Europaisches Patentamt
`European Patent Office
`
`Oo)
`
`Office européen des brevets
`
`@)
`
`Publication number:
`
`0 423 916 B1
`
`@)
`
`EUROPEAN PATENT SPECIFICATION
`
`Date of publication of patent specification: 26.04.95
`
`Int. cl: A61M 29/00, A61F 2/02
`
`&)
`
`@) Application number: 90300542.9
`Date of
`
`filing: 18.01.90
`
`@)
`
`Divisional application 94201 205.5 filed on
`18/01/90.
`
`Percutaneous stent.
`
`@)
`
`Priority: 17.10.89 US 422606
`
`Date of publication of application:
`24.04.91 Bulletin 91/17
`
`Publication of the grant of the patent:
`26.04.95 Bulletin 95/17
`
`Designated Contracting States:
`AT BE CH DE DKES FR GB GRIT LI LU NL SE
`
`Referencescited:
`GB-A- 1 205 743
`US-A- 4 580 568
`US-A- 4 739 762
`US-A- 4 830 003
`
`“Modified Gianturco Expandable Wire Stents
`in Experimental and Clinical Use", J. Rosch,
`CIRSE, Porto Cervo, Sardinia, May 25-29,
`1987, Vol. 31-No. 2, 1987
`
`"Modifications of Gianturco Expandable Wire
`Stents”, Barry T. Ushida, AJR 150:1185-1187,
`May 1988, American Roentgen Ray Society
`
`EP0423916B1
`
`
`
`@ Proprietor: Cook Incorporated
`925 South Curry Pike
`P.O. Box 489
`
`Bloomington
`Indiana 47402 (US)
`
`Inventor: Gianturco, Cesare
`2208 Valley Brook Drive
`Champaign, Illinois 61821 (US)
`Inventor: Osborne, ThomasA.
`2418 Spicewood Lane
`Bloomington, Indiana 47401 (US)
`
`Representative: Bannerman, David Gardner et
`al
`Withers & Rogers
`4 Dyer's Buildings
`Holborn
`London, EC1N 2JT (GB)
`
`
`
`Note: Within nine months from the publication of the mention of the grant of the European patent, any person
`may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition
`shall be filed in a written reasoned statement.
`It shall not be deemed to have been filed until the opposition fee
`has been paid (Art. 99(1) European patent convention).
`Rank Xerox (UK) Business Services
`(3. 10/3.09/3. 3.3}
`
`MEDTRONIC 1130
`
`MEDTRONIC 1130
`
`

`

`EP 0 423 916 B1
`
`“Exparimental Intrahepatic Portacaval An-
`astomosis: Use of Expandable Gianturco
`Stents", Josef Rosch, M.D., RSNA, 19087,
`Volume 162 No. 2
`
`"Superior Vena Cava Syndrom Associated
`with Massive Thrombosis: Treatment with
`Expandable Wire Stents", RSNA, June 1988
`
`"“Gianturce Expandable Wire Stents in the
`Treatment of Superior Vena Cava Syndrom
`Recurring After Maximum Tolerance Radi-
`ation”, Reprinted from CANCER,Vol. 60, No.
`6, September 15, 1987
`
`
`

`

`1
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`EP 0 423 916 B1
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`2
`
`Description
`
`Background of the Invention
`
`This invention relates to stents and in particu-
`the invention relates to modifications to the
`lar,
`Gianturco Expandable Wire Stent.
`is desirable in various situations to provide
`lt
`a constricted vessel portion
`means for expanding
`or for maintaining
`an open passageway through
`a
`vessel portion. Such situations arise, for example,
`in conjunction with arteriosclerosis that restricts or
`a vessel, or in conjunction
`stops blood flow through
`with diseases of the prostrate gland which restrict
`or stop flow through the urethra.
`A percutaneous stent developed by Dr. Cesare
`Gianturco is formed of a stainless steel wire ar-
`ranged in a closed, zig-zag pattern, as more
`fully
`described in U.S. Patent No. 4,580,568. The Gian-
`turco stent, or the Z-stent as it
`is also known, is
`compressed into a reduced size shape with an
`outer diameter which is many times smaller
`its
`outer diameter in an
`expanded shape. The stent is
`positioned in a passageway by
`means of a sheath
`re-
`while the stent is retained in the compressed
`or flat-ended catheter
`duced size shape. A pusher
`is used through the sheath to hold the stent
`in
`place in the passageway while the sheath is with-
`drawn, thereby allowing the stent to expand in the
`passageway into its expanded shape to hold the
`passageway open and enlarged. Thus, the Z-stent
`a
`an
`means for maintaining
`provides
`self-expanding
`open passageway. FIG. 1 illustrates the use of the
`well-known Z-stent wire within a
`body passageway.
