(12)
`
`United States Patent
`DiMatteo et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,440,164 B1
`Aug. 27, 2002
`
`US006440164B1
`
`(54) IMPLANTABLE PROSTHETIC VALVE
`
`(75) Inventors: Kristian DiMatteo, WatertoWn; Peter
`Marshal] Newburyport both of MA
`(Us)
`’
`’
`
`.
`_
`.
`.
`.
`(73) Asslgnee' Sclmed Llfe Systems’ Inc" Muck’ MA
`(Us)
`
`1/1999 Bessler et al.
`5,855,601 A
`1/1999 Angell
`5,855,602 A
`1/1999 Naughton ct a1~
`5,863,531 A
`5,954,766 A * 9/1999 Zadno-AZiZi et al. .... .. 623/1.24
`5,957,949 A
`9/1999 Leonhardt et 81.
`6,015,431 A * 1/2000 Thornton et al. ........ .. 623/1.24
`
`6,027,525 A * 2/2000 Suh et al. ................ .. 623/124
`6,110,201 A * 8/2000 Quijano et a1. ............ .. 623/21
`6,126,686 A 10/2000 Badylak e161.
`
`6,254,564 B1 * 7/2001 Wilk e161. ................... .. 604/9
`
`EP
`EP
`FR
`SU
`W0
`W0
`
`FOREIGN PATENT DOCUMENTS
`0 520 126 A1 12/1992
`0 850 607 A1
`7/1998
`2 788 217
`7/2000
`1371701211
`* 3/1986
`WO 94/04099
`3/1994
`WO 98/3240‘)
`7/1998
`
`............... .. 623/21
`
`* Cited by examiner
`
`Primary Examiner—David H. Willse
`Assistant Examiner—SuZette J. Jackson
`(74) Attorney, Agent, or Firm—Hoffmann & Baron, LLP
`
`( * ) Notice:
`
`_
`
`_
`
`_
`
`_
`
`_
`
`SubJect to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U'S'C' 154(k)) by 0 days‘
`
`(21) Appl. No.: 09/425,142
`.
`Oct- 21’ 1999
`(22) Flled:
`(51) Int. c1.7 ............................. .. A61F 2/06; A61F 2/04
`
`(52) US. Cl. .................................... .. 623/124; 623/218
`(58) Field of Search ............................. .. 623/124, 1.25,
`623/126, 2.16, 2.17, 2.18; 604/9
`
`(56)
`
`References Cited
`
`US. PATENT DOCUMENTS
`
`(57)
`
`ABSTRACT
`
`6/1856 Peale
`157192 A
`7/1988 w‘illkejr et a1‘
`43729759 A
`7/1989 Ta en
`4’8 L001 A
`6/1992 Sauter et al.
`5,123,919 A
`5,358,518 A 10/1994 Camilli
`5 409 019 A * 4/1995 Wilk ........................ .. 128/898
`5,413,599 A * 5/1995 Imachi et al. ............ .. 623/124
`5,500,014 A * 3/1996 Quijano et a1, __________ __ 623/124
`5,545,214 A
`8/1996 Stevens
`5,759,830 A
`6/1998 Vacanti et 91-
`57707193 A
`6/1998 Vacant} ct a1~
`1?;
`2105mm ct atl'l
`5,843,180 A 12/1998 Ja?e et a1‘
`5,851,232 A 12/1998 Lois
`5,855,597 A
`1/1999 Jayaraman
`
`,
`
`,
`
`erson e a .
`
`Aprosthetic valve for implantation Within a ?uid conducting
`lumen Within a body includes an elongate generally cylin
`drical radially collapsible valve body scaffold de?ning a
`.
`.
`.
`.
`.
`?uid. passageway there'through for‘ retentive positioning
`Wlthln the lumen- A fadlally collapslble leaf Valve member
`is Supported by the Scaffold includes a number of Valve leafs
`de?ectable betWeen a closed position restricting ?uid ?oW
`through the passageWay and an open position permitting
`?uid ?oW through the passageWay. The leaf valve member
`includes an interior leaf valve frame de?ning a valve leaf
`aperture Which is sealed by a ?uid impermeable non
`thrombogemc lining to prevent ?uid ?oW therethrough.
`
`-
`
`-
`
`-
`
`.
`
`48 Claims, 7 Drawing Sheets
`
`125 125b
`
`NORRED EXHIBIT 2198 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00111
`
`

