US007731742B2
`
`(12) United States Patent
`Schlick et a1.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 7,731,742 B2
`Jun. 8, 2010
`
`(54) STENT
`
`6,027,525 A
`
`2/2000 Suh et a1.
`
`
`
`6,156,064 A * 12/2000 Chouinard 6,162,244 A * 12/2000 Braun et a1. 6,669,724 B2 * 12/2003 Park et a1. FOREIGN PATENT DOCUMENTS
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`
`
`
`
`623/144
`2 l L / 3 2 6
`623/124
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`(75)
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`
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`Inventors: Tilman Schlick, Esslingen (DE); Markus Kuhnle, Urbach (DE)
`
`(73) Assignee: Boston Scienti?c Scimed, Inc., Maple
`Grove, MN (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 829 days.
`
`(21) Appl. No.: 11/059,840
`
`(22) Filed:
`
`Feb. 17, 2005
`
`(65)
`
`Prior Publication Data
`
`US 2005/0182481 A1
`
`Aug. 18, 2005
`
`(51) Int. Cl.
`A61F 2/06
`A61M 29/00
`
`(2006.01)
`2006.01
`(
`)
`623/1.13;623/1.15
`(52) US. Cl.
`623/1 13
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`References Cited
`
`(58)
`
`(56)
`
`Related US. Application Data
`
`* cited by examiner
`
`(63) Continuation of application No. 10/427,869, ?led on
`APr- 30, 2003, now abandoned
`
`Primary Examinerivy Q Bui
`(74) Attorney, Agent, or FirmiHoffmann & Baron, LLP
`
`EP
`EP
`EP
`EP
`EP
`EP
`JP
`JP
`JP
`SU
`W0
`
`1/1997
`0 888 758 A2
`5/1997
`0 775 471 A1
`0 808 614 A2 11/1997
`0 818184 A1
`1/1998
`0 901353 B1
`7/2001
`1 264 582 A2 12/2003
`10-043315
`2/1998
`10-277068
`10/1998
`2001-502192
`2/2001
`1292761
`2/ 1987
`WO 00/32137
`6/2000
`
`(57)
`
`ABSTRACT
`
`A stent (10) for transluminal implantation comprises a ?rst,
`.
`.
`.
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`second and th1rd stent sect1on (11, 12, 13) for spl1nt1ng and/or
`keeping open a holloW organ Which are connected to each
`other via elastic tubular sections (14, 15). The stent (10)
`combines atleast three different stent designs in one stent and
`can therefore be adjusted to the motion behavior of a holloW
`organ in an improved fashion (FIG. 1).
`
`US. PATENT DOCUMENTS
`
`5,897,589 A
`
`4/ 1999 Cottenceau et a1.
`
`10 Claims, 2 Drawing Sheets
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`15
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`13
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`17
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`17
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`17
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`Edwards Lifesciences Corporation, et al. Exhibit 1139, Page 1 of 6
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`

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`US. Patent
`
`Jun. 8 2010
`
`Sheet 1 of2
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`Edwards Lifesciences Corporation, et al. Exhibit 1139, Page 2 of 6
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`

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`U.S. Patent
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`
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`Edwards Lifesciences Corporation, et al. Exhibit 1139, Page 3 of 6
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`

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`US 7,731,742 B2
`
`1
`STENT
`
`The present application is a continuation of US. patent
`application Ser. No. 10/427,869 ?ledApr. 30, 2003 noW aban
`doned Which is to be incorporated in its entirety into the
`present application.
`
`BACKGROUND OF THE INVENTION
`
`The invention concerns a stent for splinting and/or keeping
`open a hollow organ, consisting of a tubular body having a
`diameter Which can be changed through axial displacement of
`the ends of the body relative to each other.
`A stent ofthis type is disclosed in EP 0 901 353 B1.
`The knoWn stent not only permits radial Widening of vessel
`narroWings but also splinting or keeping open thereof. The
`stent is introduced into a holloW organ in its narroWed and
`lengthened state and radially expanded at the narroWed loca
`tion of the holloW organ to ensure that the holloW organ
`assumes its original lumen at this location if possibly perma
`nently. For automatic expansion, Webs are used Which are
`processed into stents. The Webs can be lengthened against
`their unloaded initial structure. If the lengthening or radial
`deformation is removed, these knoWn stents return into their
`initial state through radial Widening. This effect is used for
`Widening stenoses in holloW organs to prevent their function
`from being impaired, if possible.
`
`SUMMARY OF THE INVENTION
`
`It is the object of the invention to produce a stent With
`improved and positionally stable adoption and transmission
`of the motions of the holloW organs.
`This object is achieved in accordance With the invention by
`the features of claim 1.