`FIG. 2 illustrates the use of several Z-stents
`a limited length of a body passageway.
`In
`along
`two stents are situated in
`illustrated arrangement,
`an
`overlapping arrangement, while a third stent is
`disposed slightly downstream from the other two
`stents. As discussed more
`fully in the above-re-
`ferenced Gianturco '568 patent, each of the three
`stents must be
`separately inserted using the
`sheath and pusher described above.
`Since the initial development of the expandable
`wire Z-stent, it has been discovered that over time
`a Z-stent may continue to expand to its maximum
`diameter even
`though it was
`originally deployed in
`a passageway that had a diameter
`somewhat
`smaller than the maximum outer diameter of the
`expanded stent. Thus, the end result has been in
`some cases that
`the stent becomes embedded
`In an
`deeply into the walls of
`the passageway.
`effort to address this particular problem, others in
`to
`the art have modified the expandable Z-stent
`the bends or joints of the zig-zag
`form eyes at
`configuration. A monofilament line is then threaded
`through each of the eyes at one end of the stent to
`in essence, a continuous flexible ring which
`form,
`
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`restricts the expansion of the wire stent. The mon-
`ofilament
`line is sufficiently elastic in the tensile
`direction to control the expansion of the stent to an
`optimal desired diameter.
`Further description of this modified expandable
`wire Z-stent is found in the following references:
`"Modified Gianturco Expandable Wire Stents in
`Experimental and Clinical Use", J. Rosch, CIRSE,
`Porto Cervo, Sardinia, May 25-29, 1987, vol 31-No.
`2, 1987
`"Modifications of Gianturco Expandable Wire
`Stents", Barry T. Uchida, AJR 150:1185-1187, May
`1988, American Roentgen Ray Society
`Portacaval An-
`"Experimental
`Intrahepatic
`astomosis: Use of Expandable Gianturco Stents",
`Josef Rosch, M.D., RSNA, 1987, Volume 162 No. 2
`"Superior Vena Cava Syndrome Associated
`with Massive Thrombosis: Treatment with Expand-
`able Wire Stents", RSNA, June 1988
`the
`in
`"Gianturco Expandable Wire Stents
`Treatment of Superior Vena Cava Syndrome Re-
`curring After Maximum-Tolerance Radiation", Re-
`printed from CANCER, Vol. 60, No. 6, September
`15, 1987.
`There remains, however, a need for a per-
`cutaneous stent that is self-expanding, yet can be
`retrieved after a
`period of time of insertion.
`According to the invention there is provided
`stent assembly comprising:
`a first wire formed into a closed zig-zag
`figuration including:
`an endiess series of straight sections having
`opposite ends, said straight sections being joined
`by bends at said opposite ends to form a stent;
`a set of eyes formed at several of said bends
`at one of said opposite ends; and
`a thread passing through successive ones of
`said set of eyes,
`wherein said stent is resiliently contractible into
`a
`a smaller first shape for conveyance through
`body passageway; and
`wherein said stent is resiliently expandable into
`a second shape in which the straight sections
`press against the walls of the body passageway,
`characterised in that said thread includes a
`pair
`of free ends, trailing from said stent.
`The monofilament
`thread may be passed
`through each of the eyes at one end of the stent,
`once
`through each of the eyes in a 360° loop and
`some of the eyes. The
`then again 180° through
`the monofilament preferably
`trailing free ends of
`leave the stent at opposite sides of the stent diam-
`an introducer sheath out-
`eter and extend through
`side the body passageway. The monofilament can
`be tied externally to limit the expansion of the self-
`expanding stent within the body passageway.
`The free ends of the monofilament can also be
`used to reduce the diameter of the stent to permit
`
`con-
`
`a
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`EP 0 423 916 B1
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`4
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`multiple
`
`retrieval of the stent from the body passageway.
