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`Tribeca Translations, Inc.
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`CERTIFICATION OF ACCURACY OF TRANSLATION
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` hereby certify under penalty of perjury under the laws of the United States of
`America that I am a language expert specializing in the translation of French
`language documents into English and that the attached document is a true, correct,
`and complete translation into English of the document “WO 03/003949,” originally
`written in French to the best of my knowledge and belief.
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`Date: April 18, 2017
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`___________________________
`Doina Francu
`Tribeca Translations, Inc.
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`75 Wall Street. Suite 25D. New York, NY 10005 tel: 800.482.8218 www.tribecatrans.com
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`Edwards Lifesciences Corporation, et al. Exhibit 1150, Page 1 of 23
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`(12) INTERNATIONAL APPLICATION PUBLISHED IN ACCORDANCE WITH THE
`PATENT COOPERATION TREATY (PCT)
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`
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`(19) World Intellectual Property
`Organization
`International Office
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`(43) International Publication Date
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`January 16, 2003
`(16.01.2003)
`
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`PCT
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`(81)
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`International Patent Classification7: A61F 2/24
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`International Case No.:
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`PCT/FR02/02352
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`(51)
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`(21)
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`(22)
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`International Application Date:
`July 4, 20023 (04.02.2002)
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`French
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`Filing language:
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`Publication language:
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`French
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`(83)
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`Priority data:
`01/08898
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`July 4, 2001 (04.01.2001) FR
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`(25)
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`(26)
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`(30)
`
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`(71) Applicant and
`
`(72)
`
`(10) International Publication Number
`WO 03/003949 A2
`
`Destination States (national): AE, AG, AL, AM, AT,
`AU, AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CO,
`CR, CU, CZ, DE, DK, DM, DZ, EC, EE, ES, FI, GB, GD,
`GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP,
`KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG,
`MK, MN, MW, MX, MZ, NO, NZ, OM, PH, PL, PT, RO,
`RU, SD, SE, SG, SI, SK, SL, TJ, TM, TN, TR, TT, TZ,
`UA, UG, US, UZ, VN, YU, ZA, ZM, ZW.
`
`Destination states (regional): ARIPO Patent (GH, GM,
`KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZM, ZW),
`Eurasian Patent (AM, AZ, BY, KG, KZ, MD, RU, TJ,
`TM), European Patent (AT, BE, BG, CH, CY, CZ, DE,
`DK, EE, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT,
`SE, SK, TR), OAPI Patent (BF, BJ, CF, CG, CI, CM, GA,
`GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`
`Publication:
`-
`Without the International Search Report, it will be
`republished as soon as the report is received
`[Continued on the next page]
`
`Inventor: SEGUIN, Jacques [FR/FR];
`COREVALVE,
`27 RUE Joubert, F-75008 PARIS (FR)
`
`
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`(74) Agent: CABINET GERMAIN & MAUREAU:
`12 rue Boileau, F-69006 Lyon (FR)
`
`
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`(54) Title: KIT ENABLING A PROSTHETIC VALVE TO BE PUT INTO PLACE IN A DUCT IN THE BODY
`(57) Abstract: The kit (I) comprises a
`prosthetic valve (4) which is to be implanted
`and a stent (2). According to the invention,
`the valve (4) and the stent (2) are made in
`such a way that when the stent (2) is
`expanded, the valve (4) is situated outside the
`zone(s) (10, 11, 14) of the stent (2) which are
`to be expanded.
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`Edwards Lifesciences Corporation, et al. Exhibit 1150, Page 2 of 23
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`WO 03/003949 A2
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`For an explanation of the two-letter codes and the other
`abbreviations, please refer to the “Guidance Notes on Codes
`and Abbreviations” at the beginning of each regular edition of
`the PCT Gazette.
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`Edwards Lifesciences Corporation, et al. Exhibit 1150, Page 3 of 23
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`KIT FOR PLACING A PROSTHETIC VALVE IN A DUCT IN THE BODY
`The present invention relates to a kit for placing a prosthetic valve in a duct in the
`body, especially a heart valve, and in particular an aortic valve.