`

`U.S. Patent
`
`Aug. 27, 2002
`
`Sheet 1 0f 7
`
`US 6,440,164 B1
`
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`
`NORRED EXHIBIT 2198 - Page 2
`
`

`

`U.S. Patent
`
`Aug. 27, 2002
`
`Sheet 2 0f 7
`
`US 6,440,164 B1
`
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`
`NORRED EXHIBIT 2198 - Page 3
`
`

`

`U.S. Patent
`
`Aug. 27, 2002
`
`Sheet 3 0f 7
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`US 6,440,164 B1
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`NORRED EXHIBIT 2198 - Page 4
`
`

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`U.S. Patent
`
`Aug. 27, 2002
`
`Sheet 4 0f 7
`
`US 6,440,164 B1
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`
`NORRED EXHIBIT 2198 - Page 5
`
`

`

`U.S. Patent
`
`Aug. 27, 2002
`
`Sheet 5 0f 7
`
`US 6,440,164 B1
`
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`(PRIOR ART)
`(PRIOR ART)
`
`NORRED EXHIBIT 2198 - Page 6
`
`

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`NORRED EXHIBIT 2198 - Page 7
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`U.S. Patent
`
`Aug. 27, 2002
`
`Sheet 7 0f 7
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`US 6,440,164 B1
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`NORRED EXHIBIT 2198 - Page 8
`
`

