GLOBUS MEDICAL, INC.
`EXHIBIT 1005
`IPR2015-to be assigned
`(Globus v. Flexuspine)
`1 of 38
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`US 6,595,998 B2
`Page 2
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`U.S. PATENT DOCUMENTS
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`......... .. 606/79
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`4/1999 Moskovitz et al.
`5,891,147 A
`5/1999 Boyce et al.
`5,899,939 A
`9/1999 Betz et al.
`.................. .. 606/61
`5,951,553 A
`10/1999 Scribner et 211.
`5,972,015 A
`11/1999 McKay
`5,984,922 A
`11/1999 Coates et 211.
`5,989,289 A
`2/2000 Yaccarino, 111
`6,025,538 A
`3/2000 Preissman .................. .. 606/99
`6,033,411 A
`4/2000 Reiley et al.
`6,048,346 A
`5/2000 Reiley et al.
`6,066,154 A
`6/2000 Zuchcrman ct al.
`6,074,390 A
`8/2000 Robioneck et al.
`6,106,557 A
`8/2000 Norton et al.
`......... .. 623/17.16
`6,110,210 A
`12/2000 Boriani et al.
`6,159,211 A
`12/2000 Urbahns et al.
`6,159,215 A
`3/2001 Anderson et al.
`6,200,347 B1
`3/2001 Boyd et al.
`6,206,923 B1
`4/2001 Reiley et al.
`D439,980 S
`5/2001 Reiley et al.
`6,235,043 B1
`6/2001 Scribner et al.
`6,241,734 B1
`6/2001 Gresser et al.
`6,241,771 B1
`6/2001 Reiley et al.
`6,248,110 B1
`8/2001 Murphy ................. .. 623/23.62
`6,273,916 B1
`9/2001 Betz et al.
`..... .. 606/61
`6,287,308 B1
`
`..
`. 623/17.16
`5/2002 Stone et al.
`6,387,130 B1 *
`7/2002 Erickson ..............
`623/17.16
`6,419,705 B1 *
`OTHER PUBLICATIONS
`
`........ .. 606/61
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`...... .. 623/16.11
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`......... .. 623/17.16
`
`Rich, Kenneth J ., MD et al., Letters to the Editor; SPINE,
`VOl. 25, No. 22, pp 2968-2969, 2000.
`
`Deranrod, Hervé, MD et al., “Percutaneous Vertebroplasty
`With Polymethylmethacrylate,” Interventional Procedures in
`Musculoskeletal Radiology I, Radiologic Clinics of North
`America, Vol. 36, No. 3, pp 533-546, May 1998.
`
`Cotton, Anne, MD et al., “Percutaneous Vertebroplasty:
`State of the Art,” RadioGraphics, Vol. 18, No. 2, pp 311-323,
`-Mar.-Apr. 1998.
`
`Martin, J .B. et al., “Vertebroplasty: Clinical Experience and
`Follow-up Results” Bone, V0l. 1, N0. 2, Supplement, pp
`11S-15S, Aug. 1999.
`
`Baddley, S. and Cullen J .C., “The Use of Methylmethacry-
`late in the Treaatrnent of Giant Cell Tumors of the Proxirnal
`
`Tiba”, Aust. N.Z. Surg. Vol. 49 No. 1, Feb. 1979, (3 pages).
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`Campanacci, M., Gui, L., Ranier, L. and Savini, R., “Godoli,
`The Treatment of Tinial Plateau Fractures”, Chi. Org. Mov.
`72(3), Dec., 1975 (Italian text(pp. 234—256)and English
`translation).
`
`Surgical
`Kyphon
`5,6,9,16-19).
`
`Technique
`
`Manual,
`
`1999,
`
`(pp.
`
`Kyphon Vertebral Treatment Notebook, Date unknown, (9
`pages).
`
`Kyphon web page, www.kyph0n.c0m, Mar. 13, 2001, (2
`pages).
`AOM Technique Manual, date unknown, (11 pages).
`
`* cited by examiner
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`US 6,595,998 B2
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`1
`TISSUE DISTRACTION DEVICE
`
`FIELD OF THE INVENTION
`
`The present invention involves the field of surgery, and
`particularly surgical instruments and methods of using the
`same.
