United States Patent [191
`Andersen et al.
`
`US005411552A
`[11] Patent Number:
`‘[45] Date of Patent:
`
`5,411,552
`May 2,1995
`
`[54] VALVE PROTHESIS FOR IMPLANTATION
`IN THE BODY AND A CATHETER FOR
`IMPLANTING SUCH VALVE PROTHESIS
`[76] Inventors: Henning R. Andersen, Dalvangen
`37A, DK-8270 Hoejbjerg; John M.
`Hasenkam, Aprilvej 8, DK-82l0
`Aarhus V; Lars L. Knudsen,
`RudolfWulffsgade 6,4.mf., DK-8000
`Aarhus C, all of Denmark
`[21] Appl. No.: 261,235
`[22] Filed:
`Jun. 14, 1994
`
`[63]
`
`Related US. Application Data
`Continuation of Ser. No. 961,891, Jan. 11, 1993, aban
`cloned.
`Foreign Application Priority Data
`[30]
`May18, 1990 [DK] Denmark ........................... .. 1246/90
`
`[56]
`
`[51] Int. 01.6 .............................................. .. A61F 2/24
`[52] US. Cl. ...................................... .. 623/2; 623/900;
`137/343; 137/844; 251/358
`[58] Field of Search .................. .. 623/2, 900; 137/343,
`137/844, 316; 251/358; 606/108
`References Cited
`,
`U.S. PATENT DOCUMENTS
`3,671,979 6/1972 Moulopoulos .
`4,038,703 8/1977
`4,056,854 11/1977
`4,106,129 8/ 1978
`4,297,749 11/1981
`4,343,048 8/ 1982
`4,733,665 3/1988
`4,856,516 8/ 1989
`5,037,434 8/ 1991
`5,163,953 1 1/ 1992 Vince .................................... .. 623/2
`
`_ FOREIGN PATENT DOCUMENTS
`
`0357003 3/1990 European Pat. Off. .......... .. 623/900
`1271508 ll/1986 U.S.S.R. ............................ .. 623/2
`1371701 2/1988 U.S.S.R. ................................ .. 623/2
`
`OTHER PUBLICATIONS
`Derwent Abstract No. 87-190867/27 (1987), SU
`1271508 (Gorkii Kirov Medical Ins.).
`Primary Examiner——-David H. Willse
`Attorney, Agent, or Firm-Watson, Cole, Grindle &
`Watson
`ABSTRACT
`[57]
`A valve prosthesis (9) for implantation in the body by _
`use of catheter (11) comprises a stent made from an
`expandable cylinder-shaped thread structure (2,3) com
`prising several spaced apices (4). The elastically collaps
`ible valve (4) is mounted on the stent as the commissural
`points (5) of the valve (6) are secured to the projecting
`apices (4).
`The valve prosthesis (9) can be compressed around the
`balloon means (13) of the balloon catheter (11) and be
`inserted in a channel, for instance in the aorta (10).
`When the valve prosthesis is placed correctly the bal
`loon means (13) is in?ated thereby expanding the stent
`and wedging it against the wall of aorta. The balloon
`meansv is provided with beads (14) to ensure a steady
`fastening of the valve prosthesis on the balloon means
`during insertion and expansion.
`The valve prosthesis (9) and the balloon catheter (11)
`make it possible to insert a cardiac valve prosthesis
`without a surgical operation comprising opening the
`thoracic cavity.
`
`8 Claims, 4 Drawing Sheets
`
`NORRED EXHIBIT 2216 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`Medtronic Corevalve, LLC
`v. Troy R. Norred, LLC
`Case IPR2014-00111
`
`

`

`_ 5,411,552
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`NORRED EXHIBIT 2216 - Page 2
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`US. Patent
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`May 2, 1995
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`Sheet 2 of 4
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`NORRED EXHIBIT 2216 - Page 3
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`US. Patent
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`May 2, 1995
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`Sheet 3 of 4
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`NORRED EXHIBIT 2216 - Page 4
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`US. Patent
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`May 2, 1995
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`Sheet 4 of 4
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`NORRED EXHIBIT 2216 - Page 5
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`1
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`VALVE PROTHESIS FOR IMPLANTATION IN
`THE BODY AND A CATHETER FOR
`IIVIPLANTING SUCH VALVE PROTHESIS
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`This application is a continuation of application Ser.
