 34 is a perspective view of a cavity
`instrument having an expandable cavity
`forming
`forming structure, which, in use, is deployed using
`
`5
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`15
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`20
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`25
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`30
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`(0
`
`STRYKER EXHIBIT 1027, pg. 10
`
`

`

`•
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`- 10 -
`
`•
`
`the reduced diameter cannula instrument shown in
`Fig. 33,
`the cavity forming
`instrument having a
`sliding introducer sleeve shown
`in its rearward
`position;
`Fig. 35 is a perspective view of the cavity
`instrument shown
`in Fig. 34, with
`the
`forming
`introducer sleeve moved
`forward
`to overlie and
`compress the expandable cavity forming structure;
`Fig. 36 is a perspective view of the cavity
`forming structure
`shown
`in Fig. 35, with
`the
`introducer sleeve
`(shown partially
`in section)
`coupled
`to
`the proximal
`end of
`the cannula
`instrument,
`to guide
`the expandable structure
`compressed within
`the sleeve
`into
`the
`reduced
`diameter cannula instrument without damage; and
`Fig. 37 is a perspective view of the cavity
`forming structure shown
`in Fig. 36, after the
`expandable
`structure has been guided
`by
`the
`introducer sleeve into the cannula instrument and is
`being advanced through the cannula instrument for
`deployment in bone.
`The invention may be embodied in several
`forms without departing from its spirit or essential
`characteristics. The scope of
`the
`invention is
`defined in the appended claims, rather than in the
`specific description preceding them. All embodi(cid:173)
`ments. that fall wi thin the meaning and range of
`equivalency of the claims are therefore intended to
`be embraced by the claims.
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
`Figs.
`1
`and
`2
`show
`a
`system 10 of
`functional instruments. In use, certain instruments
`of the system 10 are deployed in a purposeful manner
`to penetrate tissue and gain subcutaneous access to
`the inside of a bone. Inside bone, other instruments
`
`5
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`10
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`15
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`20
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`25
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`30
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`35
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`II
`
`STRYKER EXHIBIT 1027, pg. 11
`
`

`

`•
`
`•
`
`- 11 -
`
`of the system 10 are deployed to form a cavity in
`cancellous bone, into which a material is placed for
`therapeutic purposes.
`In the illustrated embodiment, the system
`arranged as a prepackage kit 12 in three
`10 is
`functional instrument groups 14, 16, and 18. The
`first group 14 (which Fig. 3 shows outside the kit
`12) comprises instruments whose purpose is to gain
`subcutaneous access to a bone interior. The second
`group 16 (which Fig. 4 shows outside the kit 12)
`comprises an instrument whose function is to create
`a cavity in cancellous bone. The third group 18
`(which Fig. 5 shows outside the kit 12) comprises
`instruments whose
`function
`is
`to
`introduce
`a
`material into the cavity.
`In the
`The kit 12 can take various forms.
`illustrated embodiment,
`the kit 12 comprises a
`sterile, wrapped assembly.
`Further
`details
`instrument group 14, 16 I
`follow.
`
`functional
`each
`of
`and 18 and the kit 12
`
`I.
`
`Instrument
`
`The Subcutaneous Access
`Group
`The number and type of instruments in the
`group 14 can vary. Fig. 3 shows five representative
`instruments,
`each having
`a different size and
`function.
`The Spinal Needle and Guide Pin
`A.
`As Fig. 3 shows, one instrument comprises
`a conventional spinal needle assembly 20 and a guide
`pin instrument 26.
`the spinal needle assembly 20
`In use,
`establishes the initial subcutaneous path leading to
`the
`targeted
`treatment si te.
`The guide pin
`instrument
`26
`is deployed
`through
`this path,
`
`5
`
`10
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`15
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`20
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`25
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`30
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`35
`
`/eA
`
`STRYKER EXHIBIT 1027, pg. 12
`
`

