peT
`WORLD IN'IELLEcruAL PROPERTY ORGANIZATION
`International Bureau
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`WO 95120362
`
`(11) International Publication Number:
`
`(51) International Patent Classification 6 :
`A61B 17/68, 17188
`
`Al
`
`(43) International Publication Date:
`
`3 August 1995 (03.08.95)
`
`(21) International Application Number:
`
`PCTIUS95/01011
`
`(22) International Filing Date:
`
`24 January 1995 (24.01.95)
`
`(30) Priority Data:
`08/188,224
`
`26 January 1994 (26.01.94)
`
`US
`
`(81) Designated States: AM, AT, AU, BB, BG, BR, BY, CA, CH,
`CN, CZ, DE, DK, EE, ES, FI, GB, GE, HU, JP, KE, KG,
`KP, KR, KZ, LK, LR, LT, LU, LV, MD, MG, MN, MW,
`MX, NL, NO, NZ, PL, PT, RO, RU, SD, SE, SI, SK, TJ,
`TT, UA, UZ, VN, European patent (AT, BE, CH, DE, DK,
`ES, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE), OAPI
`patent (BF, BJ, CF, CG, CI, CM, GA, GN, ML, MR, NE,
`SN, TD, TG), ARIPO patent (KE, MW, SD, SZ).
`
`(71)(72) Applicants and Inventors: REILEY, Mark, A. [US/US];
`304 Pala Avenue, Peidmont, CA 94611 (US). SCHOL1EN, Published
`With international search report.
`Arie [US/US]; 4175 Tamayo Street, Fremont, CA 94536
`(US). TALMADGE, Karen [US/US]; 2320 Bryant Street,
`Palo Alto, CA 94301 (US).
`
`(74) Agents: McGANNON, John, L. et al.; Townsend and
`Townsend Khourie and Crew, 20th floor, One Market
`Plaza, Steuart Street Tower, San Francisco, CA 94105
`(US).
`
`(54) Title: IMPROVED INFLATABLE DEVICE FOR USE IN SURGICAL PROTOCOL RELATING TO FIXATION OF BONE
`
`14
`
`20
`
`16
`
`..
`
`(57) Abstract
`
`A balloon (10) for use in compressing cancellous bone and marrow (also known as medullary bone and trabecular bone) against the
`inner cortex of bones whether the bones are fractured or not. The balloon comprises an inflatable, non-expandable balloon body (12, 14)
`for insertion into said bone. The body has a shape and size to compress at least a portion of the cancellous bone to form a cavity in the
`cancellous bone and to restore the original position of the outer cortical bone, if fractured or collapsed. The balloon is prevented from
`applying excessive pressure to the outer cortical bone. The wall or walls of the balloon are such that proper inflation of the balloon body
`is achieved to provide for optimun compression of all of the bone marrow. The balloon is folded so that it can be easily inserted into a
`bone. The balloon can be made to have a suction catheter (16). The main purpose of the balloon is the forming or enlarging of a cavity or
`passage in a bone, especially in, but not limited to, vertebral bodies.
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01519
`
`STRYKER EXHIBIT 1006, p. i
`
`

`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international
`applications under the PCT.
