United States Patent [191
`Wolfe
`
`[54] OCCLUDER FOR PROSTHETIC HEART
`VALVE ASSEMBLY
`
`[75] Inventor: Gerald W. Wolfe, Paradise, Calif.
`
`[73] Assignee: lnterMed, Inc., Wayne, Pa.
`
`[22] Filed:
`
`Mar. 26, 1976
`
`[21] Appl. No.: 670,690
`
`[52] 11.8. CI. ................................... .._ 3/l.5; 137/847
`[51] Int. Cl.2 ......................................... .. A61F 1/22
`[58] Field of Search ............... .. 3/l.5; 137/846, 847
`
`[56]
`
`References Cited
`
`:
`
`3,308,798
`
`
`
`UNITED STATES PATENTS 3/1967 Snider . . . . . . . . .. 137/846 X
`
`
`
`
`
`[11]
`[45]
`
`4,030,142
`June 21, 1977
`
`FOREIGN PATENTS OR APPLICATIONS
`
`482,441 12/1969 Switzerland .......................... .. 3/l.5
`
`Primary Examiner-Ronald L. Frinks '
`Attorney, Agent, or Firm-Weiser, Stapler & Spivak
`
`‘ ABSTRACT
`[57]
`An occluder for a prosthetic heart valve assembly
`adapted within a seating-ring passage having a body
`including a downstream sealing section comprising a
`plurality of cuspids which engage each other to de?ne
`a closed sealing section when the occluder is in its
`closed position and which ?ex outwardly relative to
`each other when the occluder is in its open position to
`de?ne a central open passage through the occluder,
`and an armature reinforcing the body. The armature
`includes an annular ring and a plurality of reinforcing
`arms hingedly connected to the ring and extending
`through each cuspid to pennit ?exure of each arm
`relative to the annular ring.
`
`9 Claims, 11 Drawing Figures
`
`......... .. 3/1.5
`5/1970 Davila ..
`3,513,485
`........ .. l37/846X
`l/1971
`Laerdal
`3,556,122
`2/1973 Mosher ................................. .. 3/l.5
`3,717,883
`3,839,741 10/1974
`Haller ................................... .. 3/15
`
`10
`_ l4
`
`|5
`
`NORRED EXHIBIT 2213 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`Medtronic Corevalve, LLC
`v. Troy R. Norred, LLC
`Case IPR2014-00111
`
`

`
`US. Patent June 21, 1977
`
`Sheet 1 of2
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`4,030,142
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`28
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`32
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`NORRED EXHIBIT 2213 - Page 2
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`

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`U.S. Patent
`
`June 21, 1977
`
`Sheet 2 of 2
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`4,030,142
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`vI
`vs'\‘\’\‘*" ’
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`NORRED EXHIBIT 2213 - Page 3
`NORRED EXHIBIT 2213 — Page 3
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`

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`1
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`4,030,142
`
`OCCLUDER FOR PROSTHETIC HEART VALVE
`ASSEMBLY
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`This invention relates to prosthetic heart valve as
`semblies, and more speci?cally to a unique center-?ow
`occluder of such assemblies.
`‘ 2. Description of the Prior Art
`It is known in the prior art to replace a diseased
`defective valve in the human heart with a prosthetic, or
`arti?cial heart valve assembly. In many cases, a patient
`has continued to live for many years with such a pros
`thetic heart valve assembly.
`'
`Prosthetic heart valve assemblies which most closely
`approximate the action of natural heart valves are of
`the center-?ow type. Speci?cally, these prosthetic
`heart valve assemblies include an elongate occluder
`which is movable between closed and opened positions
`within a seating-ring passage of a valve seat assembly.
`The occluder includes a plurality of cuspids which are
`movable radially which respect to each other between
`a closed condition when the occluder is in a closed
`position, and an opened condition when the occluder is
`in an opened position. When the cuspids are in their
`opened condition blood can ?ow through the interior
`thereof to simulate the action of a natural heart valve.
