United States Patent
`Ionescu et al.
`[45] Apr. 18, 1978
`
`
`
`Construction” by Ivan T. Bartek et al., Thorax, (1974),
`29, pp. 51-55.
`-
`“Heart Valve Replacement With Autologous Fascia
`Lata Using the Ionescu Technique” by A. S. Trimble et
`al., The Journal of Thoracic & Cardiovascular Surgery,
`vol. 61, No. 3, Mar. 1971, pp. 385-392.
`“Heart—Va1ve Replacement With Autologous Fascia
`Lata,” by M. I. Ionescu, The Lancet, Aug. 6, 1969, pp.
`335-338.
`
`Primary Examiner—Ronald L. Frinks
`Attorney, Agent, or Firm——Knobbe, Martens, Olson,
`Hubbard & Bear
`
`[57]
`
`ABSTRACI‘
`
`A tissue heart valve has a cloth-covered stent which
`provides several layers of padding over the stent edges
`and an integral sewing ring while maximizing the inter-
`nal valve diameter for a given size heart annulus. No
`edges of the cloth are exposed. A continuation of the
`pledget covers all knots of the stitches connecting the
`tissue to the stent.
`
`[54] PROSTHETIC TISSUE HEART VALVE
`
`[75]
`
`Inventors: Marian I. Ionescu, Leeds, England;
`Bruce E. Fettel, Diamond Bar, Calif‘.
`
`[73] Assignee:
`
`Shiley Laboratories, Incorporated,
`Santa Ana, Calif.
`
`[21] Appl. No.: 679,406
`
`[22] Filed:
`
`Apr. 22, 1976
`
`Int. C13 .............................................. .. A6113‘ 1/22
`[51]
`
`[52] U.S. Cl.
`. . . . . . . . . . . . . . . .
`. . . . . .. . . ... 3/1.5
`[58] Field of Search ....................................... .. 3/ 1.5, 1
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`Edwards ................................... 3/1.5
`2/1973
`9/1973 Hancock ......................... .. 3/ 1.5
`10/1976 Angell et al.
`3/1.5
`12/1976 Kaster ....................
`3/ 1.5
`
`
`
`3,714,671
`3,755,823
`3,983,581
`3,996,623
`
`FOREIGN PATENT DOCUMENTS
`
`1,264,472
`
`2/1972 United Kingdom ..................... 3/1.5
`
`OTHER PUBLICATIONS
`
`“Frame—Mounted Tissue Heart Valves: Technique of
`
`14 Claims, 9 Drawing Figures
`
`I34
`
`24
`
`12
`
`IO
`
`I34
`
`16
`
`24
`
`(cid:47)(cid:48)(cid:51)(cid:51)(cid:38)(cid:37)(cid:1)(cid:38)(cid:57)(cid:41)(cid:42)(cid:35)(cid:42)(cid:53)(cid:1)(cid:19)(cid:18)01 -(cid:1)(cid:49)(cid:66)(cid:72)(cid:70)(cid:1)(cid:18)
`(cid:46)(cid:70)(cid:69)(cid:85)(cid:83)(cid:80)(cid:79)(cid:74)(cid:68)(cid:13)(cid:1)(cid:42)(cid:79)(cid:68)(cid:15)(cid:13)(cid:1)(cid:46)(cid:70)(cid:69)(cid:85)(cid:83)(cid:80)(cid:79)(cid:74)(cid:68)(cid:1)(cid:55)(cid:66)(cid:84)(cid:68)(cid:86)(cid:77)(cid:66)(cid:83)(cid:13)(cid:1)(cid:42)(cid:79)(cid:68)(cid:15)(cid:13)
`(cid:7)(cid:1)(cid:46)(cid:70)(cid:69)(cid:85)(cid:83)(cid:80)(cid:79)(cid:74)(cid:68)(cid:1)(cid:36)(cid:80)(cid:83)(cid:70)(cid:87)(cid:66)(cid:77)(cid:87)(cid:70)(cid:13)(cid:1)(cid:45)(cid:45)(cid:36)
`(cid:87)(cid:15)(cid:1)(cid:53)(cid:83)(cid:80)(cid:90)(cid:1)(cid:51)(cid:15)(cid:1)(cid:47)(cid:80)(cid:83)(cid:83)(cid:70)(cid:69)(cid:13)(cid:1)(cid:46)(cid:15)(cid:37)(cid:15)
`(cid:36)(cid:66)(cid:84)(cid:70)(cid:1)(cid:42)(cid:49)(cid:51)(cid:19)(cid:17)(cid:18)(cid:21)(cid:14)(cid:17)(cid:17)(cid:18)(cid:18)(cid:17)
`
`
`
`[19]
`
`[11]
`
`4,084,268’
`
`