`The inventive stent therefore has the substantial advantage
`that it can have sections in the longitudinal direction With
`returning forces of different strengths. Each stent section may
`have its oWn design and/ or motion behavior such that stents
`With reduced total pre-shortening (axial lengthening of the
`free stent ends With radial compression of a stent) and special
`migration-suppressing properties can be produced. Due to the
`fact that the stent sections are connected to each other via
`elastic tubular sections, the individual stent sections remain
`highly elastic and can be adjusted to the holloW organ shapes
`in an improved fashion. The elastic tubular sections (thin
`highly ?exible and tear-proof plastic sheets) permit relative
`motion of the individual stent sections (invagination of a
`higher or lesser degree Which depends on the selected Wall
`thickness and the selected material for the elastic tubular
`sections). The inventive stent adjusts itself, if necessary, to the
`peristaltic of holloW organs Without migrating. Particular neW
`stent properties can be derived from the distance, separation
`of the individual stent sections from each other in connection
`With the elastic tubular sections Which interconnect the indi
`vidual stent sections.
`The inventive stent can be expanded by auxiliary means or
`can be designed as automatically expanding stent.
`The inventive stent sections have a Woven, braided tubular
`mesh and/or one or more phase-shifted helices in one or more
`planes.
`This is advantageous in that different support constructions
`can be used in the individual stent sections in the same stent.
`The different support constructions or support constructions
`of different distinction control the motion and deformation
`behavior of the inventive stent in a de?ned fashion.
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`In a further preferred embodiment of the invention, the
`body is formed in the unloaded expanded state from a ?rst
`stent section comprising a ?rst diameter, a second and third
`stent section comprising a second and third diameter and
`from tWo elastic tubular sections Which connect the ?rst,
`second and third stent sections.
`This is advantageous in that a three-part stent may provided
`inner lining of a holloW organ Which permits eg a bordering
`tumor to protrude elastic tubular sections of an inventive stent
`into the lumen of the stent. Support and ?xing of a stent in the
`stenosis is further improved thereby (protection from migra
`tion).
`In a further embodiment of the invention, the diameters of
`the stent sections vary. This is advantageous in that returning
`forces of different strengths may form for different locations.
`The elastic tubular sections easily adjust to cross-sectional
`changes speci?cally along a stent and in the unloaded state, a
`transition from a smaller stent section to a larger stent section
`and vice versa Without projection or creases is possible.
`In a further embodiment of the inventive stent, When sev
`eral helices are provided in several planes, at least one helix
`has an opposite Winding direction. This is advantageous in
`that the inventive stent obtains reversible torquing (torque)
`such that during expansion, the pre-torquing is returned and
`the inventive stent abuts the inner surface of a holloW organ
`like a screW. This so-called “torquing effect” can be realiZed
`in each of the individual stent sections as required.
`It is also preferred that the elastic tubular sections are
`produced from a tissue-compatible plastic material and/or the
`elastic tubular sections have different diameters in the
`unloaded state.
`This is advantageous in that the inventive stent largely
`prevents or reduces tissue irritations in the region of its tWo
`ends, When placed at its location, and it is possible to coat also
`the support constructions (Webs, helices) With a layer or lay
`ers Which form elastically tubular sections. Different diam
`eters of the stent sections in the longitudinal direction of a
`stent are thereby no problem.
`In a particularly preferred embodiment of the inventive
`stent, the body has, vieWed in cross-section, a Web in the ?rst,
`second and third stent section and/or one or more helices
`Which are surrounded by one or more elastic plastic layers
`Which merge into the elastic tubular sections in a material
`bonding fashion Without Webs and helices.
`This is advantageous in that the inner surface of an inven
`tive stent may have a particularly smooth and/or e.g. hydro
`philic layer depending on the requirements and the jacket
`With plastic layer formed in the outer periphery of the stent
`?xes the Web or helices and the outer and inner plastic coating
`can merge into the elastic tubular sections along the inventive
`stent in a material-bonding fashion. This embodiment pro
`duces particularly robust stents.
`The body of an inventive stent may have a ?lament in an
`axial direction in the Wall Which may serve as a securing
`thread Which ensures that the different stent sections are held
`together also under increased load and on the other hand this
`thread may provide X-ray shadoW. This is advantageous in
`that also after a longer prevailing time, the position of the
`stent in the holloW organ can be examined, determined and
`proven in an exact fashion. It is clear that also several ?la
`ments, eg on tWo opposite sides or in all four cross-sectional
`quadrants can be Worked into the Wall of a stent.
`The ?lament Worked into the stent in a longitudinal direc
`tion may project over the stent as securing thread and serves
`as pulling thread or for mounting the inventive stent. Several
`?laments can be Worked into the Wall of the stent vieWed
`across the periphery of the stent.