`The center-?ow occluders disclosed in prior art pros
`thetic heart valve assemblies preferably are formed of a
`plastic material, such as polypropylene, since such a
`material is generally lightweight and easily formable
`into the desired con?guration for use in heart valve
`assemblies. It has been discovered that these center
`?ow occluders, and particularly the cuspids thereof,
`become deformed after continued usage. Deformation
`of the cuspids prevents the occluder from effectively
`sealing the opening through the valve seat assembly
`when the occluder is in its closed position. This ineffec
`tive sealing of the heart valve assembly causes an unde
`sirable leakage of blood through the seating-ring pas
`sage.
`
`15
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`25
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`35
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`40
`
`2
`At least the cuspids of the occluder are formed of a
`plastic material, such as polypropylene, which is light in
`weight, and easily formable into the desired configura
`tion.
`An armature construction having greater dimen
`sional stability than the cuspids of the occluder in
`cludes an upstream annular ring and a plurality of arms
`which extends downwardly from said ring in circumfer
`entially spaced-apart relationship to each other. The
`upstream end of each arm is connected to the annular
`ring through a hinge section, and each arm extends in a
`downstream direction through the interior of a respec
`tive cuspid. Since each of the arms is connected
`through a hinge to the upstream annular ring the re
`quired ?exing action of the plastic cuspids is not im
`paired by the reinforcing arms. Moreover, since the
`arms have greater dimensional stability than the plastic
`cuspids they will reinforce the cuspids to ensure that
`deformation of said cuspids does not take place. The
`unique cooperation between the reinforcing arms and
`cuspids, as described above, represents a considerable
`improvement over prosthetic heart valve assemblies
`employing center-?ow occluders, and is neither shown
`nor suggested by any of the prior art that applicant is
`aware of.
`In one embodiment of this invention the upstream
`annular section, ?exible stems and cuspids of the oc
`cluder are molded about the armature construction as
`a unitary plastic body. In this embodiment the annular
`ring of the armature construction is disposed within the
`interior of the upstream annular section of the plastic
`body, and the downwardly extending arms of the arma
`ture construction are disposed within theinterior of the
`?exible stem and cuspids of the plastic body.
`In an altenative embodiment of this invention the
`plastic cuspids are molded individually, and the arma
`ture construction is formed as a unitary member. In this
`embodiment the ‘arms of the armature construction are
`disposed within the interior of respective‘ cuspids to
`properly position thecuspids relative to each other.
`The upstream annular ‘section and ?exible stems of the
`occluder are provided by sections of the unitary arma
`ture construction.
`It is an object of‘this invention to provide a center—
`?ow occluder for a heart valve assembly in which a
`plurality of radially movable cuspids are dimensionally
`reinforced without impairing the required movement of
`the cuspids.
`It is a further object of this invention to provide a
`center-?ow occluder for a heart valve assembly which
`promotes unrestricted, streamlined, hydraulic ?ow of
`blood through the interior thereof in a manner simulat
`ing the action of a natural heart valve.
`Other objects and a fuller understanding of the inven
`tion will become apparent by referring to the following
`description, taken in conjunction with the drawings.
`
`45
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`50
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`55
`
`SUMMARY OF THE INVENTION
`This invention relates to improvements in center
`?ow occluders of prosthetic heart valve "‘assemblies.
`The heart valve assemblies of this invention are espe
`cially designed for implantation in the human heart to
`replace the natural mitral valve; however, the valve
`assemblies of this invention also can be adapted to
`replace the tricuspid and/or aortic valves.
`An elongate occluder of this invention is adapted to
`be positioned through a seating-ring passage for move
`ment in its direction of elongation between closed and
`opened positions. The occluder includes an upstream
`annular section and a downstream sealing section, both
`of which have a maximum diameter that is larger than
`the minimum diameter of the seating-ring passage. This
`dimensional relationship prevents the occluder from
`moving out of the seating-ring passage. The down
`stream sealing section of the occluder is of a split con
`struction provided by ‘a plurality of cuspids. The cus
`pids are connected to the upstream annular section
`through ?exible stems, and are movable radially with
`respect to each other between a closed condition‘in
`which they engage each other, and an opened condi
`tion in which they are radially spaced apart to provide
`a passage through the occluder for the ?ow of blood.