`No. 961,891, ?led Jan. 11, 1993, now abandoned.
`
`10
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`5,411,552
`2
`valve prosthesis is designed for implantation and sewer
`ing on by a surgical intervention.
`Moreover, from US. Pat. Nos. 4,856,516 and
`4,733,665 different shapes of expandable stents are
`known. These stents are made to be expanded by im
`pression of a radially outward force coming from a
`balloon catheter or the like. These stents are made to
`reinforce the wall when there is a risk that the channel
`is closed and/or compressed.
`The nearest prior art may be that described in GB-A
`2,056,023. This document discloses an elastic stent as
`described by way of introduction. Thus, the stent de
`scribed comprises an elastic collapsible valve mounted
`on the cylinder surface of a cylindrical stent. However,
`the valve prosthesis including the stent is designated for
`mounting through a surgical intervention. Even though
`the stent is slightly collapsible, it will not be suited for
`implantation by a catheterization procedure.
`
`‘ BACKGROUND OF THE INVENTION
`The present invention relates to a valve prosthesis,
`preferably a cardiac valve prosthesis, for implantation
`in the body and comprising a collapsible elastical valve
`which is mounted on an elastical stent wherein the com
`missural points of the elastical collapsible valve are
`mounted on the cylinder surface of the elastical stent.
`Valve prostheses of this type are usually implanted in
`one of the channels of the body to replace a natural
`valve. In the present description the invention will be
`explained in connection with an cardiac valve prosthe
`sis for implantation in aorta. However, it will be possi
`ble to use a valve prosthesis according to the invention
`in connection with implantation in other channels in the
`body by using the same technique as the one used for
`implantation of cardiac valve prosthesis. Such an im
`plantation may, e.g., comprise the implantation of:
`. a valve (for instance a cardiac valve) in the veins,
`. a valve in the oesophagus and at the stomach,
`. a valve in the ureter and/or the vesica,
`. a valve in the biliary passages,
`. a valve in the lymphatic system, and
`. a valve in the intestines.
`An existing natural valve in the body is traditionally
`replaced with a valve prosthesis by a surgical implanta
`tion. However, a surgical implantation is often an exact
`ing operation. Thus, today the implantation of cardiac
`valves are solely made by surgical technique where the
`thoracic cavity is opened. The operation calls for the
`use of a heart, and lung machine for external circulation
`of the blood as the heart is stopped and opened during
`the surgical intervention and the arti?cial cardiac
`valves are subsequently sewed in.
`Due to its exacting character, it is impossible to offer
`such operation to certain people. For instance, this is
`due to the fact that the person is physically weak be
`cause of age or illness. Moreover, the number of heart
`and lung machines available at a hospital will be a sub
`stantially limiting factor.
`Cardiac valve prostheses that need no surgical inter
`vention are known as there are used for implantation by
`means of a technique of catheterization. Examples of
`such valve prostheses are described in US. Pat. Nos.
`3,671,979 and 4,056,854. However, both of these valve
`prostheses are connected to means which lead to the
`surface of the patient either for a subsequent activation
`of the valve or for a subsequent reposition or removal of
`the valve prosthesis. With these valve prostheses it is
`impossible to make an implantation which makes it
`possible for the patient to resume a substantially normal
`life in the same way as it is possible in connection with
`a surgical implantation of a cardiac valve.
