Ulllted States Patent [19]
`Jayaraman
`
`USOO5855597A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,855,597
`Jan. 5, 1999
`
`[54] STENT VALVE AND STENT GRAFT FOR
`PERCUTANEOUS SURGERY
`
`5,769,887
`5,776,161
`
`6/1998 Brown ....................................... .. 623/1
`7/1998 Globerman ................................ .. 623/1
`
`[75] Inventor? Swaminathan Jayaramam
`Maneswaram> Indla
`
`[73] Assignee: Iowa-India Investments Co. Limited,
`United Kingdom
`
`[21] Appl' NO‘: 852’240
`[22] Filed;
`May 7, 1997
`
`6
`Int. Cl. ...................................................... .. A61F 2/06
`
`[51]
`
`Primary Examiner—Michael J. Milano
`Attorney, Agent, or Firm—James E. Larson; Larson &
`Larson, PA
`[57]
`
`ABSTRACT
`
`A star-shaped stent and replacement valve or replacement
`graft for use in repairing a damaged cardiac valve includes
`tWo to eight star-shaped members interconnected into a
`“chain”. Once this “chain” has been created through inter
`Connection of the stapshaped members, a Central Opening
`
`[52] U-S- Cl- ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ - - - - - - - -
`
`- - - - - - - - - -- 623/1
`
`through all of the interconnected star-shaped members
`
`[58] Field of Search ........................................... .. 623/1, 12
`
`[56]
`
`References Cited
`U'S' PATENT DOCUMENTS
`
`6/1972 Moulopoulos .
`3,671,979
`4,056,854 11/1977 BoretOS et al- -
`472977749 11/1981 Devis et a1~ -
`5’332’4O2
`7/1994 Telte’lbaum '
`5,397,355
`3/1995 Mann ........................................ .. 623/1
`5,507,771
`4/1996 Gianturco .
`623/1
`5,522,881
`6/1996 LentZ ......... ..
`623/1
`5,618,301
`4/1997 Hauenstein ................................ .. 623/1
`
`receives a replacement aortic valve tri-cuspid made of any
`suitable ?exible and bio-compatible material. A catheter
`delivery system is used to deliver the stent With the aortic
`valve tri-cuspid to the desired site. The star-shaped stents are
`made by using a laser to cut out a plurality of ?at star-shaped
`members With a plurality of outWardly and inWardly directed
`points. The outWardly directed points are bent so that they
`face aWay from a plane de?ned by the inWardly directed
`points and then a series of such stents are fastened together
`in a Chain'
`
`27 Claims, 10 Drawing Sheets
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`NORRED EXHIBIT 2119 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
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`

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`U.S. Patent
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`Jan. 5, 1999
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`Sheet 1 0f 10
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`5,855,597
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`Jan. 5, 1999
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`k'SO
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`Jan. 5, 1999
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`Fig. 17
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`W70
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`

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`1
`STENT VALVE AND STENT GRAFT FOR
`PERCUTANEOUS SURGERY
`
`BACKGROUND OF THE INVENTION
`
`The present invention relates to a star-shaped stent and
`replacement valve and replacement graft for use in repairing
`a damaged cardiac valve. In the prior art, stents are known
`and are employed, usually, to maintain a blood vessel or
`other body passageWay open and free from obstruction.
`Applicant is aWare of the following US. Pat. Nos.:
`US. Pat. No. 3,671,979 to Moulopoulos
`US. Pat. No. 4,056,854 to Boretos et al.
`US. Pat. No. 4,297,749 to Davis et al.
`US. Pat. No. 5,332,402 to Teitelbaum.
`These patents relate to repairs to and replacements for
`cardiac valves. HoWever, none of these references teaches
`the features and aspects of the present invention.
`
`SUMMARY OF THE INVENTION
`
`The present invention relates to a star-shaped stent and
`replacement valve for use in repairing a damaged cardiac
`valve. The present invention includes the folloWing interre
`lated objects, aspects and features:
`(1) In a ?rst aspect, the inventive stent is made in a
`star-shape by cutting it from a ?at metal sheet, preferably in
`the range of 25 to 50 mils in thickness. The metal sheet may
`be stainless steel, titanium, elgiloy or heat activatable metal
`such as NITINOL. The star shape of the stent includes a thin
`outline of a star With the center open. Thus, for eXample,
`Where the star has ?ve outWardly directed points, the same
`star has ?ve inWardly directed points.