`

`US 6,440,164 B1
`
`1
`IMPLANTABLE PROSTHETIC VALVE
`
`FIELD OF THE INVENTION
`
`The present invention relates to the ?eld of implantable
`prostheses. More speci?cally, the present invention relates to
`implantable prosthetic cardiac, aortic, and venous valves.
`
`BACKGROUND OF THE INVENTION
`
`In human pathology, the proper functioning of both car
`diac and venous valves is of paramount importance. Disor
`ders of cardiac valves cause signi?cant morbidity and mor
`tality. These disorders affect persons of all ages and can
`result from congenital or degenerative conditions, as Well as
`from the sequelae of infections. Stenosis and insuf?ciency of
`the aortic or mitral valves have a greater incidence than
`stenosis and insuf?ciency of the tricuspid and pulmonary
`valves. Venous insufficiency is believed to contribute to
`various maladies, including edema, varicose veins, aching
`leg pain While standing, lipodermatosclerosis, and ulcer
`ations. Venous insuf?ciency is essentially caused by venous
`hypertension and chronic venous stasis due to valvular
`incompetence both of an idiopathic nature and of a second
`ary nature folloWing past illnesses of the venous systems.
`A prosthetic cardiac or venous valve may regulate the
`direction of the pulsating blood ?oW so as to limit the
`occurrence of blood stasis in the region about the valve. By
`maintaining the direction of blood ?oW therethrough, a
`prosthetic cardia, aortic, or venous valve may alleviate the
`maladies resulting from valve disorders or venous insuf?
`ciency. A prosthetic valve should therefore permit blood
`?oW in the proper predetermined direction to limit or
`prevent back?oW of the blood in a reverse direction.
`The art has seen several attempts for providing a pros
`thetic valve to alleviate the consequences of cardiac valve
`disorders and of venous insufficiency. These attempts gen
`erally fall into tWo categories, biologic valves and mechani
`cal valves. Biologic valves are comprised of a stent sup
`porting a number of circumferential lea?ets made of a
`?exible material. If the material is biologic in nature, it may
`be either a xenograft, that is, harvested from a non-human
`cadaver, or an allograft, that is, harvested from a human
`cadaver. For example, it is knoWn in the art to apply a
`pericardium biological tissue layer covering, for providing
`the valve lea?ets, to a stent Which provides structural
`annular integrity to the prosthesis. Non-biologic material
`such as polyurethane has also been used. The second cat
`egory of prosthetic valves, mechanical valves, usually com
`prise a rigid annulus supporting up to three rigid lea?ets. The
`annulus and lea?ets are frequently formed in pyrolitic
`carbon, a particularly hard and Wear resistant form of
`carbon. The annulus is captured Within a seWing ring so that
`the valve may be attached to tissue at the location of the
`replaced valve. Unfortunately, surgically positioning these
`implants typically requires suturing or seWing the device
`into the blood vessel, increasing the risk of thrombosis due
`to the resulting suturing or anastomoses of the body vessel.
`These attempts typically provide a valve structure having
`a relatively rigid tubular body structure Which supports a
`?exible valve leaf structure. That is, any structural rigidity
`imparted to the tubular body structure is separated from the
`valve leaf structure. For example, US. Pat. No. 4,759,759
`discloses a prosthetic valve having a solid stent member
`having a diametrically-opposed upstanding posts and a
`substantially cylindrical ?exible cover. The tWo portions of
`the cover extending betWeen the upstanding stent posts may
`be collapsed against each other in sealing registry over a
`
`10
`
`15
`
`25
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`35
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`45
