STRYKER EXHIBIT 1007, pg. 1
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01433
`
`

`

`viel Nam
`
`United Kingdom
`Georgia
`Guinea
`Greece
`Hungary
`Ireland
`Italy
`Japan
`Kenya
`Kyrgystan
`Democratic People's Republic
`of Korea
`Republic of Korea
`Kazakhstan
`Liechtenstein
`Sri Lanka
`Liberia
`Lithuania
`Luxembourg
`Latvia
`Monaco
`Republic of Moldova
`Madagascar
`Mali
`Mongolia
`Mauritania
`
`AM
`AT
`AU
`BB
`BE
`BF
`BC
`BJ
`BR
`BY
`CA
`CF
`CG
`CH
`CI
`CM
`CN
`CS
`CZ
`DE
`DK
`EE
`ES
`FI
`FR
`GA
`
`Armenia
`Austria
`Australia
`Barbados
`Belgium
`Burkina Faso
`Bulgaria
`Benin
`Brazil
`Belarus
`Canada
`Central African Republic
`Congo
`Switzerland
`COte d‘lvoine
`Cameroon
`China
`Czechoslovakia
`Czech Republic
`Germany
`Denmark
`Estonia
`Spain
`Finland
`France
`Gabon
`
`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.
`
`Malawi
`Mexico
`Niger
`Netherlands
`Norway
`New Zealand
`Poland
`Portugal
`Romania
`Russian Federation
`Sudan
`Sweden
`Singapore
`Slovenia
`Slovakia
`Senegal
`Swaziland
`Chad
`Togo
`Tajikistan
`Trinidad and Tobago
`Ukraine
`Uganda
`United States of Amenca
`Uzbekistan
`
`STRYKER EXHIBIT 1007, pg. 2
`
`STRYKER EXHIBIT 1007, pg. 2
`
`

`

`WO 96/39970
`
`PCT/US96/09933
`
`IMPROVED INFLATABLE DEVICE FOR USE IN SURGICAL PROTOCOLS
`
`RELATING TO TREATMENT OF FRACTURED OR DISEASED BONE
`
`This application is a continuation-in—part of
`
`U.S. Patent application Serial No. 08/485,394, filed June
`
`7, 1995, which is a continuation—in-part of U.S. patent
`
`application Serial No. 08/188,224, filed January 26, 1994
`
`entitled, "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, while avascular necrosis and bone
`
`cancers are more rare. These conditions cause bone
`
`problems that have been poorly addressed, resulting in
`
`deformities and chronic complications.
`
`The outcome of many other orthopedic procedures
`
`to treat bone, such as open surgeries involving infected
`
`bone, poorly healing bone or bone fractured by severe
`
`trauma, can also be improved. Currently, bone is
`
`prepared to receive materials such as bone graft or bone
`
`substitutes by removing diseased or injured bone using
`
`standard tools, usually made of metal. Gaps between the
`
`patient’s remaining bone and the inserted materials delay
`
`or prevent healing.
`
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`sunsrmnzsum mums)
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`STRYKER EXHIBIT 1007, pg. 3
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`STRYKER EXHIBIT 1007, pg. 3
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`

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`WO 96/39970
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`PCT/US96/09933
`
`Therapeutic substances like antibiotics and
`
`bone growth factors have not been applied to bone in a
`
`way that optimizes and maintains their contact with the
`
`desired area of bone. Antibiotics, bone growth factors
`
`and other drugs can prevent complications and hasten
`
`repair.
`
`They are currently placed as dry powders or
`
`liquids around the treated bone, or else are formulated
`into a gel or a degradable plastic polymer and inserted
`
`into areas with defects (holes in the bone). Delivered
`
`in this manner,
`
`they can be washed away by blood or other
`
`fluids, either immediately or as their carrier degrades.
`
`Also,
`
`the amount of therapeutic substance delivered in a
`
`gel or polymer can be limited by the space provided by
`
`the defect.
`
`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, but
`
`not limited to, use in the fixation of vertebral body
`
`compression fractures, Colles fractures and fractures of
`
`the proximal humerus.
`
`The method disclosed in these two patents
`
`includes a series of steps in which a surgeon or health
`
`care provider can perform to form a cavity in fractured
`
`or 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 of the epiphyses of long bones,
`
`especially avascular necrosis of the proximal femur,
`
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`SUBSTfllflE SHEEI (RULE 26)
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`STRYKER EXHIBIT 1007, pg. 4
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`STRYKER EXHIBIT 1007, pg. 4
`
`