`From US. Pat. No. 3,755,823 an elastic stent for a
`cardiac valve prosthesis is known. However, this valve
`65
`prosthesis is not designed for implantation in the body
`by catheterization. Even though this patent contains no
`detailed explanation, the description indicates that this
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`SUMMARY OF THE INVENTION
`It is the object of the present invention to provide a
`valve prosthesis of the type mentioned in the introduc
`tory part, which permits implantation without surgical
`intervention in the body and by using a catheter tech
`nique known per se and which makes it possible for the
`patient to resume a substantially normal life.
`This is achieved according to the invention with a
`valve prosthesis of the type mentioned in the introduc
`tory part, which is characterized in that the stent is
`made from a radially collapsible and re-expandable
`cylindrical support means for folding and expanding
`together with the collapsible valve for implantation in
`the body by means of a technique of catheterization.
`The collapsible elastic valve is mounted on the stent
`for instance by gluing, welding or by means of a number
`of suitable sutures.
`If the support means are made from a thread struc
`ture, this can for instance be grate shaped, loop shaped
`or helical. This makes it possible to compress the stent
`and the collapsible valve mounted thereon for placing
`on the insertion catheter. The use of a non-self-expanda
`ble stent may, e.g., be effected by a compression of the
`stent around the expansion arrangement of the catheter
`which preferably consists of a balloon. When using a
`self-expandable stent, a catheter with an expansion ar
`rangement is not used. In this case the stent is com
`pressed and is inserted into an insertion or protection
`cap from which the stent is eliminated after implanta
`tion in order to obtain an expansion due to the stresses
`in the compressed support means, which for instance
`may be made from plastics or metal. After the compres
`sion the entire outer dimension is relatively small,
`which makes it possible to introduce the valve prosthe
`sis through a channel in the body.
`When the valve prosthesis is introduced and placed
`correctly, the stent is expanded by self-expansion or by
`means of the expansion arrangement until the stent is
`given an outer dimension which is slightly larger than
`the channel in which it is placed. As the stent is elastic,
`a contraction of the stent is prevented once it is ex
`panded. The stiffness in the material of the support
`means contributes to maintain the expanded shape of
`the stent. After the expansion is made, the expansion
`arrangement of the catheter is contracted and the cathe
`ter can be removed from the channel. The inlet opening
`can subsequently be closed and the patient will then be
`able to resume a normal life.
`
`NORRED EXHIBIT 2216 - Page 6
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`4
`certain cases the weight (re?ux) on the left ventricle is
`reduced by up to approximately 75%.
`Furthermore, the stent may be made with a relatively
`great height and with a cylinder surface which is closed
`by a suitable material. Thus, a vascular prosthesis
`known per se is formed wherein the valve is mounted.
`This may facilitate the implantation of the valve pros
`thesis, for instance in the arcus aorta. Moreover, the
`great surface which abuts the inner wall of the channel
`contributes to ensure the securing of the valve prosthe
`sis in the channel. This embodiment is also suitable as
`valve prothesis which is inserted in veins. As veins have
`relatively thin and weaker walls than arteries, it is desir
`able that the valve prothesis has a greater surface to
`distribute the outward pressure which is necessary to
`secure the valve prosthesis.
`Moreover, the invention relates to a balloon catheter
`for implantating a valve prosthesis according to the
`invention and comprising a channel for injection of a
`?uid for the in?ation of the balloon means of the cathe
`ter and an insertion cap wherein the balloon means of
`the catheter and a collapsible valve prosthesis mounted
`thereon are located during the injection, characterized
`in that the balloon means are provided with a pro?led
`surface which is made to ensure a steady fastening of
`the valve prosthesis during the withdrawal of the bal
`loon means from the protection cap and the subsequent
`in?ation for the expansion of the stent.
`Different balloon catheters for implantating cores in
`the body are known. For instance, such balloon cathe
`ters are known from U.S. Pat. Nos. 4,856,516, 4,733,665
`and 4,796,629 and fromDE publication No. 2,246,526.