`Documents WO 91/17720, WO 98/29057 and EP 1 057 460 each describe such a
`kit, comprising:
`- the prosthetic valve to be implanted;
`- a radially expandable framework, called a “stent,” which is able, in the expanded
`state, to bear against the wall of the body duct to be fitted with the valve, this bearing
`making it possible to immobilize this stent with respect to this wall; and
`- means for fixing the valve to the stent.
`The placement of the stent thus permits mounting of the valve in the body duct,
`eliminating the need for an external access route and, thus, a direct surgical intervention.
`However, major drawbacks of this technique are that it entails a risk of the valve
`being damaged by the balloon used to expand the stent, and it limits the force of
`expansion that can be imparted to the stent. This limitation has repercussions on the
`anchoring of the stent, making a displacement of said kit possible. This limitation also has
`repercussions on the leaktightness of the stent in the area of the valvular ring which is
`particularly affected when calcified zones give the valvular ring an irregular form and/or a
`certain rigidity.
`Another drawback of the prior art technique is that of directly joining the
`commissures of the valvules to the stent. The result of this is that an expansion of the
`stent, and thus of the valve, different than that intended may cause poor coaptation of the
`valvules and, consequently, defective functioning of the valve. The stent, therefore, has
`to undergo a predetermined expansion, which prevents or complicates adaptation of this
`stent to the anatomical variations.
`In the case of implantation of an aortic valve, the prior art technique also has
`drawbacks in that it necessitates very exact positioning of the stent in the aorta so that
`the valve is located opposite the natural valvular ring, and it entails a risk of blocking the
`apertures of the coronary arteries that open out at the coronary ostia.
`The present invention aims to overcome these various drawbacks.
`The kit according to the invention comprises, in a manner known per se:
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`- the prosthetic valve to be implanted;
`- a radially expandable framework, called a stent, comprising at least one zone
`intended to be expanded to allow this stent, in the expanded state, to bear against the
`wall of the body duct to be fitted with the valve, this bearing making it possible to
`immobilize this stent with respect to this wall; and
`- means for mounting the valve with respect to the stent, making it possible to
`connect the valve to the stent in such a way that the placement of the stent allows the
`valve to be mounted in the body duct,
`- expansion provided means such as a balloon catheter being to trigger the
`expansion of the stent at the implantation site.
`According to the invention, the valve and the stent are designed in such a way that,
`at the moment when the stent is expanded, the valve is situated outside the zone or zones
`of the stent which are subjected to said expansion means.
`The invention thus consists in separating the valve and said zone or zones to be
`expanded, so that the expansion of the stent can be effected with a force suitable for
`perfect anchoring of this stent in the wall of the body duct to be fitted with the valve, and
`without any risk of destruction or damage of the valve.
`According to one possibility, the stent comprises a zone for mounting of the valve,
`which zone is distinct from the zone or zones of the stent to be expanded, and said
`mounting means connect the valve to this mounting zone.
`The expansion of the stent thus triggers the deployment of the valve.
`According to another possibility, said mounting means are designed in such a way
`that the valve is axially movable with respect to the stent between a position of non-
`implantation, in which it is situated outside the zone or zones of the stent which are to be
`expanded, and a position of implantation, which it can reach after expansion of the stent
`in the body duct, in which it is immobilized axially with respect to the stent.
`The valve can thus form a subassembly separate from the stent prior to placement
`of this stent in the body duct, and it can be placed in the stent once the latter has been
`implanted. Alternatively, the valve is connected to the stent before said stent is placed in
`the body duct to be treated, and consequently it is introduced into this duct with the stent;
`said mounting means then comprise means of displacement so that, once the stent has
`been expanded, the valve can be displaced between said position of non-implantation
`and said position of implantation.