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`55
`
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`
`2
`?uid passageWay de?ned by the stent. The stent, being a
`solid member, limits the radial collapsing thereof for endo
`scopic delivery Within a body lumen. The cover, being
`unsupported by the stent Within the ?uid passageWay of the
`valve, must itself provide suf?cient strength and resiliency to
`optimally regulate ?uid ?oW. Alternatively, US. Pat. No.
`5,855,691 discloses a prosthetic valve having a radially
`expandable covered stent Which de?nes an elongate ?uid
`passageWay therethrough. A ?exible valve is disposed
`Within the ?uid passageWay to regulate ?uid ?oW there
`through. The valve is formed of a ?exible and compressible
`material formed into a disc With at least three radial incisions
`to form de?ectable lea?ets. While the stent circumferentially
`supports the valve body, the lea?ets are not supported by any
`other structure Within the ?uid passageWay. There is there
`fore a need in the art for a unitary prosthetic valve construc
`tion Which provides structural reinforcement to both the
`tubular body portion of the valve and to the valve leafs
`supported thereon.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to providing a fully
`prosthetic valve having valve leafs formed from a covered
`valve leaf frame and Which may be implanted using a
`minimally-invasive, endoscopic technique.
`The present invention provides a prosthetic valve for
`implantation Within a body lumen. The prosthetic valve of
`the present invention provides a device for regulating and
`maintaining the direction of a pulsating ?uid ?oW through
`the body lumen. The valve includes a radially-collapsible
`scaffold portion and a radially-collapsible leaf valve portion.
`The scaffold portion includes a tubular open body scaffold
`de?ning a ?uid passageWay therethrough. The leaf valve
`portion is de?ectable betWeen a closed con?guration in
`Which ?uid ?oW through the valve passageWay is restricted
`and an open con?guration in Which ?uid ?oW through the
`valve passageWay is permitted.
`Each of the valve leafs desirably includes a valve leaf
`frame having an open construction so as to facilitate
`radially-collapsing or -expanding the leaf valve portion of
`the valve. Each valve leaf frame de?nes a valve leaf aperture
`With the scaffold. The present invention seals each valve leaf
`aperture to prevent ?uid ?oW therethrough. The material
`used to seal each valve leaf aperture is suf?ciently thin and
`pliable so as to permit radially-collapsing the leaf valve
`portion for delivery by catheter to a location Within a body
`lumen. A ?uid-impermeable biocompatible non
`thrombogenic valve leaf cover may be positioned on each
`valve leaf frame so as to seal the valve leaf aperture. The
`valve leaf cover may be formed from a surgically-useful
`textile such as Dacron, polyethlylene (PE), polyethylene
`terephthalate (PET), silk, Rayon, or the like. The valve leaf
`cover may also be formed of a surgically-useful polymeric
`material such as urethane, polytetra?uoroethylene (PTFE) or
`expanded polytetra?uoroethylene (ePTFE). The valve leaf
`cover may also coated With a cellular groWth-inhibiting drug
`such as Heparin or Taxol or another such composition.
`Similarly, each of the valve leaf apertures may be covered
`With cultured tissue cells derived from a either a donor or the
`host patient Which are attached to the valve leaf frames. The
`cultured tissue cells may be initially positioned to extend
`either partially or fully into each valve leaf aperture. In order
`to provide additional support to the attached cultured tissue
`cells, a micro?lter-type support mesh spanning the valve leaf
`aperture may also be provided. The present invention further
`contemplates that the supporting scaffold and valve leaf
`
`NORRED EXHIBIT 2198 - Page 9
`
`