`(2) The inventive stent is created by interconnecting from
`tWo to eight of these star-shaped members into a “chain”.
`(3) Once this “chain” has been created through intercon
`nection of the star-shaped members in a manner to be
`described in greater detail hereinafter, a central opening
`through all of the interconnected star-shaped members
`receives a replacement aortic valve tri-cuspid made of any
`suitable ?exible and bio-compatible material. A catheter
`delivery system is used to deliver the stent With the aortic
`valve tri-cuspid to the desired site Where it is eXpanded into
`position. The chain of stents can be sutured outside a knitted,
`Woven or polymeric eXtruded tube to replace a diseased
`portion of an artery in various locations, including the heart.
`(4) In the preferred embodiment, each star-shaped mem
`ber has ?ve points. HoWever, if desired, any number of
`points from tWo to ?ve may be suitably employed.
`Accordingly, it is a ?rst object of the present invention to
`provide a star-shaped stent and replacement valve for use in
`repairing a damaged cardiac valve.
`It is a further object of the present invention to provide
`such a device including a stent made of a plurality of
`interconnected star-shaped members.
`It is a still further object of the present invention to
`provide such a device including a replacement aortic valve
`tri-cuspid inserted Within the star-shaped members and
`attached thereto.
`It is a still further object of the present invention to
`provide a stent-graft for percutaneous replacement in the
`body.
`These and other objects, aspects and features of the
`present invention Will be better understood from the folloW
`ing detailed description of the preferred embodiment When
`read in conjunction With the appended draWing ?gures.
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`5,855,597
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`2
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 shoWs a perspective vieW of a thin metal sheet
`from Which a star-shaped member may be cut.
`FIG. 2 shoWs a perspective vieW of the use of a laser saW
`to cut a star-shaped member from the metal sheet of FIG. 1.
`FIG. 3 shoWs a star-shaped member that has been cut from
`the metal sheet as illustrated in FIGS. 1 and 2.
`FIG. 4 shoWs the star-shaped member of FIG. 3 ?eXed to
`a position facilitating attachment to another star-shaped
`member.
`FIG. 5 shoWs tWo such star-shaped members attached
`together by their outWardly directed points.
`FIG. 6 shoWs three pairs of star-shaped members such as
`the pair shoWn in FIG. 5, interconnected together With
`adjacent such pairs being connected by their respective
`star-shaped member inWardly directed points.
`FIG. 7 shoWs a sheet of ?exible bio-compatible material
`having tWo slits therein and Which Will be employed to
`create a replacement aortic valve tri-cuspid.
`FIG. 8 shoWs the sheet of FIG. 7 With the open edges
`thereof seWn together to form a tube.
`FIG. 9 shoWs the tube of FIG. 8 but With the slitted end
`thereof folded in three overlapping pieces to form the
`tri-cuspid.
`FIG. 10 shoWs the device of FIG. 9 inserted Within the
`three pairs of star-shaped members of FIG. 6 and af?Xed
`thereto to form an integral assembly.
`FIGS. 11, 12 and 13 shoW alternative constructions for the
`star-shaped members.
`FIG. 14 shoWs the assembly of FIG. 10 as inserted,
`through the use of a catheter, Within an aortic opening of a
`heart.
`FIG. 15 shoWs the assembly of FIG. 14 but With the
`device of FIG. 9 in?ated through the use of the catheter so
`that the entire assembly eXpands to ?ll the aortic opening
`shoWn.
`FIG. 16 shoWs the assembly of FIG. 15 remaining in place
`after the catheter has been removed therefrom.
`FIG. 17 shoWs a tubular structure of a knitted, Woven, or
`eXtruded synthetic material to Which is sutured a chain of
`stents.
`FIG. 18 shoWs a structure similar to FIG. 17 but formed
`in a shape for use in a bifurcated artery.
`FIG. 19 shoWs a bio-compatible conduit about to receive
`a patch made from a like bio-compatible material.
`FIG. 20 shoWs the patch sutured to the outside of the
`conduit.
`FIG. 21 shoWs the patch on the inside of the conduit after
`it is turned outside-in.
`FIG. 22 shoWs the conduit of FIG. 21 With a stent sutured
`to the eXterior surface.
`FIG. 23 shoWs an end vieW of the conduit of FIG. 21.
`FIG. 24 shoWs an end vieW of a conduit With tWo patches.
`FIG. 25 shoWs an end vieW of a conduit With three
`patches.