`

`WO 96/39970
`
`PCT/US96/09933
`
`. 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,
`
`and inserting an inflatable balloon-like device into the
`cavity or passage.
`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
`against the inner surface of the cortical wall of the
`
`5
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`sum SHEET (RULE 26)
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`STRYKER EXHIBIT 1007, pg. 5
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`STRYKER EXHIBIT 1007, pg. 5
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`

`

`WO 96/39970
`
`PCT/US96/09933
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`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.
`
`It has also been found that therapeutic
`
`substances can be delivered with the apparatus and
`
`methods of the above_patents in an unexpected way.
`
`It
`
`has been additionally found that the apparatus and
`
`methods of the above patents can be adapted in ways not
`
`previously described to improve open surgeries to fix,
`
`fuse or remove bone, as well as to deliver therapeutic
`
`substances during these surgeries.
`
`A need has therefore
`
`arisen for improvements in the shape, construction and
`
`size of inflatable devices for use with the foregoing
`
`apparatus and method, as well as for new methods, 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
`
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`35
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`SUBSTITUTE SHEET (RULE 26)
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`snmeRExmBn1mnge
`
`STRYKER EXHIBIT 1007, pg. 6
`
`

`

`WO 96/39970
`
`PCT/US96/09933
`
`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,
`
`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
`
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`SUBSTITUTE SHEET (RULE 26)
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`STRYKER EXHIBIT 1007, pg. 7
`
`STRYKER EXHIBIT 1007, pg. 7
`
`

`

`WO 96/39970
`
`PCT/US96/09933
`
`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.
`
`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
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`SUBSTWIE SHEET (RULE 26)
`
`STRYKER EXHIBIT 1007, pg. 8
`
`STRYKER EXHIBIT 1007, pg. 8
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`

`

`WO 96/39970
`
`PCT/US96/09933
`
`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,
`
`but does not provide information on how this balloon
`
`remains in its shape when inflated.
`
`It also does not
`
`provide methods to deliver an enhanced supply of
`
`therapeutic agent.
`
`U.S. Patent No. 4,892,550 describes an elastic
`
`balloon for anchoring a metal prosthesis inside of a
`
`bone. U.S. Patent No. 4,313,434 describes a deflatable
`
`bladder to substitute for metal rods which are placed
`
`inside the intramedullary cavity of fractured long bones
`
`(thigh,
`
`leg and arm)
`
`to keep them together while they
`
`heal.
`
`Thus,
`
`the need continues for an improved
`
`inflatable device and methods for use with fractured
`
`and/or pathological bones.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to a balloon-
`
`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, and to new methods for using
`
`these devices, and to new uses of the methods and
`
`devices.
`
`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
`
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`SW SHEET (RULE 26)
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`STRYKER EXHIBIT 1007, pg. 9
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`STRYKER EXHIBIT 1007, pg. 9
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`

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`WO 96/39970
`
`PCT/US96/09933
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`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.
`
`Substantial pressure is defined herein as pressure
`
`sufficient to displace the cortical cone beyond its
`
`normal configuration.
`
`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.
`
`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 canula, 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.
`
`A main purpose of the inflatable
`
`device,
`
`therefore,
`
`is the forming or enlarging of a
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`SUBSTITUTE SHEET (RULE 26)
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`STRYKER EXHIBIT 1007, pg. 10
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`STRYKER EXHIBIT 1007, pg. 10
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`

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`WO 96/39970
`
`PCT/US96/09933
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`cavity or passage in a bone, especially in, but not
`
`limited to, vertebral bodies.
`
`In one aspect,
`
`the invention provides 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
`
`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
`
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`
`filling.
`
`In another aspect,
`
`the invention provides new
`
`uses for these balloons, and new methods for their use.
`
`Balloons can be used to deliver therapeutic substances by
`
`coating the balloons with the therapeutic substance
`
`35
`
`before inserting the balloon into bone. When coated
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`SUBSTITUTE SHEET (RULE 26)
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`STRYKER EXHIBIT 1007, pg. 11
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`STRYKER EXHIBIT 1007, pg. 11
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`

