3.365.728
`M. L. EDWARDS ETAL
`UPHOLSTBRED HEART VALVE HAVING A SEALING RING
`v
`ADAPTED FOR DISPENSING MBDICAHBNTS
`Filed Dec. 18. 1964
`
`INV EN TORS
`MILES LOWELL EDWARDS
`By
`ALBERT sum:
`
`,4 Home]
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`Edwards Lifesciences Corporation, et al. Exhibit 1111, Page 1 of 4
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`turn red at
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`3,365,728
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`Patented Jan. 30, 1968
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`1
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`3,365,728
`UPH-OLSTERED HEART VALVE HAVING A
`SEALING RING ADAPTED FOR DISPENS
`ENG MEDICAMENTS
`Miles Lowell Edwards, Santa Ana, Calif" and Albert
`Starr, Portland, 0reg., assignors to Edwards Lab
`oratories, Inc., Santa Ana, Calif” a corporation of
`' California
`
`Filed Dec. 18, 1964, Ser. No. 419,526
`11 Claims. (Cl. 3-1)
`
`10
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`.
`In the drawing:
`FIGURE 1 is a perspective view ofan atrioventricular
`valve prosthesis embodying the features of- the invention;
`FIGURE 2 is a perspective view from a different angle
`with the ball removed;
`_
`FIGURE 3 is an enlarged view on the line 3—3 of
`FIGURE 1; and
`FIGURE 4 is an enlarged perspective view of the cloth
`sleeve used for the sewing ring.
`-
`The valve comprises, essentially, three parts, these be
`ing a valve ring 10, a movable valve member 11 and a
`suturable sewing ring 12. The valve ring 10 is preferably
`made of a strong and inert metal such as Stellite which is
`non-corrodable and has a minimum foreign body reaction
`with the blood. This ring is preferably cast and includes
`as ‘an integral part thereof a cage 13. The movable valve
`member 11 preferably comprises a silicone rubber ball
`which is con?ned in the cage 13 and adapted to seat .
`against an annular seating surface 14 in the ring 10. The
`ring 10 is shaped to provide an outwardly facing channel
`15 extending around the ring.
`The sewing ring 12 is formed in part of the cloth sleeve
`20 shown in FIGURE 4. The material of the sleeve is
`preferably knitted from a synthetic ?ber such as Te?on
`so as to be freely stretchable. One edge is inturned to form
`a hem 21. This hemmed edge portion includes a double
`draw string 22 having free ends 23 available on the out
`side of the sleeve for tightening the draw string. An in- .
`termediate portion of the sleeve is equipped with a double
`draw string 24 having free ends 25 available on the in
`side of the sleeve for tightening this draw string. In the
`opposite edge of the sleeve there is a double draw string
`26 having free ends 27 available on the outside of the
`sleeve.
`In constructing the sewing ring the sleeve 20 is first
`applied over the channel 15 with the hemmed edge 21
`overlying the cage 13 and the opposite edge extending
`beyond the left side of ring 10 in FIGURE 3. The sleeve
`is positioned so that draw string 24 overlies the channel
`15. Then the draw string 24 is tightened and its ends are
`tied. This holds the sleeve in position for the next oper4
`ation.
`A channel-shaped spreader ring 30 is then applied over
`the cloth in the channel 15. This ring is preferably made‘v
`of a suitable inert plastic such as Te?on and contains a
`diagonal split so that the ring may be applied to the chan
`nel and constricted on the cloth 20. The spreader ring is
`clamped tightly against the cloth by one or more wind
`ings of Te?on thread 31.
`_
`The valve is then ready for placement of the ?anged
`cushion ring 35. This ring is preferably molded from sili
`cone foam rubber with an L-shaped cross section having
`an outstanding radial ?ange or leg 36 and a shorter axially
`directed ?ange or leg 37. Axial flange‘ 37 is seated on they
`winding 31 and on the opposite edge portions of spreader
`ring 30 as shown.
`'
`The left end of sleeve 20 is folded over the ?ange 36
`and also over the ?ange 37, as shown. This end of the
`sleeve is secured by tightening draw string 26 and tying
`the ends. Then the hemmed edge 21 is folded over the
`flange 37 on top of the ?rst layer of cloth and the draw
`
`ABSTRACT OF THE DISCLOSURE
`A prosthesis such as a heart valve having an uphol
`stered cushion ring to accommodate and seal against ir
`regularities in the bed of tissue in which the prosthesis is
`implanted. The cushion ring is suturable and is secured to
`the prosthesis by being enfolded in a cloth sleeve con
`nected with the prosthesis. The cushion ring may be made
`of silicone foam rubber capable of absorbing and gradu
`ally exuding a medicament such as an anticoagulant or
`antibiotic.
`
`This invention relates to improvements in a heart valve
`prosthesis.
`Objects of the invention are to provide features that
`promote healing after implantation, to provide an im
`proved sewing or suture ring for attaching the valve to
`living tissue, to provide a ‘better seal between the valve
`and the natural ori?ce in which it is implanted, to pro
`vide an upholstered cushion element in the sewing ring
`which will readily adjust itself to an irregular contour of
`the natural ori?ce, to provide a valve having an effective
`- vehicle for medicament such as anticoagulant drugs or
`antibiotics and to provide the foregoing features for pros
`theses other than heart valves.