`
`60
`
`65
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is an exploded isometric view of a prosthetic
`heart valve assembly employing a unique occluder in
`accordance with this invention;
`FIG. 2A is a sectional view taken along line 2-2 of
`the heart valve assembly shown in FIG. 1 with the ele
`ments assembled and disposed in a valve-closing posi
`tion;
`FlG. 2B is a sectional view similar to FIG. 2A, but
`showing the valve assembly in an opened position;
`
`NORRED EXHIBIT 2213 - Page 4
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`4,030,142
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`3
`FIG. 2C is a sectional view similar to FIG. 2B, but
`with the valve assembly in a different condition in its
`opened position;
`FIG. 3 is a rear view of an armature construction
`employed in the occluder shown in FIG. 1;
`FIG. 4 is a side elevation view of the armature con
`struction taken along line 4-4 of FIG. 3;
`FIG. 5 is an enlarged isometric view of the upstream
`hinge end of an arm employed in the armature con
`struction;
`FIG. 6 is a partial isometric view showing a modi?ed
`construction of the downstream end of the arms em
`ployed in the armature construction;
`FIG. 7 is an exploded isometric view of a second
`embodiment of an occluder according to this invention
`with only one cuspid shown for purpose of clarity;
`FIG. 8 is a plan view of a cuspid taken along line 8—8
`of FIG. 7; and
`FIG. 9 is a sectional view taken along line 9-9 of
`20
`FIG. 7 with the elements of the occluder assembled.
`
`10
`
`4
`Referring to FIGS. 2A-2C, the seating ring 16 has an
`outwardly ?ared section 26 facing in an upstream di
`rection, and an outwardly ?ared section 28 facing in a
`downstream direction. The ?ared sections 26 and 28
`are connected at a junction 30 which establishes the
`minimum diameter of a passageway 32 through the
`seating ring 16.
`Referring again to FIG. 1, the center-?ow occluder
`12, in accordance with one embodiment of this inven
`tion, includes a one~piece plastic body 34 of a suitable
`syntheticmaterial such as polypropylene. The occluder
`12 includes a downstream sealing section 36 of a split
`construction providing a plurality of cuspids 38. The
`occluder 12 shown in FIG. 1 has four cuspids 38; how
`ever, the number of cuspids can be varied as desired.
`The more practical designs include from two to four
`cuspids. Each of the cuspids 38 is joined to an upstream
`annular section 40 through a stem section 42.
`Each of the cuspids 38 includes a substantially
`smooth inner surface 44 which is free of sharp angles or
`bends to aid in providing a streamlined ?ow path for
`blood when said cuspids are in an open condition as
`shown in FIG. 2C. Each cuspid 38 also includes an
`outer surface which is de?ned by upstream and down
`stream ?ared sections 46 and 48, respectively. These
`?ared sections are joined through a rounded apex 50
`which, when the cuspids 38 are in a closed condition as
`shown in FIGS. 2A and 28, define a continuous circle
`of a greater diameter than the circle defined by junc
`tion 30 of the seating ring 16 (FIG. 1 ). Accordingly, the
`occluder 12 cannot move out of the seating ring in an
`upstream direction. Moreover, the upstream ?ared
`sections 46, when the cuspids 38 are in a closed condi
`tion, de?ne a continuous annular surface which is sub
`stantially complimentary to the outwardly ?ared sec
`tion 28 of the seating ring 16. Accordingly, in the
`closed position of the heart valve assembly 10 as shown
`in FIG. 2A, the ?ared sections 46 of_ the cuspids 38 _will
`seat on the outwardly ?ared section 28 of the seating
`ring 16 to seal off the atrium from the ventricle as the
`ventricle contracts.