`
`US. Patent
`
`April 18, 1978
`
`Sheet 1 of 3
`
`4,084,268
`
`FIG. 1.
`
`FIG.2.
`
`FIG.3.
`
`NORRED EXHIBIT 2101 - Page 2
`
`

`
`U.S. Patent
`
`April 18, 1978 Sheet2of3
`
`4,084,268
`
`FIG.5.
`
`FIG.6.
`
`NORRED EXHIBIT 2101 - Page 3
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`

`
`US. Patent
`
`Apri118, 1978
`
`Sheet3 of3
`
`4,084,268
`
`FIG. 9.
`
`3
`7
`
`m
`i
`
`E
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`NORRED EXHIBIT 2101 - Page 4
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`

`
`1
`
`4,084,268
`
`PROSTHETIC TISSUE HEART VALVE
`BACKGROUND
`This invention relates to frame mounted, prosthetic
`tissue heart valves, and particularly to improvements in
`the construction of such valves.
`Frame-mounted fascia lata heart valves were used
`clinically by Dr. Marian I. Ionescu and Dr. D. N. Ross
`in 1969. Since that time hundreds of tissue valves made
`of autologous or homologous fascia lata, dura mater, or
`of heterologous pericardium have been implanted. A
`construction of bovine pericardial valves is reported in
`Frame-mounted Tissue Heart Valves: Technique of Con
`struction, Bartels, Holden and Ionescu, Thorax (1974)
`29, 51. As reported in that article, an important factor
`on which the long-term function of these valves de~
`pends is their construction before insertion. This inven
`tion is an improved construction over that described in
`the cited article.
`
`10
`
`20
`
`25
`
`SUMMARY OF INVENTION
`This invention is directed to an improved construc
`tion principally in the cloth covering for the valve
`frame or stent by which raw fabric or tissue edges are
`not exposed to the blood stream, particularly at the
`valve inlet, added protection is obtained against the
`frame or stitches tearing through the covering cloth,
`risk of the sewing ring separating from the valve is
`eliminated, the stitches attaching the tissue to the stent
`are covered by cloth, and the thickness of material at
`the annulus is reduced to increase the ratio of valve
`internal diameter to external valve diameter, and there
`fore to internal diameter of the heart annulus receiving
`the valve.
`Accordingly, this invention provides a prosthetic
`tissue heart valve in which a continuation of the pledget
`covers the knots of the threads used to stitch the tissue
`to the stent. This invention also provides a construction
`wherein the interior fabric cover is integral with the
`sewing ring or cuff. Further in accordance with this
`invention several layers of padding are provided along
`the edges of the stent where tearing is most likely and
`cushioning is desirable, yet only three layers of cloth
`add to the thickness of the stent at the bottom portion
`which ?ts in the heart annulus. Moreover, this invention
`provides a novel construction wherein no edges of the
`cloth fabric covering the stent are exposed to the blood
`stream.
`
`45
`
`50
`
`55
`
`DESCRIPTION OF DRAWINGS
`FIG. 1 is a perspective view of a completed valve;
`FIG. 2 is a perspective view of the same completed
`valve inverted;
`FIG. 3 is a perspective view of the stent covered with
`cloth and ready to receive the tissue, with the sewing
`ring turned down to show certain construction details;
`FIG. 4 is an exploded perspective view of the ele
`ments used in constructing the cloth covered stent;
`FIG. 5 is a perspective view of the tissue ready to be
`placed on the cloth covered stent of FIG. 3;
`FIG. 6 is a perspective view, partially in section, of
`the valve with portions removed;
`FIG. 7 is a perspective view, partially in section, of a
`portion of a partially assembled valve;
`FIG. 8 is a perspective view, partially in section, of a
`portion of a partially completed valve; and
`
`65
`
`2
