MD- 010
`
`French Patent No. 2 678 508
`
`Translated from French by
`SCIENTIFIC TRANSLATION SERVICES
`1439 Dorchester Rd.
`Eavertown, PA 19083
`
`snukis53
`
`END-O 10
`
`PARIS
`
`(12)
`
`A6lr2/06S
`
`Publication No.: 2 578 508
`(to be used for copy requests only)
`(21) National Registration No.: 91 08376
`(51) Int. Cl.S: A 61 F 2/06
`PATMIT APPLICATION
`
`Al
`
`(22 Apliato Date:_
`(22) Application Date:
`07/04/91.
`
`(30) Priority:
`(43) Date of Laying Open of the
`Application to Public
`Inspection: 01/08/93
`Bulletin 93/01.
`(56) List of documents cited in
`the Search Report: See at
`the end of this document.
`(60) References to Other Related
`National Documents:
`
`(71) Applicant(s): firm of:
`CELSA LG soci6th anonyme -
`FR.
`(72) Inventor(s): Chevillon,
`Glrard; Cottenceau, Jean-
`Phillippe; Deneuville,
`Robert; Nadal, Guy; and
`and Roussigne, Maurice.
`
`(73) Patentee(s):
`
`(74) Agent: Lerner & Bruile
`S.c.P.
`
`(54) Reinforcing Element for Ennan Blood Vessels.
`
`(57) The present invention pe,-tains to a reinforcing element for
`human blood vessels of the type comprising an elongated
`agains- the inner wall of the vessel to be
`reinforcement fitting.
`reinforced.
`
`To make it possible to prepare continuous junctions,
`especially at the level of bifurcations, at least two elements (8,
`9) are provided according to the present invention, which comprise
`self-locking coils (11, 13) permitting continuous junctions.
`
`The present invention pertains, in particular, to reinforcing
`elements for the aortoiliac bifurcation.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1032-1
`
`

`

`END-0 I0
`
`Pro- LO Pae
`
`NO. 2 678 508
`
`34-137
`
`The present invention pa--ains to improvements to reinforcing
`elements for human blood vessels, especially for the treatment of
`stenosis.
`Narrowing of blood vessels, arteries or veins, which leads to
`severe circulatory problems, such as atherosclerosis or phlebitis,
`may occur, especially in elderly subjects. One method of treatment
`elements, commonly designated by
`-ing
`consists of implanting re
`the term "stents," inside te veins or arteries to be reinforced;
`the purpose of these rein-foring elements is to prevent the
`narrowing of the vessel at their site of implantation, and/or to
`repair or reinforce the vessel in that area.
`Two implantation tech.nizues are currently possible: Either
`percutaneous implantation, using the method developed by Seldinger,
`or implantation after surgica denudation and opening of the route
`of access.
`Practitioners frequently have to operate on human blood
`vessels (implantation of int-avenous filters, recanalization of
`arteries affected by atherosclerosis, etc.).
`It is sometimes necessary to complement the surgical procedure
`by implanting a "stent." This is frequently done to free arteries
`of obstructions, which is pez_-ormed with various devices, such as a
`dilating balloon or machine systems.
`A "stent" is a reinforcing element implanted inside a vessel"
`Its function is to act as
`percutaneously (or semiper-~aneously).
`a support for preventing a s=ponaneous ,reclosure of the vessel, or
`to maintain attached to it a par: of the wall that became detached
`during the procedure, or to prevent the future occlusion of the
`Vessel following a progression of the atheromatous disease.
`"Stents" have come into general use during the last few years;
`they are said to be par tic-: a:r y effective in the "large vessels."
`The "stents" are most oftean made of a mechanical system which
`expands once located at its site of use. The expansion is either
`spontaneous (elastic system) or mechanically forced (expansion with
`a dilating balloon).
`The use of "stents" is cur.renly limited to the straight
`sections of vessels simply because of their cylindrical shape,
`which does not make pcssible a junction with bifurcations.
`To reinforce a vessel ha-ving a bifurcation, the practitioner
`is reduced to implanting a "sen"''
`in each branch of the
`of the bifurcation unprotected,
`bifurcation, leaving the ".j.ction"
`with all the shor=:mings and risks this may imply.
`the "stan:" implanted is no longer sufficient,
`if
`Moreover,
`and a reoperation is necessary upstream or downstream of the
`the operation is particularly delicate,
`element already implanted,
`
`W.L. Gore & Associates, Inc.
`Exhibit 1032-2
`
`