`
`15
`
`25
`
`35
`
`45
`
`55
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`SPECIFIC DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`With reference, ?rst, to FIG. 1, a metal sheet is generally
`designated by the reference numeral 10 and is of a uniform
`thickness, preferably in the range of 25 to 50 mils. With
`reference to FIG. 2, a laser saW 11 emits a beam 13 that may
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`be used to cut a star-shaped member 15 from the sheet 10.
`Other processes for cutting out a star-shaped member 15
`includes chemical etching, electrolysis and other selective
`removal techniques. As seen in FIG. 2, the star-shaped
`member 15 includes ?ve outWardly directed points 17 and
`?ve inWardly directed points 19. The center of the star
`shaped member 15 is open as best seen With reference to
`FIG. 3.
`With reference to FIG. 4, given the thinness of the
`metallic material used to create the star-shaped member 15,
`it may easily be ?exed to assume the con?guration shoWn in
`FIG. 4 With the outWardly directed points 17 sloping doWn
`Wardly With respect to a plane de?ned by the inWardly
`directed points 19.
`With reference to FIG. 5, tWo such star-shaped members,
`modi?ed as shoWn in FIG. 4 may be interconnected together
`by engaging their respective outWardly directed points 17
`and Welding them together using any suitable technique. As
`shoWn in FIG. 5, each star-shaped member 15 has its
`inWardly directed points 19 free and unattached.
`With reference to FIG. 6, a plurality of pairs of star
`shaped members 15 such as the pair illustrated in FIG. 5 may
`be interconnected together by interconnecting pairs of
`inWardly directed points 19 through any suitable means such
`as Welding to form the structure 20 illustrated in FIG. 6 and
`consisting of three such pairs of star-shaped members 15
`interconnected together.
`With reference to FIGS. 7—10, a sheet 30 of a ?exible
`bio-compatible material such as, for example, silk,
`DACRON, NYLON, polytetra?uoroethylene or polyure
`thane is formed in a rectangular shape including sides 31, 33,
`a bottom Wall 35, and a top Wall 37 in Which tWo slits 39 and
`41 are formed to de?ne three ?aps 34, 36 and 38. With
`reference to FIG. 8, the sides 31 and 33 are abutted together
`and are attached through a technique such as, for example,
`seWing, employing the thread 43 as shoWn. Thereafter, With
`reference to FIG. 9, the three ?aps 34, 36 and 38 formed by
`the slits 39 and 41 are folded in overlapping fashion as seen
`in FIG. 9 to form a replacement aortic valve tri-cuspid
`device 45.
`With reference to FIG. 10, the device 45 may be inserted
`Within the three pairs of star-shaped members 15 assembled
`together as illustrated in FIG. 6 and described hereinabove
`and may be af?xed therein through seWing at 47 that attaches
`the members 15 at the area of the inWardly directed points
`19 as shoWn. The device so assembled is designated in FIG.
`10 by the reference numeral 50.
`With reference to FIGS. 14, 15 and 16, the device 50 is
`attached to a catheter 1 and is inserted into an opening 3 in
`the aortic valve area Within the heart 2. As shoWn in FIG. 15,
`the catheter 1 is employed to in?ate the device 50 so that it
`?lls the opening 3. During this in?ation process, the indi
`vidual star-shaped members 15 are further deformed from
`their orientation as seen in FIG. 10 and this deformation is
`maintained once the catheter 1 is removed as shoWn in FIG.
`16 to maintain the device 45 in the expanded state shoWn to
`obscure the opening 3 and provide a replacement aortic
`tri-cuspid valve.
`FIGS. 11, 12 and 13 shoW alternative constructions for the
`star-shaped member. Thus, FIG. 11 shoWs a star-shaped
`member 60 that consists of ?ve arcuately shaped outWardly
`directed points 61 and ?ve arcuate inWardly directed por
`tions 63. FIG. 12 shoWs a four pointed star-shaped member
`70 having four arcuately shaped outWardly directed points
`71 and four inWardly directed points 73. FIG. 13 shoWs a
`three pointed star-shaped member 80 having three outWardly
`
`15
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`25
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`35
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`45
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`55
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`65
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`4
`directed points 81 and three inWardly directed points 83.
`Each of the members 60, 70 or 80 may be employed in the
`same manner described hereinabove as is the case With the
`star-shaped member 15. Each of the members 60, 70 or 80
`may be formed from a metal sheet such as the metal sheet
`10 illustrated in FIG. 1 and employing the same process
`illustrated in FIG. 2. Each of these members 60, 70 or 80
`may be manipulated in the manner described in FIGS. 4, 5
`and 6.