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`Said mounting means can then comprise one or more of the following
`arrangements:
`- fastening members such as spikes, hooks or claws which are mounted on the
`valve and are able to be inserted into the wall delimiting said body duct; these fastening
`members can be oriented radially with respect to the valve so as to be able to be inserted
`into said wall upon radial deployment of the valve, or they can be oriented tangentially
`with respect to the valve so as to be able to be inserted into said wall upon a pivoting of
`the valve about its axis or upon a longitudinal movement with respect to the stent;
`- burstable vesicles which are filled with biological adhesive or other suitable
`adhesive product and are placed on the outer face of the valve, these vesicles being able
`to burst when the valve is brought into its position of implantation, in particular by their
`being crushed between the valve and the stent;
`- at least one circular or helical wire or band integrated in the peripheral wall of the
`valve and having a shape memory, so that it keeps the valve pressed against the stent in
`the position of implantation of this valve;
`- conduits formed in, or fixed on, the peripheral wall of the valve, and rods formed
`on the stent, or vice versa, these rods being able to be engaged and being able to slide
`through these conduits as the valve moves from its position of non-implantation to its
`position of implantation, it being possible to provide means such as hooks in order to
`immobilize these conduits with respect to these rods in said position of implantation; wires
`can be connected to the ends of said rods and can pass through said conduits in order to
`easily guide these rods in these conduits.
`Preferably, the means for mounting the valve with respect to the stent are designed
`in such a way that, beyond a threshold of expansion of the stent, they permit a different
`expansion of the valve and of the stent, so that a variation in the degree of expansion of
`the stent has no effect on the degree of expansion of the valve.
`The valve is thus not connected directly to the stent, and in particular, it is not
`connected to the stent in the area of the commissures of its valvules; in the expanded
`position of the stent, it can have a predetermined diameter appropriate to it, independently
`of the diameter of the stent. After implantation, the valve thus has a configuration ensuring
`that it functions properly irrespective of the degree of expansion of the stent, and this
`expansion of the stent can be adapted to the anatomical variability encountered at the
`implantation site.
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`The stent and/or the valve can comprise one or more elements limiting the
`maximum diameter of expansion of the valve, in particular, in the area of the commissure
`points of this valve. These elements can be longitudinal wires belonging to the stent, or a
`framework element belonging to the valve.
`Preferably, the valve has a peripheral wall with a diameter not constant in the axial
`direction, in particular, a frustoconical shape whose diameter decreases in the distal
`direction, and the zone of the stent intended to receive this peripheral wall of the valve
`has a shape corresponding to that of this peripheral wall.
`This peripheral wall and this zone of the stent thus define a determined position of
`mounting of the valve in the stent, and they ensure that the valve is held in position in the
`stent.
`
`The stent advantageously has a middle portion with a smaller diameter than its
`end portions. It can, in particular, have the general form of two inverted truncated cones
`or an hourglass shape.
`In the case where the kit according to the invention permits mounting of an aortic
`valve, the stent is thus at a distance from the wall of the body duct, in particular by means
`of a conical or hourglass shape, allowing body fluid to pass to the coronary vessels in the
`area of the coronary ostia. The valve has a shape corresponding to that zone of the stent
`in whose area it is intended to be mounted.
`Advantageously,
`- the valve has a peripheral wall;
`- the stent has, in the distal continuation of that zone of the stent intended to receive
`the valve, a foldable portion; this foldable portion is movable between an extended
`position, in which it is situated in the distal continuation of said zone, and a folded position,
`in which it is placed against the inner face of the peripheral wall of the valve and traps this
`peripheral wall between it and said zone of the stent, and
`- retaining means are provided for keeping this foldable portion in this folded
`position.
`The peripheral wall of the valve is thus pressed against the stent, which ensures
`leaktightness of the valve with respect to the stent.
`According to a preferred embodiment of the invention in this case, said retaining
`means are formed by a wire made of a material which is rigid but has a degree of elastic
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`flexibility, for example, a metal material having an undulated form and extending over the
`entire circumference of said foldable portion.
`Preferably, the stent comprises a sheath made of an impermeable biocompatible
`material and at least partially covering it.
`This sheath forms a fixation base for the valve and at the same time a means of
`sealing between the stent and the wall of the body duct.
`The sheath can advantageously have lateral openings which can be positioned
`opposite the coronary ostia at the time of implantation and thus avoid any zone of
`stagnation or non-circulation of the blood.