`

`•
`
`- 12 -
`
`•
`
`followed by progressively larger instruments, as
`will be described later.
`The spinal needle assembly 20 comprises a
`stylet 22, which is slidably deployed within a
`stylus 24. The stylus 24 typically has, for example,
`about
`an
`eleven gauge diameter. other gauge
`diameters can be used, according to the gauge of the
`guide pin instrument 26 used.
`In use,
`the guide pin instrument 26 is
`deployed through the subcutaneous path established
`by the spinal needle assembly 20, by exchange with
`the needle stylet 22. The guide pin instrument 26
`serves
`to guide
`the establishment of
`the main
`operative pathway to the targeted treatment site.
`The remaining instruments 28, 30, and 32 in
`the group 14 share some common features, although
`they are
`intended,
`in use,
`to perform different
`functions. These instruments 28, 30, and 32 are each
`made of a rigid, surgical grade plastic or metal
`material. These
`instruments 28, 30, and 32 each
`comprises an elongated, cylindrical body having a
`proximal end 34 and a distal end 36.
`B. The Obturator Instrument
`an
`as
`functions
`The
`instrument
`28
`obturator. Its distal end 36 is tapered to present
`a penetrating surface 38.
`In use, the surface 38 is
`intended to penetrate soft tissue in response to
`pushing or twisting forces applied by the physician
`at the proximal end 34.
`the obturator
`The proximal end 34 of
`instrument 28 presents a flanged surface 40, which
`tapers from a
`larger outer diameter to a smaller
`outer diameter in the direction of the proximal end
`34. The flanged surface 40
`includes an array of
`circumferentially spaced teeth 42.
`
`5
`
`10
`
`15
`
`==
`: : :
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1027, pg. 13
`
`

`

`•
`
`- 13 -
`
`.'
`
`An interior lumen 44 extends through the
`obturator instrument 28 from the distal end 36 to
`the proximal end 34. The interior lumen 44 is sized
`to accommodate the guide pin instrument 26, as will
`be described in greater detail later.
`C. The Cannula Instrument
`The instrument 30 functions as a cannula or
`guide sheath. The cannula instrument 30 is somewhat
`larger in diameter than and not as
`long as the
`obturator instrument 28. The cannula instrumen't 30
`includes an interior lumen 46 that extends from its
`distal end 36 to its proximal end 34. The interior
`lumen 46 is sized to accept the obturator instrument
`The size of the interior lumen 46 permits a
`28.
`physician to slide and rotate the cannula instrument
`30 relative to the obturator instrument 28, and vice
`versa, as will be described in greater detail later.
`The distal end 36 of the cannula instrument
`30 presents an end surface 48.
`In use,
`the end
`surface 48 of the cannula instrument 30 is intended
`to penetrate soft tissue surrounding the obturator
`instrument 28
`in response to pushing or' twisting
`forces applied at the proximal end 34.
`The proximal end 34 carries an enlarged
`fitting 50. The fitting 50 tapers from a
`larger
`diameter to a smaller diameter in the direction of
`the proximal end 34. Like the tapered flange 40 on
`the obturator instrument 28, the tapered fitting 50
`has an array of circumferentially spaced teeth 52.
`The tapered fitting 50 of the cannula instrument 30
`possesses a larger maximum outer diameter than the
`maximum outer diameter of the tapered flange 40 of
`the obturator instrument 28.
`The cannula instrument 30 includes measured
`markings 118 along its length(see Fig. 3}.
`The
`
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`STRYKER EXHIBIT 1027, pg. 14
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`

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`•
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`14 -
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`•
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`measured markings 118 gauge the depth of insertion.
`The markings 118 can be placed, for example, at one
`centimeter intervals. As Fig. 3 shows, the markings
`118 can be consecutively numbered, beginning at the
`distal end 36, so that the physician can ascertain
`the insertion depth at a glance.
`D. The Drill Bit Instrument
`The instrument 32 functions as a drill bit.
`The drill bit instrument 32 has generally the same
`physical dimensions as the obturator instrument 28.
`Like the obturator instrument 28,
`the drill bit
`instrument 32
`is intended,
`in use,
`to fit for
`sliding and rotational movement within the interior
`lumen 46 of the cannula instrument 30.
`The distal end
`36 of
`the drill bit
`instrument 32 includes machined cutting edges 54. In
`use, the cutting edges 54 are intended to penetrate
`hard tissue in response to rotation and longitudinal
`load forces applied at the proximal end 34 of the
`drill bit instrument 32.
`tapered
`The proximal end 34 presents a
`flange 56, which is substantially identical to the
`flange 40 on the obturator instrument 28. Like the
`obturator
`instrument 28,
`the
`tapered flange 56
`changes from a larger diameter to a smaller diameter
`in the direction of the proximal end 34.
`The
`tapered flange 56 of the drill bit instrument 32
`also includes an array of circumferentially spaced
`teeth 58. The form and orientation of the teeth 58
`on the drill bit instrument 32 correspond to the
`form and orientation of
`the
`teeth 42 on
`the
`obturator instrument 28.
`E. The Handle
`The group includes a handle 60. The handle
`60 engages the functional instruments 28, 30, and 32
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`STRYKER EXHIBIT 1027, pg. 15
`
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`