`

`US 6,440,164 B1
`
`3
`frames may be formed of either a bioabsorbable material or
`a non-bioabsorbable material. It is contemplated that the
`scaffold and valve leaf frames Which are formed from a
`bioabsorbable material Will eventually be displaced by the
`tissue cells as the tissue cells mature. Eventually the cells
`alone Will provide the fully functioning valve. Alternatively,
`When the scaffold and valve leaf frames are formed from a
`non-bioabsorbable material, the cultured cells provide a
`means for reducing any undesirable biological response by
`the host.
`The leaf valve member is normally spring biased toWards
`the closed con?guration. The present invention also con
`templates biasing the leaf valve member toWards the open
`con?guration to simulate knoWn anatomical mechanics of a
`valve in Which the leaf valve portion Would close upon
`experiencing suf?cient back ?oW pressure from the direction
`doWnstream from the valve.
`The leaf valve portion desirably includes a number of
`valve leafs Which are de?ected betWeen the closed and open
`con?gurations When the ?uid pressure differential there
`across exceeds a predetermined threshold. That is, the ?uid
`pressure differential acts to open the valve When the ?uid
`pressure upstream of the valve leaf portion is greater than the
`?uid pressure doWnstream of the valve leaf portion.
`Each of the valve leafs is de?ectably supported by the
`scaffold at a ?exible hinge. The present invention contem
`plates that the open and closed con?gurations of the valve
`may be de?ned either doWnstream or upstream of the
`?exible hinges. It is desired that the scaffold portion of the
`valve Will eventually provide ?uid-tight engagement With
`the body lumen although it is contemplated that some
`leaking or ?uid ?oW betWeen the scaffold portion and the
`body lumen is still acceptable. Just as it is preferred, but not
`required, that the valve leafs prevent ?uid ?oW in the closed
`con?guration, it is recogniZed that substantial restriction of
`?uid ?oW past the scaffold-lumen interface may still provide
`a prosthetic valve exhibiting acceptable performance char
`acteristics.
`The present invention shoWs and describes both a bicus
`pid valve and a six-leaf valve, although designs employing
`a different number of valve leafs are clearly Within the scope
`of the present invention. The bicuspid valve includes a pair
`of leaf frames Which de?ect about a hinge positioned
`doWnstream of the closable valve opening. The six-leaf
`variant includes valve leafs Which de?ect about hinges
`positioned upstream of the closable valve opening.
`The abutting engagement betWeen adjacent valve leafs,
`While desirably providing a ?uid-tight seal, is contemplated
`to signi?cantly restrict back?oW past the valve leafs. The
`abutting engagement betWeen adjacent valve leafs may
`therefore provide less than complete ?uid integrity While
`still achieving the desired performance parameters.
`The scaffold of the valve includes a ?rst end de?ning a
`?rst opening, a second end de?ning a second opening, a
`substantially cylindrical interior face, a substantially cylin
`drical exterior face, and at least one radially-extending
`scaffold opening communicating betWeen interior and exte
`rior faces. The interior face generally de?nes the ?uid
`passageWay. The scaffold and leaf valve member are formed
`to be expandable from a ?rst diameter permitting delivery
`through the body lumen to a second radially-expanded
`diameter for retentively engaging the body lumen at a
`desired location. The scaffold may be formed having a shape
`memory favoring radial self-expansion or may be formed so
`as to permit radial expansion by a delivery balloon Which is
`de?ated and WithdraWn after scaffold expansion against the
`
`10
`
`15
`
`25
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`35
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`45