`
`BACKGROUND OF THE INVENTION
`
`A variety of physical conditions involve two tissue sur-
`faces that, for treatment of the condition, need to be dis-
`tracted from one another and then supported away from one
`another. Such distraction may be to gain exposure to select
`tissue structures, to apply a therapeutic pressure to select
`tissues, to return tissue structures to their anatomic position
`and form, or in some cases to deliver a drug or growth factor
`to alter, influence or deter further growth of select tissues.
`Depending on the condition being treated, the tissue surfaces
`may be opposed or contiguous and may be bone, skin, soft
`tissue, or a combination thereof. An optimal
`treatment
`method includes distracting and supporting the tissue sur-
`faces simultaneously.
`A minimally invasive distraction and support device
`would have significant application in orthopaedic surgical
`procedures, including acute and elective procedures to treat
`bone fractures and degenerative changes of the skeletal
`system and including vertebral compression fractures, inter-
`body fusion, vertebral disc augmentation or replacement,
`and other compression fractures including, but not limited to
`tibial plateau compression fractures, calcaneous compres-
`sion fractures, distal tibia fractures, distal radius (wrist)
`fractures, crushed or fractured orbit and orthopaedic oncol-
`ogy. Further, a minimally invasive distraction and support
`device would have application in non-orthopaedic surgical
`procedures in plastic surgery (for example facial
`reconstruction), gastrointestinal surgery and urological sur-
`gery (for example the treatment of incontinence).
`Vertebral Compression Fractures
`A vertebral compression fracture is a crushing injury to
`one or more vertebrae. Vertebral fractures are generally
`associated with osteoporosis (the “brittle bone” disease),
`metastasis, and/or
`trauma. Osteoporosis reduces bone
`density, thereby weakening bones and predisposing them to
`fracture.
`
`The osteoporosis-weakened bones can collapse during
`normal activity. In severe cases of osteoporosis, actions as
`simple as bending forward can be enough to cause a verte-
`bral compression fracture. Vertebral compression fractures
`are the most common type of osteoporotic fractures accord-
`ing to the National Institute of Health. The nieclianism of
`these fractures is one of fiexion with axial compression
`where even minor events cause damage to the weak bone.
`While the fractures may heal without
`intervention,
`the
`crushed bone may fail to heal adequately. Moreover, if the
`bones are allowed to heal on their own, the spine will be
`deformed to the extent the vertebrae were compressed by the
`fracture. Spinal deformity may lead to breathing and gas-
`trointestinal complications, and adverse loading of adjacent
`vertebrae.
`
`Vertebral fractures happen most frequently at the thora-
`columbar junction, with a relatively normal distribution of
`fractures around this point. Vertebral fractures can perma-
`nently alter the shape and strength of the spine. Commonly,
`they cause loss of height and a humped back. This disorder
`(called kyphosis or “dowager’s hump”) is an exaggeration of
`the spinal curve that causes the shoulders to slump forward
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`and the top of the back to look enlarged and humped. In
`severe cases, the body’s center of mass is moved further
`away from the spine resulting in increased bending moment
`on the spine and increased loading of individual vertebrae.
`Another contributing factor to vertebral fractures is meta-
`static disease. When cancer cells spread to the spine, the
`cancer may cause destruction of part of the vertebra, weak-
`ening and predisposing the bone to fracture.
`Osteoporosis and metastatic disease are common root
`causes leading to vertebral fractures, but trauma to healthy
`vertebrae also causes minor to severe fractures. Such trauma
`
`may result from a fall, a forceful jump, a car accident, or any
`event that stresses the spine past its breaking point. The
`resulting fractures typically are compression fractures or
`burst fractures.
`
`Vertebral fractures can occur without pain. However, they
`often cause a severe “band-like” pain that radiates from the
`spine around both sides of the body. It is commonly believed
`that the source of acute pain in compression fractures is the
`result of instability at the fracture site, allowing motion that
`irritates nerves in and around the vertebrae.