`In FIGS. 17 and 18 a tube 90 made from knitted, Woven
`or an extruded bio-compatible polymer has a chain of stents
`15 sutured 92 to the tube 90. This single graft 94 or the
`bifurcated graft 96 resulting from the joining of the tube 90
`and the stents 15 can be used to replace a diseased portion
`of an artery in various locations including the heart.
`An alternate process for preparing a stent graft according
`to this invention shoWn in FIGS. 19—25, employs a conduit
`100 made from a bovine or synthetic bio-compatible mate
`rial such as polytetra?uoroethylene, DACRON® or a poly
`ester coated With an anticoagulant such as Warfarin or
`heparin. A single patch 104 is sutured to the exterior 102 of
`conduit 100. Thereafter, end 106 is pulled inside the conduit
`100 as shoWn in FIG. 20 so that the patch 104 ends up on
`the inside of the conduit 100 as shoWn in phantom in FIG.
`21. A stent 108 as described in the speci?cation previously
`as stent 15 is thereafter sutured to the exterior 103 of conduit
`100. The single patch 104 acts as a valve as seen in FIG. 23.
`The blockage of blood How is shoWn in phantom With the
`patch 104 identi?ed as 105 When it acts to block blood ?oW
`through the conduit 100.
`Patches 110 and 112 can be sutured to conduit 100 in like
`manner to patch 104 to form a bicuspid valve as shoWn in
`FIG. 24. When patches 110 and 112 are closed (identi?ed
`noW as 111 and 113, respectively) the block How of blood
`through conduit 100.
`Patches 114, 116 and 118 can be sutured to conduit 100 in
`like manner to patch 104 to form a tricuspid valve as shoWn
`in FIG. 25. When patches 114, 116 and 118 are closed
`(identi?ed noW as 115, 117, and 119, respectively) they
`block How of blood through conduit 100.
`As such, an invention has been described in terms of a
`preferred embodiment thereof Which ful?lls each and every
`one of the objects of the invention as set forth hereinabove
`and provides a neW and useful star-shaped stent and replace
`ment valve for use in repairing a damaged cardiac valve of
`great novelty and utility.
`Of course, various changes, modi?cations and alterations
`in the teachings of the present invention may be contem
`plated by those skilled in the art Without departing from the
`intended spirit and scope thereof.
`As such, it is intended that the present invention only be
`limited by the terms of the appended claims.
`I claim:
`1. A stent comprising:
`a) a plurality of star-shaped members, each including:
`i) a plurality of outWardly directed points and an equal
`plurality of inWardly directed points;
`ii) an open center;
`iii) said outWardly directed points being bent and facing
`aWay from a plane de?ned by said inWardly directed
`points;
`b) said star-shaped members being connected together.
`2. The stent of claim 1, Wherein said star-shaped members
`are connected together by a connection that fastens at least
`one outWardly directed point of one star-shaped member
`With a corresponding outWardly directed point of an adjacent
`star-shaped member.
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`3. The stent of claim 1, wherein said star-shaped members
`are connected together by a connection that fastens at least
`one inwardly directed point of one star-shaped member with
`a corresponding inwardly directed point of an adjacent
`star-shaped member.
`4. The stent of claim 2, wherein adjacent said star-shaped
`members form a pair of star-shaped members, and further
`including two pairs of star-shaped members being fastened
`together by a connection that fastens at least one inwardly
`directed point of one star-shaped member of one such pair
`with a corresponding inwardly directed point of one star
`shaped member of an adjacent pair.
`5. The stent of claim 3, wherein adjacent said star-shaped
`members form a pair of star-shaped members, and further
`including two pairs of star-shaped members being fastened
`together by a connection that fastens at least one outwardly
`directed point of one star-shaped member of one such pair
`with a corresponding outwardly directed point of one star
`shaped member of an adjacent pair.
`6. The stent of claim 1, wherein each star-shaped member
`has ?ve outwardly directed points and ?ve inwardly directed
`points.
`7. The stent of claim 1, wherein each star-shaped member
`has four outwardly directed points and four inwardly
`directed points.
`8. The stent of claim 1, wherein each star-shaped member
`has three outwardly directed points and three inwardly
`directed points.
`9. The stent of claim 4, further including a replacement
`aortic valve tri-cuspid fastened within said pairs of star
`shaped members.
