WO 2012/006124
`
`PCT/US2011/042252
`
`3/10
`
`121
`\
`
`FIG. 4A
`1.24
`
`FIG. 4B
`
`121 12'2
`
`101
`
`" \
`
`124
`
`i23
`
`FIG. 4C
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1601 of 2319
`
`

`

`WO 2012/006124
`
`PCT/US2011/042252
`
`4/10
`
`FIG. 4E
`
`FIG. 4F
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1602 of 2319
`
`

`

`WO 2012/006124
`
`PCT/US2011/042252
`
`5/10
`
`'-'":-:-.--..,;,._,,,,, ....... ,, ... :-..,:-.:-.:-.:-,.-..,-..,,,,:-.,,,,,,,,,,,,,,,, ......................................... ,~,:-:,:::,::~;:--_
`·-~ ..... ,'-:.
`
`-
`
`.
`
`-
`
`....... ,,,~,, ..... ;.,.,,,, .... ,...._,,,,,,, ..... ,..;,;,_-..~
`
`12:2 Nnt
`Si10"t..-'t1
`
`FIG. SA
`
`FIG. SB
`
`2i 2
`
`✓ .... ----------
`
`101
`
`:,.;; :,.,,,,~..._,,,-..:..,;.,.,,..;,.,,,,,""''""-:--..:::-~:--'.'-~':-~'"'::-:,::.,;:,:_:,:::,:::,::t~x,,': .... .._,,,,,,x ... :---:--:--:--:--::-:-;.;:-..;_,..;_...;:.;;...;_,.._x·
`
`FIG. SC
`
`FIG. SD
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1603 of 2319
`
`

`

`WO 2012/006124
`
`PCT/US2011/042252
`
`6/10
`
`FIG. SE
`
`120
`p 22 rHJt sho-wn)
`
`14©
`l
`l
`-~!,,}'~ ->/i1!-~-,.,,.,,--
`
`§31
`
`214
`
`224
`.,, . .,,,,,,_""""""--""..,,..._ ... ..,.._ ... -.. ~.,,....,.
`
`Prrudma! catheter pmts
`and hubs no1 shown
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1604 of 2319
`
`

`

`WO 2012/006124
`
`PCT/US2011/042252
`
`7/10
`
`FIG. 6A
`
`Traction ek>nnates sheath
`"¼~eave and red~!ces diarneter
`
`I
`
`Ill! · ·
`
`13'1
`,;~
`""'~~ ... , ...... .._~~
`
`~~,~~- •,
`~
`.i.
`. -~~-
`i
`~'~~~~
`
`t
`t
`
`221 or 1 t2 .,~.,,,,--
`
`~;
`
`t
`
`FIG. 68
`
`131 ~\
`
`··~---·::e,.,~ ~ --;~-: _:~:;:}~~·::.-~- _·:~: ... :.~.-. ~.,.. .............. "'-
`
`224. -¥>~
`
`FIG. 6C
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1605 of 2319
`
`

`

`WO 2012/006124
`
`PCT/US2011/042252
`
`8/10
`
`t 1 /'/341
`
`i
`"4-"
`
`~~~,H-,.~~-IU<.·
`
`...... »
`
`.. »
`
`... ---
`
`-.( w
`
`:-N ~ ~ ~~~~~~~~~~~~~~~~~~»:~~~'«* * -~ -~ ~ :.6.
`
`:u:
`
`ut-UJ.:.UW.•».».».:,,X:«
`-
`-
`..
`.. ..
`.
`.
`.
`
`,,.,·"',._---~-- ;3,44
`
`{
`
`FIG. 6D
`
`FIG. 6E
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1606 of 2319
`
`