`
`55
`
`65
`
`4
`body lumen. The scaffold may further provide at least one
`radially outWardly projecting hook member for retentively
`engaging the ?uid conduit When expanded thereagainst.
`The present invention also contemplates forming both the
`scaffold and the valve leaf frames as a unitary support trellis.
`The unitary trellis may be formed by a single undulating
`Wire bent to form both the radially expandable scaffold
`portion and the radially expandable valve leaf frames. While
`various con?gurations for the unitary support trellis of the
`present invention are contemplated, one preferred con?gu
`ration bends a Wire along a longitudinally extending and
`retracting undulating path so as to alternately de?ne a
`collapsible and expandable leaf frame aperture and then a
`collapsible and expandable scaffold aperture. The Wire may
`be laid along a ?at surface so as to form a planar trellis
`preform. The trellis preform may then be Wrapped about an
`elongate cylindrical mandrel. The valve leaf frames may be
`de?ected about their respective hinges to establish a shape
`memory in either the open or closed con?guration either
`prior to or after Wrapping the trellis preform about the
`mandrel.
`The trellis is desirably formed from a biocompatible metal
`or polymeric material. The trellis may additionally be
`formed from a shape-memory material to more reliably
`provide the required geometry to function effectively Within
`the valve once radially expanded at a site Within a lumen.
`The trellis may be formed from an alloy of nickel and
`titanium in speci?c proportions knoWn in the art as nitinol.
`Alternatively, the trellis may be formed from a polymeric
`material Which alloWs the trellis to be radially collapsed for
`delivery to a site in a lumen but then radially expands to
`return to an unde?ected shape so as to function effectively
`Within the valve.
`The present invention also contemplates attaching an
`elongate generally cylindrical ?rst biocompatible non
`thrombogenic liner to the trellis. The ?rst liner may be
`positioned on either the interior or exterior face of the
`scaffold. The ?rst liner may also provide the sealing cover
`for the valve leaf frame apertures. The ?rst liner may be
`trimmed to span betWeen adjacent valve leafs in the open
`con?guration so as to provide a larger surface area for the
`body ?uid to act upon When urging the valve leafs betWeen
`the open and closed con?guration. The ?rst liner may also be
`trimmed to provide at least one ?ap extending in the
`doWnstream direction beyond each valve leaf. Each ?ap may
`then be folded over the adjacent valve leaf frame and
`laminated through a valve leaf aperture to the liner.
`Furthermore, an elongate generally cylindrical second
`biocompatible non-thrombogenic liner may be positioned on
`the scaffold opposite the ?rst liner. The second liner may
`desirably extend only along a portion of the scaffold or fully
`along scaffold. The ?rst and second liners may be joined so
`as to fully encase either just the scaffold or the entire trellis.
`It is contemplated that the ?rst and second liners may be
`laminated together through one or more openings de?ned by
`the trellis. Additionally, the second liner may be formed by
`folding the ?rst liner over the ?rst end of the scaffold so as
`to extend at least partially along the opposite face of the
`scaffold as the ?rst lining.
`Each liner positioned on the trellis may inhibit thrombus
`formation and facilitate tissue ingroWth therethrough for
`assimilating the valve of the present invention into the body
`lumen. ToWards this latter goal, one or both of the liners may
`be formed from a porous textile or polymeric material. It is
`further contemplated that either liner may be formed from an
`xenograft of cellular tissue from a donor such as bovine
`
`NORRED EXHIBIT 2198 - Page 10
`
`