`Advantageously, in the case where the kit according to the invention comprises
`said foldable portion, this foldable portion is formed by a continuation of said sheath,
`forming a sleeve beyond that zone of the stent intended to receive the valve.
`Perfect leaktightness is thus obtained between the valve and the stent.
`The stent preferably has, fixed on said sheath, at least one inflatable peripheral
`chamber which can be inflated in order to form a seal ensuring leaktightness between the
`stent and the wall of the body duct to be fitted with the valve.
`This leaktightness is thus guaranteed notwithstanding the possible presence of
`calcified portions which give a cardiac ring an irregular shape.
`Advantageously in this case, the stent has two inflatable peripheral chambers
`placed on each side of that portion of the stent intended to bear against a cardiac valvular
`ring.
`
`The stent can have a cylindrical portion which can bear against a cardiac valvular
`ring, and a distal portion connected to this cylindrical portion.
`This distal portion at least partially forms said zone intended to receive the
`peripheral wall of the valve. The advantage is that said wall of impermeable biocompatible
`material is situated, in the area of this portion, at a distance from the wall of the body duct,
`which, in the case of implantation of an aortic valve, eliminates the risk of masking the
`coronary ostia.
`The stent can also have a frustoconical or widened proximal portion whose
`diameter decreases in the distal direction and is able, in the case of implantation of a
`heart valve, to bear against the wall of the ventricle or corresponding auricle of the heart.
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`With this proximal portion, it is possible to define the position of the stent, and thus
`subsequently of the valve, with respect to the zone of implantation. It also helps ensure
`complete immobilization of the stent.
`The stent can also have a supplementary bearing portion connected by filiform
`rods to said distal portion or to said cylindrical portion, these filiform rods having lengths
`such that this supplementary bearing portion is positioned beyond the coronary ostia.
`According to an additional characteristic, the stent has hooks which are movable
`between a retracted position, which they occupy before expansion of the stent, and a
`position of deployment into which they are brought upon deployment of the stent and in
`which they are inserted into a wall delimiting the body duct.
`The stent can also have a portion near to the valvular ring, or situated opposite or
`on this valular ring, and having a high radial force, that is to say a radial force able to
`erase the local anatomical irregularities, for example calcifications, with a view to
`reinforcing the leaktightness at the junction between the stent, the sheath and the wall of
`the treated duct.
`This portion can be deployed with the aid of an expansion system with a high radial
`force and low compliance, for example a balloon.
`For a proper understanding of the invention, the latter is described again
`hereinbelow with reference to the attached schematic drawing showing, by way of
`nonlimiting examples, three possible embodiments of the kit according to the invention.
`Figure 1 is a side view of an expandable framework called a “stent,” which forms
`part of the kit;
`Figure 2 is a longitudinal cross-section through a sheath forming part of the kit;
`according to a first embodiment;
`Figure 3 is a longitudinal cross-section through a heart valve forming part of the kit,
`according to this first embodiment;
`Figure 4 is view of a detail of the stent, on an enlarged scale;
`Figure 5 is a view of another detail of the stent, on an enlarged scale, in a state of
`non-expansion of the stent;
`Figure 6 is a view of the same detail, in a cross-section along the line VI-VI in
`Figure 5;
`Figure 7 is a view similar to Figure 5, in a state of expansion of the stent;
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`Figure 8 and is a view of the same detail, in cross-section along the line VIII-VIII in
`Figure 7;
`Figure 9 is a longitudinal cross-section through the kit according to the invention,
`after implantation in an aorta;
`Figure 10 is a longitudinal cross-section through the sheath and the valve forming
`part of the kit according to the invention, in a second embodiment, with the catheter used
`for introducing the valve into this sheath;
`Figure 11 is a perspective view of the valve according to the second embodiment;
`Figure 12 is a view similar to Figure 10, after placement of the valve;
`Figure 13 is a view, similar to Figure 9, of the kit according to a third embodiment;
`Figure 14 is a perspective view of the valve which can be placed in the stent shown
`in Figure 13, and
`Figures 15 through 17 are views of the kit according to the third embodiment, in a
`cross-section along the lines XV-XV, XVI-XVI and XVII-XVII, respectively, in Figure 13.