`The upstream annular section 40 of the occluder 12
`has an outwardly ?ared surface 52 which overlies the
`outwardly ?ared section 26 of the seating ring 16. The
`?ared surface 52 is substantially complimentary in
`shape to the ?ared section 26. Accordingly, the up
`stream annular section 40 of the occluder seats on the
`?ared section 26 of the seating ring 16 when the oc
`cluder 12 is in its opened position (FIGS. 2B and 2C) to
`prevent the occluder from moving out of the seating
`ring passageway 32 in a downstream direction.
`When the ventricle contracts the back pressure acts
`against the downstream ?ared sections 48 of the cus
`pids 38 to force the occluder into its valve sealing posi
`tion shown in FIG. 2A. The camming action between
`upstream ?ared section 46 of each cuspid 38 and the
`inner surface of the seating ring 16 assists in forcing the
`cuspids 38 into engagement with each other to seal off
`the central passage through the occluder 12. When the
`ventricle expands, or relaxes, blood entering the atrium
`through the pulmonary veins will establish a pressure
`drop across the heart valve assembly 10 to move the
`occluder 12 into its opened condition shown in FIG.
`2C..In this opened condition the cuspids 38 are ?exed
`radially outwardly from each other to provide an unin
`terrupted ?ow path through the center of the occluder
`12. As the highest pressure in the heart shifts from the
`ventricle to the atrium during operation of the heart an
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS OF THE INVENTION
`The center-?ow occluders of this invention prefer
`ably are employed in prosthetic heart valve assemblies
`adapted to replace the natural mitral valve in the
`human heart. The prosthetic mitral valve is inserted
`between the left atrium and left ventricle of the heart.
`Blood ?ows into the left atrium from the lungs through
`the pulmonary veins, and then through the prosthetic
`mitral heart valve assembly into the left ventricle from
`where it is pumped through the aortic valve for distri
`bution through the body. When the ventricle contracts
`to pump the ‘blood through the aortic valve, the result
`ing pressure should close the heart valve assembly to
`prevent the reverse ?ow of blood back into the atrium.
`Upon relaxation, or expansion of the ventricle, the
`pressure built up by blood entering the atrium through
`the pulmonary veins should open the heart valve as
`sembly to permit blood to ?ow from the atrium into the
`ventricle. The above-described sequence is repeated
`continuously during normal operation of the heart.
`Referring to FIG. 1, a prosthetic mitral heart valve
`assembly 10 includes a unique center-?ow occluder, 12
`disposed for movement within a valve seat assembly 14.
`The valve seat assembly 14, in accordance with the
`broadest aspects of this invention, can be of any suit
`able construction which provides a passageway in
`which the occluder 12 is movable.
`Referring to FIG. 2A, a preferred valve seat assembly
`14 includes a soft seating ring 16, a hard, rigid, cast
`supporting ring 18 and a ?xation cover 20. The seating
`ring 16 preferably is made of silicone, or other equiva
`lent material, and is molded with a recess 22 disposed
`continuously about its outer periphery. The supporting
`ring 18 can be formed of a hard plastic or metallic
`material, and includes an inwardly directed annular
`projection 24 which is disposed within the recess 22 of
`the seating ring 16 to maintain the seating ring in its
`60
`desired configuration. The fixation cover 20, which is a
`Dacron mesh cloth or other suitable material, is se
`cured about the supporting ring 18, and is initially
`secured to the heart tissue by suturing. After the ?xa
`tion cover 20 has been sutured to the heart tissue,
`thrombosis, which is the formation of clots, is relied
`upon to retain the valve seat assembly 14 in its proper
`position within the heart.
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`NORRED EXHIBIT 2213 - Page 5
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`4,030,142
`5
`6
`still permitting adequate hinging action between the
`interval of time will exist when there is substantially a
`ring 56 and the arms 58.
`zero pressure drop across the heart valveiassembly 10.