`FIG. 9 is a sectional view, through the valve at a post
`of a completed valve.
`Referring to FIG. 4, the valve includes a thin-walled
`stent 2 having an annular base 4 and three equally
`spaced upright posts 6 with scalloped upper edges 8 on
`the stent between posts 6. Throughout this application
`the term upper will be used for convenience to refer to
`the out?ow end of the valve and lower will be used to
`refer to the inflow side, recognizing that the valve may
`not be upright where installed. Also, the term upper
`edge of the stent is used to include the side edges of the
`posts 6. Referring now to FIG. 1 the stent supports a
`tissue valve element 10 which surrounds the stent and
`has three cusps l2, l4, and 16 meeting along their upper
`edge portions in the closed position. The cusps are free
`to separate when the pressure below the valve exceeds
`that above to pass blood through the valve in a known
`manner. The flow of blood is from bottom to top in
`FIG. 1 along the axis 23 of the valve. Applicants refer
`to the article cited above in the application for a more
`complete description of the tissue and its assembly and
`operation.
`A pledget and cover 24 extends down the outside of
`the tissue at each post, and a sewing ring or cuff 26 is
`provided for grafting the prosthetic valve into the heart
`valve annulus using well known surgical procedures.
`Referring again to FIG. 4, the stent may be con
`structed of any of the known materials, suitable for
`cloth covered prosthetic heart valves, titanium or nick
`el-cobalt alloy or Teflon or Delvon plastic being among
`the alternatives available. Its bottom edge 28 preferably
`is slightly scalloped having its high points 30 beneath
`the posts 6. Each post 6 has sewing holes, 32, 34, and 36
`three in the illustrated embodiment, spaced vertically
`near its upper end. Additional sewing holes 38, and 40
`are spaced around the circumference of the base. In the
`illustrated embodiment the base 4 has one sewing hole
`38 at the base of each post and ?ve 40 between adjacent
`posts, but that number can be varied, as can the number
`on the posts.
`The cloth covering preferably is of Dacron velour
`and includes an inner sleeve 42, a three piece outer
`sleeve 44, and three interior post sewing pads 46. The
`inner sleeve originally is of a cylindrical shape with
`scallops 48 removed as shown in FIG. 4, corresponding
`generally with the scallops 8 on the upper edge of the
`stent. The outside diameter of the inner sleeve is about
`the same as the inside diameter of the stent base 4. The
`outer sleeve pieces 44 can advantageously be cut from a
`cylinder of cloth to the shape shown, such that each has
`a post portion 50 with a rounded top 52 and two scal
`loped side edges 54, 56 and a base portion 58 with
`straight side edges 60, 62. The interior post pads 46 are
`each a short length of fabric of the same width as the
`posts 6 and having a rounded top 64.
`Referring to FIGS. 8 and 9, three outer sleeve pieces
`44 are each located on the outside of a respective stent
`post 6 and folded over the scalloped edges 8 and top of
`the stent post terminating at 78 ?ush with the inside
`surface of the stent. The three outer cloth pieces 44 do
`not cover the outside of the stent base 4 between the
`regions of the posts 6 as is evident from the spaces
`shown in FIG. 4, but extend to the seams 96 shown in
`FIG. 3. As best shown in FIG. 9, the bottom edge 66 of
`each outer sleeve piece is folded over the bottom edge
`28 of the stent and then folded back at 70 to form a two
`layer 72, 74 pad at the bottom edge 28 and terminates at
`66 about flush with the outer surface of the stent.
`
`NORRED EXHIBIT 2101 - Page 5
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`