`In these three embodiments, those elements or parts which are identical or similar
`and are found again from one embodiment to another are designated by the same
`reference numbers.
`Figures 1 through 3 show, respectively, an expandable framework 2 called a “stent,”
`a sheath 3, and a prosthetic valve 4. This stent 2, this sheath 3, and this valve 4 form a
`kit 1, which can be seen in Figure 9, allowing the valve 4 to be placed in an aorta 100,
`showing the location of the coronary ostia 101 and the origin of the coronary vessels 104.
`Referring to Figure 1, it will be seen that the stent 2 comprises in succession, from
`one axial end to the other, in the proximal to distal direction, a proximal frustoconical
`portion 10, a proximal cylindrical portion 11, a distal frustoconical portion 12, several
`connection rods 13, and a distal cylindrical portion 14.
`This stent 2 is made of a metal, steel or alloy with shape memory. This shape-
`memory material can in particular be the one known by the brand name “NITINOL.”
`The portions 10 through 12 and 14 are made up of a network of filaments forming
`juxtaposed meshes of diamond shape or, for portion 10, of triangle shape. The material
`from which the stent 2 is made is such that these meshes can pass from a contracted
`configuration, in which the filaments are near one another, giving
`the meshes an
`elongated shape, to an expanded configuration, shown in Figure 1, and in detail in Figure
`7, in which the filaments are spaced apart from one another.
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`In the contracted configuration, the kit 1 can be introduced into the aorta 100 by
`means of a catheter, as far as the zone in which the prosthetic valve 4 is to be implanted;
`in the expanded configuration, the stent 2 bears against the aorta 100, the wall 102 of the
`ventricle and the natural valvular ring 103 in the manner shown in Figure 9, such that it
`permits implantation of the valve 4 in place of the natural valve, the latter having been
`removed beforehand if necessary.
`Referring to Figures 1 and 9, it will be seen that the portion 10 has a diameter
`decreasing in the distal direction, this portion 10 being configured so that, in the expanded
`state, it bears against the wall 102 of the ventricle of the heart.
`In the expanded state, the portion 11 has a diameter such that it is able to bear
`against the natural valvular ring 103 and a radial force such that it can push the natural
`valve (or its remnants after partial exeresis) against the ring 103 in order to ensure
`leaktightness at this site. This portion 11 has deployable hooks 15, shown more
`particularly in Figures 5 through 8. These hooks 15 permit anchoring of the stent 2 in the
`aorta 100 via the sheath 3.
`As shown in Figures 5 and 6, each hook 15 extends in the longitudinal direction of
`a mesh, being connected in a pivotable manner to a proximal zone 16 of connection of
`two proximal filaments 17. This hook 15 has a curved and tapered free end 15a, and a
`face 15b directed to the inside of the stent 2 and of rounded shape. The distal zone 18 of
`connection of the two other filaments 19 which is situated opposite the base of the hook
`15 is able to bear, during expansion of the stent 2, on this face 15b, as will be inferred
`from comparison of Figures 6 and 8. The fact that this zone 18 bears along this face 15b
`makes it possible to deploy the hook 15 radially outward of the stent 2 and maintain this
`hook 15 in the deployed position in which its tapered end 15a is inserted into the wall of
`the ring 103. The hooks can have a fishhook shape in order to prevent their removal.
`The portion 12 is directly connected to the portion 11 and has a diameter
`decreasing in the distal direction. This portion 12 is intended to extend to the area of the
`coronary ostia 101 and to receive the valve 4. Its frustoconical shape means it is possible
`to keep the sheath 3 at a distance from the coronary ostia 101 and thus prevent any risk
`of covering the apertures 104 of the coronary vessels which open out in these.