`However, the known balloon catheters have a smooth
`or a slightly wavy surface. The use of such balloon
`catheter is disadvantageous for mounting a valve pros
`thesis in a channel having a large ?ow as for instance
`the aorta. A large humour flow is able to displace the
`stent on the smooth surface of the balloon and makes an
`accurate positioning difficult. This drawback has been
`remedied with the balloon catheter according to the
`present invention as the pro?led surface prevents a
`displacement of the valve prosthesis in relation to the
`balloon means during introduction and the subsequent
`in?ation of the balloon means.
`In connection with the implantation, any prior art
`technique may be used to supervise an accurate intro
`duction and positioning of the valve prosthesis. Thus,
`guide wires for the catheter, X-ray supervision, injec
`tion of X-ray traceable liquids, ultrasonic measuring,
`etc., may be used.
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`The valve prosthesis according to the invention does
`not require'an actual operation but merely a small inter
`vention to optionally expose the body channel, e.g., a
`vein, through which the insertion takes place. Thus,
`patients for whom an operation would be associated
`with high risk can be offered implantation of, for in
`stance, cardiac valves. After the implantation has taken
`place, the after-treatment will advantageously be
`shorter than normally, which means fewer hospital days
`for the patient. Moreover, it is assumed that it will be
`possible to implantate the valve prosthesis under local
`anaesthetic.
`The valve prosthesis can be used to replace a natural
`valve or to establish a new valve function in one of the
`channels in the body which do not naturally contain a
`valve. For instance this goes for veins (arteries and
`veins) on a place without natural valves. The function
`of the valve prosthesis is then to ensure that the blood
`flows in one direction only. The valve is meant to be
`used in veins in the legs of persons suffering from vari
`cose veins (varices).
`In persons having varicose veins the blood ?ows in a
`wrong direction, viz. from the central veins in the cen
`tre of the leg towards the super?cial veins. Among
`other things, this is due to the changed pressure in the
`25
`legs, upright working position and other conditions. A
`valve prosthesis according to the invention may easily
`be placed in the veins and prevent the flow of the blood
`in a wrong direction.
`_
`Also, the valve prosthesis can be used in connection
`with diseases, for instance cancerous tumors, where too
`much humour is produced. If the humour is able to ?ow
`from the cancerous tumor through several channels, it
`is possible to drain the humour in one desired direction
`through the channels of the body by an appropriate
`placing of the valve prosthesis.
`When the valve prosthesis is used as a cardiac valve
`prosthesis in the aorta, it is possible to mount it in three
`positions, viz., in the descending part of the aorta, in a
`position between the coronary arteries and the left ven
`tricle of the heart, or in the aorta in a position immedi
`ately after the mouth of the coronary arteries.
`The cardiac valve prosthesis can also be used in other
`places than in the aorta. Thus, the valve prosthesis can
`be used in the pulmonary artery and/ or the right ventri
`cle of the heart for replacing the pulmonary valves.
`Likewise, the cardiac valve prosthesis can be used in the
`passage between the right auricle of the heart and the
`right ventricle of the heart (tricuspidalostium) and the
`passage between the left auricle of the heart and the left
`ventricle of the heart (mistralostium) for replacing the
`tricuspidal valve and the mitral valve, respectively.
`Even though the cardiac valve preferably is meant to
`be used for patients suffering from aorta insuf?ciency
`and who cannot be offered an open heart surgery, the
`valve prosthesis can also be used for patients in connec
`tion with treatment of aorta stenosis. Several of the
`patients with aorta stenosis are elderly people who
`cannot be offered a surgical cardiac operation. The
`patients are offered balloon dilatation of the aorta steno
`sis which may result in an aorta insuf?ciency as a side
`effect of the treatment.