`
`AT
`AU
`BB
`BE
`BF
`BG
`DJ
`DR
`BY
`CA
`CF
`CG
`CH
`CI
`CM
`CN
`CS
`CZ
`DE
`DK
`ES
`FI
`FR
`GA
`
`Austria
`Australia
`Barbados
`Belgium
`Burkina Paso
`Bulgaria
`Benin
`Brazil
`Belarus
`Canada
`Central African Republic
`Congo
`Switzerland
`COte d'Ivoire
`Cameroon
`China
`Czechoslovakia
`Czech Republic
`Germany
`Denmark
`Spain
`Finland
`France
`Gabon
`
`GB
`GE
`GN
`GR
`HU
`IE
`IT
`JP
`KE
`KG
`KP
`
`KR
`KZ
`LI
`LK
`LU
`LV
`MC
`MD
`MG
`ML
`MN
`
`United Kingdom
`Georgia
`Guinea
`Greece
`Hungary
`Ireland
`Italy
`Japan
`Kenya
`Kyrgystan
`Democratic People's Republic
`of Korea
`Republic of Korea
`Kazakhstan
`Liechtenstein
`Sri Lanka
`Luxembourg
`Latvia
`Monaco
`Republic of Moldova
`Madagascar
`Mali
`Mongolia
`
`MR
`MW
`NE
`NL
`NO
`NZ
`PL
`PT
`RO
`RU
`SD
`SE
`SI
`SK
`SN
`TD
`TG
`TJ
`TT
`UA
`US
`UZ
`VN
`
`MilUritania
`Malawi
`Niger
`Netherlands
`Norway
`New Zealand
`Poland
`Portugal
`Romania
`Russian Federation
`Sudan
`Sweden
`Slovenia
`Slovakia
`Senegal
`Chad
`Togo
`Tajikistan
`Trinidad and Tobago
`Ukraine
`United States of America
`Uzbekistan
`VietNam
`
`STRYKER EXHIBIT 1006, p. ii
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`1
`
`IMPROVED INFLATABLE DEVICE FOR USE IN
`SURGICAL PROTOCOL RELATING TO FIXATION OF BONE
`
`This invention relates to improvements in the
`surgical treatment of bone conditions of the human and
`other animal bone systems and, more particularly, to an
`inflatable balloon-like device for use in treating such
`bone conditions. osteoporosis, avascular necrosis and
`bone cancer are diseases of bone that predispose the bone
`to fracture or collapse. There are 2 million fractures
`each year in the united states, of which about 1.3
`million are caused by osteoporosis. Avascular necrosis
`and bone cancers are more rare but can cause bone
`problems that are currently poorly addressed.
`
`BACKGROUND OF THE INVENTION
`In u.s. Patents 4,969,888 and 5,108,404, an
`apparatus and method are disclosed for the fixation of
`fractures or other conditions of human and other animal
`bone systems, both osteoporotic and non-osteoporotic.
`The apparatus and method are especially suitable for use
`in the fixation of, but not limited to, vertebral body
`compression fractures, Colles fractures and fractures of
`the proximal humerus.
`The method disclosed in these two patents
`includes a series of steps which a surgeon or health care
`provider can perform to form a cavity in pathological
`bone (including but not limited to osteoporotic bone,
`osteoporotic fractured metaphyseal and epiphyseal bone,
`osteoporotic vertebral bodies, fractured osteoporotic
`vertebral bodies, fractures of vertebral bodies due to
`tumors especially round cell tumors, avascular necrosis
`
`t
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 1
`
`

`
`W095/20362
`
`PCTfUS95/01011
`
`c:<.
`of the epiphyses of long bones, especially avascular
`necrosis of the proximal femur, distal femur and proximal
`humerus and defects arising from endocrine conditions).
`The method further includes an incision in the
`skin (usually one incision, but a second small incision
`may also be required if a suction egress is used)
`followed by the placement of a guide pin which is passed
`through the soft tissue down to and into the bone.
`The method further includes drilling the bone
`to be treated to form a cavity or passage in the bone,
`following which an inflatable balloon-like device is
`inserted into the cavity or passage and inflated. The
`inflation of the inflatable device causes a compacting of
`the cancellous bone and bone marrow against the inner
`surface of the cortical wall of the bone to further
`enlarge the cavity or passage. The inflatable device is
`then deflated and then is completely removed from the
`bone. A smaller inflatable device (a starter balloon)
`can be used initially, if needed, to initiate the
`compacting of the bone marrow and to commence the
`formation of the cavity or passage in the cancellous bone
`and marrow. After this has occurred, a larger,
`inflatable device is inserted into the cavity or passage
`to further compact the bone marrow in all directions.
`A flowable biocompatible filling material, such
`as methylmethacrylate cement or a synthetic bone
`substitute, is then directed into the cavity or passage
`and allowed to set to·a hardened condition to provide
`structural support for the bone. Following this latter
`step, the insertion instruments are removed from the body
`and the incision in the skin is covered with a bandage.
`While the apparatus and method of the above
`patents provide an adequate protocol for the fixation of
`bone, it has been found that the compacting of the bone
`marrow and/or the trabecular bone and/or cancellous bone
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 2
`
`

`
`W095/10362
`
`PCTIUS95/01011
`
`3
`against the inner surface of the cortical wall of the
`bone to be treated can be significantly improved with the
`use of inflatable devices that incorporate additional
`engineering features not heretofore described and not
`properly controlled with prior inflatable devices in such
`patents. A need has therefore arisen for improvements in
`the shape, construction and size of inflatable devices
`for use with the foregoing apparatus and method, and the
`present invention satisfies such need.