`10. The stent of claim 9, wherein said replacement aortic
`valve tri-cuspid includes a tubular body.
`11. A method of making a stent-valve including the steps
`of:
`a) forming a bio-compatible cylindrical conduit and sutur
`ing a patch of a bio-compatible substance to an exterior
`surface of the conduit;
`b) pulling an end of the conduit inside the conduit until the
`patch is located on an interior surface of the conduit
`with the former exterior surface of the conduit now the
`interior surface;
`c) suturing a plurality of stents according to claim 1 to the
`exterior surface of the conduit; and
`d) deploying the patch on the inside surface of the conduit
`to form a mono-cuspid valve.
`12. The method according to claim 11 wherein two
`patches are sutured spaced apart to the exterior surface of the
`conduit in step a) so that a bicuspid valve is formed.
`13. The method according to claim 11 wherein three
`patches are sutured spaced apart to the exterior surface of the
`conduit in step a) so that a tricuspid valve is formed.
`14. The method according to claim 11 wherein an anti
`coagulant is coated on the conduit and patch to prevent
`clotting around the valve.
`15. A method of making a stent including the steps of:
`a) forming a plurality of ?at star-shaped members each
`including a plurality of outwardly directed points and
`an equal plurality of inwardly directed points and an
`open center;
`b) bending said outwardly directed points so that they face
`away from a plane de?ned by said inwardly directed
`points;
`c) fastening said star-shaped members together.
`16. The method of claim 15, wherein said fastening step
`includes the step of connecting said star-shaped members
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`a O
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`5 m
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`6
`together by fastening at least one outwardly directed point of
`one star-shaped member with a corresponding outwardly
`directed point of an adjacent star-shaped member.
`17. The method of claim 15, wherein said fastening step
`includes the step of connecting said star-shaped members
`together by fastening at least one inwardly directed point of
`one star-shaped member with a corresponding inwardly
`directed point of an adjacent star-shaped member.
`18. The method of claim 16, wherein adjacent said
`star-shaped members form a pair of star-shaped members,
`and said method further including the step of fastening two
`pairs of star-shaped members together by fastening at least
`one inwardly directed point of one star-shaped member of
`one such pair with a corresponding inwardly directed point
`of one star-shaped member of an adjacent pair.
`19. The method of claim 17, wherein adjacent said
`star-shaped members form a pair of star-shaped members,
`and said method further including the step of fastening two
`pairs of star-shaped members together by fastening at least
`one outwardly directed point of one star-shaped member of
`one such pair with a corresponding outwardly directed point
`of one star-shaped member of an adjacent pair.
`20. The method of claim 15, wherein said forming step
`includes the step of forming a plurality of ?at star-shaped
`members each having ?ve outwardly directed and ?ve
`inwardly directed points.
`21. The method of claim 18, further including the step of
`fastening a replacement aortic valve tri-cuspid within said
`pairs.
`22. The method of claim 19, wherein adjacent said
`star-shaped members form a pair of star-shaped members,
`and said method further including the step of fastening two
`pairs of star-shaped members together by fastening at least
`one inwardly directed point of one star-shaped member of
`one such pair with a corresponding inwardly directed point
`of one star-shaped member of an adjacent pair.
`23. The method of claim 15 wherein the plurality of
`?at-star shaped members are derived from cutting a ?at
`metal sheet of a material selected from the group consisting
`of stainless steel, titanium, elgiloy or NITINOL.
`24. A stent comprising:
`a) a plurality of star-shaped members, each including:
`i) ?ve outwardly directed points and ?ve inwardly
`directed points;
`ii) an open center;
`iii) said outwardly directed points being bent and facing
`away from a plane de?ned by said inwardly directed
`points;
`b) said star-shaped members being connected together in
`a plurality of pairs;
`c) two pairs of star-shaped members being fastened
`together by a connection fastening at least one inwardly
`or outwardly directed point of one star-shaped member
`of one such pair with a corresponding inwardly or
`outwardly directed point of one star-shaped member of
`an adjacent pair;
`d) a replacement aortic valve tri-cuspid fastened within
`said pairs of star-shaped members and including a
`tubular body.
`25. The stent according to claim 24 wherein the star
`shaped members are sutured to the tubular body.
`26. The stent according to claim 25 wherein the tubular
`body is bifurcated.
`27. The stent according to claim 24 wherein the tubular
`body is a knitted, woven or extruded polymeric material
`acceptable to living tissue.
`
`*
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`*
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`*
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`*
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`*
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