`

`WO 2012/006124
`
`PCT/US2011/042252
`
`9/10
`
`~400
`
`FIG. 7
`
`411
`
`416
`
`121 ~~""""--.,__
`.
`~'-'-~'-~'-~'-"lS:l:l-'-~'-'-~'-~~~'-'-~'-~'-'-'ll!&'-'-~'-" ~'!l
`~ ...... ,~~~ ........... ~~~~"'~''~?''~ ............ ~ ...... ~~~-....~ ~
`
`. __ _ {;_ _ .. ~~~zb.;-~¢~->>\::¼?a122c::---._-----~--~-- -_ ___
`
`~.~~ .... ~~,~~~~..._,,-.....,-....-»"!'-~~~~~~~.._... .... ,,,,,,-....,-.....-»~~,'-'''''''''":'-... ,. ... ..: ... ,,,-..,,,,,..:..::...:...:., ... :-.:,.x..:: ............ ~,,,,,~~''''-.,.'~~'~''"''''''''''''~'~~,~~,~~,..,_.,.,_,,..,_..,_,,,~ ... :-,._,-,.. ...... ~..:.~ ... ':'''''''"':':'"':':': ... ,..:,.:,.:--:,.:-:,..,,..::.,:..: . ..:-:...:...:,..:: ... x..:··.
`.
`-'
`_:.,<:
`..
`·-
`..
`
`.
`
`~
`
`·-.-121
`
`~500
`
`131
`
`FIG. 8A
`
`-----------------
`t t
`t t
`
`141
`
`FIG. 88
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1607 of 2319
`
`

`

`WO 2012/006124
`
`PCT/US2011/042252
`
`10/10
`
`500
`
`'
`\ _____ i.,.,.,,-.-"".,.,,❖ ,.,.,,_,,.,.,.,,-.c•""""'-'''Ji
`
`FIG. BC
`
`End View
`fSt1t-<1th 524 Not Stmwn)
`
`FIG. 8D
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1608 of 2319
`
`

`

`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`29 March 2012 (29.03.2012)
`
`PCT
`
`1111111111111111 IIIIII IIIII 111111111111111 II Ill 1111111111111111111111111 IIII IIIIIII IIII IIII IIII
`
`(10) International Publication Number
`WO 2012/040643 A2
`
`(51) International Patent Classification:
`A61F 2124 (2006.01)
`A61F 2182 (2006.01)
`A61F 2104 (2006.01)
`A61L 27104 (2006.01)
`A61L 27128 (2006.01)
`A61M 25101 (2006.01)
`
`(21) International Application Number:
`PCT/US2011/053120
`
`(22) International Filing Date:
`23 September2011 (23.09.2011)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`(30) Priority Data:
`61/385,867 23 September 2010 (23.09.2010)
`13/243,980 23 September201l (23.09.2011)
`
`English
`
`English
`
`US
`US
`
`(74) Agent: YASKANIN, Mark; Holme Roberts & Owen
`LLP, 1700 Lincoln Street, Suite 4100, Denver, CO 80203
`(US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA,CH,CL,CN,CO,CR,CU,CZ,DE,DK,DM,DO,
`DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP,
`KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD,
`ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI,
`NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU,
`RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ,
`TM,TN,TR,TT,TZ, UA, UG, US, UZ, VC, VN,ZA,
`ZM,ZW.
`
`(71) Applicant (for all designated States except US): COLIB-
`RI HEART VALVE LLC [US/US]; 2150 W. 6th Ave,
`Suite M, Broomfield, CO 80020 (US).
`
`(84)
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): FISH, R., David
`[USiUS]; 6349 Vanderbilt Street, Houston, TX 77005
`(US). PANIAGUA, David [CR/US]; 3813 Drummond
`Street, Houston, TX 77025 (US). INDUNI, Eduardo
`[CR/CR]; Resi Alajuela H7, Alajuela, 906-4050 (CR).
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG,
`ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ,
`TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
`EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
`L V, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
`SM, TR), OAPI (BF, BJ, CF, CG, CL CM, GA, GN, GQ,
`GW, ML, MR, NE, SN, TD, TG).
`
`---;;;;;;;;;;;;;;;
`
`(54) Title: PERCUTANEOUSLY DELNERABLE HEART OR BLOOD VESSEL VALVE WITH FRAME HAVING ABLU(cid:173)
`MINALL Y SITUATED TISSUE MEMBRANE
`
`[Continued on next page]
`
`(57) Abstract: A prosthetic valve implantable by
`catheter without surgery includes a frame with an ab(cid:173)
`luminal surtace extending between a proximal end of
`the frame and a distal end of the frame, and a single
`layer of a biocompatible membrane material mounted
`to the abluminal surface of the frame. The single lay(cid:173)
`er ofbiocompatible membrane is located such that an
`interior surface of the membrane sheet extends be(cid:173)
`tween the proximal end of the frame and the distal
`end of the frame, and resides radially exterior the ab(cid:173)
`luminal surface of the frame. In at least one embodi(cid:173)
`ment, the disposition of membrane sheet at all points
`of attachment is entirely exterior/ab luminal to the
`frame, such that no part of the abluminal surface of
`the membrane sheet contacts the frame.
`
`pmr-:,cilons} al11YNS
`radia.Hy inwa1d
`movement of l&'lfiets
`into ooaptation {ciosOO)
`po,;!liof!
`
`100
`
`124b
`
`120
`
`O!RECTlON !S FROM l'
`
`W!TIJIN THE VAL VE
`100. at.DOD FLOW
`
`rHE PROX!f,-iAL END
`112 TDW.',RO THE
`D!STAL END i"'iE
`
`A
`/ \
`J
`i
`I
`
`i
`
`136
`
`Figure 1A
`
`-;
`
`;;;;;;;;;;;;;; -
`-;;;;;;;;;;;;;;;
`
`;;;;;;;;;;;;;;;
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1609 of 2319
`
`