`As to these patients it is possible to insert a valve
`prosthesis in the descending or ascending part of the
`aorta thoracalis a few days or weeks before the balloon
`dilatation. As a result thereof, the left ventricle is pro
`tected against weight if the subsequent balloon dilata
`tion of the stenosis results in aorta insufficiency. In
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`
`DESCRIPTION OF THE DRAWINGS
`The invention will now be explained in detail with
`reference to the accompanying schematical drawing,
`wherein
`FIG. 1 shows a perspective view of a stent without a
`valve,
`FIG. 2 is a perspective view of a valve prosthesis
`according to the invention made from the stent shown
`in FIG. 1 having a biological valve mounted thereon,
`FIG. 3 is a partial view through the aorta illustrating
`a partially in?ated balloon catheter,
`' FIG. 4 is a cross section through the'embodiment
`shown in FIG. 9,
`FIG. 5-7 are views illustrating the introduction and
`implantation of a valve prosthesis of the invention in the
`aorta,
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`FIG. 8-10 are views illustrating three possible posi
`vided by using balloon means with an indentation in the
`surface (not shown).
`tions of a cardiac valve prosthesis, and
`FIG. 11-12 are perspective views illustrating two
`FIG. 4 shows a cross section through the embodi
`further embodiments of a valve prosthesis having a
`ment shown in FIG. 3 illustrating the placing of the
`closed cylindrical wall.
`beads 14 on the tri-sectional balloon means 13.
`A balloon catheter of the above-described type
`which was used in tests of implantating the cardiac
`valve prosthesis 9 in pigs had the following dimensions.
`Each of the three balloons was 60 mm in length and 15
`mm in diameter. The total diameter for the three in
`?ated balloons was 31 mm and in the balloon catheter
`used two beads 14 having a height of 3 mm were
`mounted on each side of the three balloons. The beads
`had a spacing of 15 mm. The protection cap 11A of the
`balloon catheter had an outer diameter of 13.6 mm and
`an inner diameter of 12.5 mm and a length of 75 cm. The
`balloon catheter was provided with a standard guide
`wire having a diameter of 0.9 mm and a length of 300
`cm.
`FIGS. 5-7 show the valve prosthesis 9 at different
`steps in introducing and implantating in the aorta 10 by
`means of the catheter 11 having the in?atable balloon
`means 13. The cardiac valve prosthesis 9 is initially
`placed above the de?ated balloon means 13 and com
`pressed manually around the balloon means (FIG. 5),
`whereafter the outer diameter for the valve prosthesis is
`approximately 10 mm. After the introduction and posi
`tioning, the balloon means 13 is in?ated (FIG. 6),
`thereby contributing an outer dimension of approxi
`mately 30 mm to the cardiac valve prosthesis. To obtain
`an effective fastening in the aorta, the outer dimension
`of the cardiac valve prosthesis is greater than the diame
`ter of the aorta. This means that the prosthesis is tight
`against the inner wall of the aorta with a pressure which
`is sufficiently large to counteract a detachment due to
`the ?ow of the blood. The balloon catheter 11 may
`subsequently be removed from the aorta 10 (FIG. 7).
`Due to the stiffness of the metal the valve prosthesis
`will prevent a contraction. However, smaller contrac
`tions may occur (< 10% diameter reduction) after the
`de?ation and removal of the balloon catheter 13. When
`the valve prosthesis is mounted as shown in FIG. 7, the
`patient will be able to resume a substantially normal life
`after a few days.