`•
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`- 15 -
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`•
`
`in a removable, slip fit fashion to aid a physician
`in manipulating the instruments during use.
`The handle 60 is made from a molded or cast
`rigid plastic or metal material. The handle 60 is
`shaped to be comfortably and securely grasped by a
`normal human hand. The shape and size to accommodate
`this
`function
`can, of course, vary.
`In
`the
`illustrated embodiment, the handle 60 is elongated
`along a main axis to fit comfortably across the palm
`of the hand.
`The handle 60 includes a center post 62,
`which is integrally molded to the handle 60 about
`its geometric center. The center post 62 extends
`downward to give the handle 60 a general T-shape.
`The handle
`60
`includes
`two
`interior
`cavities or sockets 64 and 66 in the center post 62.
`The sockets guide the attachment between the handle
`60 and the instruments 28, 30, and 32. The first and
`second sockets 64 and 66 are sized to present
`unique attachment sites for different functional
`instruments.
`The first socket 64 includes an array of
`circumferentially spaced grooves 68, which, in form
`and orientation, match the
`teeth 42 and 58 at the
`proximal ends 34 of the obturator instrument 28 and
`the drill bit instrument 32. The first socket 64
`accepts the tapered flange 40 or 56 of either the
`obturator instrument 28 or .the drill bit instrument
`32. The teeth 42 and 58 of either tapered flange 40
`or 56 mesh in a slip-fit with the grooves 68 of the
`running slip-fit allows
`first socket 64. The
`to either
`longitudinal
`force
`to
`be
`applied
`through the handle 60.
`instrument 28 or 32
`The
`running slip-fit also prevents relative rotation
`between either instrument 28 or 32 and the first
`
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`STRYKER EXHIBIT 1027, pg. 16
`
`

`

`•
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`- 16 -
`
`•
`
`socket 64, thereby permitting torsional or twisting
`forces to be applied to either instrument 28 or 32
`by
`the handle 60, with an
`increased mechanical
`advantage.
`The second socket 66 is larger than the
`first socket 64 and is sized to accept the larger
`tapered fitting 50 of the cannula instrument 30. The
`second
`socket
`66
`includes
`an
`array
`of
`circumferentially spaced grooves 70, which, in form
`and orientation~ match the teeth 52 on the tapered
`fitting 50. The teeth 52 of the tapered fitting 50
`mesh in a slip-fit with the grooves 70 of the second
`socket 66. The
`running slip-fit allows both
`longitudinal and torsional forces to be applied to
`the cannula instrument 30 through the handle 60,
`with increased mechanical advantage.
`As shown in phantom lines in Fig.3, a first
`passage 72 extends through the top of the handle 60,
`through the center post 62, and into the first
`socket 64. The passage 72 is generally aligned with
`the center of the first socket 64 and is sized to
`pass the guide pin instrument 26 (see Fig. 12).
`Likewise, as also shown in phantom lines in
`Fig. 3) a second passage 74 extends through the top
`of the handle 60, through the center post 62, and
`into
`the second socket 66. The passage 74
`is
`generally aligned with the center of the second
`socket 66 and is sized to pass the either obturator
`instrument 28 or the drill bit instrument 32 (see
`Fig. 14).
`Further details of the handle 60 can be
`found in copending u.s. Patent Application Serial
`No. 09/014,229, filed January 27, 1998, and entitled
`"A Slip-Fit Handle for Hand-Held Instruments that
`Access Interior Body Regions."
`
`5
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`STRYKER EXHIBIT 1027, pg. 17
`
`