`The present valve comprises a valve ring or body hav
`' ing a movable valve member. Connected to the periphery
`of the valve ring is a suturable sewing ring by which the
`valve may be connected by sutures with living tissue
`around the natural ori?ce ir which the valve is implanted.
`The sewing ring is upholstered with a ring of compressible
`cushion material which will conform to irregularities in
`the bed in which the valve is placed whereby a good seal
`is established and leakage between the valve and the tissue ,
`is prevented'T-his upholstery ring may be made of a ma
`terial which may be utilized as a vehicle for medicament
`such as anticoagulant drugs or antibiotics. An atrioven
`tricular valve is illustrated by way of example, for use in
`either the mitral or tricuspid positions, but important fea
`tures of the invention are also applicable to valves for
`other positions in the heart, such as the aortic valve. The
`general features of the upholstery ring are also useful in
`prostheses other than heart valves.
`The invention will be better understood and the fore
`going and other objects and advantages will become ap
`parent from the following description of the preferred
`embodiment illustrated on the drawing. Various changes
`may be made, however, in details of construction and ar
`rangement of parts and certain features may be used
`without others. All such modi?cations within the scope
`of the appended claims are included in the invention.
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`Edwards Lifesciences Corporation, et al. Exhibit 1111, Page 2 of 4
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`3,365,728
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`string 22 is tightened and tied. After the hemmed edge
`in said channel, a pre'shaped ring of coherent, suturable
`21 is folded over, the knot in draw string 22 will be on
`cushion material of L-shaped crosssection having one leg
`the under side of this hem so that the knot may be tucked
`of the L seated on said securing means and the other leg
`under and covered by the hem. Finally, the extreme edge
`in outstanding position, the end portions of said sleeve
`of the hem is secured to the underlying layer of cloth by
`being folded over said cushion ring and over each other
`stitching 48 in the corner between ?anges 36 and‘37 and
`in overlapping relation on said seated leg, circumferential
`the cloth is pressed to make it ‘lie smoothly on the cushion
`draw strings in said overlapped portions of said sleeve,
`ring 35. The draw strings and stitching 40 are preferably
`and stitching securing said overlapped portions to each
`made of Te?on thread.
`other.
`in the implantation of the valve in mitral positior, the
`2. An upholstered heart valve comprising a valve ring
`radial flange 36 is sutured to the annulus of the natural
`having a movable valve member, an outwardly facing
`ori?ce and to the atrium side. The rubber cushion ring 35
`channel around said ring, a cloth sleeve having a plu
`rality of draw strings, one of said draw strings being
`conforms to any irregularities of tissue contour which may
`tightened in said channel, means clamping a portion of
`exist because of disease or other causes and forms an ef
`fective seal against the tissue. The layer of cloth 20 over
`said sleeve in said channel, a pro-shaped suturing and scal
`lying the flange 36 provides an effective medium for the
`ing ring of coherent, suturable cushion material enclosed
`ingrowth of tissue over the whole surface of the sewing
`in another portion of said sleeve, and a draw string in
`ring so that, upon healing, the sewing ring becomes per
`said other portion holding said cushion ring to said valve
`ring.
`manently connected with the tissue in addition to, and
`independently of, ‘the applied sutures. Both the cloth 20
`3. A ?anged atrioventricular valve comprising a valve
`cushion ring 35 are capable of expansion and con
`ring having a movable valve member, an outwardly fac
`ing channel around said ring, a cloth sleeve having draw
`traction. and distortion in any direction, with natural
`movements of the supporting tissue during pulsations of
`strings in its end and intermediate portions, said inter
`the heart so that there is no tendency for the sewing ring
`mediate draw string being tightened in said channel, means
`to pull loose from the supporting tissue.
`clamping said intermediate portion of said sleeve in said
`The silicone rubber of the cushion ring 35 provides a
`channel, a pre-shaped ring of coherent, suturable cushion
`vehicle for a medicament. The major problems in valve
`material surrounding said clamping means, said cushion
`implantation are blood clotting and infection. Silicone
`ring having a radial flange and an axial ?ange, one end
`rubber has the capacity to absorb an anticoagulant drug,
`of said sleeve being folded over said cushion ring and
`secured on said axial ?ange by one of said end draw
`such as heparin. or a suitable antibiotic, and exude the
`drug slowly over a relatively long period of time While
`strings, the other end of said sleeve being folded over said
`healing is in progressv "thus. the cushion ring supplies the
`axial ?ange and secured by the other end draw string,
`medicament directly at the point where it is needed. All
`and stitches securing said two sleeve ends together in
`of the ivelbknown anticoagulants and antibiotics which
`the corner between said two ?anges.
`4. An upholstered heart valve comprising a valve ring
`are commonly used in heart operations are absorbable
`having a movable valve member, said valve ring having
`in and cxudnblc from silicone rubber. The two types of
`drugs may he used together in ring 35, if desired.