`The portion 12 additionally comprises a series of internal arms 25, shown more
`particularly in Figure 4. Each arm 25 is connected via its proximal end to a junction zone
`16 of two proximal filaments 17 of a mesh, in proximity to the portion 11, and has a curved
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`distal end 25a. These arms 25 are inclined toward the inside of the portion 12 before
`placement of the valve 4 on the stent 2, and Figure 4 shows that in this position they can
`receive the valve 4. The latter actually comprises a peripheral wall 30 in which there are
`longitudinal tunnels 31 for receiving the arms 25; these can then be folded back against
`the wall of the portion 12, either by deformation of the material constituting the arms 25
`and/or the portion 12, or by shape memory when use is made of a material with shape
`memory. These arms 25 thus allow the valve 4 to be mounted in the portion 12, as shown
`in Figure 9.
`The connection rods 13 connect the distal edge of the portion 12 to the proximal
`edge of the portion 14. They are arranged uniformly on the periphery of the stent 2 and,
`as is shown in Figure 9, they have a length which is sufficient to ensure that the portion
`14 is placed, after implantation, beyond the coronary ostia 101.
`The spacing of these rods 13 can be curbed by an annular element making it
`possible to limit the upper diameter of the valve 4 to a predefined size.
`The portion 14 for its part has, in the expanded state, a slightly greater diameter
`than the internal diameter of the aorta 100, and it bears against the wall of the latter once
`the stent 2 has been put in place. This portion 14 can be equipped with hooks 15.
`The sheath 3 is made of an impermeable biocompatible material, such as
`pericardial tissue, material known under the name “DACRON,” or a polymer such as
`polyurethane, and it has portions 35, 36 and 37. These portions 35, 36 and 37 can be
`connected, respectively, to the portions 10, 11 and 12 and can closely match these
`portions 10 through 12 when the latter are in the expanded state. The connection between
`the sheath 3 and the portions 10 through 12 is formed by seams when the kit 1 is
`assembled. The connection can also be effected by molding of a polymer material.
`At the proximal end, the sheath 3 has a flap 40 extending on the outer face of the
`portion 35. This flap 40 has, near its free edge, an inflatable peripheral chamber 41. This
`chamber 41 can be inflated so as to form a seal ensuring leaktightness between the
`sheath 3 and the wall of the ventricle 102, on the proximal side of the natural valvular ring
`103.
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`At the distal end, the sheath 3 has a flap 42 extending on the outer face of the
`portion 12. Near its free edge, this flap 42 comprises an inflatable peripheral chamber 43,
`similar to the chamber 41 and able to be inflated in the same way as the latter. This
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`chamber 43 ensures leaktightness between the sheath 3 and the ring 103, on the distal
`side of the latter.
`It will be seen from Figure 2 that the flap 42 forms a distal sleeve 45 extending
`beyond the distal edge of the portion 12, and it is clear from Figure 9 that this sleeve 45
`can be folded back inside the portion 12. This sleeve 45 includes a metal wire 46
`extending over the entire circumference, this wire 46 having an undulated shape and
`being elastically deformable. The deformability of this wire 46 allows the sleeve 45 to pass
`from its extended position shown in Figure 2 to its folded position shown in Figure 9, in
`which it is maintained by elastic return of the wire 46. In this folded position, the sleeve
`45 is placed against the inner face of the peripheral wall 30 of the valve 4 and traps this
`wall 30 between it and said portion 12.
`The valve 4 can be made of a biological material or of a synthetic material, or of a
`combination of these two types of materials. Its peripheral wall 30 has a frustoconical
`shape adapted to its tight engagement in the portion 12 when the arms 25 are folded back
`against this portion 12, which ensures complete immobilization of the valve 4 in the stent
`2.
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`The kit 1 is assembled by placing the sheath 3 on the stent 2 and placing the valve
`4 on the arms 25, the stent 2 being in the contracted state. The kit 1 is then placed in a
`catheter permitting its introduction into the patient's body, this catheter including one or
`more inflatable balloons able to deploy the portions 10, 11 and 14. This catheter is then
`brought into position in the aorta 100. The balloons are then inflated in order to deploy
`the portions 10, 11 and 14; the forced deployment of the portion 11 by the balloons
`ensures the deployment of the hooks 15 and triggers deployment of the portion 12, and
`consequently of the valve 4. The chambers 41, 43 are then inflated to ensure
`leaktightness of the sheath 3 with respect to the ring 103, and the sleeve 45 is folded
`back inside the portion 12 in order to clamp the peripheral wall 30 of the valve 4 against
`this portion 12.
