`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(51) International Patent Classification 6 :
`WO 98/29057
`A61F 2/24
`
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`
`(11) International Publication Number:
`
`Al
`
`(43) International Publication Date:
`
`9 July 1998 (09.07.98)
`
`(21) International Application Number:
`
`PCT/EP97 /07337
`
`(22) International Filing Date:
`
`31 December 1997 (31.12.97)
`
`(30) Priority Data:
`31 December 1996 (31.12.96)
`96402929.2
`(34) Countries for which the regional or
`international application was .filed:
`
`EP
`
`GB et a!.
`
`(71) Applicant (for all designated States except US): CORDIS
`CORPORATION [US/US]; 40 Technology Drive, Warren,
`NJ 07059 (US).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): LETAC, Brice [FR/FR];
`15, allee de Ia Cedraie, F-76130 Mont-Saint-Aignan (FR).
`CRIBIER, Alain [FR/FR]; 2, rue Alain, F-76150 Maromme
`(FR).
`
`(74) Agents: GUTMAN, Ernest et a!.; Ernest Gutman - Yves
`Plasseraud S.A., 3, rue Chauveau-Lagarde, F-75008 Paris
`(FR).
`
`(81) Designated States: AL, AM, AT, AU, AZ, BA, BB, BG, BR,
`BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GE,
`GH, GM, GW, HU, IL, IS, JP, KE, KG, KP, KR, KZ, LC,
`LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX,
`NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM,
`TR, TT, UA, UG, US, UZ, VN, YU, ZW, ARIPO patent
`(GH, GM, KE, LS, MW, SD, SZ, UG, ZW), Eurasian patent
`(AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European patent
`(AT, BE, CH, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU,
`MC, NL, PT, SE), OAPI patent (BF, BJ, CF, CG, CI, CM,
`GA, GN, ML, MR, NE, SN, TD, TG).
`
`Published
`With international search report.
`Before the expiration of the time limit for amending the
`claims and to be republished in the event of the receipt of
`amendments.
`
`(54) Title: VALVE PROSTHESIS FOR IMPLANTATION IN BODY CHANNELS
`
`(57) Abstract
`
`is
`invention
`The present
`aimed to provide a valve prothesis
`(IV) especially used in case of
`aortic stenosis, which structure is
`capable of resisting the powerful
`recoil
`force and
`to stand
`the
`forceful balloon inflation performed
`to deploy the valve and to embed
`it in the aortic annulus. A valve
`prothesis (13) for implantation in
`a body channel according to the
`invention comprises a collapsible
`valvular structure
`(14) and an
`expandable frame (10, 10') on
`which said valvular structure (14)
`is mounted. The valvular structure
`(14)
`is composed of a valvular
`tissue compatible with the human
`body and blood, the valvular tissue being sufficiently supple and resistant to allow said valvular structure (14) to be defmmed from a
`closed state to an opened state. Said valvular tissue forms a continuous surface and is provided with guiding means (17) formed or
`incorporated within, said guiding means creating stiffened zones which induce said valvular structure (14) to follow a patterned movement
`in its expansion to its opened state and in its turning back to its closed state. The valvular structure can be extended to an internal cover
`(19) which is fastened to the lower end (15) of the valvular structure to prevent from regurgitation.