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`WO 96/39970
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`PCT/US96/09933
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`_ 10 _
`
`balloons are inflated in bone,
`
`the therapeutic substances
`
`are pressed into the cancellous bone while that bone is
`
`being compressed by the balloon. This allows desired
`
`amounts of the therapeutic substance to be delivered
`
`directly to the site of therapy in a manner that is
`
`maintained over time.
`
`The balloons can also be used
`
`during minimally invasive or open surgeries to provide an
`
`improved space for orthopedic implants, bone graft, bone
`
`substitutes, acrylic cements, bone fillers, bone growth
`
`factors, chemotherapeutic agents, antibiotics or other
`
`drugs.
`
`The agents inside the bone can be intended to
`
`treat the bone itself or to serve as a reservoir of drug
`
`for a structure nearby, such as an osteosarcoma.
`
`In yet another aspect of the invention,
`
`the
`
`balloons can be used to temporarily provide structural
`
`support for a fractured or diseased bone.
`
`In this
`
`embodiment,
`
`the fractured or diseased bone can be treated
`
`by inflating the balloon at the treatment site and
`
`leaving it in place until the surrounding cortical bone
`
`heals.
`
`In other words,
`
`the balloon will take the place
`
`of the biocompatible filling material used in previous
`
`methods to support the fractured or diseased bone.
`
`The
`
`invention will include a mechanism for sealing the
`
`inflated balloon outside of the bone cavity, but within
`
`the patient.
`
`The sealing mechanism can include a metal
`
`or plastic clip, a check valve activated by unscrewing
`
`the inflation tube, a plug for sealing the inner passage
`
`of the balloon or the like. Similar to previous
`
`embodiments,
`
`the balloon will be delivered into the bone
`
`and inflated to compress the inner cancellous bone and
`
`create a cavity therein.
`
`The inflated balloon will then
`
`be sealed, e.g., by inserting a plug within the inflation
`
`opening,
`
`the inflation tube will be removed from the
`
`patient, and the percutaneous incision will be closed.
`
`The fluid pressure within the balloon provides sufficient
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`SUBSTITUTE SHEET (RULE 26)
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`STRYKER EXHIBIT 1007, pg. 12
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`STRYKER EXHIBIT 1007, pg. 12
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`

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`WO 96/39970
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`PCT/US96/09933
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`-11-
`
`support for the bone to allow the bone to heal.
`
`The
`
`balloon can be left in the bone cavity in the inflated
`
`configuration for an amount of time necessary for the
`
`outer cortical bone to completely or at least partially
`
`heal, usually about 1 day to 3 months and preferably
`
`about 6-8 weeks.
`
`In this aspect of the invention,
`
`the
`
`balloon is providing at least four functions:
`
`(1)
`
`realigning the bones;
`
`(2) eliminating or at least
`
`reducing diseased inner cancellous bone;
`
`(3)
`
`strengthening the outer cortical bone by providing
`
`additional calcium from the compressed inner cancellous
`
`bone which is incorporated into the outer cortical bone
`
`as it heals; and (4) acting as an internal cast while the
`
`cortical bone heals.
`
`After the cortical bone has healed,
`
`the
`
`surgeon can access the balloon through the same or
`
`another percutaneous incision to deflate the balloon by
`
`removing the clip, plug or,
`
`in the case of a check valve,
`
`by screwing the inflation tube back into the balloon.
`
`In
`
`many cases,
`
`the cortical bone will have become
`
`sufficiently strengthened through healing with additional
`
`calcium from the compressed cancellous.
`
`In these cases,
`
`the balloon will be removed from the bone cavity.
`
`The
`
`balloon may include a coating, such as Gelfoam or an
`
`antibiotic, on its outer surface to stop bleeding,
`
`prevent infection, minimize bone growth into the balloon
`
`and/or to facilitate separation of the balloon from the
`
`bone when the balloon is deflated.
`
`If, however,
`
`the
`
`surgeon determines that the cortical bone is still too
`
`weak (e.g.,
`
`through a bone density scan or other
`
`measurement), appropriate supporting material, such as
`
`acrylic cements, bone substitutes, bone fillers or bone
`
`growth factors, can be inserted into the bone cavity
`
`before removal of the balloon.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`SUBSTITUTE SHEET (RULE 26)
`
`STRYKER EXHIBIT 1007, pg. 13
`
`STRYKER EXHIBIT 1007, pg. 13
`
`