`

`WO 2012/040643 A2 1111111111111111 IIIIII IIIII 111111111111111 II Ill 1111111111111111111111111 IIII IIIIIII IIII IIII IIII
`
`Published:
`-
`
`without international search report and to be republished
`upon receipt of tlzat report (Rule 48.2(g))
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1610 of 2319
`
`

`

`WO 2012/040643
`PCT/US2011/053120
`PERCUTANEOUSLY DELIVERABLE HEART OR BLOOD VESSEL VAL VE WITH
`
`FRAME HAVING ABLUMINALL Y SITUATED TISSUE MEMBRANE
`
`FIELD
`
`The present invention relates to the field of medical devices, and more particularly, to a
`
`percutaneously deliverable heart valve and to a percutaneously deliverable blood vessel valve.
`
`BACKGROUND
`
`Heart valve disease is a common degenerative condition that compromises physiologic
`
`function and causes limiting symptoms and threat to life in millions of patients all over the
`
`world. There are various underlying causes, but malfunction of heart valves is ultimately
`
`expressed as insufficient conduction of blood through the plane of the valve due to narrowing of
`
`the anatomic pathway (stenosis), or as incompetent closure that allows blood to return back
`
`through the valve again, thereby reducing the effective forward conduction of blood through the
`
`valve (insufficiency or regurgitation). These hemodynamic states lead to 1) deficiency of
`
`cardiac output and 2) adverse loads on the pumping chambers of the heart, both of which in tum
`
`lead to functional compromise of the patient and often premature death unless effectively
`
`corrected.
`
`Definitive corrective treatment of heart valve disease is conventionally performed by
`
`open-chest surgical techniques, wherein the valve is manipulated, repaired, or replaced with a
`
`prosthetic valve under direct vision. Heart valve surgery is performed in hundreds of thousands
`
`of cases yearly world-wide, but carries a high burden of cost, morbidity, and mortality,
`
`especially in susceptible patients who may be elderly or otherwise physiologically compromised
`
`by collateral disease. Further, the costs and resource requirements of the surgical enterprise
`
`restrict the availability of heart valve replacement to many more patients all over the world.
`
`In pursuit of alternatives to heart valve surgery, over the last ten years a number of
`
`development programs have brought percutaneous, trans-catheter implantation of prosthetic
`
`heart valves into commercial use in the European Union (EU) and into pivotal clinical trials in
`
`the United States of America. Initial clinical experience in the EU was directed toward patients
`
`who had critical aortic valve stenosis, but were deemed to be at unacceptably high risk for open(cid:173)
`
`heart surgical valve replacement. In several thousand such cases, utilizing both balloon(cid:173)
`
`expandable and self-expanding designs in two separate programs, percutaneous heart valve
`
`replacement (PHVR) was shown to be feasible and possibly competitive with surgery in selected
`
`patients with 12-18 month mortality rates of about 25%. Grube E., et al., Progress and Current
`
`Status of Percutaneous Aortic Valve Replacement: Results of Three Device Generations of the
`
`Core Valve Revalving System, Circ. Cardiovasc Intervent. 2008;1 :167-175.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1611 of 2319
`
`