`
`Prior Techniques for the Manufacture of Balloons for
`In-Patient Use
`A review of the prior art relating to the
`manufacture of balloons shows that a fair amount of
`background information has been amassed in the formation
`of guiding catheters which are introduced into
`cardiovascular systems of patients through the brachial
`or femoral arteries. However, there is a scarcity of
`disclosures relating to inflatable devices used in bone,
`and none for compacting bone marrow in vertebral bodies
`and long bones.
`In a dilatation catheter, the catheter is
`advanced into a patient until a balloon is properly
`positioned across a lesion to be treated. The balloon is
`inflated with a radiopaque liquid at pressures above four
`atmospheres to compress the plaque of the lesion to
`thereby dilate the lumen of the artery. The balloon can
`then be deflated, then removed from the artery so that
`the blood flow can be restored through the dilated
`artery.
`
`A discussion of such catheter usage technique
`is found and clearly disclosed in u.s. Patent 5,163,989.
`Other details of angioplasty catheter procedures, and
`details of balloons used in such procedures can be found
`in U.s. Patents 4,323,071, 4,332,254, 4,439,185,
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 3
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`,
`
`'I
`4 , 168 ,. 224, 4, 516 , 672, 4, 538 , 622, 4, 554 , 929, and
`4,616,652.
`Extrusions have also been made to form prism
`shaped balloons using molds which require very accurate
`machining of the interior surface thereof to form
`acceptable balloons for angioplastic catheters. However,
`this technique of extrusion forms parting lines in the
`balloon product which parting lines are limiting in the
`sense of providing a weak wall for the balloon itself.
`Patent 5,163,989 discloses a mold and technique
`for molding dilatation catheters in which the balloon of
`the catheter is free of parting lines. The technique
`involves inflating a plastic member of tubular shape so
`as to press it against the inner molding surface which is
`heated.
`Inflatable devices are molded into the desired
`size and shape, then cooled and deflated to remove it
`from the mold. The patent states that, while the balloon
`of the present invention is especially suitable for
`forming prism-like balloons, it can also be used for
`forming balloons of a wide variety of sizes and shapes.
`A particular improvement in the catheter art
`with respect to this patent, namely u.s. Patent
`4,706,670, is the use of a coaxial catheter with inner
`and outer tubing formed .and reinforced by continuous
`helical filaments. Such filaments cross each other
`causing the shaft of the balloon to become shorter in
`length while the moving portion of the shank becomes
`longer in length. By suitably balancing the lengths and
`the angle of the weave of the balloon and moving portions
`of the filaments, changes in length can be made to offset
`each other. Thus, the position of the inner and outer
`tubing can be adjusted as needed to keep the balloon in a
`desired position in the blood vessel.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`STRYKER EXHIBIT 1006, pg. 4
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`s-
`Other disclosures relating to the insertion of
`inflatable devices for treating the skeleton of patients
`include the following:
`u.s. Patent 4,313,434 relates to the fixation
`of a long bone by inserting a deflated flexible bladder
`into a medullary cavity, inflating the balloon bladder,
`sealing the interior of the long bone until healing has
`occurred, then removing the bladder and filling the
`opening through which the bladder emerges from the long
`bone.
`
`u.s. Patent 5,102,413 discloses the way in
`which an inflatable bladder is used to anchor a metal rod
`for the fixation of a fractured long bone.
`other references which disclose the use of
`balloons and cement for anchoring of a prosthesis include
`u.s. Patents 5,147,366, 4,892,550, 4,697,584, 4,562,598,
`and 4,399,814.
`A Dutch patent, NL 901858, discloses a means
`for fracture repair with a cement-impregnated bag which
`is inflated into a preformed cavity and allowed to
`harden.
`
`It can be concluded from the foregoing review
`of the prior art that there is little or no sUbstantive
`information on inflatable devices used to create cavities
`in bone. It does not teach the shape of the balloon
`which creates a cavity that best supports the bone when
`appropriately filled. It does not teach how to prevent
`balloons from being spherical when inflated, when this is
`desired. Current medical balloons can compress bone but
`are too small and generally have the wrong configuration
`and are generally not strong enough to accomplish
`adequate cavity formation in either the vertebral bodies
`or long bones of the body.