`Referring to FIG. 4, the annular ring 56 includes
`The same zero pressure drop will existwhen the highest
`hinge~locating offsets 74 which are spaced 90° apart.
`pressure within the heart shifts from the atrium to the
`These hinge-locating offsets receive the hinge section
`ventricle. During these periods of zero pressure‘drop
`60 of respective arms 58 to prevent the arms from
`across the heart valve assembly 10 the occluder 12
`moving circumferentially about the annular ring. The
`may, due to the chest position of the user, be disposed
`number of hinge-locating offsets 74 will depend upon
`in its open position shown in FIG. 28. However, just as
`the number of cuspids employed in the occluder 12.
`is the case with a natural heart valve, the cuspids 38 will
`For example, if only two‘cuspids are employed in the
`remain in a closed condition to seal off the central
`occluder, only two hinge-locating offset 74 will be pro
`passage through the occluder 12.
`vided, and these offsets will be disposed [80° from each
`In order for the heart valve assembly 10 to properly
`other=
`operate for its required life two factors are extremely
`Referring to FIGS. 2A-2C and 4, the downstream
`important. First, the occluder must have dimensional
`end of each arm 58 is provided with overlapping bent
`stability so that it will properly seat against the seating
`sections 76 and 78. These bent sections are employed
`ring 16 to prevent the leakage of blood from the ventri
`to properly position the arms 58 within a mold as plas
`cle to the atrium when the valve assembly is closed.
`tic body 34 of the occluder is molded about the arma
`Secondly, the cupids 38 must be capable \of continu
`ture construction. Moreover, these bent sections, by
`ously ?exing between their opened and closed condi
`virtue of extending transversely of the general down
`tions without malfunctioning. The improvements to
`stream direction of the arms 58, provide additional
`center-?ow occluders in accordance with this invention
`reinforcement for the downstream end of the cuspids
`accomplishes both of these objectives.
`Referring to’ FIGS. 2A~2C, 3 and 4, the occluder 12
`38.
`‘
`Referring to FIG. 6, an alternative construction is
`includes a unique reinforcing armature construction 54
`shown for the downstream end of each arm 58. Speci?
`for establishing shape stability of the occluder 12, while
`cally each arm 58 is split and bent to provide oppositely
`still permitting the cuspids 38 to properly ?ex about
`directed tabs 80 and 82, respectively. These tabs pro
`their stem sections 42. The armature construction 54
`vide‘the same function as the overlapping bent sections
`preferably is constructed of a metallic material having
`76 and 78 described in the preceding paragraph.
`greater structural stability than the material which is
`Referring to FIGS. 7-9, a second embodiment of a
`employed to form the occluder body 34.. For example,
`center-?ow occluder 12a includes separately molded,
`titanium has been employed satisfactorily in the fabri- '
`unitary cuspids 38a. Only one cuspid 38a is shown in
`cation of the armature construction 54. Preferably the
`FIG. 7 for purpose of clarity. A passage 84 is provided
`plastic body 34 of the occluder 12 is molded about the
`through each cuspid 38a, and extends in a general
`armature construction 54 so that armature construc
`downstream direction from an upper surface 86 (FIGS.
`tion is disposed within the interior of the plastic body.
`8 and 9). The cuspids 38a can be formed of the same
`The armature construction 54 includes a continuous
`plastic material as is employed to form the one-piece
`annular ring 56 disposed within the upstream annular
`plastic body 34 of the occluder 12.
`section 40 of the occluder 12 (FIGS. 2A-C). A plural
`Referring to FIG. 7, a unitary metallic armature con
`ity of arms 58 are secured to the ring 56 through hinge
`struction 34a, which has greater structural rigidity than
`sections 60; each arm extending in a downstream direc
`the plastic cuspids 38a, includes an upstream annular
`tion through the cuspids 38. The hinge connection
`section 560 and a plurality of circumferentially spaced
`between each arm 58 and the- ring 56 is extremely
`reinforcing arms 58a. Each of the arms 58a is con
`important, and is necessary in order to permit flexing of
`nected to the annular section 56a through a hinge sec
`the cuspids to take place without the possiblity of bind
`tion 60a and a radially offset section 88. Each radially
`offset section 88 provides a downwardly directed
`shoulder 90 having a function which will be described
`later.