`FIGS. 8-10 show the positioning of the valve pros
`thesis 9 as cardiac valve prosthesis in the aorta 10 in
`three different positions, i.e., in a position between the
`coronary arteries 20 and the left ventricle of the heart
`21 (FIG. 8), in a position immediately after the mouth of
`the coronary arteries in the ascending part of the aorta
`(FIG. 9), and in a position in the descending part of the
`aorta 10. The positioning of the valve prosthesis is
`chosen in accordance with the diagnosis of the illness of
`the patient. By placing the cardiac valve prosthesis as
`shown in FIG. 8, there is a risk of detachment and/or
`covering the mouth of the coronary arteries, and there
`fore it is preferred to use a higher stent which, for in
`stance, comprises several rings 7,8 placed on top of each
`other. This allows a ?xation of the prosthesis at a place
`after the mouth of coronary arteries even though the
`valve itself is in the position between the coronary ar
`teries and the left ventricle. FIGS. 8 and 9 show how a
`contrast medium 23 is injected by means of a so-called
`pigtail catheter for registration of the tightness of the
`implantated valve prosthesis 9.
`A specific embodiment for a valve prosthesis and a
`balloon catheter for implantating the valve prosthesis
`has been explained above. However, it is obvious that it
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`FIG. 1 shows a stent 1 made by support means in the
`form of two 0.55 mm surgical stainless steel wires 2,3.
`The wires are folded in 15 loops. Three loops 4 are 14
`mm in height and are intended to secure the commis
`sural points 5 (see FIG. 2) from a biological cardiac
`valve 6 which is mounted in the stent 1. The remaining
`loops have a height of 8 mm. These loops form circum
`ferentially expandable sections 25 between the commis
`sural points 5 forming commissural supports. Each of
`the two folded wires 2,3 is bent to form rings 7,8 which
`are closed by welding the ends. The two rings are
`placed on top of each other as will appear from FIG. 1
`20
`and they are mutually secured by means of a number of
`sutures (not shown). The lower ring is circumferentially
`expandable at least along sections thereof which corre
`spond to the circumferentially expandable sections 25.
`By using a substantially cylindrical thread structure
`with projecting apices, a reduction in weight is obtained
`as compared to a stent which is exclusively cylindrical
`with the same loop heights for all the loops.
`The biological valve 6 was removed from a slaugh
`tered pig of 100 kg. The valve was cleaned before
`mounting in the stent 1. The cleaned valve has an outer
`diameter of 25-27 mm and the height of the three com
`missural points Sis 8 mm. The valve 6 is mounted in the
`stent by means of a suitable number of sutures to form
`the cardiac valve prosthesis 9 shown in FIG. 2. The
`35
`valve prosthesis produced is used for performing tests in
`pigs by implantation of cardiac valve prosthesis. How
`ever, the cardiac valve prosthesis for use in human
`beings has a corresponding form.
`FIG. 3 shows a partial view through the aorta 10. A
`40
`balloon catheter 11 is introduced in the aorta according
`to the direction of an arrow 12. In the Figure shown the
`balloon means 13 of the balloon catheter is led out of the
`protection cap 11A and is partly in?ated through a fluid
`channel 15, which is led to the surface of the patient.
`The balloon means 13 constitutes a tri-sectional balloon
`upon which the cardiac valve prosthesis is placed. In
`the form shown, the cardiac valve prosthesis is ex
`panded exactly to be in contact with the aorta 10. The
`balloon means 13 is provided with three projecting
`50
`beads 14 which are engaged with the one side of the
`cardiac valve prosthesis 9. The blood ?owing through
`the aorta according to the direction of an arrow 16 will
`thus cause the cardiac valve prosthesis 9 to abut on the
`beads 14 and the valve cannot be displaced in relation to
`the balloon means 13. Moreover, the balloon catheter
`used comprises a central channel 17 to receive a guide
`wire 18 which is used in a way known per se for super
`vising the introduction of the catheter through ?uoro
`scopi. In the shown embodiment beads 14 are only used
`at one side of the valve prosthesis, but, however, it will
`often be desirable to use the beads in pairs placed along
`lines parallel to the ‘longitudinal axes 19 through the
`balloon means 13. In this case the spacing of the pair of
`beads 14 will correspond to the height of the loops of