`
`Until recently, treatment of vertebral compression frac-
`tures has consisted of conservative measures including rest,
`analgesics, dietary, and medical regimens to restore bone
`density or prevent further bone loss, avoidance of injury, and
`bracing. Unfortunately,
`the typical patient
`is an elderly
`person who generally does not tolerate extended bed rest
`well. As a result, minimally invasive surgical methods for
`treating vertebral compression fractures have recently been
`introduced and are gaining popularity.
`One technique used to treat vertebral compression frac-
`tures is injection of bone filler into the fractured vertebral
`body. This procedure is commonly referred to as percuta-
`neous vertebroplasty. Vertebroplasty involves injecting bone
`filler (for example, bone cement) into the collapsed vertebra
`to stabilize and strengthen the crushed bone.
`In Vertebroplasty, physicians typically use one of two
`surgical approaches to access thoracic and lumbar vertebral
`bodies: transpedicular or extrapedicular. The transpedicular
`approach involves the placement of a needle or wire through
`the pedicle into the vertebral body, and the physician may
`choose to use either a unilateral access or bilateral trans-
`
`pedicular approach. The second approach, the extrapedicular
`technique, involves an entry point through the posterolateral
`corner of the vertebral body. The needle entry point
`is
`typically 8 cm to 12 cm lateral of the mid-sagittal plane, with
`the skin incision typically closer to 8 cm in the proximal
`spine and generally closer to 12 cm in the distal spine. In
`general, one cannula is placed to fill the vertebral body with
`the extra-pedicular approach.
`Regardless of tlie surgical approach, the physician gen-
`erally places a small diameter guide wire or needle along the
`path intended for the bone filler delivery needle. The guide
`wire is advanced into the vertebral body under fluoroscopic
`guidance to the delivery point within the vertebrae. The
`access channel into the vertebra may be enlarged to accom-
`modate the delivery tube. In some cases, the delivery tube is
`placed directly and forms its own opening. In other cases, an
`access cannula is placed over the guide wire and advanced
`into the vertebral body. After placement,
`the cannula is
`replaced with the delivery tube, which is passed over the
`guide pin. In both cases, a hollow needle or similar tube is
`placed into the vertebral body and used to deliver the bone
`filler into the vertebra.
`
`In this procedure, lower viscosities and higher pressures
`tend to disperse the bone filler throughout the vertebral body.
`However, such conditions dramatically increase the risk of
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`3
`bone filler extravasation from the vertebral body. The trans-
`pedicular approach requires use of a relatively small needle
`(generally 11 gauge or smaller). In contrast, the extrapedicu-
`lar approach provides suflicient room to accommodate a
`larger needle (up to 6 mm internal diameter in the lumbar
`region and lower thoracic regions). In general, the small
`diameter needle required for a transpedicular approach
`necessitates injecting the bone filler in a more liquid (less
`viscous) state. Further, the pressure required to flow bone
`filler through a small gauge needle is relatively high. The
`difliculty of controlling or stopping bone filler flow into
`injury sensitive areas increases as the required pressure
`increases. The larger needle used in the extrapedicular
`approach allows injection of bone filler in a thicker, more
`controllable viscous state. Therefore, many physicians now
`advocate the extrapedicular approach so that the bone filler
`may be delivered through a larger cannula under lower
`pressure.
`Caution must be taken to prevent cxtravasation, with the
`greatest attention given to preventing posterior extravasation
`because it may cause spinal cord trauma. Physicians typi-
`cally use fluoroscopic imaging to monitor bone filler propa-
`gation and to avoid flow into areas of critical concern. If a
`foraminal
`leak results,
`the patient may require surgical
`decompression and/or suffer paralysis.
`Kyphoplasty is a modified vertebral fracture treatment
`hat uses one or two balloons, similar to angioplasty
`Jalloons,
`to attempt
`to reduce the fracture and restore
`vertebral height prior to injecting the bone filler. Two
`Jalloons are typically introduced into the vertebra via bilat-
`eral transpedicular cannulae. The balloons are inflated to
`reduce the fracture. After the balloon(s) is deflated and
`emoved, leaving a relatively empty cavity, bone cement is
`injected into the vertebra. In theory, inflation of the balloons
`restores vertebral height. However, it is difficult to consis-
`ently attain r11ear1ir1gful height restoration. It appears the
`inconsistent results are due, in part, to the manner in which
`he balloon expands in a compressible media and the struc-
`ural orientation of the trabecular bone within the vertebra.