`
`19
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 1 of 67
`
`
`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
`
`AL
`AM
`AT
`AU
`AZ
`BA
`BB
`BE
`BF
`BG
`BJ
`BR
`BY
`CA
`CF
`CG
`CH
`CI
`CM
`CN
`cu
`cz
`DE
`DK
`EE
`
`Albania
`Atmenia
`Austria
`Australia
`Azerbaijan
`Bosnia and Herzegovina
`Barbados
`Belgium
`Burkina Faso
`Bulgaria
`Benin
`Brazil
`Belarus
`Canada
`Central African Republic
`Congo
`Switzerland
`Cote d'Ivoire
`Cameroon
`China
`Cuba
`Czech Republic
`Germany
`Denmark
`Estonia
`
`ES
`FI
`FR
`GA
`GB
`GE
`GH
`GN
`GR
`HU
`IE
`IL
`IS
`IT
`JP
`KE
`KG
`KP
`
`KR
`KZ
`LC
`LI
`LK
`LR
`
`Spain
`Finland
`France
`Gabon
`United Kingdom
`Georgia
`Ghana
`Guinea
`Greece
`Hungary
`Ireland
`Israel
`Iceland
`Italy
`Japan
`Kenya
`Kyrgyzstan
`Democratic People's
`Republic of Korea
`Republic of Korea
`Kazakstan
`Saint Lucia
`Liechtenstein
`Sri Lanka
`Liberia
`
`LS
`LT
`LU
`LV
`MC
`MD
`MG
`MK
`
`ML
`MN
`MR
`MW
`MX
`NE
`NL
`NO
`NZ
`PL
`PT
`RO
`RU
`SD
`SE
`SG
`
`Lesotho
`Lithuania
`Luxembourg
`Latvia
`Monaco
`Republic of Moldova
`Madagascar
`The former Yugoslav
`Republic of Macedonia
`Mali
`Mongolia
`Mauritania
`Malawi
`Mexico
`Niger
`Netherlands
`Norway
`New Zealand
`Poland
`Portugal
`Romania
`Russian Federation
`Sudan
`Sweden
`Singapore
`
`SI
`SK
`SN
`sz
`TD
`TG
`TJ
`TM
`TR
`TT
`UA
`UG
`us
`uz
`VN
`YU
`zw
`
`Slovenia
`Slovakia
`Senegal
`Swaziland
`Chad
`Togo
`Tajikistan
`Turkmenistan
`Turkey
`Trinidad and Tobago
`Ukraine
`Uganda
`United States of America
`Uzbekistan
`VietNam
`Yugoslavia
`Zimbabwe
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 2 of 67
`
`
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`wo 98/29057
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`PCT/EP97/07337
`
`VALVE PROSTHESIS FOR IMPLANTATION IN BODY
`
`CHANNELS
`
`The present invention relates to a valve prosthesis for implantation
`
`5
`
`in body channels, more particularly but not only to, cardiac valve prosthesis
`
`to be implanted by a transcutaneous catheterization technique.
`
`The valve prosthesis can be also applied to other body channels
`
`provided with native valves, such as veins or in organs (liver, intestine,
`
`urethra, ... ).
`
`10
`
`The present invention also relates to a method for implanting a
`
`valve prosthesis, such as the valve according to the present invention.
`
`Implantable valves, which will be indifferently designated hereafter
`
`as "IV", "valve prosthesis" or "prosthetic valve", permits the reparation of a
`
`valvular defect by a less invasive technique in place of the usual surgical
`
`15
`
`valve implantation which, in the case of valvular heart diseases, requires
`
`thoracotomy and extracorporeal circulation. A particular use for the IV
`
`concerns patients who cannot be operated on because of an associated
`
`disease or because of very old age or also patients who could be operated
`
`on but only at a very high risk.
`
`20
`
`Although the IV of the present invention and the process for
`
`implanting said IV can be used in various heart valve diseases, the
`
`following description will first concern the aortic orifice in aortic stenosis,
`
`more particularly in its degenerative form in elderly patients.
`
`Aortic stenosis is a disease of the aortic valve in the left ventricle of
`
`25
`
`the heart. The aortic valvular orifice is normally capable of opening during
`systole up to 4 to 6 cm2
`
`, therefore allowing free ejection of the ventricular
`
`blood volume into the aorta. This aortic valvular orifice can become tightly
`
`stenosed, and therefore the blood cannot anymore be freely ejected from
`
`the left ventricle. In fact, only a reduced amount of blood can be ejected by
`
`30
`
`the left ventricle which has to markedly increase the intra-cavitary pressure
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 3 of 67
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`2
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`to force the stenosed aortic orifice. In such aortic diseases, the patients can
`
`have syncope, chest pain, and mainly difficulty in breathing. The evolution
`
`of such a disease is disastrous when symptoms of cardiac failure appear,
`
`since 50 % of the patients die in the year following the first symptoms of the
`
`5
`
`disease.
`
`The only commonly available treatment is the replacement of the
`
`stenosed aortic valve by a prosthetic valve via surgery: this treatment
`
`moreover providing excellent results. If surgery is impossible to perform,
`
`i.e., if the patient is deemed inoperable or operable only at a too high
`
`10
`
`surgical risk, an alternative possibility is to dilate the valve with a balloon
`
`catheter to enlarge the aortic orifice. Unfortunately, a good result is
`
`obtained only in about half of the cases and there is a high restenosis rate,
`
`i.e., about 80% after one year.