`Each hinge section 60a is provided, in part, by cir
`cumferentially spaced, upwardly directed recesses 92
`and 94 in the upstream annular section 560. These
`upwardly directed recesses enhance the spring action
`of the hinge section 60a to enhance radial ?exure of the
`arms 58a relative to each other.
`Referring to FIG. 7, each of the reinforcing arms 58a
`includes notched side margins which provide a plurality
`of barbs 96. Each barb is provided by a side surface
`segment 98 which extends in an inclined direction
`toward the central axis of the arm in a downstream
`direction‘, and an upper, transversely extending surface
`segment 100. A plurality of cut out regions, or aper
`tures 102 are provided along the longitudinal extending
`axis of each of the arms 58a to lighten the weight of
`each arm without adversely affecting its reinforcing
`capability.
`In use each of the arms 58a is forced through the
`‘passage 84 in a respective cuspid 38a to properly retain
`the cuspids in operative position relative to each other.
`
`Referring to FIGS. 2A-2C, the cuspids 38 preferably
`are constructed with their thickest region in transverse
`alignment with the rounded apex 50. In order to prop
`erly reinforce that region so that the outer configura
`tion of each cuspid does not becomes distorted during
`use, each arm 58 includes transversely offset, inclined
`sections 64 and 66 disposed at an angle of approxi
`mately 90° to each other. These inclined sections pro:
`videv sufficient reinforcement for the cuspids 38 in their
`thickest region to prevent the outer con?guration of '
`said cuspids from becoming distorted duringuse. As
`explained earlier, distortion of the outer con?guration
`of the cuspids 38 will prevent proper conformation of
`the occluder 12 with the seating ring 16; resulting in
`undesirable leakage of blood from the ventricle into the
`atrium when the valve assembly 10 is closed.
`Referring to FIGS. 3-5‘, the hinge section 60 of each
`arm 58 is formed by a bent upstream end of the arm to
`form transversely aligned passages 68 and 70 con
`nected to each other through a clip section 72. The clip
`section ,72 can be forced outwardly over the annular
`ring 56 to provide a snap-friction fit with said ring while
`
`mg.
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`35
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`40
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`3. The elongate occluder according to claim 2,
`wherein the annular ring of the armature construction
`includes hinge-locating offset sections disposed cir
`cumferentially about said annular ring, the hinge sec
`tion‘of each reinforcing arm being connected to said
`annular ring in an offset section thereof.
`4. The elongate occluder according to claim 3,
`wherein the number of hinge-locating offset sections in
`the annular ring is equal to the number of cuspids of the
`downstream sealing section of the occluder.
`5. The elongate occluder according to claim 3,
`wherein each reinforcing arm of the armature con
`struction has a transversely bent downstream section.
`6. The elongate occluder according to claim 1,
`wherein each cuspid includes an upstream and a down
`stream ?ared section, said ?ared sections being joined
`at a rounded apex which constitutes the thickest region
`of each cuspid, the downstream reinforcing arm asso
`ciated with each cuspid having an annular offset sec
`tion intermediate its ends for enhancing the reinforce
`ment of each cuspid in the region of the apex.
