USOO7276078B2
`
`US 7,276,078 B2
`(10) Patent No.:
`(12) Unlted States Patent
`
`Spenser et a1.
`(45) Date of Patent:
`Oct. 2, 2007
`
`(54) PARAVALVULAR LEAK DETECTION,
`SEALING, AND PREVENTION
`
`(75)
`
`Inventors: Benjamin Spenser, Caesarea (IL);
`.
`_
`.
`Edzfgsmel (IL)’
`’
`(73) Assignee: Edwards Lifesciences PVT, Irvine, CA
`(US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U30 1540’) by 434 days~
`
`4,345,340 A
`4,470,157 A
`4,574,803 A
`
`8/1982 Rosen
`9/ 1984 Love
`3/1986 Storz
`
`2
`,
`,
`4,655,771 A
`4,733,665 A
`i
`4,787,901 A
`4,796,629 A
`
`2031::
`au
`y
`4/1987 Wallsten
`3/1988 Palmaz
`gigset 31'
`11/1988 Baykut
`1/1989 Grayzel
`.
`(commued)
`FOREIGN PATENT DOCUMENTS
`
`(21) Appl. No.: 10/883,575
`
`DE
`
`195 32 846
`
`3/1997
`
`(22)
`
`Filed:
`
`Jun. 30, 2004
`
`(65)
`
`Prior Publication Data
`
`US 2006/0004442 A1
`
`Jan’ 5’ 2006
`
`(51)
`
`Int. Cl.
`(2006.01)
`A61F 2/24
`(52) us. Cl.
`................................................... .. 623/124
`(58) Field of Classification Search ....... .. 623/2.172.41
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`US PATENT DOCUMENTS
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`11/1968 Berry
`35811 15 A
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`3,714,971 A
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`3,755,823 A *
`9/1973 Hancock .................. .. 623/218
`45035349 A
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`
`(Continued)
`OTHER PUBLICATIONS
`
`Transcatheter Umbrella Closure of Valvular and Paravalvular
`Leaks, Hourihan et a1., Journal of the American College of Cardi-
`ology, v01. 20, N0. 6, pp. 1371-1377, (1992).
`
`Primary Examinerisuzette Gherbi
`(74) Attorney, Agent, or FirmiDavid L~ Hauser
`
`(57)
`
`ABSTRACT
`
`The present invention provides a series of new percutaneous
`concepts of paravalvular repairs including identifying the
`leak location, several repair techniques and finally built-in
`means for leak prevention, built on percutaneous valves. A
`catheter-delivered device locates cavities occurring between
`a prosthetic valve and the wall of the body vessel where the
`valve is implanted, the cavities producing paravalvular leaks
`diastoleS the device comprising at least one of a
`plurality of flexible wires, the wire having attached to it a
`balloon, wherein the balloon is pulled by the leak through
`the cavity and wherein the wire then serves to mark the
`.
`.
`ca‘my locauon'
`
`6 Claims, 20 Drawing Sheets
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060, US. Patent 8,992,608, Exhibit 2030
`
`Page 01 of 31
`
`Page 01 of 31
`
`

`

`US 7,276,078 B2
`
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
`
`4,878,495
`4,878,906
`4,883,458
`4,966,604
`4,979,939
`4,986,830
`4,994,077
`5,007,896
`5,026,366
`5,047,041
`5,059,177
`5,085,635
`5,089,015
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`5,332,402
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`5,411,552
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`5,480,424
`5,545,209
`5,554,185
`5,591,195
`5,716,417
`5,749,890
`5,855,597
`5,925,063
`5,957,949
`6,027,525
`6,132,473
`6,168,614
`6,171,335
`6,221,091
`6,245,102
`6,299,637
`6,302,906
`6,425,916
`6,440,164
`6,454,799
`6,458,153
`6,461,382
`6,468,660
`6,482,228
`6,488,704
`6,569,196
`6,605,112
`6,730,118
`6,769,434
`6,786,925
`6,790,229
`6,797,002
`6,821,297
`6,830,584
`6,830,585
`6,866,650
`6,872,223
`6,875,231
`6,893,460
`6,908,481
`6,951,571
`7,147,663
`2001/0002445
`2001/0007956
`2001/0021872
`2002/0029014
`2002/0032481
`2002/0042651
`2002/0107565
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`11/1989
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`3/1994
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`* 12/1994
`3/1995
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`8/1995
`1/1996
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`
`*
`
`Grayzel
`Lindemann et al.