`U.S. Patents 4,969,888 and 5,108,404 disclose a
`checker-shaped balloon for compressing cancellous bone,
`
`5,
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 5
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`b
`but does not provide information on how this balloon
`remains in its shape when inflated.
`Thus, the need continues for an improved
`inflatable device for use with pathological bones and the
`treatment thereof.
`
`SUMMARY OF THE INVENTION
`The present invention is directed to a balloon(cid:173)
`like inflatable device or balloon for use in carrying out
`the apparatus and method of the above-mentioned patents
`4,969,888 and 5,108,404. Such inflatable devices,
`hereinafter sometimes referred to as balloons, have
`shapes for compressing cancellous bone and marrow (also
`known as medullary bone or trabecular bone) against the
`inner cortex of bones whether the bones are fractured or
`not.
`
`In particular, the present invention is
`directed to a balloon for use in treating a bone
`predisposed to fracture or to collapse. The balloon
`comprises an inflatable, non-expandable balloon body for
`insertion into said bone. The body has a predetermined
`shape and size when substantially inflated sUfficient to
`compress at least a portion of the inner cancellous bone
`to create a cavity in the cancellous bone and to restore
`the original position of the outer cortical bone, if
`fractured or collapsed. The balloon body is restrained
`to create said predetermined shape and size so that the
`fully inflated balloon body is prevented from applying
`substantial pressure to the inner surface of the outer
`cortical bone if said bone is unfractured or uncollapsed.
`In addition to the shape of the inflatable
`device itself, another aspect of importance is the
`construction of the wall or walls of the balloon such
`that proper inflation the balloon body is achieved to
`provide for optimum compression of all the bone marrow.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 6
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`7
`The material of the balloon is also desirably chosen so
`as to be able to fold the balloon so that it can be
`inserted quickly and easily into a bone using a guide pin
`and a cannula, yet can also withstand high pressures when
`inflated. The balloon can also include optional ridges
`or indentations which are left in the cavity after the
`balloon has been removed, to enhance the stability of the
`filler. Also, the inflatable device can be made to have
`an optional, built-in suction catheter. This is used to
`remove any fat or fluid extruded from the bone during
`balloon inflation in the bone. Also, the balloon body
`can be protected from puncture by the cortical bone or
`canula by being covered while inside the canula with an
`optional protective sleeve of suitable material, such as
`Kevlar or PET or other polymer or substance that can
`protect the balloon. The main purpose of the inflatable
`device, therefore, is the forming or enlarging of a
`cavity or passage in a bone, especially in, but not
`limited to, vertebral bodies.
`The primary object of the present invention is
`to provide an improved balloon-like inflatable device for
`use in carrying out a surgical protocol of cavity
`formation in bones to enhance the efficiency of the
`protocol, to minimize the time prior to performing the
`surgery for which the protocol is designed and to improve
`the clinical outcome. These balloons approximate the
`inner shape of the bone they are inside of in order to
`maximally compress cancellous bone. They have additional
`design elements to achieve specific clinical goals.
`Preferably, they are made of inelastic material and kept
`in their defined configurations when inflated, by various
`restraints, including (but not limited to) use of
`inelastic materials in the balloon body, seams in the
`balloon body created by bonding or fusing separate pieces
`of material together, or by fusing or bonding together
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 7
`
`

`
`W095/10361
`
`PCTIUS95/01011
`
`f
`opposing sides of the balloon body, woven material bonded
`inside or outside the balloon body, strings or bands
`placed at selected points in the balloon body, and
`stacking balloons of similar or different sizes or shapes
`on top of each other by gluing or by heat fusing them
`together. optional ridges or indentations created by the
`foregoing structures, or added on by bonding additional
`material, increases stability of the filler. Optional
`suction devices,. preferably placed so that if at least
`one hole is in the lowest point of the cavity being
`formed, will allow the cavity to be cleaned before
`filling.
`
`Among the various embodiments of the present
`invention are the following:
`1. A doughnut (or torus) shaped balloon with
`an optional built-in suction catheter to remove fat and
`other products extruded during balloon expansion.
`2. A balloon with a spherical outer shape
`surrounded by a ring-shaped balloon segment for body
`cavity formation.