`7. An elongate occluder of a prosthetic heart valve
`assembly, said occluder being adapted to be positioned
`through a seating-ring passage for movement in its
`direction of elongation between closed and opened
`positions, said occluder including an upstream annular
`section and a downstream sealing section, both of
`which have a larger maximum diameter than the mini
`mum diameter of the seating-ring passage, said down
`stream sealing section being provided by a plurality of
`cuspids which engage each other to de?ne a closed
`sealing section when the occluder is in a closed posi
`tion, each of said cuspids being joined to the upstream
`annular section through a ?exible hinge section for
`permitting outward ?exure of said cuspids when the
`occluder is in an opened position to define a central
`open passage through the occluder for the ?ow of
`blood; the improvement wherein the upper annular
`section and hinge section of the occluder are part of a
`unitary armature construction, said armature construc
`tion further including a plurality of circumferentially
`spaced arms extending in a downstream direction rela
`tive to the upper annular section, said cuspids being
`separate unitary plastic members, and each arm of the
`unitary armature construction extending into the inter
`ior of a respective cuspid for retaining said cuspids in
`their proper operative position and for reinforcing said
`cuspids.
`8. The elongate occluder according to claim 7,
`wherein the upstream end of each arm is connected to
`a respective hinge section through a radially offset
`section providing a downwardly facing shoulder engag
`ing an upstream surface of its respective cuspid for
`achieving the proper positioning of the cuspids relative
`to each other.
`9. The occluder according to claim 7, wherein each
`arm includes a plurality of outwardly directed barbs
`provided at each side margin thereof, said barbs ?rmly
`engaging internal surfaces of each cuspid for retaining
`said cuspids in proper position relative toeach other.
`i
`* ‘I!
`* ill
`
`7
`The inclined surface segments 98 of the side margins of
`each arm 58a permits easy insertion of the arms into
`the passages 84 of respective cuspids 38a. The arms
`58a are suf?ciently ?exible to follow the con?guration
`of passages 84 (FIG. 9). The barbed construction of the
`side margins of each arm 58a functions in a manner
`similar to a fish hook, and resists the withdrawal of the
`arms from the cuspids. The arms 58a are inserted into
`the passages 84 of the cuspids 38a until the down
`wardly directed shoulder 90 adjacent the upstream end
`of each arm 58a engages the upper surface 86 of its
`respective cuspid (FIG. 9). In this manner the down
`wardly directed shoulder 90 functions to properly posi
`tion each of the cuspids relative to each other.
`In the embodiment shown in FIGS. 7-9, the upstream
`annular section of the occluder 12a is provided by the
`upstream annular section 56a of the armature con
`struction, and the stem section of the occluder 12a is
`provided by the hinge section 60a of the armature
`construction.
`Having described my invention, I claim:
`1. An elongate occluder of a prosthetic heart valve
`assembly, said occluder being adapted to be positioned
`through a seating-ring passage for movement in its
`direction of elongation between closed and opened
`positions, said occluder including a unitary plastic body
`having an upstream annular section and a downstream
`sealing section, both of which have a larger maximum
`diameter than the minimum diameter of the seating
`30
`ring passage, said upstream annular section being
`adapted to engage a surface de?ning the seating-ring
`passage when the occluder is in an opened position and
`the downstream sealing section being adapted to en
`gage a surface de?ning the seating-ring passage when
`the occluder is in its closed position, said downstream
`sealing section being provided by a plurality of cuspids
`which engage each other to de?ne a closed sealing
`section when the occluder is in a closed position, a
`?exible stern section interconnecting the upstream
`annular section of the unitary plastic body with each of
`the cuspids for pennitting outward ?exture of said
`cuspids when the occluder is in an opened position to
`de?ne a central open passage through the occluder for
`the ?ow of blood; the improvement comprising an
`armature construction disposed within the unitary plas
`tic body for reinforcing said body, said armature con
`struction including an annular ring disposed within the
`upstream annular section of the plastic body, and a
`reinforcing arm extending in a downstream direction
`through each ?exible stem and its associated cuspid,
`each reinforcing arm including a hinge section adjacent
`its upstream end end and connected to the annular ring
`to permit ?exure of each arm relative to said annular’
`ring.
`2. The elongate occluder according to claim 1,
`wherein the hinge section of each arm includes a bent
`upstream end of the arm providing transversely aligned
`passageways disposed in frictional engagement with the
`annular ring.
`
`60
`
`65
`
`NORRED EXHIBIT 2213 - Page 7