`As will be apparent from the above, the valve 4 and the stent 2 of the kit 1 are
`designed in such a way that the valve 4 is situated outside the zone or zones 10, 11, 14
`to be expanded. The stent 2 can be expanded with a force of expansion adapted for
`perfect anchoring of this stent 2 in the receiving walls 100, 102, 103, and without any risk
`to the valve 4.
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`Edwards Lifesciences Corporation, et al. Exhibit 1150, Page 13 of 23
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`The hooks 15 ensure complete immobilization of the kit 1 in the aorta 100, and the
`chambers 41, 43, and also the sleeve 45, ensure complete leaktightness of the kit 1 with
`respect to the aorta 100.
`In the second embodiment of the kit 1, the valve 4 is not mounted in advance inside
`the stent 2 but is placed in it once the stent 2 has been expanded.
`As shown in Figure 10, the sheath 3 then has internal tubes 50 formed in such a
`way as to protrude inside the stent 2 once this sheath 3 is engaged on the stent 2. These
`tubes 50 can in particular be sewn or fixed by any other means to the sheath 3 after the
`latter has been placed on the stent 2.
`Referring to Figure 11, it will be seen that the peripheral wall 30 of the valve 4 has,
`in place of the tunnels 31, a series of pin-shaped clips 51. Each clip 51 has an inner arm
`52 engaged longitudinally in the wall 30, and a rectilinear outer arm 53 extending along
`the outer face of the wall 30. The arms 53 terminate in curved ends and are connected to
`wires 55 engaged and able to slide in the tubes 50.
`As shown in Figure 10, a catheter 80 is used to bring the valve 4 into position in
`the sheath 3. The valve 4 is engaged with sliding on the catheter 80, and the wires 55,
`after passing through the tubes 50, are engaged in the catheter 80 from the direction of
`the distal opening thereof and pass through this catheter 80 in order to be actuated from
`the outside. The valve 4 is put into place and deployed by pulling on the different wires
`55 so as to engage the different arms 53 in the tubes 50. The inner arms 52 can comprise
`(see Figure 12) proximal hooks which complete the deployment of the valve 4 by being
`fastened to the wall of the sheath 3, for example by means of inflation of a balloon.
`In the third embodiment of the kit 1 shown in Figure 13, the stent 2 forms a median
`cage delimited by a ring 60 and by longitudinal wires 61, in which cage the valve 4 is
`tightly inserted. As is shown in Figure 14., the valve 4 has a lateral wall 30 of tubular
`shape in which three lateral openings 65 are formed. These openings 65 are positioned
`opposite the coronary ostia 101 and permit a natural flow of blood, without risk of
`stagnation in the area of these coronary ostia 101.
`The invention provides a kit 1 for placing a valve 4 in a body duct 100, said kit
`having the following advantages over similar kits in the prior art:
`- elimination of the risk of damage to the valve 4 by the balloon or balloons used
`to expand the stent 2;
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`Edwards Lifesciences Corporation, et al. Exhibit 1150, Page 14 of 23
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`- possibility of applying a considerable force of expansion to the stent 2, which
`ensures the anchoring of the kit 1; this considerable force of expansion additionally
`permits this anchoring by means of the deployable hooks 15;
`- elimination of the risk of dilation of the valve 4 beyond a diameter no longer
`permitting its optimal functioning, in particular through loss of coaptation of the valvules;
`- possibility of obtaining perfect leaktightness of the kit 1 in the area of the valvular
`ring 103 and of the valve 4;
`- elimination of the risk of blocking of the coronary ostia 101;
`- maintenance of a flow of body fluid all around said kit 1 once the latter is implanted.
`It goes without saying that the invention is not limited to the embodiment described
`above by way o