`65
`the stent. This makes it possible to make an effective
`fastening of a valve prosthesis on balloon means. More
`over, the fastening on the balloon means may be pro
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`is possible to modify the valve prosthesis depending on
`elastical valve having a plurality of commissural points,
`wherein the stent comprises:
`the desired use, and moreover, it is possible to modify
`cylindrical support means which is radially collaps
`the catheter used in the implantation. Thus, the stent of
`the valve prosthesis may be made solely of one closed
`ible for introduction within the body channel and
`which has a plurality of circumferentially-expanda
`ring folded in a number of loops or with three or more
`mutually secured loop-shaped rings placed on top of
`ble sections such that the cylindrical support means
`is radially expandable for being secured within the
`each other. Moreover, it is possible to make the stent
`body channel; and
`having a thread structure which instead of loops is grate
`a plurality of commissural supports projecting from
`shaped, helical or is formed otherwise if only it is en
`sured that the form of the stent permits the compression
`one side of the cylindrical support means in a direc
`and expansion of the stent and fastening of the collaps
`tion generally parallel to the longitudinal axis
`thereof for supporting the commissural ‘points of
`ible valve. Instead of a biological valve it might be
`possible to use other collapsible valves, such as valves
`the collapsible valve, at least one circumferentially
`expandable section of the cylindrical support
`made from synthetic materials, e. g., polyurethane. It is
`also possible to use valves with more or fewer ?aps than
`means lying between each of the commissural sup
`three.
`ports, such that the collapsible valve may be col
`lapsed and expanded together with the cylindrical
`It is possible to make the valve prosthesis with a
`support means for implantation in the body channel
`closed cylinder surface as illustrated in FIGS. 11 and
`12. In both Figures the support means of the valve
`by means of a technique of catheterization.
`2. A valve prosthesis according to claim 1, wherein
`prosthesis is made of an elongated tubular means 24
`having a closed cylinder surface. This valve prosthesis
`the cylindrical support means is made of a thread struc
`is intended to expand by self-expansion or by means of
`ture.
`.
`a catheter according to the invention. This prosthesis is
`especially suitable for placing in veins and other chan
`nels where only a small pressure is exerted against he
`wall of the channel. In FIG. 11 the valve 6 is mounted
`at the end of the tubular means 24. In FIG. 12 an em
`bodiment is shown where the valve 6 is mounted in a
`central position in the tubular means 24.
`An explanation of a method of implantating a valve
`prosthesis according to the invention is given below:
`a valve prosthesis 9 made of a stent 1 and a collapsible
`valve 6, as described above, is placed on a de?ated
`balloon means and is manually compressed
`thereon,
`the balloon means 13 and the valve prosthesis are
`drawn into an insertion cover 11A,
`a guide wire 18 is inserted into the left ventricle of the
`heart through the central opening 17 of the balloon
`catheter under continuous ?uoroscopi,
`the insertion cover 11A conveys the guide wire 18 to
`a point in the channel in the immediate vicinity of
`the desired position of the valve prosthesis,
`the balloon means 13 is pushed out of the protection
`cap 11A and the valve prosthesis is positioned in
`the desired position if necessary by use of further
`registration means to ensure an accurate position
`mg,
`the balloon means 13 is in?ated with a certain over
`stretching of the channel,
`the balloon means 13 is de?atated, and
`the balloon means 13, the guide wire 18 and the pro
`tection cap 11A are drawn out and the opening in
`the channel, if any, wherein the valve prosthesis is
`inserted can be closed.
`We claim:
`1. A valve prosthesis for implantation in a body chan
`nel, the valve prosthesis comprising a collapsible elasti
`cal valve which is mounted on an elastical stent, the
`
`3. A valve prosthesis according to claim 2, wherein
`the thread structure comprises several spaced apices
`projecting from the one side of the cylindrical structure
`and in a direction along the longitudinal axis of the
`cylinder and that the commissural points of the valve
`are attached to the projecting apices.