`3. A balloon which is kidney bean shaped in
`configuration. Such a balloon can be constructed in a
`single layer, or several layers stacked on top of each
`other.
`
`4. A spherically shaped balloon approximating
`the size of the head of the femur (i.e. the proximal
`femoral epiphysis).
`such a balloon can also be a
`hemisphere.
`5. A balloon in the shape of a humpbacked
`banana or a modified pyramid shape approximating the
`configuration of the distal end of the radius (i.e. the
`distal radial epiphysis and metaphysis).
`6.
`A balloon in the shape of a cylindrical
`ellipse to approximate the configuration of either the
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 8
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`5
`
`q
`medial half or the lateral half of the proximal tibial
`epiphysis. Such a balloon can also be constructed to
`approximate the configuration of both halves of the
`proximal tibial epiphysis.
`7. A balloon in the shape of sphere on a base
`to approximate the shape of the proximal humeral
`epiphysis and metaphysis with a plug to compress
`cancellous bone into the diaphysis, sealing it off.
`8. A balloon device with optional suction
`
`10
`
`device.
`
`Protective sheaths to act as puncture
`9.
`guard members optionally covering each balloon inside its
`catheter.
`
`The present invention, therefore, provides
`improved, inflatable devices for creating or enlarging a
`cavity or passage in a bone wherein the d~vices are
`inserted into the bone. The configuration of each device
`is defined by the surrounding cortical bone and adjacent
`internal structures, and is designed to occupy about 70-
`90% of the volume of the inside of the bone, although
`balloons that'are as small as about 40% and as large as
`about 99% are workable for fractures.
`In certain cases,
`usually avascular necrosis, the balloon size may be as
`small as 10% of the cancellous bone volume of the area of
`bone being treated, due to the localized nature of the
`fracture or collapse. The fully expanded size and shape
`of the balloon is limited by additional material in
`selected portions of the balloon body whose extra
`thickness creates a restraint as well as by either
`internal or external restraints formed in the device
`including, but not limited to, mesh work, a winding or
`spooling of material laminated to portions of the balloon
`body, continuous or non-continuous strings across the
`inside held in place at specific locations by glue inside
`or by threading them through to the outside and seams in
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 9
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`/0
`the balloon body created by bonding two pieces of body
`together or by bonding opposing sides of a body through
`glue or heat. Spherical portions of balloons may be
`restrained by using inelastic materials in the
`construction of the balloon body, or may be additionally
`restrained as just described. The material of the
`balloon is preferably a non-elastic material, such as
`polyethylene tetraphthalate (PET), Kevlar or other
`patented medical balloon materials. It can also be made
`of semi-elastic materials, such as silicone or elastic
`material such as latex, if appropriate restraints are
`incorporated. The restraints can be made of a flexible,
`inelastic high tensile strength material including, but
`not limited, to those described in u.S. Patent 4,706,670.
`The thickness of the balloon wall is typically in the
`range of 2/1000ths to 25/1000ths of an inch, or other
`thicknesses that can withstand pressures of up to 250-400
`psi.
`
`A primary goal of percutaneous vertebral body
`augmentation of the present invention is to provide a
`balloon which can create a cavity inside the vertebral
`body whose configuration is optimal for supporting the
`bone. Another important goal is to move the top of the
`vertebral body back into place to retain height where
`possible, however, both of these objectives must be
`achieved without fracturing the cortical wall of the
`vertebral body. This feature could push vertebral bone
`toward the spinal cord, a condition which is not to be
`desired.
`
`The present invention satisfies these goals
`through the design of inflatable devices to be described.
`Inflating such a device compresses the calcium-containing
`soft cancellous bone into a thin shell that lines the
`inside of the hard cortical bone creating a large cavity.
`
`STRYKER EXHIBIT 1006, pg. 10
`
`

`
`W095/20362
`
`PCTJUS95/01011
`
`1/
`At the same time, the biological components
`(red blood cells, bone progenitor cells) within the soft
`bone are pressed out and removed by rinsing during the
`procedure. The body recreates the shape of the inside of
`an unfractured vertebral body, but optimally stops at
`approximately 70 to 90% of the inner volume. The
`balloons of the present invention are inelastic, so
`maximally inflating them can only recreate the
`predetermined shape and size. However, conventional
`balloons become spherical when inflated. Spherical
`shapes will not allow the hardened bone cement to support
`the spine adequately, because they make single points of
`contact on each vertebral body surface (the equivalent of
`a circle inside a square, or a sphere inside a cylinder).