`

`US 6,440,164 B1
`
`5
`cardial tissue, or homograft of cellular tissue formed from
`the host patient.
`It is also contemplated by the present invention that the
`prosthetic valve may also be attached to the interior surface
`of a second radially collapsible prosthetic ?uid conduit. The
`second ?uid conduit may be selected from many knoWn
`stent and covered stent designs knoWn in the art. The second
`?uid conduit further maintains the patency of the lumen to
`either side of the valve and may also include a biocompatible
`?uid impermeable non-thrombogenic lining on either or
`both of its oWn inner or outer surfaces. The materials used
`to form the second ?uid conduit may also be selected to be
`either bioabsorbable or non-bioabsorbable as may be
`desired.
`The present invention is also directed to methods of
`making the prosthetic valve of the present invention.
`While the present invention has been described generally,
`the present invention Will be more readily appreciated in a
`reading of the “Detailed Description of the Invention” With
`reference to the folloWing draWings.
`
`10
`
`15
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 shoWs side elevational vieW of a prosthetic venous
`valve of the present invention in a closed, ?oW restricting
`con?guration.
`FIG. 2 shoWs a top elevational vieW of the prosthetic
`venous valve of FIG. 1 in the closed con?guration.
`FIG. 3 shoWs a side elevational vieW of the prosthetic
`venous valve of FIG. 1 in an open, ?oW conducting con
`?guration.
`FIG. 4 shoWs a top elevational vieW of the prosthetic
`venous valve of FIG. 1 in the open con?guration.
`FIG. 5 shoWs the unitary support trellis of the prosthetic
`venous valve of FIG. 1.
`FIG. 6 shoWs a front elevational vieW of the unitary
`support trellis of the present invention in a ?at trellis preform
`con?guration.
`FIG. 7 is a side elevational vieW of the unitary support
`scaffolding and valve lea?et frames upon being stressed to
`provide for a self-closing valve.
`FIG. 8 depicts one step in a method of constructing the
`prosthetic valve of the present invention by Wrapping the
`unitary support scaffolding and valve lea?et frames about a
`non-thrombogenic lining positioned about a mandrel.
`FIG. 9 shoWs an isometric vieW of a unitary support trellis
`for a prosthetic valve of the present invention.
`FIG. 10 shoWs a perspective vieW of a prosthetic valve of
`the present invention in an open con?guration and in Which
`the scaffold portion of the valve is substantially uncovered.
`FIG. 11 shoWs a side elevational vieW of the prosthetic
`valve of FIG. 10.
`FIG. 12 shoWs a side elevational vieW of the prosthetic
`valve of FIG. 10 in an open con?guration.
`FIGS. 13A—D depicts a further embodiment of the present
`invention in Which adjacent leaf frames are joined at a
`location therealong to reduce the siZe of the valve ?oW
`opening.
`FIG. 14 shoWs an embodiment a prosthetic valve of the
`present invention in Which a unitary support trellis is posi
`tioned over a liner.
`FIG. 15 shoWs an alternate embodiment of a prosthetic
`valve of FIG. 14 in Which a second liner is positioned on the
`trellis to eXtend across the proXimal end of the scaffold
`portion.
`
`25
`
`35
`
`45
`
`55
`
`65
`
`6
`FIG. 16 is a side elevational vieW of an alternate embodi
`ment of a prosthetic valve of the present invention in an
`open, ?oW-conducting con?guration in Which a non
`thrombogenic Webbing spans betWeen each adjacent lea?et
`of the valve.
`FIG. 17 shoWs an alternate embodiment of the present
`invention in Which a secondary support scaffolding is
`formed to the doWnstream side of the valve lea?ets.
`FIG. 18 shoWs a still further embodiment of the present
`invention in Which a number of de?ectable valve leafs are
`attached Within the ?uid-conducting passageWay to a
`radially-expandable prosthetic support structure.
`FIG. 19 is a partial cut-aWay of the embodiment of FIG.
`10 depicting the valve lea?ets in a closed, ?oW-restricting
`con?guration.
`FIG. 20 is a partial cut-aWay of the embodiment of FIG.
`11 depicting the valve leafs in an open, ?oW-conducting
`con?guration.
`FIG. 21 depicts an alternate embodiment of a covered
`valve leaf of the present invention to be attached to a radially
`expandable outer conduit.
`FIGS. 22 and 23 depict a prosthetic bicuspid valve of the
`prior art in the open and closed con?gurations, respectively.
`FIGS. 24A—B are respective side and top elevational
`vieWs of a prosthetic bicuspid valve of the present invention
`in the closed con?guration.
`FIGS. 25A—B are respective side and top elevational
`vieWs of a prosthetic bicuspid valve of the present invention
`in the open con?guration.
`FIGS. 26A—B depict a unitary scaffold for the prosthetic
`bicuspid valve of FIG. 24 in the closed con?guration.
`FIG. 26C depicts the scaffold for the prosthetic bicuspid
`valve of FIG. 24 in the open con?guration.
`FIGS. 27A—B are respective side and top elevational
`vieWs of another embodiment of the prosthetic bicuspid
`valve of FIG. 24, having a larger valve leaf and shalloWer
`valve cusp, in the closed con?guration.
`FIGS. 28A—B are respective side and top elevational
`vieWs of the prosthetic bicuspid valve of FIG. 27A in the
`open con?guration.
`FIGS. 29A—B are side elevational vieWs of the scaffold of
`the prosthetic bicuspid valve of FIG. 27A and FIG. 28A,
`respectively.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`The present invention relates generally to method and
`apparatus for providing a ?uid ?oW check valve for a body
`lumen. A preferred embodiment of the present invention is
`particularly suitable for forming an endoluminal prosthetic
`valve for vascular applications. The prosthetic valve of the
`present invention regulates and maintains the direction of a
`pulsating ?uid ?oW through a body lumen. The prosthetic
`valve of the present invention is con?gured to open and
`close in response to the ?uid pressure differential across the
`valve. The valve includes a radially-collapsible scaffold
`portion and a radially-collapsible leaf valve portion Which
`alloWs the valve to be delivered via catheter through the
`body lumen in Which it Will be emplaced. The scaffold
`portion includes a tubular open body scaffold de?ning a ?uid
`passageWay therethrough. The leaf valve portion is de?ect
`able betWeen a closed con?guration in Which ?uid ?oW
`through the valve passageWay is restricted and an open
`con?guration in Which ?uid ?oW through the valve passage
`Way is permitted.
`
`NORRED EXHIBIT 2198 - Page 11
`
`