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`Edwards Lifesciences Corporation, et al. Exhibit 1139, Page 4 of 6
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`US 7,73l,742 B2
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`3
`In a further embodiment of the invention, the proximal end
`region of the body of the inventive stent, vieWed across the
`periphery of the body, comprises a Worked-in thread Whose
`length projects past the stent. This is advantageous in that
`such a thread can produce a thread ring similar to a tobacco
`bag seam Which facilitates removal of a placed stent. Pulling
`together of the proximal stent end like a tobacco bag permits
`removal of the inventive stent from the bordering holloW
`organ tissue and pulling out of the holloW organ by the thread.
`In a further embodiment, the distal end of the body has a
`return valve, in particular a foil valve, Which is advantageous
`in that When the inventive stent is placed in the oesophagus,
`liquid or other nutrients can ?oW only in one direction. The
`foil valve formed as re?ux valve consists of tWo thin foil
`sheets Which are Welded together eg at the edges.
`Web-free means at the same time no meshes or helices.
`Further advantages of the invention can be extracted from
`the description of the draWing. The features mentioned above
`and beloW can be used in accordance With the invention either
`individually or in arbitrary combination. The embodiments
`mentioned are not to be understood as exhaustive enumera
`tion but rather have exemplary character.
`
`BRIEF DESCRIPTION OF THE DRAWING
`
`FIG. 1 shoWs a side vieW of ?rst embodiment of an inven
`tive stent;
`FIG. 2 shoWs a side vieW of a second embodiment of an
`inventive stent;
`FIG. 3 shoWs a side vieW of a third embodiment of an
`inventive stent; and
`FIG. 4 shoWs a side vieW of a fourth embodiment of an
`inventive stent.
`The ?gures shoW the inventive stent in a highly schema
`tised fashion.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`FIG. 1 shoWs a stent 10 Which is formed from a ?rst stent
`section 11, a second stent section 12, a third stent section 13,
`a ?rst elastic tubular section 14 and a second elastic tubular
`section 15. The stent 10 is shoWn in an unloaded expanded
`state. The support construction in the stent sections 11, 12, 13
`is a Web 16 Which may be tubularly braided or Woven. The
`individual ?laments of the Web may be produced from metal,
`plastic or carbon. The ?rst stent section 11 may be the tubular
`Web 16 itself or the Web 16 is additionally surrounded by a
`plastic jacket. The gaps (meshes) of the Web 16 may be open
`or closed. The second and third stent section 12, 13 have a
`larger diameter than the ?rst stent section 11. The Web 16 of
`the ?rst stent section 11 Was also chosen as support construc
`tion in the stent sections 12, 13. The diameters of the indi
`vidual ?laments of the Web 16 in the stent sections 12, 13 may
`be different from the ?lament diameters of the ?laments used
`in the ?rst stent section 11.
`The stent sections 11, 12, 13 are connected to each other via
`a ?rst and second elastic tubular section 14, 15. The elastic
`tubular sections 14, 15 are produced from a ?exible thin
`plastic material, eg silicon, and permanently and securely
`connect the stent sections 11, 12, 13. The elastic tubular
`sections 14, 15 can safely bridge diameter changes betWeen
`the individual stent sections 11, 12, 13 and can adjust to the
`surface contour in a holloW organ Without forming gaps. The
`stent 10 can be lengthened in the direction of arroWs 17 and be
`shortened again after lengthening. The present case concerns
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`an automatically expanding stent 10 Which has a smaller
`diameter in the lengthened state than in the expanded state
`shoWn in the ?gure.
`FIG. 2 shoWs a stent 20 consisting of a ?rst stent section 21,
`a second stent section 22, a third stent section 23 and a ?rst
`and second elastic tubular section 24, 25. The stent sections
`21, 22, 23 are inseparably interconnected via the elastic tubu
`lar sections 24, 25. The stent sections 21, 22, 23 have a helix
`26 as support construction Which is embedded into a stretch
`able elastic plastic material. The elastic tubular sections 24,
`25 have no reinforcing materials such that the stent sections
`21, 22, 23 are individually and mutually movable. The stent
`sections 21, 22, 23 can be lengthened and shortened in the
`direction of arroWs 27. The elastic tubular sections 24, 25
`folloW the motions of the stent sections 21, 22, 23.
`FIG. 3 shoWs a stent 30 comprising a ?rst stent section 31,
`a second stent section 32 and a third stent section 33. The stent
`sections 31, 32, 33 are permanently connected via a ?rst and
`a second elastic tubular section 34, 35.
`The support construction in the ?rst stent section 31 is a
`?rst and second helix 36 of opposite Winding directions. A
`helix 36 is disposed in a ?rst plane in the ?rst stent section 31
`embedded in a plastic material, and another helix 36 extends
`in the second plane Which has an opposite Winding direction.