`The balloons of the present invention recreate the flat
`surfaces of the vertebral body by including restraints
`that keep the balloon in the desired shape. This
`maximizes the contacts between the vertebral body
`surfaces and the bone cement, which strengthens the
`spine.
`In addition, the volume of bone cement that fills
`these cavities creates a thick mantle of cement (4 mm or
`greater), which is required for appropriate compressive
`strength. Another useful feature, although not required,
`are ridges in the balloons which leave their imprint in
`the lining of compressed cancellous bone. The resulting
`bone cement "fingers" provide enhanced stability.
`The balloons which optimally compress
`cancellous bone in vertebral bodies are the balloons
`listed as balloon types 1, 2 and 3 above. These balloons
`are configured to approximate the shape of the vertebral
`body. Since the balloon is chosen to occupy 70 to 90% of
`the inner volume, it will not exert undue pressure on the
`sides of the vertebral body, thus the vertebral body will
`not expand beyond its normal size (fractured or
`unfractured). However, since the balloon has the height
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 11
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`I~
`of an unfractured vertebral body, it can move the top,
`which has collapsed, back to its original position.
`A primary goal of percutaneous proximal humeral
`augmentation is to create a cavity inside the proximal
`humerus whose configuration is optimal for supporting the
`proximal humerus. Another important goal is to help
`realign the humeral head with the shaft of the humerus
`when they are separated by a fracture. Both of these
`goals must be achieved by exerting pressure primarily on
`the cancellous bone, and not the cortical bone. Undue
`pressure against the cortical bone could conceivably
`cause a worsening of a shoulder fracture by causing
`cortical bone fractures.
`The present invention satisfies these goals
`through the design of the inflatable devices to be
`described.
`Inflating such a device compresses the
`cancellous bone against the cortical walls of the
`epiphysis and metaphysis of the proximal humerus thereby
`creating a cavity.
`In some cases, depending on the
`fracture location, the balloon or inflatable device may
`be used to extend the cavity into the proximal part of
`the humeral diaphysis.
`Due to the design of the "sphere on a stand"
`balloon (described as number 7 above), the cavity made by
`this balloon recreates or approximates the shape of the
`inside cortical wall of the proximal humerus. The
`approximate volume of the cavity made by the "spherical
`on a stand balloon" is 70 to 90% that of the proximal
`humeral epiphysis and metaphysis, primarily, but not
`necessarily exclusive of, part of the diaphysis. The
`shape approximates the shape of the humeral head. The
`"base" is designed to compress the trabecular bone into a
`"plug" of bone in the distal metaphysis or proximal
`diaphysis. This plug of bone will prevent the flow of
`injectable material into the shaft of the humerus,
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 12
`
`

`
`W095/10362
`
`PCTlUS95/01011
`
`13
`improving the clinical outcome. The sphere can also be
`used without a base.
`A primary goal of percutaneous distal radius
`augmentation is to create a cavity inside the distal
`radius whose configuration is optimal for supporting the
`distal radius. Another important goal is to help fine
`tune fracture realignment after the fracture has been'
`partially realigned by finger traps. Both of these goals
`must be achieved by exerting pressure primarily on the
`cancellous bone and not on the cortical bone. Excessive
`pressure against the cortical bone could conceivably
`cause cortical bone fractures, thus worsening the
`condition.
`The present invention satisfies these goals
`through the design of inflatable devices either already
`described or to be described.
`The design of the "humpbacked banana", or
`modified pyramid design (as described as number 5 above),
`approximates the shape of the distal radius and
`therefore, the cavity made by this balloon approximates
`the shape of the distal radius as well. The approximate
`volume of the cavity to be made by this humpbacked banana
`shaped balloon is 70 to 90% that of the distal radial
`epiphysis and metaphysis primarily of, but not
`necessarily exclusive of, some part of the distal radial
`diaphysis.
`Inflating such a device compresses the
`cancellous bone against the cortical walls of the
`epiphysis and metaphysis of the distal radius in order to
`create a cavity.
`In some cases, depending on the
`fracture location, the osseous balloon or inflatable
`device may be used to extend the cavity into the distal
`part of the radial diaphysis.