`
`Aortic stenosis is a very common disease in people above seventy
`
`15
`
`years old and occurs more and more frequently as the subject gets older.
`
`As evidenced, the present tendency of the general evolution of the
`
`population is becoming older and older. Also, it can be evaluated, as a
`
`crude estimation, that about 30 to 50% of the subjects who are older than
`
`80 years and have a tight aortic stenosis, either cannot be operated on for
`
`20
`
`aortic valve replacement with a reasonable surgical risk or even cannot be
`
`considered at all for surgery.
`
`It can be estimated that, about 30 to 40 persons out of a million per
`
`year, could benefit from an
`
`implantable aortic valve positioned by a
`
`catheterization technique. Until now, the implantation of a valve prosthesis
`
`25
`
`for the treatment of aortic stenosis is considered unrealistic to perform
`
`since it is deemed difficult to superpose another valve such an implantable
`
`valve on the distorted stenosed native valve without excising the latter.
`
`From 1985, the technique of aortic valvuloplasty with a balloon
`
`catheter has been introduced for the treatment of subjects in whom surgery
`
`30
`
`cannot be performed at all or which could be performed only with a
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 4 of 67
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`3
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`prohibitive surgical risk. Despite the considerable deformation of the
`
`stenosed aortic valve, commonly with marked calcification, it is often
`
`possible to enlarge significantly the aortic orifice by balloon inflation, . a
`
`procedure which is considered as low risk.
`
`5
`
`However, this technique has been abandoned by most physicians
`
`because of the very high restenosis rate which occurs in about 80% of the
`
`patients within 10 to 12 months. Indeed, immediately after deflation of the
`
`balloon, a strong recoil phenomenon often produces a loss of half or even
`
`two thirds of the opening area obtained by the inflated balloon. For
`
`10
`
`instance, inflation of a 20 mm diameter balloon in a stenosed aortic orifice
`
`of 0.5 cm2 area gives, when forcefully and fully inflated, an opening area
`
`equal to the cross sectionnal area of the maximally inflated balloon, i.e.,
`
`about 3 cm 2
`
`• However, measurements performed a few minutes after
`
`deflation and removal of the balloon have only an area around 1 cm2 to 1.2
`
`15
`
`cm 2 • This is due to the considerable recoil of the fibrous tissue of the
`
`diseased valve. The drawback in this procedure has also been clearly
`
`shown on fresh post mortem specimens.
`
`20
`
`25
`
`However, it is important to note that whereas the natural normal
`aortic valve is able to open with an orifice of about 5 to 6 cm2 and to
`
`accommodate a blood flow of more that 15 1/min. during heavy exercise for
`instance, an opening area of about 1.5 to 2 cm2 can accept a 6 to 8 1/min
`blood flow without a significant pressure gradient. Such a flow corresponds
`
`to the cardiac output of the elderly subject with limited physical activity.
`
`Therefore, an IV would not have to produce a large opening of the
`aortic orifice since an opening about 2 cm2 would be sufficient in most
`subjects, in particular in elderly subjects, whose cardiac output probably
`
`does not reach more than 6 to 8 1/min. during normal physical activity. For
`
`instance, the surgically implanted mechanical valves have an opening area
`which is far from the natural valve opening that ranges from 2 to 2.5 cm2
`
`,
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 5 of 67
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`PCT/EP97/07337
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`mainly because of the room taken by the large circular structure supporting
`
`the valvular part of the device.
`
`The prior art describes examples of cardiac valves prosthesis that
`
`are aimed at being implanted without surgical intervention by way of
`
`5
`
`catheterization. For
`
`instance, US patent no 5,411,552 describes a
`
`collapsible valve able to be introduced in the body in a compressed
`
`presentation and expanded in the right position by balloon inflation.
`
`Such valves, with a semi-lunar leaflet design, tend to imitate the
`
`natural valve. However, this type of design is inherently fragile, and such
`
`10
`
`structures are not strong enough to be used in the case of aortic stenosis
`
`because of the strong recoil that will distort this weak structure and
`
`because they would not be able to resist the balloon inflation performed to
`
`position the implantable valve. Furthermore, this valvular structure is
`
`attached to a metallic frame of thin wires that will not be able to be tightly
`
`15
`
`secured against the valve annulus. The metallic frame of this implantable
`
`valve is made of thin wires like in stents, which are implanted in vessels
`
`after balloon dilatation. Such a light stent structure is too weak to allow the
`
`implantable valve to be forcefully embedded into the aortic annulus.