`

`WO 96/39970
`
`PCT/US96/09933
`
`-12-
`
`The methods of the above—mentioned patents and
`
`the improvements herein can be applied anywhere in the
`
`skeleton where there is cancellous and/or trabecular
`
`and/or medullary bone.
`
`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. This embodiment can also be a square or a
`
`rectangle instead of a kidney bean.
`
`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
`
`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
`
`10
`
`15
`
`20
`
`25
`
`30
`
`SUBSITWTE SHEET (RULE 26)
`
`STRYKER EXHIBIT 1007, pg. 14
`
`STRYKER EXHIBIT 1007, pg. 14
`
`

`

`WO 96/39970
`
`PCT/US96/09933
`
`_ 13 _
`
`cancellous bone into the diaphysis, sealing it off.
`
`Such
`
`an-embodiment can also be a cylinder.
`
`8.
`
`A balloon in the shape of a boomerang to
`
`approximate the inside of the femoral head, neck and
`
`lesser trochanter, allowing a procedure to prevent hip
`fracture.
`
`9.
`
`A balloon in the shape of a cylinder to
`
`approximate the size and shape of the inside of the
`
`proximal humerus or of the distal radius.
`
`A balloon device with an optional
`10.
`suctional device. and
`
`11. Protective sheaths to act as puncture
`
`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 devices 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
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`SUBSTITUTE SHEET (RULE 26)
`
`STRYKER EXHIBIT 1007, pg. 15
`
`STRYKER EXHIBIT 1007, pg. 15
`
`

`

`WO 96/39970
`
`PCT/U596/09933
`
`-14-
`
`or by threading them through to the outside and seams in
`
`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.
`
`One important 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 changing the outer diameter of the sides
`
`of the vertebral body, either by fracturing the cortical
`
`wall of the vertebral body or by moving already fractured
`
`bone. 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
`
`10
`
`15
`
`20
`
`25
`
`30
`
`SUBSTITUTE SHEET (RULE 26)
`
`STRYKER EXHIBIT 1007, pg. 16
`
`STRYKER EXHIBIT 1007, pg. 16
`
`

`

`WO 96/39970
`
`PCTIUS96/09933
`
`-15-
`
`soft cancellous bone into a thin shell that lines the
`
`inside of the hard cortical bone creating a large cavity.
`
`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
`
`10
`
`15
`
`20
`
`25
`
`bone cement "fingers" provide enhanced stability.
`
`The balloons which optimally compress
`
`30
`
`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
`
`35
`
`sides of the vertebral body,
`
`thus the vertebral body will
`
`SUBSTITUTE SHEET (RULE 26)
`
`STRYKER EXHIBIT 1007, pg. 17
`
`STRYKER EXHIBIT 1007, pg. 17
`
`

`

`WO 96/39970
`
`PCT/US96/09933
`
`-16—
`
`not expand beyond its normal size (fractured or
`
`unfractured). However, since the balloon has the height
`
`of an unfractured vertebral body, it can move the tqp,
`
`which has collapsed, back to its original position. Any
`
`number of individual balloons can be stacked, and stacks
`
`containing any of the balloons of types 1, 2 and 3 can be
`
`mixed in shape and/or size to provide greater flexibility
`
`and/or control.
`
`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.
`
`pDue 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
`
`10
`
`15
`
`20
`
`25
`
`3O
`
`35
`
`SUBSTITUTE SHEET (RULE 26)
`
`STRYKER EXHIBIT 1007, pg. 18
`
`STRYKER EXHIBIT 1007, pg. 18
`
`

`

`WO 96/39970
`
`PCT/US96/09933
`
`-17-
`
`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,
`
`improving the clinical outcome.
`
`The sphere can also be
`
`used without a base. Alternatively,
`
`the balloon can be
`
`shaped like a fat cylinder, with one end at the top of
`
`the humeral head attached to the catheter and the other
`
`end filling the function of the plug.
`
`The cylinder can
`
`also be formed so that the diameter of the end in the
`
`humerus is greater than the diameter of the end which
`
`function