`Tibial Plateau Compression l-'ractures
`Atibial plateau fracture is a crushing injury to one or both
`of the tibial condylcs resulting in a depression in the articular
`surface of the condyle. In conjunction with the compression
`fracture,
`there may be a splitting fracture of the tibial
`alateau. Appropriate treatment for compression fractures
`depends on the severity of the fracture. Minimally displaced
`compression fractures may be stabilized in a cast or brace
`without surgical intervention. More severely displaced com-
`aression with or without displacement fractures are treated
`via open reduction and internal fixation.
`Typically, the underside of the compression fracture is
`accessed either through a window cut (a relatively small
`esection)
`into the side of the tibia or by opening or
`displacing a splitting fracture. A bone elevator is then used
`o reduce the fracture and align the articular surface of the
`ibial condyle. A fluoroscope or arthroscope may be used to
`visualize and confirm the reduction. Bone filler is placed into
`he cavity under the reduced compression fracture to main-
`ain the reduction. If a window was cut into the side of the
`ibia, the window is packed with graft material and may be
`secured with a bone plate. If a splitting fracture was opened
`o gain access,
`then the fracture is reduced and may be
`stabilized with bone screws, bone plate and screws, or a
`JUIIICSS plate and screws. (Both of these methods are very
`invasive and require extensive rehabilitation.)
`Spinal Interbody Fusion
`Spinal fusion is most frequently indicated to treat chronic
`Jack pain associated with instability or degenerative disc
`
`4
`disease that has not responded to less invasive treatments.
`Fusion is also prescribed to treat
`trauma and congenital
`deformities. Spinal fusion involves removal of the spinal
`disc and fusing or joining the two adjacent vertebrae. The
`primary objective for patients suffering from instability is to
`diminish the patient’s pain by reducing spinal motion.
`Spinal fusions are generally categorized into two large
`groups:
`instrumented and non-instrumented.
`In non-
`instrumented procedures, the physician removes tissue from
`the unstable disc space and fills it with some form of bone
`graft that facilitates the fusion of the two adjacent vertebral
`bodies.
`Instrumcntcd procedures are similar to non-
`instrumented procedures, except
`that
`implants (generally
`metallic) are also applied to further stabilize the vertebrae
`and improve the likelihood of fusion.
`Conventional instrumented procedures generally utilize
`plates, rods, hooks, and/or pedicle screws through various
`surgical approaches. These conventional
`implants are
`secured to the vertebral bodies that are being fused. Inter-
`body fusion devices were introduced in the 1990’s as a less
`invasive surgical alternative, although interbody devices are
`increasingly being used ir1 conjunction with pedicle screws.
`Interbody devices are implanted into the disc space to
`restore the normal disc spacing, utilizing tension in the
`annulus to stabilize the fusion unit. Interbody fusion pro-
`vides a large area of the vertebral end plate for establishing
`bony filsion, a viable blood supply from the decorticated end
`plates, and dynamic compressive loading of the graft site.
`The interbody devices are generally filled with a bone filler
`to facilitate fusion. Interbody devices can be categorized in
`three primary groups: spinal fusion cages, which are avail-
`able in a variety of shapes including rectangular, round-
`faced, and lordotic; allograft bone dowels and wedges
`(which are also available in various shapes); and titanium
`mesh (although titanium mesh is not
`itself a structural
`spacer).
`Interbody fusion is typically completed through a
`posterior, an anterior, or a lateral intertransverse approach.
`Each of these techniques has limitations. Lumbar interbody
`filsion presents a challenging surgical procedure and rela-
`tively high pscudoarthrosis rates. As a result, this approach
`is increasingly combined with additional internal fixation
`devices such as pedicle screw fixation.