`

`US 6,440,164 B1
`
`7
`The preferred embodiment of the prosthetic valve of the
`present invention is designed to be biased towards a closed,
`?oW-restricting con?guration. The valve opens When suf?
`cient ?uid pressure is applied to the lea?ets from the
`upstream direction. Desirably the valve Will open When the
`pressure differential across the lea?ets reaches about 1—20
`mm Hg. When the pressure differential is too loW, the valve
`closes to prevent back ?oW. The valve desirably Withstands
`up to about 100 mm Hg of back ?oW pressure. When the
`pressure differential from blood ?oWing the desired direc
`tion is removed, the valve returns to the closed con?gura
`tion.
`As Will be described in further detail hereinbeloW for the
`six-leaf variant of the present invention, the leaf valve
`portion is connected to the scaffold portion so that the valve
`leafs are de?ectable about an annularly extending hinge line.
`The location of the hinge line along the length of the leaf
`valve portion in?uences the ?uid pressure required to open
`and close the valve. In the closed con?guration, the valve
`leaf portion substantially restricts ?uid ?oW through the
`valve by providing a biocompatible impermeable non
`thrombogenic covering extending from the hinge line in
`registry With the passageWay.
`Referring noW to the draWings, FIGS. 1—5 depict a
`prosthetic valve 10 of the present invention. Valve 10
`provides a radially-collapsible trellis 24 having an open
`construction. Trellis 24 includes an elongate tubular body
`scaffold 30 supporting a number of de?ectable valve leaf
`frames 52 de?ectable about a hinge line 22. Each valve leaf
`frame 52 de?nes a leaf frame aperture 62 Which is sealed by
`a valve cover 80 positioned on trellis 24. The remainder of
`trellis 24 may also be covered With one or more liners 82 and
`88, or may be left uncovered altogether. The covered leaf
`frames 52 form the de?ectable valve leafs 40 Which may be
`moved out of abutting engagement With each other so as to
`permit ?uid ?oW through valve 10 in response to the ?uid
`pressure upstream thereof.
`Valve 10 is provided for implantation Within the ?uid
`passageWay of a body lumen, such as for replacement of a
`cardial, arterial, or venous valve, to regulate the ?oW of a
`bodily ?uid therethrough in a single direction. Valve 10 is
`constructed from biocompatible materials so as to minimiZe
`any adverse body reaction to the implantation of valve 10.
`Valve 10 includes an elongate tubular body portion 12 and
`a leaf valve portion 14. Valve 10 includes an upstream end
`16, a doWnstream end 18, and an elongate ?uid passageWay
`20 extending therebetWeen along a valve axis lv. Leaf valve
`portion 14 is connected to body portion 12 to extend in
`overlying registry With passageWay 20. Leaf valve portion
`14 includes one or more valve leafs 40 Which are de?ectable
`With respect to body portion 12 about a hinge line 22
`betWeen a closed con?guration, shoWn in FIGS. 1 and 2,
`restricting ?uid ?oW through passageWay 20, and an open
`con?guration, shoWn in FIGS. 3 and 4, permitting ?uid ?oW
`through passageWay 20. As shoWn in FIGS. 13A—D, hinge
`line 22 may be alternatively formed along the length of valve
`portion 14 by joining adjacent valve leafs 40 at a midWay
`location 22‘. Locating hinge line 22 further doWnstream
`from body portion 12 increases the required higher ?uid
`pressure differential to de?ect the valve leafs to the open
`con?guration.
`Leaf valve portion 14 may provide any number of valve
`leafs 40. While six valve leafs are provided and discussed by
`reference to FIGS. 1—4, a bicuspid valve con?guration is
`also contemplated and Will be further discussed hereinbe
`loW. Still referring to FIGS. 1—4, each of the valve leafs 40
`are similarly-siZed and -shaped and include opposed ?rst
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`8
`and second major surfaces 42 and 44, respectively. Each ?rst
`major surface 42 of a valve leaf 40 is oriented in facing
`opposition toWards upstream end 16 of valve 10. Each of the
`valve leafs 40 provide a saWtooth perimetrical edge formed
`by a ?rst and second leaf edge 46 and 48, respectively, Which
`are positionable in abutting engagement With a leaf edge of
`an adjacent valve leaf 40 to de?ne the closed con?guration
`of valve 10. Similarly, as best shoWn in FIG. 4, the leaf edges
`46 and 48 de?ne a valve leaf opening 50 When in the open
`con?guration. Valve leaf opening 50 is in ?uid communi
`cation With passageWay 20.
`All of the valve leafs 40 are formed having a spring bias
`toWards either the open or the closed con?guration. When all
`of the valve leafs 40 are spring biased toWards the closed
`con?guration, the open con?guration may be attained When
`the ?uid pressure acting on the ?rst major surfaces 42 of the
`valve leafs 40 overcomes both the ?uid pressure acting on
`the second major surfaces 44 of the valve leafs 40 of valve
`10 and any spring bias closing force imparted to the valve
`leafs 40 acting to close the valve leafs. Should the ?uid
`pressure from the doWnstream end 28 of valve 10 become
`too great relative to the upstream ?uid pressure, the valve
`leafs 40 Will also be urged toWards the closed con?guration.
`Each valve leaf 40 desirably curves inWard such that the
`second major surface 44 has a concave shape to better
`collect back?oW and urge the valve leafs 40 toWards the
`closed con?guration. The prosthetic valve 10 of the present
`invention thereby provides a device for regulating and
`maintaining the direction of a pulsating ?uid ?oW through
`the body lumen. While leaf valve portion 14 is normally
`spring biased toWards the closed con?guration, it is also
`contemplated, hoWever, to bias leaf valve portion 14 toWards
`the open con?guration in order to simulate knoWn anatomi
`cal mechanics of certain valves. Thus, When biased toWards
`the open con?guration, leaf valve portion 14 Would close
`upon experiencing suf?cient back ?oW pressure from the
`doWnstream end 28 of valve 10.
`FIG. 5 shoWs the unitary support trellis 24 employed by
`valve 10. Trellis 24 may be formed from a material exhib
`iting shape memory characteristics or from a material Which
`is readily expandable by a balloon catheter. Trellis 24 is
`generally an elongate tube being coaxial With valve axis lv.
`Trellis 24 has opposed upstream and doWnstream ends 26
`and 28. Upstream end 26 of trellis 24 is further de?ned by
`a radially collapsible body scaffold 30. DoWnstream end 28
`of trellis 24 is further de?ned by a radially-collapsible leaf
`valve frameWork 32.
`Trellis 24 may be formed from a Wide variety of materials
`and in a Wide variety of con?gurations. Radially-expandable
`endovascular stents knoWn in the art provide useful basic
`designs for modi?cation into a support trellis of the present
`invention and may be