`
`Moreover, there is a high risk of massive regurgitation (during the diastolic
`
`20
`
`phase) through the spaces between the frame wires which is another
`
`prohibitive risk that would make this implantable valve impossible to use in
`
`clinical practice.
`
`Furthermore, an important point in view of the development of the
`
`IV is that it is possible to maximally inflate a balloon placed inside the
`
`25
`
`compressed implantable valve to expand it and insert it in the stenosed
`
`aortic valve up to about 20 to 23 mm in diameter. At the time of maximum
`
`balloon inflation, the balloon is absolutely stiff and cylindrical without any
`
`waist. At that moment, the implantable valve is squeezed and crushed
`
`between the strong aortic annulus and the rigid balloon with the risk of
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 6 of 67
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`5
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`causing irreversible damage to the valvular structure of the implantable
`
`valve.
`
`SUMMARY OF THE INVENTION
`
`The invention is aimed to overcome these drawbacks and to
`
`5
`
`implant an IV which will remain reliable for years.
`
`A particular aim of the present invention is to provide an IV,
`
`especially aimed at being used in case of aortic stenosis, which structure is
`
`capable of resisting the powerful recoil force and to stand the forceful
`
`balloon inflation performed to deploy the IV and to embed it in the aortic
`
`10
`
`annulus.
`
`Another aim of the present invention is to provide an efficient
`
`prosthesis valve which can be implanted by a catheterization technique, in
`
`particular in a stenosed aortic orifice, taking advantage of the strong
`
`structure made of the distorted stenosed valve and of the large opening
`
`15
`
`area produced by preliminary balloon inflation, performed as an initial step
`
`of the procedure.
`
`A further aim of the present invention is to provide an implantable
`
`valve which would not produce any risk of fluid regurgitation.
`
`A further aim of the present invention is to provide a valve
`
`20
`
`prosthesis implantation technique using a two-balloon catheter and a two(cid:173)
`
`frame device.
`
`These aims are achieved according to the present invention which
`
`provides a valve prosthesis of the type mentioned in the introductory part
`
`and wherein said valve prosthesis comprises a collapsible continuous
`
`25
`
`structure with guiding means providing stiffness and a frame to which said
`
`structure is fastened, said frame being strong enough to resist the recoil
`
`phenomenon of the fibrous tissue of the diseased valve.
`
`The IV, which is strongly embedded, enables the implantable valve
`
`to be maintained
`
`in
`
`the right position without any risk of further
`
`30
`
`displacement, which would be a catastrophic event.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 7 of 67
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`More precisely, this valvular structure comprises a valvular tissue
`
`compatible with the human body and blood, which is supple and resistant
`
`to allow said valvular structure to pass from a closed state to an open state
`
`to allow a body fluid, more particularly the blood, exerting pressure on said
`
`5
`
`valvular structure, to flow. The valvular tissue forms a continuous surface
`
`and is provided with guiding means formed or incorporated within, creating
`
`stiffened zones which induce the valvular structure to follow a patterned
`
`movement from its open position to its closed state and vice-versa,
`
`providing therefore a structure sufficiently rigid to prevent diversion, in
`
`10
`
`particular into the left ventricle and thus preventing any regurgitation of
`
`blood into the left ventricle in case of aortic implantation.
`
`Moreover, the guided structure of the IV of the invention allows the
`
`tissue of this structure to open and close with the same patterned
`
`movement while occupying as little space as possible in the closed state of
`
`15
`
`the valve. Therefore, owing to these guiding means, the valvular structure
`
`withstands the unceasing movements under blood pressure changes
`
`during the heart beats.
`
`More preferably, the valvular structure has a substantially truncated
`
`hyperbolo'idal shape in its expanded position, with a larger base and a
`
`20
`
`growing closer neck, ending in a smaller extremity forming the upper part of
`
`the valvular structure. The valvular structure has a curvature at its surface
`
`that is concave towards the aortic wall. Such a shape produces a strong
`
`and efficient structure in view of the systolo-diastolic movement of the
`
`valvular tissue. Such a valvular structure with its simple and regular shape
`
`25
`
`also lowers the risk of being damaged by forceful balloon inflation at the
`
`time of IV deployment.