`

`END- 010L
`
`FrenI
`
`L Patent Na. 2 679 508
`
`34-137
`
`because a "stent," once implanted, cannot practically be withdrawn
`and cannot be connected to another one, either.
`
`The object of the present invention is to solve the above-
`described problems.
`
`Therefore, the reinforcing element for human blood vessels, of
`the type comprising an elongated reinforcement fitting against the
`inner wall of the vessel to be reinforced, following the general
`shape of a helical curve, is characterized according to the present
`invention in that in order to make possible continuous junctions,
`i.e., junctions between at least two such elements, the element
`comprises coils at a point of its length to permit the intertwining
`of these coils with matching coils of another element ntended to
`be joined with the first one at the level of the said matching
`coils of the said other element.
`
`According to an embodiment that can be frequently used, the
`said specially matching coils of one of the elements intended to be
`joined and/or the other have a larger diameter than the other
`coils.
`
`The present invention, its use and its applications will be
`explained in greater detail below on the basis of the following
`description in reference to the drawings attached, in which:
`Figure 1 schematically shows a bifurcation of vessels provided
`with prior-art "stents;"
`
`Figure 2 schematically shows how the same bifurcation could be
`provided with reinforcing elements designed according to the
`present invention;
`
`Figure 3 shows the system according to Figure 2 with the
`intertwined elements in place;
`Figure 4 shows the usa of a particular spring in relation to a
`lateral branch;
`Figure 5 shows a view of a particular spring according to
`Figure 4, but at another angle, the spring being rotated by about
`906 around its axis;
`Figure 6 shows two elements, one of which is
`an extension for the other; and
`Figure 7 shows the two elements according to Figure 6 in the
`in place.
`position in which the extension is
`With reference first t: Figure 1, a bifurcation of vessels is
`shown, which may be, e.g., the aortoiliac bifurcation.
`its
`in
`The bifurcation, designated by reference number i
`entirety, would consequently be formed by the junction of the aorta
`2 with the left 3 and righ: 4 iliac arteries.
`
`intended to form
`
`W.L. Gore & Associates, Inc.
`Exhibit 1032-3
`
`

`

`E ND- 010
`
`Fr ronc% Paz
`
`No. 2 678 $08-
`
`34-137
`
`Assuming that a problem due to stenosis is encountered at this
`level, it would be possible to ar-range so-called "stents,"
`designated by the reference nu:hers 5, 6 and 7, respectively, in
`the areas to be protected. These "stents" are implanted as was
`described above. They are f:-ed by sleeves of an appropriate
`diameter, and are elastic or ncnelastic, depending on the
`implantation techniques emplcyed.
`
`The three reinforcing elements 5, 6 and 7 leave unprotected
`the center of the bi-ureation ., which is particularly exposed
`especially because of the tensi:ns which may occur at the upper
`ends 5a, 6a and 7a of the eleme.ts 5, 6 and 7.
`
`With reference to Figure 2, it will be explained how an
`improved element according to the present invention can be formed,
`which can be perfectly implanted at the bifurcation without causing
`any stresses at the junction.
`
`It is seen in Figure 2 that the system implanted according to
`the present invention comprises' to reinforcing elements,
`designated by the respective reference numbers 8 and 9.
`The reinforcing element 8 is in the form of a helical coil
`spring comprising two parts, na=iely, a part 10, which follows a
`helical curve having a given diameter corresponding essentially to
`the internal diameter of the left iliac artery 3, and a second part
`11 coiled along a helical curve with a larger diameter
`corresponding to that of the acrta 2.
`
`The second element 9 is li'ewise in the form of a coil spring
`comprising a first part 12 coiled spirally with a diameter
`corresponding essentially to that of the iliac artery 4, the part
`12 being terminated by twoc c:ils forming the part 13 of a diameter
`equivalent to that of part I of the element 10.
`is understood that the element 9 can be joined with the
`It
`element 8 as is suggested by the arrow 14 and illustrated in
`position in Figure 3 in such a 'ay as to make the coils 13 coincide
`at the base of the coils 1i, an.d the coils 13 intertwine with the
`coils 11, and complete reinforcament of the bifurcation, including
`the junction, is ensured under the best conditions.
`
`The following procedure ay be used to implant the element.
`The reinforcing element 8 is
`introduced via a puncture or
`incision of the left femcral a-tary; the position is adjusted under
`fluoroscopic control.
`The i=mp=anation
`is performed
`in an
`appropriate catheter,
`the reinf:rcing element being in the
`compressed pcsiticn and will blcck itself while expanding in the
`intended area once released and dropped into place.
`
`Once the element is thus in place in the position
`schematically shown in Figure 2, the second element 9 is introduced
`through a puncture or an incisi:n of the right femoral artery,
`always by means of a catheter, wi:h the spring in the compressed
`
`W.L. Gore & Associates, Inc.
`Exhibit 1032-4
`
`