`The support structure of the stent sections 32, 33 is a Web 38
`Which is connected to the ?rst stent section 31 via the elastic
`tubular sections 34, 35. The stent 30 can be lengthened and
`shortened in the direction of arroWs 37.
`FIG. 4 shoWs a side vieW of a further inventive stent 40
`Which is composed of a ?rst stent section 41, a second stent
`section 42, a third stent section 43, a ?rst elastic tubular
`section 44 and a second elastic tubular section 45. The support
`structure is oppositely Winding helices 46 Which extend in
`tWo different planes. The helices 46 are embedded in a plastic
`material Which is also used for the elastic tubular sections 44,
`45. The elastic tubular sections 44, 45 have no helices. The
`stent 40 can be lengthened in the direction of arroWs 47 and
`subsequently be expanded in a radial direction and shortened
`in a longitudinal direction. The plastic coating of the helices
`46 is selected such that the surface contour 48 is formed on the
`outer surface Which is determined by the selected cross-sec
`tional shape of the helices 46 used. The distal end has a foil
`valve 50 Which permits passage through the stent 40 only
`from the proximal end toWards the distal end. If a ?uid or solid
`?oWs through the stent 40 from the proximal end to the distal
`end, the foil valve opens and the foil sheets open i.e. they are
`moved aWay from each other. If nothing ?oWs through the
`stent 40, the foil sheets abut and close the lumen, formed by
`the stent 40, at one end.
`In a longitudinal direction of the stent 40, a ?lament 51 is
`Worked into the Wall of the stent 40 over the entire length
`Which serves as securing thread for the different sections of
`the stent 40. The ?lament 51 may project past the stent 40
`such that the stent 40 can be mounted or be pulled in the
`holloW organ via the ?lament 51. The proximal end of the
`stent 40 has a thread 52 as thread ring vieWed over the periph
`ery of the stent. If the thread 52 is pulled together, the lumen
`of the third stent section 43 is also highly reduced and the
`positioned stent 40 is released from the inner surface of the
`holloW organ. The stent 40 can be removed from a holloW
`organ via the thread 52.
`A stent 10 for transluminal implantation comprises a ?rst,
`second and third stent section 11, 12, 13 for splinting and/or
`keeping open a holloW organ, Which are connected to each
`other via elastic tubular sections 14, 15. The stent 10 com
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`Edwards Lifesciences Corporation, et al. Exhibit 1139, Page 5 of 6
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`

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`US 7,731,742 B2
`
`5
`bines at least three different stent designs in one stent 10 and
`can be adjusted to the motion behavior of a hollow organ in an
`improved fashion.
`We claim:
`1. Stent for splinting and/ or keeping open a holloW organ,
`consisting of a tubular body having a diameter Which can be
`changed through axial displacement of the ends of the body
`relative to each other, Wherein the body comprises at least
`three stent sections comprising different cross-sections Which
`can be expanded irrespectively of each other, comprising a
`Woven, braided tubular Web and one or more phase-shifted
`helices in one or more planes Which are connected to each
`other via at least tWo elastic tubular sections Which do not
`contain meshes or helices and further Wherein the body is
`formed, in an unloaded expanded state, from a ?rst stent
`section having a ?rst diameter, a second stent section having
`a second diameter and a third stent section having a third
`diameter, Wherein the at least tWo elastic tubular sections
`comprises a ?rst elastic tubular section connecting said ?rst
`stent section to said second stent section, and a second elastic
`tubular section connecting said second stent section to said
`third stent section.
`2. Stent according to claim 1, characterized in that the
`diameters of the stent sections are different.
`3. Stent according to claim 1, characterized in that When
`several helices are provided in several planes, at least one
`helix has an opposite Winding direction.
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`4. Stent according to claim 1, characterized in that the
`elastic tubular sections comprise a tissue-compatible plastic
`material and/or have different diameters.
`5. Stent according to claim 1, characterized in that the
`body, vieWed in cross-section, has a Web in the ?rst, second
`and third stent sections and one or more helices Which are
`surrounded by one or more elastic plastic layers Which merge
`into the elastic tubular sections in a material-bonding fashion
`Without Webs and helices.
`6. Stent according to claim 1, characterized in that the body
`has at least one ?lament in the Wall in the axial direction.
`7. Stent according to claim 1, characterized in that a thread
`is Worked into the proximal end region of the body, vieWed
`over the periphery of the body, Whose length projects past the
`stent.
`8. Stent according to claim 1, characterized in that the distal
`end of the body comprises a return valve, in particular a foil
`valve.
`9. Stent according to claim 1, characterized in that the
`tubular sections are made from thin, highly ?exible and tear
`proof plastic material eg silicon.
`10. Stent according to claim 1, Wherein the second diam
`eter of the second stent section and the third diameter of the
`third stent section are larger than the ?rst diameter of the ?rst
`stent section.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1139, Page 6 of 6
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