`4. A valve prosthesis according to claim 3, wherein
`the elastically collapsible valve is a biological trilobate
`valve.
`5. A valve prosthesis to claim 4, wherein the stent is
`made from a stainless steel wire folded in a number of
`loops and bent into a circle and welded to form a closed
`ring, wherein the stent comprises two or more such
`closed rings which are mutually connected end to end
`to form the cylindrical thread structure, and wherein
`three of the loops in a ring at an end of said stent are
`folded with a greater height than the remaining loops to
`form the apices to which the commissural points of the
`biological valve are attached.
`6. A valve prosthesis according to claim 5, wherein
`each of the rings of the stent is made from a wire having
`a diameter of 0.55 mm and a loop height of approxi
`mately 8 mm and approximately 14 mm for the three
`greater loops, and wherein the cylindrical thread struc
`ture produced and the collapsible valve mounted
`thereon in a folded state have an outer diameter of
`approximately 10 mm and in expanded state an outer
`diameter of approximately 30 mm.
`7. A valve prosthesis according to claim 5, wherein
`the stent is made to be ?xed through the expansion at
`one point in the channel wherein the valve prosthesis is
`inserted, which point is different from the point where
`the valve is mounted in the stent.
`8. A valve prosthesis according to claim 1, wherein
`the cylinder surface of the support means is closed to
`form a tubular element.
`* * * * *
`
`45
`
`50
`
`55
`
`65
`
`NORRED EXHIBIT 2216 - Page 9
`
`

`

`US005411552C1
`(12) EX PARTE REEXAMINATION CERTIFICATE (8463rd)
`United States Patent
`US 5,411,552 C1
`(10) Number:
`Aug. 16, 2011
`Anderson et al.
`(45) Certi?cate Issued:
`
`(54) VALVE PROTHESIS FOR IMPLANTATION IN
`THE BODY AND A CATHETER FOR
`IMPLANTING SUCH VALVE PROTHESIS
`
`(75) Inventors: Henning R. Anderson, Hoejbjerg (DK);
`John M. Hasenkam, Aarhus V (DK);
`Lars L. Knudsen, Aarhus C (DK)
`
`(73) Assignee: Edwards Lifesciences AG, St.-Prex
`(CH)
`
`Reexamination Request:
`No. 90/009,779, Jul. 9, 2010
`
`Reexamination Certi?cate for:
`Patent No.:
`5,411,552
`Issued:
`May 2, 1995
`Appl. No.:
`08/261,235
`Filed:
`Jun. 14, 1994
`
`Related US. Application Data
`
`(63) Continuation ofapplication No. 07/961,891, ?led on Jan. 11,
`1993, now abandoned.
`
`(51) Int. Cl.
`A61F 2/24
`
`(2006.01)
`
`(52) US. Cl. ...................... .. 623/218; 137/343; 137/844
`(58) Field of Classi?cation Search ..................... .. 623/2
`See application ?le for complete search history.
`
`(56)
`
`References Cited
`
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`
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`DE
`DE
`DK
`
`2246526
`E 60 500 B
`36 40 745 A1
`691 13 818 T2
`1246/90
`
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`
`(Continued)
`OTHER PUBLICATIONS
`
`First Expert Report of Professor John R. Pepper in German
`High Court of Justice Chancery Division Patents Court,
`HC07 CO1243 signed Apr. 28, 2008.
`
`(Continued)
`Primary Examinericary E Wehner
`
`(57)
`
`ABSTRACT
`
`A valve prosthesis (9) for implantation in the body by use of
`catheter (11) comprises a stent made from an expandable
`cylinder-shaped threaded structure (2,3) comprising several
`spaced apices (4). The elastically collapsible valve (4) is
`mounted on the stent as the commissural points (5) of the
`valve (6) are secured to the projecting apices (4).
`
`The valve prosthesis (9) can be compressed around the bal
`loon means (13) of the balloon catheter (11) and be inserted
`in a channel