`Shiber
`Reiss
`Shiber
`Owens et a1.
`Dobben
`Shiber
`Leckrone
`Samuels
`Towne et al.
`Cragg
`Ross
`Sabbaghian et al.
`Vince
`Boyles
`Shturman
`Teitelbaum
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`Pavcnik et al.
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`Roberts et a1.
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`Taheri et a1.
`Girard et al.
`Shaknovich
`Jayaraman
`Khosravi
`Leonhardt et al.
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`Khosravi
`Jayaraman
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`Garrison et a1.
`Di Matteo et al.
`Schreck
`Bailey et al.
`Cao
`Ogle et al.
`Norred ............... ..
`Connelly et al.
`Vesely
`Moll et al.
`Spenser et a1.
`Liddicoat
`Schoon
`Berreklouw
`Spence
`Snyders
`Seguin
`Artof
`Stevens
`Roberts
`Anduiza
`Spenser et a1.
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`Srivastava
`Berg et al.
`Vesely
`Letac et al.
`Bailey et al.
`Jayaraman
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`Liddicoat
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`
`.......... ..
`
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`
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`
`623/238
`
`9/2002
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`4/2003
`2003/0069492 A1
`6/2003
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`2/2004
`2004/0029436 A1
`5/2004
`2004/0093060 A1
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`10/2004
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`11/2004
`2004/0225353 A1
`11/2004
`2004/0225354 A1
`11/2004
`2004/0225355 A1
`12/2004
`2004/0260390 A1
`1/2005
`2005/0010287 A1
`1/2005
`2005/0021136 A1
`2/2005
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`2/2005
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`3/2005
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`3/2005
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`2005/0075584 A1
`4/2005
`2005/0075712 A1
`4/2005
`2005/0075717 A1
`4/2005
`2005/0075719 A1
`4/2005
`2005/0075724 A1
`4/2005
`2005/0075725 A1
`4/2005
`2005/0075730 A1
`4/2005
`2005/0075731 A1
`5/2005
`2005/0096738 A1
`5/2005
`2005/0113910 A1
`6/2005
`2005/0131438 A1
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`2005/0137683 A1
`6/2005
`2005/0137686 A1
`6/2005
`2005/0137692 A1
`6/2005
`2005/0137695 A1
`6/2005
`2005/0137701 A1
`6/2005
`2005/0143807 A1
`6/2005
`2005/0143809 A1
`7/2005
`2005/0165477 A1
`7/2005
`2005/0165479 A1
`9/2005
`2005/0197695 A1
`9/2005
`2005/0203549 A1
`9/2005
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`2005/0203618 A1
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`2005/0228495 A1
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`2005/0234546 A1
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`2005/0240200 A1
`10/2005
`2005/0240262 A1
`2/2006
`2006/0025854 A1*
`2/2006
`2006/0025855 A1*
`2006/0287717 A1* 12/2006
`
`Yang
`Abrams et al.
`Cribier
`Spenser et al.
`Sequin et al.
`Mourles et al.
`Tu
`
`Myers
`Williamson
`Ortiz
`Langberg
`Pavcnik
`Lobbi
`Berreklouw
`Seguin et al.
`Quijano
`Khairkhahan
`Duran
`McGuckin, Jr.
`Allen
`Stevens
`Sarac
`Macoviak
`Xie
`Seguin
`Arad
`Seguin
`Numamoto
`Siess
`Liddicoat
`Le
`Di Matteo
`Cali
`Biancucci
`Nguyen
`Bergheim
`Svanidze
`Rowe
`Myers
`Artof
`Cali
`Paniagua
`Cohn
`Hezi-Yamit et al.