`
`A trunco-hyperbolo'idal shape with a small diameter at the upper
`
`extremity facilitates the closure of the valve at the beginning of diastole in
`
`initiating the starting of the reverse movement of the valvular tissue towards
`
`30
`
`its base. Another advantage of this truncated hyperbolo'idal shape is that
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 8 of 67
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`PCT/EP97 /07337
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`the upper extremity of the valvular structure, because of its smaller
`
`diameter, remains at a distance from the coronary ostia during systole as
`
`well as during diastole, thus offering an additional security to ensure not to
`
`impede at all the passage of blood from the aorta to the coronary ostia.
`
`5
`
`As another advantageous embodiment of the invention, the guiding
`
`means of the valvular structure are inclined strips from the base to the
`
`upper extremity of the valvular structure with regard to the central axis of
`
`the valvular structure. This inclination initiates and imparts a general
`
`helicoidal movement of the valvular structure around said central axis at the
`
`10
`
`time of closure or opening of said structure, such a movement enabling to
`
`help initiate and finalize the closure of the valvular structure. In particular,
`
`this movement improves the collapse of the valvular structure towards its
`
`base at the time of diastole and during the reversal of flow at the very
`
`beginning of diastole. During diastole, the valvular structure thus falls down,
`
`15
`
`folding on itself and collapses on its base, therefore closing the aortic
`
`orifice. The strips can be pleats, strenghthening struts or thickened zones.
`
`In other embodiments, said guiding means are rectilinear strips
`
`from the base to the upper extremity of the valvular structure. In this case,
`
`the guiding means can comprise pleats, struts or thickened zones. In a
`
`20
`
`particular embodiment,
`
`the stiffened zones
`
`then created can be
`
`advantageously
`
`two main portions,
`
`trapezoidal
`
`in shape,
`
`formed
`
`symmetrically one to each other with regard to the central axis of the
`
`valvular structure, and two less rigid portions separating said two main
`
`portions to lead to a tight closeness in shape of a closed slot at the time of
`
`25
`
`closure of the upper extremities of the main portions of the valvular
`
`structure. The thickened zones can be extended up to form the stiffened
`
`zones.
`
`More particularly, each of said main slightly rigid portions occupy
`
`approximately one third of the circumference of the valvular structure when
`
`30
`
`this latter is in its open position. The slightly rigid portions maintain the
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`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 9 of 67
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`valvular structure closed during diastole by firmly applying themselves on
`
`each other. The closure of the valvular structure at the time of diastole thus
`
`does not have any tendency to collapse too much towards the aortic
`
`annulus.
`
`5
`
`Preferably, the guiding means are a number of pleats formed within
`
`the tissue by folding, or formed by recesses or grooves made in the tissue.
`
`The shape of the pleats is adapted to achieve a global shape of the desired
`
`type for said position.
`
`Alternatively, the guiding means are made of strengthening struts,
`
`10
`
`preferably at least three, incorporated in the tissue in combination or not
`
`with said pleats.
`
`The guiding means and, in particular, the strengthening struts, help
`
`to prevent the valvular tissue from collapsing back too much and to reverse
`
`inside the left ventricle through the base of the frame, preventing the risk of
`
`15
`
`blood regurgitation.
`
`In a preferred prosthetic valve of the invention, said valvular tissue
`
`is made of synthetic biocompatible material such as Teflon® or Dacron®,
`
`polyethylene, polyamide, or made of biological material such as
`
`pericardium, porcine leaflets and the like. These materials are commonly
`
`20
`
`used in cardiac surgery and are quite resistant, particularly to folding
`
`movements due to the inceasing systolo-diastolic movements of the
`
`valvular tissue and particularly at the junction with the frame of the
`
`implantable valve.
`
`The valvular structure is fastened along a substantial portion of an
`
`25
`
`expandable frame, by sewing, by molding or by gluing to exhibit a tightness
`
`sufficiently hermetical to prevent any regurgitation of said body fluid
`
`between the frame and the valvular structure.
`
`Preferably, an internal cover is coupled or is integral to the valvular
`
`structure and placed between said valvular structure and the internal wall of
`
`30
`
`the frame to prevent any passage of the body fluid through said frame.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1003, p. 10 of 67
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`9
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`Therefore, there is no regurgitation of blood as it would be the case if there
`
`were any space between the valvular structure fastened on the frame and
`
`the zone of application of the frame on the aortic annulus. The internal
`
`cover makes a sort of "sleeve" at least below the fastening of the valvular
`
`5
`
`structure covering the internal surface of the frame and thus prevents any
`
`regurgitation of blood through the frame.