`in a method a tube is threaded over the free
`Thus,
`ends of the monofilament and advanced along the
`passageway until the tube is adjacent the expand-
`ed stent. The free ends are then pulled thereby
`contracting the outer diameter of the stent until the
`diameter is approximately equal to the diameter of
`the tube. A sheath can then beintroduced over the
`tube and over the reduced diameter portion of the
`stent to further collapse the remaining length of the
`stent. The entire assembly,
`including the tube,
`sheath, stent and monofilament can then be re-
`moved from the body passageway.
`is side cross-sectional view of a
`1
`FIG.
`body
`passageway with a
`self-expanding wire stent of the
`prior art situated therein.
`FIG. 2 is a view similar to FIG.
`1
`showing the
`use of several stents of the prior art within the body
`passageway.
`FIG. 3 is a side elevational view of a stent
`known from the prior art documents mentioned
`above on
`p.2/1.20 to p.3/1.4.
`FIG. 4 is an end elevational view of the struc-
`ture of FIG. 3.
`FIG. 5 is a side elevational view of a
`stent.
`FIG. 6 is a side elevational view of another
`multiple stent.
`FIG. 7A is a side elevational view of still an-
`other embodiment of the present invention shown
`in its expanded state.
`FIG. 7B is a side elevational view of the struc-
`ture of FIG. 7A shown with one end in its con-
`tracted state.
`FIG. 8 is a sectional view of a body passage-
`a method of
`insertion of
`the self-
`way showing
`expanding stent of the present invention.
`FIG. 9 is a sectional view of the body passage-
`way similar to FIG. 8 following insertion of the self-
`expanding stent.
`FIG. 10A is a sectional view of the body pas-
`one step of a
`sageway shown in FIG. 9 showing
`method of retrieval of the self-expanding stent of
`one embodimentof the present invention.
`FIG. 10B is a view similar to FIG. 10A showing
`another step of the methodofretrieval.
`FIG. 10C is a view similar to FIG. 10B showing
`the method of
`retrieval of
`the
`another step of
`presentinvention.
`The embodiments of Figs. 5 and 6 are outside
`the scopeof this invention.
`an understand-
`For the purposes of promoting
`ing of the principles of the invention, reference will
`now be made to the embodimentillustrated in the
`drawings and specific language will be used to
`describe the same.
`now more
`particularly to the draw-
`Referring
`ings, there is illustrated in FIGS. 3-4 a side eleva-
`
`tion of a known percutaneous stent 10 which is
`formed from a
`length 11 of stainless steel wire
`formed in a closed zig-zag configuration. The ends
`a sleeve 12 which is
`the wire are closed by
`of
`welded or
`tightly squeezed against the ends of the
`a continuous or endless configura-
`wire to produce
`tion. The length 11 of wire is arranged in a number
`of
`sections
`13. Adjacents
`side-by-side straight
`straight sections 13 of the stents are adjoined by
`cusps 14.
`Up to this point, the stent 10 in most respects,
`similar to the Z-stent described in U.S. Patent No.
`In particular, the specific embodimentof
`4,580,568.
`the invention includes the wire 11 which is of
`a 0,045 cm
`(0.018 inch) outer
`stainless steel having
`diameter. The cusps 14, that is the joint between
`adjacents straight sections 13, generally circum-
`scribes a radius of no more than 0.2 cm or about
`the stent 10 is ca-
`.08 inch. As thus configured,
`pable of being compressed into a
`relatively much
`smaller outer diameter than that shown in FIGS. 3-
`in order to permit insertion of the stent into the
`4,
`use of a catheter or sheath.
`body passageway by
`The cusps 14 of the stent are formed into a
`number of eyes 20. The eyes may be formed in
`the continuous wire 11 and the intersection be-
`tween adjacent straight sections 13 at the cusps 14
`a
`are soldered or welded together
`to provide
`closed loop for the eyes 20. The eyes may have a
`diameter of approximately three times the wire
`diameter, or about 0,137 cm
`(.054 inch).
`Multiple stents may be combined as shown in
`In FIG. 5, two self-expanding stents
`Figs. 5 and 6.
`10’ and 10” are connected or attached at the eyes
`20' and 20" at the ends of each of the stents. Each
`of the stents 10° and 10” are
`generally identical to
`the stent 10 just described.