`In all interbody surgical approaches, a relatively large
`opening is made in the annulus. The nuclear material is
`removed and the end plates are decorticated to facilitate
`bony fusion. Overall,
`the use of interbody devices has
`resulted in mixed clinical outcomes. Placement of a fixed
`height device presents challenges in proper tensioning of the
`annulus. For these and other reasons, there is concern over
`long-term stability of interbody devices and fusion r11ass.
`SUMMARY OF THE INVENTION
`
`The invention provides a combination of a temporary or
`long term implantable device and instrumentation to place
`the device, in which tissue surfaces are distracted along an
`axis to enable access to the space between the tissues.
`Generally, the invention provides wafers for stacking upon
`one another to provide an axially extending column to
`distract and support tissue surfaces. While a primary use of
`the invention is to reduce and stabilize vertebral compres-
`sion fractures, the invention may be used in any situation
`where it is desirable to distract two tissue surfaces. The
`
`tissue, or combinations
`tissue may be bone, skin, soft
`thereof. Further, the surfaces may be opposed surfaces of
`contiguous elements or surfaces of opposed elements. Thus,
`the invention may be used to treat vertebral compression
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`fractures, for replacement of vertebral discs, as an interbody
`fusion device, wedge opening high tibial osteotomy, tibial
`tuberosity elevation, as well as for treating other compres-
`sion fractures including, but not
`limited to tibia plateau
`fractures, calcaneous, distal tibial fractures, or distal radius
`(wrist) fractures. The invention may also be used for restor-
`ing the floor of the orbit, for elevating soft tissue in cosmetic
`applications, or in incontinence applications as a urethral
`restrictor. Alternately, the invention may be used in similar
`veterinary applications.
`The Distraction Device
`
`The terms “vertical”, “up”, etc., are occasionally used
`herein for ease of understanding, and these terms should be
`taken in reference to the vertebrae of a standing patient.
`Thus, “vertical” refers generally to the axis of the spine. We
`may also utilize mutually perpendicular “X”, “Y” and “Z”
`axes to describe configurations and movement, with the
`Z—axis being the axis of the column of wafers, that is, the
`direction in which this column grows as wafers are added
`sequentially to it. The X-axis refers to the axis extending
`generally in the direction of movement of each wafer as it is
`advanced to a position beneath a preceding wafer, and the
`Y-axis is perpendicular to both the X- and Z-axes. The
`wafers are sometimes described with reference to permitted
`degrees of freedom or restraint when they are placed in a
`column. It should be understood that these permitted degrees
`of freedom or restraint refer to the permitted or restrained
`movement of one wafer with respect to an adjacent wafer
`along one or more of the three axes, and the permitted or
`restrained rotation between adjacent wafers about one or
`more of these axes.
`
`The distraction device includes a plurality of stackable
`wafers designed for insertion between tissue surfaces to
`form a column. The wafer column is assembled in vivo to
`
`rovide a distraction force as well as support and stabiliza-
`ion of the distracted tissue. Preferably, the wafers place
`distraction force in one direction only and thus provide
`directional distraction. The distraction device may be per-
`nanently implanted, in which case the wafer column may be
`used alone or in conjunction with a bone filler material.
`Alternately, the distraction device may be used temporarily
`o manipulate tissues and then removed.
`In use,
`the wafers are preferably stacked between two
`issue surfaces as they are implanted, thereby distracting and
`supporting the tissue surfaces simultaneously. In the verte-
`3ral compression fracture application,
`it
`is preferable to
`distract along the Z—axis (along the axis of the spine) to
`estore vertebral height. However, in other applications, it
`nay be preferable to provide distraction in a different
`direction. The features of a wafer and a column of wafers
`
`will be described relative to position and direction. The top
`of a wafer or the top of the column is defined as the face of
`he wafer or column in the direction of distraction. The
`I)Ott0I1‘l of a wafer or the bottom of the column is defined as
`
`he face opposite the top face. In similar fashion, above and
`velow a wafer or column implies along the top and bottom
`of the wafer or column, respectively. Each wafer has a
`leading edge that enters the forming column first and a
`railing edge opposite the leading edge. The sides of the
`wafer are adjacent the leading and trailing edges and the top
`and bottom faces of the wafer. In general,
`the sides are
`longer than the leading and trailing edges, however the sides
`may be shorter than the leading and trailing edges. The axis
`of the colur11r1 is defined as a line parallel to the direction of
`distraction.