`A primary goal of percutaneous femoral head (or
`humeral head) augmentation is to create a cavity inside
`the femoral head (or humeral head) whose configuration is
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 13
`
`

`
`W095/10362
`
`PCTIUS95/01011
`
`It(
`optimal for supporting the femoral head. Another
`important goal is to help compress avascular (or aseptic)
`necrotic bone or support avascular necrotic bone is the
`femoral head. This goal may include the realignment of
`avascular bone back into the pos'ition it previously
`occupied in the femoral head in order to improve the
`spherical shape of the femoral head. These goals must be
`achieved by exerting pressure primarily on the cancellous
`bone inside the femoral head.
`The present invention satisfied these goals
`through the design of inflatable devices either already
`described or to be described.
`The design of the spherical osseous balloon
`(described as balloon type 4 above) approximates the
`shape of the femoral head and therefore creates a cavity
`which approximates the shape of the femoral head as well.
`(It should be noted that the spherical shape of this
`inflatable device also approximates the shape of the
`humeral head and would, in fact, be appropriate for
`cavity formation in this osseous location as well.)
`Inflating such a device compresses the cancellous bone of
`the femoral head against its inner cortical walls in
`order to create a cavity.
`In some cases, depending upon
`the extent of the avascular necrosis, a smaller or larger
`cavity inside the femoral head will be formed.
`In some
`cases, if the area of avascular necrosis is small, a
`small balloon will be utilized which might create a
`cavity only 10 to 15% of the total volume of the femoral
`head.
`If larger areas of the femoral head are involved
`with the avascular necrosis, then a larger balloon would
`be utilized which might create a ,much larger cavity,
`approaching 80 to 90% of the volume of the femoral head.
`The hemispherical balloon approximates the
`shape of the top half of the femoral (and humeral) head,
`and provides a means for compacting cancellous bone in an
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`STRYKER EXHIBIT 1006, pg. 14
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`l.b
`area of avascular necrosis or small fracture without
`disturbing the rest of the head. This makes it easier to
`do a future total joint replacement if required.
`A primary goal of percutaneous proximal tibial
`augmentation is to create a cavity inside the proximal
`tibia whose configuration is optimal for supporting
`either the medial or lateral tibial plateaus. Another
`important goal is to help realign the fracture fragments
`of tibial plateau fractures, particularly those features
`with fragments depressed below (or inferior to) their
`usual location. Both of these objectives·must be
`achieved by exerting pressure on primarily the cancellous
`bone and not the cortical bone. Pressure on the cortical
`bone could conceivably cause worsening of the tibial
`plateau fracture.
`The present invention satisfies these goals
`through the design of the inflatable devices to be
`described.
`Inflating such a device compresses the
`cancellous bone against the cortical walls of the medial
`or lateral tibial plateau in order to create a cavity.
`Due to the design of the "elliptical cylinder"
`balloon (described as balloon type 6 above) the cavity
`made by this balloon recreates or approximates the shape
`of the cortical walls of either the medial or lateral
`tibial plateaus. The approximate volume of the cavity to
`be made by the appropriate elliptical cylindrical balloon
`is 50 to 90% of the proximal epiphyseal bone of either
`the medial half or the lateral half of the tibial.
`other objects of the present invention will
`become apparent as the following specification
`progresses, reference being had to the accompanying
`drawings for an illustration of the invention.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`STRYKER EXHIBIT 1006, pg. 15
`
`

`
`W095/20362
`
`PCTIUS95/01011
`
`If:
`BRIEF DESCRIPTION OF THE DRAWINGS
`Fig. 1 is a perspective view of a first
`embodiment of the balloon of the present invention, the
`embodiment being in the shape of a stacked doughnut
`assembly;
`
`Fig. 2 is a vertical section through the
`balloon of Fig. 1 showing the way in which the doughnut
`portions of the balloon of Fig. 1, fit into a cavity of a
`vertebral body;
`Fig. 3 is a schematic view of another
`embodiment of the balloon of the present invention
`showing three stacked balloons and string-like restraints
`for limiting the expansion of the balloon in directions
`of inflation;
`Fig. 4 is a top plan view of a spherical
`balloon having a cylindrical ring surrounding the
`balloon;
`
`Fig. 5 is a vertical secti