`In constructing the
`union between the two stents 10’ and 10”, the first
`stent 10’ is formed from a
`single length of stainless
`steel wire 11°. The length of wire 11’ is formed into
`the zig-zag and eye configuration although the
`cusps 14 are not immediately soldered. The free
`ends of the length of wire 11’ are joined by way of
`the sleeve 12’. Once the first stent 10’ has been
`the second stent 10” is formed from a
`formed,
`11” of stainless steel wire. The sec-
`second length
`11” is formed into the zig-zag and eye
`ond length
`so that the eyes 20” formed at one
`configuration
`end of the stent are interlocked with the eyes 20’ of
`the first stent 10’. Once the second stent 10” is
`a sleeve 12” is used to connect the ends
`complete,
`of the length of wire 11’ and the cusps 14 and 14”
`can then be joined or soldered.
`A similar method of construction can be used
`to interconnect a stent
`10°, which is identical to the
`stent 10 described above, with a
`single skirt stent
`16’, as shown in FIG. 6.
`In this particular embodi-
`the single skirt stent 16’ does not have a
`ment,
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`EP 0 423 916 B1
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`6
`
`number of eyes defined at the free end of the skirt.
`The free end of the skirt 16’ may be formed into
`the configuration of hooks to prevent migration of
`the stent and skirt combination once the combina-
`tion is placed within the body passageway. It is
`understood that in FIGS 5 and 6, the eyes at one
`end of one stent or skirt may be connected to a
`stent having only bends or cusps at its connecting
`end, in a manner similar to the connection between
`skirt 16’ and a similar skirt 16” shownin FIG. 6.
`In an embodiment of the present invention See
`Figures 7A and 7B, a stent 30 is formed from a
`length of wire 31 into a
`zig-zag configuration iden-
`tical to the stent 10 shown in FIG. 3. A number of
`eyes 35 are formed at least at one end of the stent
`a monofilament of bio-
`30. A thread 40, preferably
`is passed through successive
`compatible material,
`eyes around the circumference of
`the expanded
`stent 30. The thread 40 is passed through the eyes
`one end 40a through each
`35 by first passing
`successive eye 35 while retaining the other end
`40b outside and apart from the stent 30. The first
`end 40a of the thread 40 is threaded once
`through
`each of the eyes 35 in a 360° loop and then 180°
`further through successive eyes, or about 540°
`the stent, so that
`around the circumference of
`some of the eyes 35 will have two passes of the
`thread 40 therethrough. Thus, as shownin FIG. 7A,
`the two free ends 40a and 40b of the thread 40 are
`situated at 180° opposite eyes 35 of the stent 30.
`one
`The thread 40 can then be used to collapse
`end of the self-expanding wire stent by pulling both
`free ends 40a and 40b of the thread 40. When the
`free ends 40a and 40b are
`pulled simultaneously,
`the diameter of the thread 40, and therefore the
`diameter of one end of the stent 30,
`is decreased.
`Alternatively, the thread 40 can be used to limit the
`expanded diameter of the stent by tying the free
`ends 40a and 40b directly adjacent the stent.
`In using the percutaneous stent of the present
`invention, an insertion technique similar to that de-
`scribed in the Gianturco ‘568 patent is employed,
`as shown in FIG. 8. A self-expanding stent 50
`includes a number of eyes 55 at each end of the
`stent 50 and is identical in all respects to the stent
`30 shown in FIG. 7A. The monofilament thread 56
`passes through the eyes 55 at one end of the stent
`the stent is com-
`50.
`In the method of insertion,
`pressed to its reduced diameter and disposed with-
`in a sheath 60, as shownin FIG. 8. The free ends
`56a and 56b of the filament 56 extend outside the
`sheath 60 and exterior to the patient's body for
`access after the stent has been inserted. For exam-
`ple, when the stent is used as a
`prostatic stent, the
`filament 56 has a
`length of 30 to 40 cm measured
`from the stent 50 to each of the free ends 56a and
`56b, so that the free ends may extend down from
`the prostate gland to the end of the urethra. When
`
`the stent 50 is used as a vascular stent, the length
`of
`the filament 56 may be considerably shorter,
`provided the ends 56a and 56b are situated outside
`the puncture site and are
`sufficiently long to be
`anchored onto the skin nearby.
`In the preferred embodiment, the free ends 56a
`so that
`and 56b of the filament 56 are tied together
`can be easily controlled and maintained.