`
`In the present invention, the frame is a substantially cylindrical
`
`structure capable of maintaining said body channel open in its expanded
`
`state and supporting said collapsible valvular structure.
`
`10
`
`In a preferred embodiment of the invention, the frame is made of a
`
`material which is distinguishable from biological tissue to be easily visible
`
`by non invasive imaging techniques.
`
`Preferably, said frame is a stainless metal structure or a foldable
`
`plastic material, made of intercrossing, preferably with rounded and smooth
`
`15
`
`linear bars. This frame is strong enough to resist the recoil phenomenon of
`
`the fibrous tissue of the diseased valve. The size of the bars and their
`
`number are determined to give both the maximal rigidity when said frame is
`
`expanded and the smallest volume when the frame is compressed.
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`More preferably, the frame has projecting curved extremities and
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`presents a concave shape. This is aimed at reinforcing the embedding and
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`the locking of the implantable valve in the distorted aortic orifice.
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`In a preferred embodiment of the present invention, the IV is made
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`in two parts, a first reinforced frame coupled with a second frame which is
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`made of thinner bars than said first frame and which is embedded inside
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`the second frame. This second frame to which the valvular structure is
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`fastened as described above, is preferably less bulky than the first frame to
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`occupy as little space as possible and to be easily expanded using low
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`pressure balloon inflation.
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`The present invention also relates to a double balloon catheter to
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`separately position the first frame in the dilated stenosed aortic valve and
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`place the second frame that comprises the valvular structure. This catheter
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`comprises two balloons fixed on a catheter shaft and separated by few
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`centimeters.
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`The first balloon is of the type sufficiently strong to avoid bursting
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`even at a very high pressure inflation and is aimed at carrying, in its
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`deflated state, a strong frame aimed at scaffolding the previously dilated
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`stenosed aortic valve. The second balloon is aimed at carrying the second
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`frame with the valvular structure.
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`An advantage of this double balloon catheter is that each balloon
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`has an external diameter which is smaller than known balloons since each
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`element to be expanded is smaller.
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`Moreover, such a double balloon catheter allows to enlarge the
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`choice for making an efficient valvular structure enabling to overcome the
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`following two contradictory conditions:
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`1) having a soft and mobile valvular structure capable of opening
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`and closing freely in the blood stream, without risk of being damaged by
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`balloon inflation; and
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`2) needing a very strong structure able to resist the recoil force of
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`the stenosed valve and capable of resisting, without any damage, a strong
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`pressure inflation of the expanding balloon.
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`Furthermore, the shaft of said double balloon catheter comprises
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`two lumens for successive and separate inflation of each balloon. Of note,
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`an additional lumen capable of allowing a rapid inflation takes additional
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`room in the shaft.
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`25
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`The invention also relates to a method of using a two-balloon
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`catheter with a first frame and second frame to which a valve prosthesis of
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`the type previously described is fastened.