`

`•
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`- 17 -
`
`•
`
`Further details regarding the use of the
`handle 60 and the associated instruments 26, 28, and
`30 will be provided later.
`II. The cavity Forming Instrument
`As Fig. 4A shows, the group 16 includes an
`instrument 76, which is deployed thrqugh the cannula
`instrument 30 to a
`location inside bone (see Fig.
`20). When so deployed, the instrument 76 serves to
`form a cavity in cancellous bone.
`The
`instrument 76 can be constructed in
`various ways.
`In the illustrated embodiment, the
`instrument 76 includes a flexible catheter tube 78
`having a proximal end 80 and a distal end 82. The
`proximal end 80 carries a handle grip 84
`to
`faci-litate gripping and maneuvering the catheter
`tube 78. The materials for the catheter tube 78 are
`selected to facilitate its advancement through the
`cannula instrument 30. The catheter tube 78 can be
`constructed, for example, using standard flexible,
`medical grade plastic materials, like vinyl, nylon,
`polyethylenes,
`ionomer,
`polyurethane,
`and
`polyethylene tetraphthalate
`(PET).
`The catheter
`- tube 78 can also include more rigid materials to
`impart greater stiffness and thereby aid in its
`manipulation. More rigid materials that can be used
`for this purpose include stainless steel, nickel-
`titanium alloys (Nitinol™ material), and other metal
`alloys.
`
`The distal end 82 of the instrument 76
`an
`exp?ndable
`structure 86.
`In
`the
`carries
`illustrated embodiment, the expandable structure 86
`is made from a polyurethane or an elastomer (e.g.,
`silicone or nylon) material. The structure 86 has
`been preformed
`to possess
`a desired shape by
`exposure to heat and pressure, e.g., through the use
`
`5
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`STRYKER EXHIBIT 1027, pg. 18
`
`

`

`•
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`- 18 -
`
`•
`
`of conventional thermoforming techniques.
`As Fig. 4B shows,
`the catheter body 78
`includes an interior lumen 88, which communicates
`with the interior of the structure 86. A fitting 90
`on the proximal end 80 of the catheter tube 78 (see
`Fig. 4B) communicates with the lumen 88. The fitting
`90 couples the lumen 88 to a source 92 of fluid,
`e.g., sterile saline (see Fig. 21), or a radiopaque
`contrast medium.
`The fluid is introduced from the source 92
`the structure 86 under positive pressure,
`into
`causing the structure 86 to expand. During expansion
`inside bone, the material selected for the structure
`86 preferably resists deformation,
`so that the
`expanded shape inside bone essentially corresponds
`to its expanded shape outside bone, i.e., when in an
`open air environment. This allows the physician to
`select in an open air environment a structure 86
`having an expanded shape desired
`to meet
`the
`targeted therapeutic result, with the confidence
`that the expanded shape inside bone will be similar
`in important respects. In addition to being able to
`expand its volume while resisting deformation inside
`bone, the material of the structure 86 preferable
`withstands abrasion, tearing, and puncture when in
`contact with cancellous bone.
`The
`shape of
`the structure 86, when
`expanded inside bone, is selected by the physician,
`taking into account the morphology and geometry of
`the site to be treated. The shape of the cancellous
`bone to be compressed, and the local structures that
`could be harmed if bone were moved inappropriately,
`are generally understood by medical professionals
`using textbooks of human skeletal anatomy along with
`their knowledge of the site and its disease or
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`STRYKER EXHIBIT 1027, pg. 19
`
`

`

`•
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`- 19 -
`
`•
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`injury. The physician is also able to select the
`expanded shape inside bone based upon prior analysis
`of the morphology of the targeted bone using, for
`example, plain film x-ray, fluroscopic x-ray, or MRI
`or CT scanning. The expanded shape inside bone is
`selected to optimize the formation of a cavity that,
`e.g., when filled with a suitable material, provides
`support across the region of the bone being treated.
`As one general guideline, in cases where
`the bone disease causing fracture (or the risk of
`fracture) is the loss of cancellous bone mass (as in
`osteoporosis), the selection of the expanded shape
`of the structure 86 inside bone should take into
`account that from 30% to 90% of the cancellous bone
`volume
`should
`be
`compacted. Another general
`guideline is the amount that the targeted fractured
`bone region has been displaced or depressed.
`The
`expansion of the structure 86 within the cancellous
`bone region inside a bone can elevate or push the
`fractured cortical wall back to or near its anatomic
`position occupied before fracture occurred.
`In the illu

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