`they
`When the stent 50 is compressed within the sheath
`60, a pusher 61 is used to hold the stent 50 in
`position when the body passageway while the
`sheath 60 is withdrawn. The pusher 61 may have a
`channel 62 within which the monofilament 56 can
`or
`be disposed to prevent any pinching
`tugging of
`the filament while the sheath 60 is being removed.
`the pusher 61 can
`Once the sheath is removed,
`also be removed so that the stent 50 remains in
`position within the body passageway as shownin
`FIG. 9. The monofilament 56 trails the stent and
`as described above.
`passes outside the body
`the stent 50
`In certain medical operations,
`need only be positioned temporarily within the
`in another method, illus-
`body passageway. Thus,
`trated with reference to FIGS. 10A-10C,
`the stent
`50 is
`retrieved from the body passageway and
`In this method, a tube 70 is threaded
`removed.
`over the free ends of the monofilament 56 and
`inserted into the body passageway along the mon-
`it is adjacent the implanted stent
`ofilament 56 until
`50, as shown in FIG. 10A. Once the tube 70 is
`positioned directly adjacent the stent 50, the free
`ends of the monofilament 56 can be pulled through
`or
`the tube 70,
`thereby compressing
`contracting
`one end of the stent 50 to a reduced diameter, as
`shown in FIG. 10B. With the end of the stent 50
`thus compressed, a sheath 75 can be introduced
`into the body passageway over the tube 70, as
`shown in FIG. 10C. The sheath 75 has an inner
`diameter larger than the reduced diameter of the
`end of the stent 50. The sheath 75 is continually
`conveyed into the body passageway over the tube
`it contacts and compresses the remaining
`70 until
`the self-expanding stent 50. Once the
`length of
`covers or shrouds the stent
`sheath 75 completely
`50, that is when the stent 50 is disposed entirely
`can be
`within the sheath 75, the entire assembly
`In the pre-
`removed from the body passageway.
`ferred embodimentof this method, the tube 70 and
`sheath 75 are
`composed of medical grade plastic,
`such as an
`8-polyethylene tubing.
`
`Claims
`
`1. A-stent assembly (10) comprising:
`a first wire formed into a closed zig-zag
`configuration including:
`an endless series of straight sections (13)
`having opposite ends, said straight sections
`
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`being joined by bends (14) at said opposite
`ends to form a stent;
`a set of eyes (20) formed at several of said
`bends at one of said opposite ends; and
`a thread (40) passing through successive
`onesof said set of eyes,
`wherein said stent is resiliently contractible
`into a smaller
`first shape for conveyance
`a
`body passageway; and
`through
`wherein said stent is resiliently expandable
`sec-
`into a second shape in which the straight
`tions press against the walls of the body pas-
`sageway,
`characterised in that said thread includes a
`pair of free ends (40a, 40b), trailing from said
`stent.
`
`The stent assembly of claim 1, wherein:
`said second shapeof said stent includes a
`circumference at said one of said opposite
`ends, said set of eyes being situated at said
`circumference; and
`said thread passes through successive
`eyes (20) at
`least 360° around said circum-
`ference.
`
`The stent assembly of claim 2, wherein said
`thread passes through successive eyes (20)
`around said circumfer-
`approximately 540°
`ence.
`
`The stent assembly of claim 1, wherein said
`are
`sufficiently long to
`free ends (40a, 40b)
`extend outside the body passageway when
`said stent is situated within the passageway.
`
`further
`
`The stent assembly (10) of claim 1,
`comprising:
`a second wire (11") formed into a closed
`zig-zag configuration including:
`sec-
`a second endless series of straight
`sec-
`tions having opposite ends, said straight
`tions being joined by bends (14") at said op-
`posite ends to form a second stent;
`a second set of eyes (20") formed at sev-
`eral of said bends at one of said opposite
`ends;
`wherein said second stent
`is
`resiliently
`contractible into a smaller first shape for con-
`a
`veyance through
`body passageway;
`wherein said second stent (10") is resil-
`iently expandable into a second shape in
`which the straight sections press against the
`walls of the body passageway; and
`wherein said second set of eyes (20") of
`said second wire are
`engaged about said first
`wire (11°) at one of said opposite ends.