`

`WO 2012/040643
`PCT/US2011/053120
`Typically, the current percutaneous heart valve (PHV) designs, including the
`
`commercialized Medtronic CoreValve and the Edwards Lifesciences Sapien valves, comprise a
`
`biological membrane forming the operating leaflets of the valve, mounted within the interior of a
`
`metal frame, that is then collapsed onto a delivery catheter or balloon, and then constrained
`
`within an outer sheath. After an initial dilation of the diseased valve with a large balloon, this
`
`assembly is then advanced to the plane of the valve and deployed by self-expansion or by
`
`balloon expansion.
`
`PHV designs are confronted by several central challenges. More particularly, the
`
`functioning valve leaflets are typically constructed of flexible and compressible tissue
`
`membrane valve members attached by sutures to a surrounding stent frame that together must be
`
`durable, yet of sufficiently low mass to allow for passage in collapsed form into the patient's
`
`body through an anatomic pathway-a peripheral artery, for example-of limited diameter,
`
`leading to the implantation site within the central circulation system. This condition favors
`
`simple, yet robust design geometries.
`
`Secondly, the PHV in its implanted operating configuration must emulate both the
`
`opening mechanics and the closing mechanics of the native heart valve-two differing
`
`geometries and mechanical forms afforded by the native anatomy of the aortic valve, for
`
`example, but with the limitation that the PHV must effectively embody both within its physical
`
`and operational envelope without the benefit of the grossly different anatomical forms native to
`
`the aortic valve.
`
`As a practical matter, the measures of effective function are simple-the pressure
`
`gradient during forward passage of blood across the valve must be as low as possible, typically 5
`
`- 10 mmHg or less. While achieving this, the "success" of operation in the closed configuration,
`
`wherein the leaflets are pressed together along lines of apposition by the pressure of the blood
`
`pumped beyond the valve, would also appear to be simply measured by the amount of retrograde
`
`blood passage back into the pumping chamber-the "regurgitation" or "leakage."
`
`However, since this closed phase of valve function is the phase in which the principal
`
`force loads are applied to the valve membrane leaflets, and since the manner in which the design
`
`of the valve distributes these forces determines the durability of the valve, the real measure of
`
`the valve's closing function is best understood by how well the design minimizes and distributes
`
`the force loads on the valve leaflets. To date, this problem has not been sufficiently addressed.
`
`In the field of blood vessel diseases certain conditions may be advantageously treated by
`
`insertion of valves into an affected patient's blood vessels. Currently no such valve devices are
`
`available, though investigation of this approach has suggested potential clinical utility for blood
`
`vessel valves, and in particular for valves to be inserted into the vein system for particular
`
`- 2 -
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1612 of 2319
`
`