`the wafers are stacked to form a
`During implantation,
`column to simultaneously distract and support the two tissue
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`surfaces. The invention provides that trailing wafers can be
`positioned above or below the leading wafers to form a
`column. In one embodiment, the wafers are designed to be
`beveled at both their leading and trailing edges so that when
`lined up end-to-end, force on the trailing edge of the trailing
`wafer causes its leading edge to slide below the trailing edge
`of the leading wafer, thereby lifting up the leading wafer.
`Likewise, the bevel of the leading and trailing edges may be
`reversed enabling insertion of a trailing wafer above a
`leading wafer. Alternately,
`the leading and trailing edges
`may be chevron shaped or curved when viewed from the
`side, enabling insertion of trailing wafers between any two
`leading wafers or on the top or bottom of the column. In
`another embodiment, the wafers may be configured with
`blunt edges wherein the wafers are stacked with the insertion
`instrument. In all embodiments, by repeating the process
`with consecutive wafers,
`the column height
`increases to
`restore vertebral height.
`The specific configuration of each wafer may be altered to
`better suit the application for which the wafer will be used.
`For instance, the thickness of the wafer and the angle of the
`bevel may be varied to provide a mechanical advantage and
`insertion force within acceptable ranges for a given appli-
`cation. A more acute bevel angle will provide greater vertical
`force for a given insertion force. In addition, wafer thickness
`may be varied to increase or decrease resolution available to
`the physician in performing a given surgical procedure. A
`thinner wafer will provide greater displacement resolution
`and incremental force generation to the physician in per-
`forming the procedure. Avariation of wafer thicknesses may
`be used in combination to form a column and multiple
`wafers may be inserted into the column simultaneously. The
`top and bottom faces of a wafer may be parallel or oblique
`to enable building a column that
`is straight or curved,
`respectively. Parallel or oblique—faced wafers may be used
`independently or in combination to build a column that has
`straight and/or curved sections.
`In order to place the wafers between the tissue surfaces,
`a wafer inserter is positioned within the surgical site with
`access at its distal tip to the tissue surfaces to be distracted
`and supported. Awafer is placed on the track and a plunger
`is used to advance the wafer to the distal end of the track.
`
`This is repeated with consecutive wafers until a column of
`sufficient height is created per physician discretion. After the
`wafer(s) have been inserted, the insertion device is removed.
`The distal end of the insertion device may be manufactured
`from the same material as the wafers and/or be detachable.
`In this embodiment, the distal end of the insertion instrument
`would be detached after placing the wafer column, and the
`instrument removed.
`Optionally, bone filler may be injected into the vertebra to
`further stabilize the distracted tissues. The first wafer
`
`inserted may be longer and/or wider than subsequent wafers.
`The size differential may facilitate bone filler flow around
`the wafers. In addition, the wafers can be designed with
`various tunnels, grooves, and/or holes to improve wafer
`encapsulation, bonding between the wafers and any injected
`bone filler, and to provide a pathway for bone filler to
`penetrate the wafer column.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 shows a vertebral body having a compression
`fracture displacing its superior and anterior edge.
`FIG. 2 shows a vertebral body, following treatment of a
`compression fract11re.
`FIG. 3 illustrates a plan view of a distraction device
`insertion apparatus according to an embodiment of the
`invention, placed within a vertebral body shown in cross-
`section.
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`US 6,595,998 B2
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`7
`FIG. 4 illustrates a cross-sectional view of the insertion
`apparatus of FIG. 3 deploying a distraction device according
`to an embodiment of the present invention.
`FIG. 5 illustrates a cross-sectional View of the insertion
`
`apparatus of FIG. 4 deploying a distraction device according
`to an alternate embodiment of the present invention.
`FIG. 6 shows a plan view of a configuration of distraction
`device according to one embodiment of the present inven-
`tion.
`
`FIG. 7 shows an alternate plan view of the distraction
`device configuration of FIG. 6.