`
`The stent assembly of claim 5, wherein:
`said first wire (11') includes a third set of
`eyes formed at several bends at the other of
`said opposite ends of said first wire; and
`said second set of eyes of said second
`wire are
`interengaged with said third set of
`eyes.
`
`Patentanspriiche
`
`1.
`
`Eine Dilatator- oder Stent-Anordnung (10) auf-
`weisend:
`einen ersten in geschlossene Zick-Zack-
`Konfiguration gelegten Draht, aufweisend
`eine endlose Serie von
`gestreckten oder
`geraden Abschnitten (13) mit gegentiberliegen-
`den Enden, wobei die geraden Abschnitte Uber
`an den gegentiberliegenden
`Biegestellen (14)
`Enden verbunden sind, um einen Stent zu bil-
`den;
`
`einen Satz von Ohren (20), die an
`einigen
`an dem einen der gegeniiber-
`der Biegestellen
`liegenden Enden ausgebildet sind, und
`einen Faden (40), der durch aufeinander-
`folgende S&tze der Ohre hindurchgeht,
`in eine kleinere erste
`wobei der Stent
`Form zum
`Transport durch einen Kérperdurch-
`gang nachgiebig zusammenziehbar ausgebil-
`detist;
`und wobei der Stent in eine zweite Form
`in wel-
`nachgiebig aufweitbar ausgebildet
`ist,
`cher die geraden Abschnitte gegen die Wande
`des K6rperdurchganges driicken,
`dadurch gekennzeichnet, daB der Faden
`ein Paar freie Enden (40a, 40b) hat, die von
`dem Stent weggerichtet sind bzw. diesem fol-
`gen.
`
`in wel-
`
`Die Stent-Anordnung nach Anspruch 1,
`chem
`die zweite Form des Stents einen Um-
`an dem einen der sich gegentiberlie-
`fangsteil
`genden Enden aufweist, wobei die Ohre an
`diesem Umfangsteil angeordnet sind; und
`der Faden durch aufeinanderfolgende Ohre
`(20) hindurch Uber wenigstens 360° um den
`Umfangsteil herum verlauft.
`
`Die Stent-Anordnung nach Anspruch 2, wobei
`der Faden durch aufeinanderfolgende Ohre
`um
`ungefahr 540° um dem Umfangsteil
`(20)
`herum lauft.
`
`Die Stent-Anordnung nach Anspruch 1, worin
`die freien Enden (40a, 40b) ausreichend lang
`ausgebildet sind, um aus dem K6rperdurch-
`gang herauszureichen, wenn der Stent
`inner-
`halb des Durchganges angeordnetist.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
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`EP 0 423 916 B1
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`10
`
`Die Stent-Anordnung (10) nach Anspruch 1x,
`weiterhin aufweisend:
`einen zweiten Draht (11"'), welcher in eine
`geschlossene Zick-Zack-Konfiguration gebildet
`ist und aufweist:
`eine zweite endlose Serie von
`geraden Ab-
`schnitten mit gegentiberliegenden Enden, wo-
`bei die geraden Abschnitte durch Biegestellen
`an den gegentiberliegenden Enden ver-
`(14")
`bunden sind, um einen zweiten Stent zu bil-
`den;
`
`einen zweiten Satz von Ohren (20") die an
`an dem einen der
`einigen der Biegestellen
`gegentiberliegenden Enden ausgebildet sind;
`in eine kleinere
`worin der zweite Stent
`erste Gestalt zum
`Transport durch einen Kér-
`zusammenziehbar
`nachgiebig
`
`perdurchgang
`ausgebildetist;
`wobei der zweite Stent (10") in eine zweite
`in
`Form nachgiebig aufweitbar ausgebildet ist,
`welcher die geraden Abschnitte sich gegen die
`WA4nde des Kérperdurchganges pressen; und
`wobei der zweite Satz von Ohren (20") des
`zweiten Drahtes um den ersten Draht
`(11°)
`herum an dem einen der gegentiberliegenden
`Enden im Eingriff angeordnetist.
`
`Die Stent-Anordnung nach Anspruch 5, wobei
`der erste Draht (11') einen dritten Satz von
`Ohren aufweist, die an verschiedenen Bieges-
`tellen an dem anderen der gegentiberliegen-
`den Enden des ersten Drahtes ausgebildet
`sind und
`der zweite Satz von Ohren des zweiten
`Drahtes
`in Zwischeneingriff mit dem dritten
`Satz von Ohren angeordnetist.