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`NORRED EXHIBIT 2101 - Page 6
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`

`
`4,084,268
`5
`the valve thickness. All of this as well as the other fea
`tures expressed or inherent from the above discussion
`provide an improved valve construction well suited for
`commercial production.
`What is claimed is:
`1. A prosthetic heart valve comprising:
`a stent having an annular base and upright posts;
`tissue valve means circumscribing said stent posts;
`thread extending through said tissue stitching said
`tissue to said posts, said thread being twisted into
`knots outside the tissue;
`a ?rst layer of fabric extending along each said post
`outside said tissue;
`said thread also stitching said ?rst layer to said posts;
`a second layer of fabric covering said knots which are
`located between said ?rst and second layers; and
`said ?rst and second layers of fabric being a narrow
`pledget strip which is integral and continuous and
`folded back on itself over the knots.
`2. A prosthetic heart valve in accordance with claim
`1 and further comprising:
`cloth fabric covering said post between said post and
`said tissue.
`3. A prosthetic heart valve in accordance with claim
`1 wherein:
`said tissue is formed generally in a cylindrical shape
`circumscribing the posts of said stent as a group
`and is tacked around each individual post to form
`cusps for closing the valve passage.
`4. A cloth covered stent for a prosthetic heart valve
`comprising:
`a stent having an annular base and plural upright
`posts;
`cloth fabric covering the interior surface of said stent;
`cloth fabric covering the exterior surface of said
`stent;
`a cylindrical tissue valve circumscribing said stent
`posts and said exterior cloth fabric;
`said interior fabric being tightly wrapped around the
`bottom edge of said stent covering the bottom edge
`of said exterior fabric, and preventing loose cloth at
`the bottom edge.
`5. A cloth covered stent in accordance with claim 4
`and further comprising:
`said interior fabric where wrapped around the bot
`tom edge of said stent extending over the bottom
`edge of said tissue valve to cover said edge, and
`forming an integral annular sewing ring for graft
`ing the stent onto a heart annulus.
`6. A stent in accordance with claim 5 and said sewing
`ring further comprising:
`an annular fabric pad circumscribing the stent base;
`said interior fabric extending from its wrap around
`the bottom edge of the stent to wrap around the
`fabric pad and terminating in an edge adjacent said
`pad entirely covered by a layer of its own fabric.
`7. A stent in accordance with claim 4 wherein:
`said bottom edge of the exterior fabric is doubled
`over the bottom edge of the stent to form two
`60
`layers of cloth cover tight against said bottom edge
`in addition to the layer of the covering interior
`fabric.
`8. A stent in accordance with claim 4 wherein:
`said interior and exterior fabrics are folded tightly
`over the top edge of said stent to form three layers
`of cloth covering over said edge.
`9. A stent in accordance with claim 8 wherein:
`
`65
`
`1O
`
`25
`
`30
`
`.35
`
`45
`
`50
`
`55
`
`6
`said fabric is folded over the outer surface of the stent
`adjacent its top edge to formthree layers of cloth
`on said outer surface adjacent the top edge.
`10. A stent in accordance with claim 4 wherein:
`at least partway around the stent the interior and
`exterior fabric are integral.
`-
`.v
`I"
`11. A stent in accordance with claim 4 wherein:
`said fabric is folded around the posts of said stent to
`form three layers of fabric on the outside of each
`
`post.
`
`>
`
`~
`
`12. A stent in accordance with claim 4 and further
`
`comprising:
`
`_
`
`_
`
`.
`
`r
`
`a second layer of fabric on the interior of said posts.
`13. A cloth covered stent for a prosthetic heart valve
`comprising:
`,
`a thin-walled stent having an annular base and plural
`upright posts, said stent having upper and lower
`edges;
`a layer of cloth fabric covering the exterior surface of
`said stent;
`a cylindrical tissue valve circumscribing said stent
`and said exterior fabric;
`a layer of cloth fabric covering the interior surface of
`said stent;
`three layers of cloth fabric tightly wrapped over and
`covering the upper edge of said stent;
`three layers of cloth fabric tightly wrapped over and
`covering the lower edge of said stent;
`the bottom portion of the stent base which ?ts in the
`heart annulus having only one layer of cloth cover
`ing the interior and only two layers covering the
`exterior; and
`said fabric having no edges exposed.
`14. A prosthetic heart valve comprising:
`a thin-walled, rigid stent having an annular base and
`three equally spaced upright posts extending axi
`ally from said base;
`the upper edge of said stent being scalloped in a
`smooth curve between said posts;
`the bottom edge of said stent being scalloped with the
`high points on the scallops beneath the respective
`posts;
`said stent base having a plurality of holes there
`through spaced around its circumference;
`each said stent post having a plurality of holes there
`through spaced along its length;
`three pieces of exterior Dacron velour fabric each
`covering the exterior of a post and of the base
`adjacent the post;
`each of said three pieces of exterior fabric being
`wrapped over the upper edge of the stent in a single
`layer and being folded over the bottom edge of the
`stent in a double layer;
`an interior Dacron velour fabric covering the interior
`surface of the stent;
`said interior fabric being folded over the top edge of
`the stent in a double layer where covered by the
`interior fabric;
`said interior fabric being folded over the top edge of
`the stent in a triple layer and also extending down
`to cover the exterior surface of the stent base
`where not covered by the exterior fabric and termi
`nating in a double fold over the bottom edge of the
`stent base;
`the portion of the interior fabric folded over the
`upper edge of the stent also providing second and
`third layers of fabric on the exterior of the stent
`posts over the holes through the posts and along
`
`NORRED EXHIBIT 2101 - Page 7
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`

`
`4,084,268
`7
`the outer surface of the stent adjacent its upper
`edge;
`'
`, a fabric sewing pad between the interior surface of
`each post at the holes through the post and interior
`fabric;
`a generally cylindrical, valve element of bovine peri»
`cardium tissue circumscribing the stent and fabric
`cover;
`' stitches tacking the tissue around each, post causing
`' the tissue normally to close in three cusps;
`a Te?on fabric piedget strip outside the tissue at each .
`'post, each said pledget strip including a?rst layer
`adjacent said tissue and a second layer outside ?rst
`‘layer, said layers being integrally formed by a fold
`at the upper end and being stitched together along
`their long edges;
`
`8
`thread stitches attaching said tissue to said stent ‘
`through the holes therethrough, allof said thread
`stitches being knotted between the two layers of,
`said pledget;
`I
`the bottom of said interior fabric ‘being, wrapped over
`said double layer of fabric on‘ the bottom edge, of ,
`the stent and extending outward and?upward to
`form an integral sewing ring;
`the sewing ring having an annular three layered‘ pad
`of Teflon fabrie'covered by two layers‘of the'inte-r
`rior fabric on the underside and a single layer on
`the upper side, the edge of said inner fabric being '
`on the inner layer of the two underside layers and!
`covered‘ by the outer layer‘of said twolayers; and
`said sewing ring being sewn to said tissue and cover
`ing the bottom edges of the pledget.
`* * a:
`s s
`
`20
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`25
`
`35
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`45
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`50
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`55
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`60
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`65
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`NORRED EXHIBIT 2101 - Page 8