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`DESCRIPTION OF THE DRAWINGS
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`The invention will now be explained and other advantages and
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`features will appear with reference to the accompanying schematical
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`drawings wherein :
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`- Figures 1 a, 1 b and 1 c illustrate, in section views, respectively, the
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`normal aortic valve in systole, in diastole and a stenosed aortic valve;
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`- Figures 2a and 2b illustrate two examples of a metallic frame
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`which are combined to a valvular structure according to the present
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`invention;
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`- Figures 3a and 3b illustrate a frame according to the invention in
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`its expanded position with an opening out of the extremities, respectively,
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`with a cylindrical and a concave shape;
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`- Figures 4a and b illustrate an IV of the invention respectively in its
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`compressed position and in its expanded position in an open position as in
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`systole;
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`15
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`- Figures 5a and 5b illustrate respectively an IV of the invention in
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`its closed position and a sectional view according to the central axis of such
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`a valvular structure which is closed as in diastole;
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`- Figures 6a to 6d illustrate a sectional view according to the central
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`axis of an IV according to the present invention and showing the internal
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`cover and the external cover of the valvular structure overlapping partially
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`or non overlapping the frame bars;
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`- Figure 7 illustrates the frontal zig-zag fastening line of the valvular
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`tissue on the frame;
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`- Figures 8a and 8b illustrate, respectively, a perspective view of a
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`valvular structure and an internal cover made all of one piece and a
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`perspective view of the corresponding frame into which they will be inserted
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`and fastened;
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`- Figures 9a and 9b illustrate inclined strengthening struts, an
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`example of a valvular structure according to the invention, respectively in
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`the open position and in the closed position;
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`- Figures 1 Oa and 1 Ob illustrate an example of a valvular structure
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`comprising pleats, respectively in the open and in the closed position;
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`- Figures 11 a and 11 b illustrate a valvular structure comprising two
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`trapezo"idal slightly rigid portions, respectively in the open and in the closed
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`5
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`position;
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`Figures 11 c to 11 e illustrate a valvular structure comprising a
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`rectangular stiffened zone, respectively in the open, intermediate and
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`closed position;
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`- Figures 12a and 12b illustrate, respectively, a perspective and
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`cross sectional views of an
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`implantable valve
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`in
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`its compressed
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`presentation squeezed on a balloon catheter;
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`- Figures 13a to 131 illustrate views of the successive procedure
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`steps for the IV implantation in a stenosed aortic orifice;
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`- Figure 14 illustrate an implantable valve made in two parts in its
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`compressed presentation squeezed on a two-balloon catheter with a
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`reinforced frame on a first balloon and with the implantable valve on the
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`second balloon; and
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`- Figures 15a to 15f illustrate the successive steps of the
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`implantation of the implantation valve in two parts with a two-balloon
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`catheter;
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`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
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`In the diastole and systole illustrations of section views of Figures
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`1 a and 1 b, the arrows A indicates the general direction of the blood flow.
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`The semi-lunar leaflets 1 and 2 of a native aortic valve (with only two out of
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`three shown here) are thin, supple and move easily from the completely
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`open position (systole) to the closed position (diastole). The leaflets
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`originate from an aortic annulus 2a.
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`The leaflets 1' and 2' of a stenosed valve as illustrated in Figure 1 c,
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`are thickened, distorted, calcified and more or less fused, leaving only a
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`small hole or a narrow slit 3, which makes the ejection of blood from the left
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`ventricle cavity 4 into the aorta 5 difficult and limited. Figures 1 a to 1 c show
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`also the coronary artery ostium 6a and 6b and Figure 1 a shows, in
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`particular, the mitral valve 7 of the left ventricle cavity 4.
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`An
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`implantable valve according
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`to
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`the
`
`invention essentially
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`5
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`comprises a supple valvular structure supported by a strong frame. The
`
`positioning of the
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`implantable valve is an
`
`important point since the
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`expanded frame has to be positioned exactly at the level of the native
`
`valvular leaflets 1, 2 of the native valve, the structures of which are pushed
`
`aside by the inflated balloon.
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`10
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`Ideally, the implantable valve is positioned with the fastening line of
`
`the valvular structure on the frame exactly on the remains of the crushed
`
`stenosed valve to prevent any regurgitation of blood. In practice, it is
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`difficult to position the implantable valve within less than 2 or 3 mm.
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`However, any risk of regurgitation of blood is eliminated with the presence
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`15
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`of an internal cover, as will be described below.
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`The upper limit of the frame should be placed below the opening of
`
`the coronary arteries, i.e., the coronary ostia 6, or at their level so that the
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`frame does not impede free blood flow in the coronary arteries. This point is
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`a delicate part of positioning an IV since the distance between the superior
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`20
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`limit of the leaflets of the natural valve and the coronary ostia 6 is only
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`about 5 to 6 mm. However, the ostia are located in the Valsalva sinus 8
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`which constitutes a hollow that are located a little out of the way. This helps
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`to prevent from impeding the coronary blood flow by the IV.
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`At the time of implantation, the operator evaluates the exact
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`25
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`positioning of the coronary ostia by looking at the image produced by a
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`sus-valvular angiogram with contrast
`
`injection performed before
`
`the
`
`implantation procedure. This image will be fixed in the same projection on a
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`satellite TV screen and will permit the evaluation of the level of the origin of
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`the right and left coronary arteries. Possibly, in case the ostia are not
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`30
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`clearly seen by sus-valvular angiography, a thin guide wire, as those used
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`in coronary angioplasty, is positioned in each of the coronary arteries to
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`serve