`

`WO 2012/040643
`
`PCT/US2011/053120
`
`conditions. In the first example, insufficiency of the inlet (atrioventricular) tricuspid valve to the
`
`right ventricle of the heart results in regurgitation of blood back into the right atrium, which,
`
`serving to receive blood flow returning in the veins from the entire body, then results in turn in
`
`suffusion and swelling (edema) of all the organs, most notably in the abdomen and extremities,
`
`insufficient forward conduction of blood flow from the right ventricle into the lungs causing
`
`compromise of pulmonary function, and ultimately pump failure of the right heart. Collectively
`
`these conditions are termed right heart failure, a condition that leads to incapacity and possibly
`
`to death if progressive and uncorrected. Often, the remedy is surgical repair or replacement of
`
`the tricuspid valve, but results are uncertain, damage to the right ventricle being often
`
`irreversible, and progressive heart failure may supervene despite technically successful valve
`
`surgery.
`
`In a yet a further example, insufficiency of vein function due to the incompetence or
`
`destruction of intrinsic valves within the vein system leads to acute then chronic swelling of the
`
`veins and their dependent lymphatics and tissues. This condition can affect the deep veins of the
`
`body, commonly the lower extremities or pelvis, or the superficial veins of the lower extremities
`
`in particular, leading to progressive expansion of the veins and further valvular incompetence, a
`
`condition known as varicose veins. Millions of people worldwide suffer from these conditions
`
`and enormous funds are expended on procedures to destroy or remove these dilated incompetent
`
`veins. It has long been hoped that some form of implantable valve for the vein system could
`
`alleviate these conditions.
`
`Several references of interest have been reviewed in preparation of the present
`
`disclosure. The applicants do not admit that the any one or more of the following references
`
`constitute citable prior art.
`
`U.S. Patent No. 7,758,632 to Hojeibane discloses a valve construct wherein all
`
`embodiments include stent portions that act as proximal and distal anchors that are
`
`interconnected by connecting members, and further include a "cantilever valve strut" that acts as
`
`a biasing arm to "facilitate the opening and closing of the membrane assembly." Such
`
`structures may disrupt the flow channel and potentially interfere with membrane integrity when
`
`crimping the valve to mount it on an expandable balloon. In addition, at the point of
`
`engagement of the tissue against the connecting members, there is relatively intense focal stress
`
`along the straight connecting member - especially at the free edge of the leaflet. Hojeibane
`
`further utilizes flaps 403 and cusps 404 that may be independent components attached to the
`
`tubular membrane to form the membrane assembly 102. Accordingly, Hojeibane does not
`
`appear to use a flat sheet of membrane.
`
`- 3 -
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1613 of 2319
`
`

`

`WO 2012/040643
`
`PCT/US2011/053120
`
`U.S. Patent No. 7,025,780 to Gabbay discloses two separate uses of a device referred to
`
`as a "stent." The first use is that of the stent in a surgical valve wherein it is a supportive
`
`structure to give shape and mechanical support to the tissue leaflets formed upon it. This device
`
`in Gabbay is like a surgical tissue valve. As shown in Figs. 5 and 6 of Gabbay, the stent is
`
`disposed outside of at least an inner tissue leaflet layer. In the second use, as shown in Figs. 1
`
`and 2 of Gabbay, a tissue valve of some type is disposed within an outer frame of the vascular
`
`stent type. In this case, the tissue layer is not disposed upon the abluminal surface of the outer
`
`stent frame. The reader is directed to column 1, lines 61-63 of Gabbay that state "The prosthesis
`
`includes a valve apparatus located within a stent apparatus to form a stented valve." Gabbay
`
`further references only a "valve apparatus comprising an animal pulmonic heart valve."
`
`Accordingly, Gabbay fails to disclose a valve formed of flat tissue membrane wherein the tissue
`
`membrane is attached to the abluminal surface of a frame.
`
`U.S. Patent Application Publication No. 2006/0190074 to Hill is directed to venous
`
`valves, and as such, the structural embodiments shown in Hill do not appear robust enough for
`
`application as prosthetic heart valves, such as in the aortic valve position. The valve material is
`
`referred to as a "cover" comprising a matrix and "integrated flexible support members 124" -
`
`essentially a reinforcing layer applied to the matrix. While tissue sources of "extracellular
`
`membrane" are cited as possible sources for the matrix, the use of a single layer tissue
`
`membrane for the leaflets is not disclosed in Hill.
`
`With further reference to U.S. Patent Application Publication No. 2006/0190074, Hill
`
`also does not describe how the cover material is attached to the frame to achieve a sufficiently
`
`robust construct for utilization as a prosthetic heart valve. That is, while Hill generally discusses
`
`attachment of the cover to the frame at Paragraph [0072] using a variety of possible fasteners,
`
`none are shown and described relative to the frame. Of particular relevance is that while Hill
`
`mentions coupling the cover 108 to the frame 102 at connection regions 132 and 134, there is no
`
`mention of coupling the cover 108 to the arcuate portions of the frame members 126 that lead to
`
`the connection regions 132 and 134.
`
`Accordingly, there is a need to address the shortcomings discussed above.
`
`SUMMARY
`
`It is to be understood that the present invention includes a variety of different versions or
`
`embodiments, and this Summary is not meant to be limiting or all-inclusive. This Summary
`
`provides some general descriptions of some of the embodiments, but may also include some
`
`more specific descriptions of other embodiments.
`
`As noted above, the real measure of the valve's closing function is best understood by
`
`how well the design minimizes and distributes the force loads on the valve leaflets. This
`
`-4-
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1614 of 2319
`
`