`

`rea~ ? atant no. 2 678 sca
`
`34-137
`
`position. The element is 'i::duced to the area in which the
`connection must be made, and it is dropped and released, so that
`the coils 13 will expand at the level of the two lower coils of the
`part of the element 8 which [par ]
`is designated by reference
`number 11 and is
`located in the aorta. Thus dropped in place, the
`element will block and lIck itself, and the two parts 8, 9 of the
`element will mutually block each other in the position shown in
`Figure 3.
`Figure 4 shows a partirclar design of a spring 15 which can
`make possible an easier i nta.'rtwininq of an element which must
`function, e.g., in a lateral bifurcation.
`the spring 15 comprises a
`is apparent from
`As
`igure 4,
`certain number of loops designated by reference number 16 in the
`shape of a U, which leave openings between the coils and facilitate
`the introduction of a coil, such as the first coil 17 of a spring
`18, introduced laterally in the compressed state.
`is assumed
`it
`in Figure 4,
`In the example shown schematically
`that the spring 15 was implanted into a vessel designated by
`reference number 19, and that the spring 18 was implanted in a
`smaller, lateral vessel 20. It is seen that the coil 17 is
`distinctly larger than the coils of part 18 to facilitate the
`intertwining of the coil 17 in position with the spring 15 and to
`prevent any displacement of the unit thus intertwined during the
`implantation.
`
`Figure 5 shows the spring 15 rotated by about 900 in the
`direction of arrow 21 in relation to the position of the same
`spring shown in Figure 4 to help better understand the winding of
`this spring.
`Figure 6 shows a reinfor:ing element formed by a helical
`spring 22, and reference number 23 designates another spring
`element intended to form an extension of the element 22.
`The element 23 forming the extension comprises essentially
`coils 24 having the same diametar as those of the element 22, and a
`two in the example shown,
`small number of coils at one end, e.g.,
`which are designated by the reference number 25 and have a slightly
`larger diameter.
`is possible to intertwine the
`thus understood that it
`is
`It
`coils 25 having a larger diameter inside the coils of the element
`22 after implantation of the compressed spring in the usual manner
`the desired position, with the first two coils 25
`and dropping in
`of the extension 23 covering the last two coils of the element 22
`previously implanted.
`is thus possible according to the
`is understood that it
`It
`present invention. to extend reinforcing elements for vessels if
`in the case of a progression of atheromatous disease
`needed, e.g.,
`in a patient already having "stents" implanted.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1032-5
`
`

`

`ED-O 10
`
`rrench Patent No. 2 678 508
`
`34-137
`
`Numerous possible forms and variants of the embodiment of the
`"springs" forming the reinforcing elements according to the present
`invention are, of course, conceivable and can be used.
`Biocompatible steels with good elastic memory, especially
`special steels with high cobalt and chromium contents, are
`preferably used to prepare the elements.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1032-6
`
`

`

`--
`
`L
`
`II
`
`__
`
`ENd-010
`
`French ?atant No.
`
`2
`
`&78 SOL
`
`J" ,.37
`
`1. Reinforcing element for
`human blood Vessels of the type
`ement fitting against the inner
`comprising an elongated rei.n.f
`wall of the vessel to be reinf:rced and having the general shape of
`a helical curve, characterized in that to make it, possible to
`prepare continuous junctions between at least two such elements (8,
`the said element (5, 15) comprises said matching coils
`9; 15, 18),
`(11, 16) at one point of its length to make possible the
`intert ining of these said ccils with said two corresponding
`17) of another said element (9, 18) intended to
`matching coils (13,
`one at the level of the said matching
`be joined with the first
`18).
`Coils (13, 17) of the said other element (9,
`2. Element in accordance w-th claim 1, characterized in that
`17) of one and/or the other
`the said specially matching coils (13,
`of the said elements intended to be joined have a larger diameter
`than the other coils.
`3. Element in accordance with claim 2, characterized in that
`within the framework of the embodiment of a Y-shaped branching, the
`element (3) matches the coils 11 having a first diameter
`said first
`corresponding to that of the principal blood vessel (2) which it
`must support, and it is extended by said coils (10) of a smaller
`(3) which it must
`diameter correspcnding to that of a branch vessel
`support, and the said second element (9) is composed of a small
`number of said coils (13) having a diameter corresponding to that
`(2) and said consecutive coils (12) of a.
`of the principal vessel
`smaller diameter correspondingq to that of the second branch vessel
`(4) to be supported, and the said coils (13) of the larger diameter
`of the said second element (9) will intertwine with the said coils
`(11) of a Corresponding diameter of the said first element (8) at
`the site of the bifurcation, where the diameter of the coils of the
`said first element (3) changes.
`4. Element in accordance with claim 1 or claim 2,
`characterized in that in the case of the implantation of a said
`(23) of a said element (22) already implanted, the
`extension
`element intended to form the extension comprises, at the top, at
`the site where it must intertfine with the end of the first
`element, a small n-e=er of said matching coils (25) to intertwine
`with the said end of the first element.
`5. Element in accordance with cLaim 4, characterized in that
`the said matching coils (25) of the said second element have a
`larger diameter than the said first element (22).
`6. Element in accordance with one of the above claims,
`characterized in that it
`is made of self-expanding and
`biocompatible "spring" steel with elastic memory, such as a steel
`containing cobalt and chromium.
`
`Z'd
`
`rtZ0
`
`9¢}0:9:
`
`7
`
`sis
`
`W.L. Gore & Associates, Inc.
`Exhibit 1032-7
`
`

`

`3ND-0ICFrench PttNo.
`
`2 678 508
`
`7. Element ±in acordanc with one of the above claims ,
`at least
`charateriedzi that the coils of t.hGeelemnts matchk(16
`locally, especially to faec14tate the mutual intertwining of the
`coils of the two conn~eed elements .
`Figure 1
`Figure 7
`
`its91.d
`
`t
`
`S1S
`
`W.L. Gore & Associates, Inc.
`Exhibit 1032-8
`
`