`FIG. 8 shows a plan view of a configuration of distraction
`device according to an alternate embodiment of the present
`invention.
`
`FIG. 9 shows an alternate plan view of the distraction
`device configuration of FIG. 8.
`FIG. 10 shows a plan view of a configuration of distrac-
`tion device according to an alternate embodiment of the
`present invention.
`FIG. 11 shows an alternate plan view of the distraction
`device configuration of FIG. 10.
`FIG. 12 shows a plan view of a configuration of distrac-
`tion device according to an alternate embodiment of the
`present invention.
`FIG. 13 shows a sectional view of the distraction device
`
`configuration of FIG. 12.
`FIG. 14 shows a plan view of a configuration of distrac-
`tion device according to an alternate embodiment of the
`present invention.
`FIG. 15 shows a sectional view of the distraction device
`configuration of FIG. 14.
`FIG. 16 shows a plan view of a configuration of distrac-
`tion device according to an alternate embodiment of the
`present invention.
`FIG. 17 shows an alternate plan view of the distraction
`device configuration of FIG. 16.
`FIG. 18 shows a plan view of a configuration of distrac-
`tion device according to an alternate embodiment of the
`present invention.
`FIG. 19 shows an alternate plan view of the distraction
`device configuration of FIG. 18.
`FIG. 20 shows a plan view of a configuration of distrac-
`tion device according to an alternate embodiment of the
`present invention.
`FIG. 21 shows an alternate plan view of the distraction
`device configuration of FIG. 20.
`FIG. 22 shows a plan view of a configuration of distrac-
`tion device according to an alternate embodiment of the
`present invention.
`FIG. 23 shows an alternate plan view of the distraction
`device configuration of FIG. 10.
`FIG. 24 shows a plan view of a distraction device accord-
`ing to an alternate embodiment of the present invention.
`FIG. 25 shows a plan view of a configuration of several
`of the distraction device of FIG. 24.
`
`FIG. 26 shows an alternate plan view of the configuration
`of the distraction device of FIG. 25.
`
`FIG. 27 shows a plan view of a configuration of distrac-
`tion device deployed within a vertebral body, shown in
`sectional view.
`
`FIG. 28 shows a plan view of a further configuration of
`distraction device being deployed within a vertebral body,
`shown in sectional view.
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`FIG. 29 show a sectional view of a portion of an insertion
`device according to one embodiment of the present inven-
`tion.
`FIG. 30 shows a sectional view of an entire insertion
`device, a section of which is depicted in FIG. 29.
`FIG. 31 show a plan view of a series of undeployed
`distraction devices connected by a tether according to one
`embodiment of the present invention.
`FIG. 32 shows a plan view of an alternate state of the
`distraction devices of FIG. 31.
`
`FIG. 33 shows a plan view of an alternate state of the
`distraction devices of FIG. 31.
`FIG. 34 shows a sectional view of an insertion device
`according to one embodiment of the present invention.
`FIG. 35 shows a sectional view of a portion of the
`insertion device of FIG. 34.
`
`FIG. 36 shows a sectional view of a portion of the
`insertion device of FIG. 35.
`
`FIG. 37 shows a sectional view of a portion of an insertion
`device according to an alternate embodiment of the present
`invention.
`
`FIG. 38 shows a plan view of an alternate state of the
`insertion device of FIG. 37.
`FIG. 39 shows a sectional View of an insertion device
`
`according to an embodiment of the present invention, con-
`figured to deploy distraction device similar to that depicted
`in FIGS. 31-33.
`FIG. 40 shows a sectional view of an alternate state of the
`
`insertion device depicted in FIG. 39, configured for the
`removal of the distraction device similar to that depicted in
`FIGS. 31—33.
`FIGS. 41-45 show sectional views of an embodiment of
`
`an insertion device according to the present invention, with
`corresponding suitable distraction device, in various states
`attendant to clinical deployment.
`FIG. 46 shows a plan view of a clinical deployment
`device according to an alternate embodiment of the present
`invention, inserted into a vertebral body, shown in cross-
`section.
`
`FIG. 47 depicts the implementation of a regimen for
`treatment of a vertebral compression according to an
`emb