`

`WO 2012/040643
`
`PCT/US2011/053120
`
`condition favors design geometries in which closing apposition of the leaflet surfaces is
`
`achieved with a minimum of traction force on the valve attachment points to the frame. To this
`
`end the inventive valve achieves this and other operational advantages by situating the operating
`
`tissue membrane to the exterior/abluminal surface of the valve frame rather than the
`
`interior/luminal space of the frame and by distributing the operating force loads of the valve
`
`along the curved edges forming the distal (downstream to flow direction) end of the frame. No
`
`other known percutaneously implantable or even surgical valve bioprosthesis utilizes this
`
`configuration with the tissue membrane mounted entirely upon the abluminal aspect of the
`
`device frame which carries the closed valve force loads along the distal formed edge of the
`
`frame corresponding to the lines of attachment of the leaflet membrane.
`
`Accordingly, in at least one embodiment, an implantable prosthetic valve is provided that
`
`includes a frame and tissue membrane. Advantageously, the tissue membrane resides to the
`
`exterior of the frame along an axial length of the frame in the flow direction of the implantable
`
`prosthetic valve when implanted. That is, the membrane sheet resides entirely exterior or
`
`abluminal to the frame when the valve is in the fully open condition and at least at all attachment
`
`points when the valve is partly or completely closed. The attachment points may comprise a
`
`plurality of sutures that are used to attach the membrane sheet to the frame at a variety of
`
`locations, such as at one or more intersections of the frame.
`
`The descriptions of the inventive valve are focused for the purpose of technical
`
`specification upon the replacement heart valve application, but will apply as well to the blood
`
`vessel valve device. By way of example, in addition to use of the valves described herein to
`
`replace heart valves, methods and devices described herein also provide for transcatheter
`
`implantation of a valve into the inferior vena cava (the principal conduit vein from the lower
`
`body inserting into the right heart) to act as an upstream substitute in part for the tricuspid valve.
`
`Such a valve device would be advantageously designed to be low in mass with large effective
`
`orifice. The inventive valve device is proposed as suitable to this purpose. Alternatively, the
`
`condition of right heart failure may be treated in part by interposing valves into the vein system
`
`farther upstream in the venous return flow, such as in the subclavian or principal iliac veins.
`
`Accordingly, in at least one embodiment, an implantable prosthetic valve is provided for
`
`controlling, at least in part, a flow of blood, comprising:
`
`a frame having an abluminal frame surface, a proximal end, and a distal end, wherein the
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`proximal end is situated at an inlet end of the frame relative to the flow of blood when
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`implanted, and wherein the distal end is situated at an outlet end of the frame relative to the flow
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`of blood when implanted, the frame having a tubular flow path through its interior; and
`
`- 5 -
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1615 of 2319
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`PCT/US2011/053120
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`a tissue membrane attached to the frame, the tissue membrane having an interior surface
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`and an exterior surface;
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`wherein the interior surface of the tissue membrane is situated exterior the abluminal
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`frame surface of the frame between the proximal end and distal end of the frame, when the valve
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`is in the fully open position, the interior surface of the tissue membrane intersecting the tubular
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`flow path of the frame when the tissue membrane is located in a closed position.
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`A percutaneous, trans-catheter prosthetic valve for implantation in a patient is provided,
`
`compnsmg:
`
`a frame including an abluminal surface extending between a proximal end of the frame
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`and a distal end of the frame, wherein the frame is collapsible and expandable and adapted for
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`trans-catheter delivery; and
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`a biocompatible tissue material mounted to the abluminal surface of the frame to form a
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`plurality of valve leaflets, wherein an entire interior surface of the biocompatible tissue material
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`between the proximal end of the frame and the distal end of the frame resides radially exterior to
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`the abluminal surface of the frame:
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`(a) at all points of attachment; and