`
`Revendications
`
`1. Un ensemble dilatateur (10) comprenant:
`un
`premier fil métallique formé selon une
`en
`zig-zag fermée comportant:
`configuration
`une série sans fin de sections droites (13)
`lesdites sec-
`ayant des extrémités opposées,
`tions droites étant réunies par des coudes (14)
`auxdites extrémités opposées pour former un
`dilatateur ;
`un
`jeu d'oeillets (20) formés sur
`plusieurs
`desdits coudes 4 une
`premiére desdites extré-
`mités opposées
`et
`au travers des oeillets
`un fil
`(40) passant
`successifs dudit jeu d'oeillets,
`ledit dilatateur est susceptible
`dans lequel
`d'étre contracté élastiquement selon une pre-
`miére configuration plus petite pour étre ache-
`miné au travers d'un passage corporel ; et
`ledit dilatateur est susceptible
`dans lequel
`d'étre dilaté élastiquement selon une deuxiéme
`
`configuration dans laquelle les sections droites
`appuient contre les parois du passage corpo-
`rel,
`
`caractérisé en ce que ledit
`fil comprend
`deux extrémités libres (40a, 40b) trainant a
`partir dudit dilatateur.
`
`L'ensemble dilatateur selon la revendication 1,
`danslequel :
`ladite deuxiéme configuration dudit dilata-
`une circonférence sur ladite pre-
`teur présente
`miére extrémité desdites extrémités opposées,
`ledit jeu d'oeillets étant situé sur ladite circon-
`férence; et
`ledit fil passe au travers des oeillets suc-
`au moins sur 360°
`autour de
`cessifs (20)
`ladite circonférence.
`
`L'ensemble dilatateur selon la revendication 2,
`ledit fil passe au travers des oeil-
`dans lequel
`sur
`lets
`successifs
`(20)
`approximativement
`540° autour de ladite circonférence.
`
`L'ensemble dilatateur selon la revendication 1,
`libres
`lesdites extrémités
`dans lequel
`(40a,
`40b) sont suffisamment longues pour s'étendre
`4 l'extérieur du passage corporel lorsque ledit
`dilatateur est disposé dans ledit passage.
`
`L'ensemble dilatateur (10) selon la revendica-
`tion 1, comprenant, en outre :
`un deuxiéme fil métallique (11") formé se-
`en
`lon une
`zig-zag fermée com-
`configuration
`prenant:
`une deuxiéme série sans fin de sections
`lesdi-
`droites ayant des extrémités opposées,
`tes sections droites étant réunies par des cou-
`des (14") auxdites extrémités opposées pour
`former un deuxiéme dilatateur,
`un deuxiéme jeu d'oeillets (20") formés
`sur
`plusieurs desdits coudes 4 I'une desdites
`extrémités opposées;
`ledit deuxiéme dilatateur est
`dans lequel
`se-
`susceptible d'€tre
`contracté élastiquement
`lon une
`premiére configuration plus petite pour
`étre acheminé au travers d'un passage corpo-
`rel ;
`
`dans lequel ledit deuxiéme dilatateur (10")
`se-
`est susceptible d'étre dilaté élastiquement
`lon une deuxiéme configuration dans laquelle
`les sections droites appuient contre les parois
`du passage corporel ; et
`dans lequel les oeillets dudit deuxiéme jeu
`d'oeillets (20) dudit deuxiéme fil métallique
`sont enfilés autour dudit premier fil métallique
`(11') a l'une desdites extrémités opposées.
`
`10
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`EP 0 423 916 B1
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`12
`
`L'ensemble dilatateur selon la revendication 5,
`dans lequel :
`ledit premier fil métallique (11') comprend
`un troisiéme jeu d'oeillets formés sur
`plusieurs
`coudes 4 l'autre desdites extrémités opposées
`dudit premier fil métallique ; et
`Les oeillets dudit deuxiéme jeu d'oeillets
`dudit deuxiéme fil métallique sont en
`prise
`mutuelle avec ledit troisiame jeu d'oeillets.
`
`10
`
`15
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`20
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`25
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`30
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`35
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`EP 0 423 916 B1
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` Fig.]
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`EP 0 423 916 B1
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