`an outwardly facing channel therearound, a cloth sleeve
`This characteristic of silicone rubber is inherent in the
`having a portion secured in said channel, a pre-shaped
`ring of coherent, suturable cushion material extending
`mturc of the matcri :l and does not depend upon a sponge
`like porosity to hold the medicament in openings of
`outside of said channel, an annular fold of said sleeve
`enclosing said cushion ring and securing said cushion
`visible size. The medicament is retained in the body of
`the rubber and not in the openings resulting from its
`ring to said Valve ring, and circumferential draw strings
`foamy texture. Preferably, such openings are closed and
`in the portion of said sleeve secured in said channel and
`in said folded portions of said sleeve.
`sealed on the surfaces of the ring by a surface ?lm of the
`rubber. In ‘this way the rubber cushion element may
`5. An upholstered heart valve comprising a valve ring
`function effectively as a seal against the leakage of blood
`having a movable valve member, a cloth having a portion
`and still hold the desired medicament by absorption. How
`secured around the periphery of said ring and having an
`ever, the rubber may have a somewhat open pore sponge
`outstanding annular fold extending around said periph
`like texture, if desired, and still function effectively as a
`cry, and a pre-shaped ?ller ring of coherent, suturable
`seal. This type of texture will accommodate ingrowth of
`cushion material seated substantially against said valve
`tissue throughout the body of the ring. The described
`ring and ?lling said fold of cloth, said cushion ring impart
`scaled surface of the present ring is punctured in many
`ing shape and body to said fold of cloth but being resilient
`places by sutures in implantation, which affords adequate
`and compressible to accommodate and seal against irreg
`opportunity for ingrowth.
`ularities of the bed of tissue in which the valve is placed.
`The cloth itself is not capable of holding such a medica
`6. A heart valve as de?ned in claim 5, said cushion
`ring being made of a molded material.
`ient for slow release over a long period of time; If the
`medicament were to be absorbed into the cloth, it would
`7. A heart valve as de?ned in claim 6, said molded
`material being foam rubber.
`be quickly washed away into the blood stream and be
`come entirely ineffective long before the need for the
`8. A heart valve as de?ned in claim 5, said valve ring
`medicament ceases to exist. For this reason the cloth is
`having a peripheral channel therearound, and means sc
`not impregnated with medicament.
`curing said portion of said cloth in said channel.
`The silicone rubber ball 11 may also be employed as
`9. A heart valve as de?ned in claim 8, said securing
`a dispenser for absorbed medicament, if desired.
`means comprising a winding of ?lamentary material.
`By making suitable changes in the structural details,
`10. A heart valve as de?ned in claim 5, said cloth
`the principal features of the present construction may be
`comprising a sleeve.
`embodied in valves for other positions such as the aortic
`11. A heart valve as de?ned in claim 10, said sleeve
`and in prostheses other than heart valves.
`containing circumferential draw strings.
`Having now described our invention and in what man
`ner the same may be used, what we claim as new and
`desire to protect by Letters Patent is:
`1. An upholstered heart valve comprising a valve ring
`hiding a movable valve member, said valve ring having
`an outwardly facing channel thcrearound, a cloth sleeve,
`gncans securing an intermediate portion of said sleeve
`
`References Cited
`UNITED STATES PATENTS
`
`3,093,831
`3,099,016
`
`6/1963 Jordan _______________ __ 3—-—1
`7/1963 Edwards ____________ __-.. 3--l
`
`(Other references on following page)
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`10
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`20
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`40
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`G U
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`70
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`3,365,728
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`“Sutureless Aortic and Mitral Prosthetic Valves,”
`George J. Magovern et al., Journal of Thoracic ‘and Cardi- ,
`ovascular Surgery, vol. 48, No. 3, September 1964, pp.
`346-361.
`“A Hinged-Lea?et Valve for Total Replacement of the
`Human Aortic Valve” by Vincent Goff et al., Journal of
`Thoracic and Cardiovascular Surgery, vol. 48, No. 5,
`November 1964, pp. 713-725.
`
`‘
`
`5
`UNITED STATES PATENTS
`3,279,996 10/1966 Long et al. ________ __ 167--82
`3,263,239
`8/1966 Edwards et a1 __________ __ 3-1
`OTHER REFERENCES
`“Prosthetic Replacement of the Mitral Valve,” Lancet,
`Nov. 24, 1962, p. 1087.
`“Evolution of Aortic Valvular Prothesis” by Earle B.
`Kay et al., Journal of Thoracic and Cardiovascular Sur
`gery, March 1963, pp. 372-381, vol. 45, N0. 3.
`“Evolution of Two Prostheses for Total Replacement of
`the Mitral Valve,” Frederick S. Cross et al., Journal of
`Thoracic and Cardiovascular Surgery, December 1963, pp.
`719-725, vol. 46, No. 3.
`
`10
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`RICHARD A. GAUDET, Primary Examiner.
`R. L. FRINKS, Assistant Examiner.
`‘
`
`1."
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`Edwards Lifesciences Corporation, et al. Exhibit 1111, Page 4 of 4
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