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`(b) when the plurality of valve leaflets are in an operationally fully open position.
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`In at least one embodiment the frame comprises a metal alloy substantially configured as
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`tubular stent member. In at least one embodiment a proximal portion of the frame includes a
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`ring. In at least one embodiment a proximal portion of the frame comprises a circumferential
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`zig-zag of wire. In at least one embodiment a proximal portion of the frame includes a lattice.
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`In at least one embodiment the lattice is circumferentially continuous. In at least one
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`embodiment the lattice is circumferentially discontinuous. In at least one embodiment a distal
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`end of the frame includes two or more areas of axial continuity with the proximal end, wherein
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`the two or more areas of axial continuity comprise axially oriented projections. In at least one
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`embodiment the frame further comprises a distally positioned stabilization framework
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`comprising at least one of circumferential or radial continuity with the axially oriented
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`projections. In at least one embodiment the frame includes two or more regions of
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`circumferential discontinuity through which operating leaflets of the biocompatible tissue
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`material move radially inward and outward in closing and opening operation, respectively. In at
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`least one embodiment the biocompatible tissue material between the proximal end of the frame
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`and the distal end of the frame resides substantially adjacent the abluminal surface of the frame.
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`In at least one embodiment the biocompatible tissue material does not contact a luminal surface
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`of the frame. In at least one embodiment an exterior surface of the biocompatible tissue material
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`does not contact a luminal surface of the frame.
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`- 6 -
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1616 of 2319
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`In accordance with at least one embodiment, the frame can be a closed cell lattice type
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`construct of circumferentially corrugated/sinusoidal/zig-zag rings. In accordance with at least
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`one embodiment, the frame can be a wire loop with axial loops forming a support for each
`
`commissure. In at least one embodiment, the frame includes a proximal portion, wherein at least
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`some of the abluminal surface of the proximal portion includes a tissue sheet attached thereto.
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`In at least one embodiment, a prosthetic valve for implantation in a patient is provided,
`
`compnsmg:
`
`a frame including an abluminal surface extending between a proximal edge of the frame
`
`and a distal edge of the frame, the distal edge undulating axially to define at least two areas of
`
`circumferential discontinuity in the frame, wherein the frame is collapsible and expandable and
`
`adapted for trans-catheter delivery; and
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`a single layer of a biocompatible membrane material mounted to the abluminal surface of
`
`the frame to form leaflet portions, wherein the leaflet portions are collocated with the at least
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`two areas of circumferential discontinuity in the frame.
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`In at least one embodiment the leaflet portions are attached to the frame at least along
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`curved frame members formed by the distal edge of the frame and corresponding to the radially
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`outward boundaries of the leaflet cusps.
`
`In at least one embodiment, no portion of the biocompatible membrane material is
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`mounted to an interior surface of the frame. In at least one embodiment, the frame comprises a
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`metal alloy substantially configured as tubular stent member. In at least one embodiment, a
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`proximal portion of the frame includes a lattice to which the biocompatible membrane material
`
`is circumferentially mounted entirely upon the abluminal aspect of the tubular stent member. In
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`at least one embodiment, at least some proximal portion of the frame does not include
`
`biocompatible membrane material mounted to its luminal or abluminal surfaces. In at least one
`
`embodiment, the biocompatible membrane material extends between the proximal edge and the
`
`distal edge of the frame. In at least one embodiment, a distal portion of the frame further
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`includes a distally extending stabilizing framework comprising a plurality of axially oriented
`
`support members that each extend from a distally extending frame projection situated adjacent
`
`the at least two areas of circumferential discontinuity in the frame. In at least one embodiment,
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`the prosthetic valve further comprises a plurality of radial support members interconnecting the
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`axially oriented support members. In at least one embodiment, the prosthetic valve further
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`comprises a wire guide, wherein the wire guide is coaxially aligned with an axis of the valve,
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`and wherein the wire guide is configured to allow for a coaxial passage of a guide wire such that
`
`coaxial alignment of the distally extending stabilizing framework may be facilitated during valve
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`- 7 -
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1617 of 2319
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`deployment. In at least one embodiment, the wire guide comprises at least one of a ring and a
`
`tube.
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`A method of preparing a percutaneous, trans-catheter prosthetic valve is also provided,
`
`the method comprising mounting a single layer of a biocompatible tissue material to an
`
`abluminal surface of a trans-catheter deliverable frame such that an interior surface of the
`
`biocompatible tissue material between a proximal end of the trans-catheter deliverable frame and
`
`a distal end of the trans-catheter deliverable frame resides radially exterior to and substantially
`
`adjacent the abluminal surface of the trans-catheter deliverable frame. In at least one
`
`embodiment the method further comprises compressing and crimping the trans-catheter
`
`deliverable frame, with the biocompatible tissue material mounted thereto, upon a delivery
`
`catheter. In at least one embodiment the method further comprises implanting the trans-catheter
`
`deliverable frame with the biocompatible tissue material mounted thereto into a patient. In at
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`least one embodiment the trans-catheter deliverable frame comprises a stent. In at least one
`
`embodiment the method further comprises mounting the trans-catheter deliverable frame and the
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`biocompatible tissue material mounted thereto on a mandrel.
`
`In accordance with at least one embodiment, a method of constructing a prosthetic valve
`
`is provided, the method, comprising attaching a biocompatible membrane material to a
`
`collapsible and expandable frame to form a trans-catheter deliverable prosthetic valve, wherein
`
`an entire interior surface of the biocompatible membrane material is located exterior of the
`
`abluminal surface of the collapsible and expandable frame when leaflet portions of the
`
`biocompatible membrane material are in the valve's operationally open position. In at least one
`
`embodiment, the method further comprises associating the biocompatible prosthetic valve with a
`
`catheter.
`
`In at least one embodiment, a prosthetic trans-catheter deliverable valve is provided that
`
`does not include one or more biasing members within the inner flow channel of the valve. That
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`is, with the exception of the membrane during closure of the valve ( when the flow cycle is not
`
`antegrade from proximal to distal through the valve), the inner flow channel is devoid of flow
`
`channel obstructions.
`
`In at least one embodiment, a prosthetic trans-catheter valve includes a flat membrane
`
`sheet interconnected to a frame. In at least one embodiment, a flat membrane sheet is
`
`interconnected to the abluminal surface of a frame using a plurality of sutures, wherein at least
`
`some of the sutures are applied in a buttonhole suture pattern.
`
`Various components are referred to herein as "operably associated." As used herein,
`
`"operably associated" refers to components that are linked together in operable fashion, and
`
`- 8 -
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1618 of 2319
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`encompasses embodiments in which components are linked directly, as well as embodiments in
`
`which additional components are placed between the two linked components.
`
`As used herein, "at least one," "one or more," and "and/or" are open-ended expressions
`
`that are both conjunctive and disjunctive in operation. For example, each of the expressions "at
`
`least one of A, B and C," "at least one