`Salahieh
`Haug
`Salahieh
`Salahieh
`Pavcnik
`Salahieh
`Anduiza
`Drews
`Stacchino
`Realyvasquez
`Forster
`Sharkawy
`Macoviak
`Nugent
`Bergheim
`White
`..
`Lashinski et al.
`.. 623/1.25
`Lashinski et al.
`623/2.1
`Rowe et a1.
`............. .. 623/2.11
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`DE
`DE
`DE
`
`195 46 692
`198 57 887
`199 07 646
`10049812
`10049813
`
`6/1997
`7/2000
`8/2000
`4/2002
`4/2002
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`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`EP
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`EP
`FR
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`SU
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`1271508
`WO 91/17720
`WO 92/17118
`WO 93/01768
`WO 98/29057
`WO 99/33414
`WO 99/40964
`WO 99/47075
`WO 00/41652
`WO 00/47139
`WO 00/64380
`WO 01/49213
`WO 01/54625
`WO 01/62189
`
`4/2002
`4/2002
`6/1985
`12/1994
`7/1998
`12/2000
`4/2001
`7/2004
`7/2004
`11/2004
`9/2005
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`11/1986
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`10/1992
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`7/1999
`8/1999
`9/1999
`7/2000
`8/2000
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`7/2001
`8/2001
`8/2001
`
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`W0
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`WO 01/97715
`WO 02/41789
`WO 02/43620
`WO 02/47575
`W0 02/036048
`W0 03/003949
`W0 03/011195
`W0 03/094793
`WO 2004/058106
`WO 2004/089250
`WO 2004/089253
`WO 2004/093728
`WO 2004/105651
`WO 2005/002466
`WO 2005/004753
`WO 2005/009285
`WO 2005/011534
`WO 2005/011535
`WO 2005/023155
`WO 2005/027790
`WO 2005/046528
`WO 2005/046529
`WO 2005/048883
`WO 2005/096993
`
`* cited by examiner
`
`9/2001
`12/2001
`5/2002
`6/2002
`6/2002
`10/2002
`1/2003
`2/2003
`11/2003
`7/2004
`10/2004
`10/2004
`11/2004
`12/2004
`1/2005
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`5/2005
`5/2005
`6/2005
`10/2005
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`US 7,276,078 B2
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`US 7,276,078 B2
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`FIG. 3
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`US 7,276,078 B2
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`U.S. Patent
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`Sheet 5 of 20
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`US 7,276,078 B2
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`25
`
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`FIG. 5d
`
`Page 08 of 31
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`U.S. Patent
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`Sheet 6 0f 20
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`US 7,276,078 B2
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`Page 09 of 31
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`U.S. Patent
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`Sheet 7 0f 20
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`US 7,276,078 B2
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`Page 10 of 31
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`U.S. Patent
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`Sheet 8 0f 20
`
`US 7,276,078 B2
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`Page 11 of 31
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`U.S. Patent
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`Sheet 9 0f 20
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`US 7,276,078 B2
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`Page 12 of 31
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`Sheet 10 0f 20
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`US 7,276,078 B2
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`U.S. Patent
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`Sheet 11 0f 20
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`US 7,276,078 B2
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`US 7,276,078 B2
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`121
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`FIG. 12
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`172
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`FIG. 19d
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`US 7,276,078 B2
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`1
`PARAVALVULAR LEAK DETECTION,
`SEALING, AND PREVENTION
`
`FIELD OF THE INVENTION
`
`invention relates to implantable devices.
`The present
`More particularly it relates to the prevention, detection, and
`repair of paravalvular leaks around cardiac valve prostheses.
`
`BACKGROUND OF THE INVENTION
`
`Cardiac valve implantation is well known in the art. Less
`well addressed is how to detect possible leaks between the
`valve and surrounding blood vessel, how to seal such leaks,
`or how to design the valve such that it automatically seals
`the leaks.
`
`Machiraju in U.S. Pat. No. 5,554,184, entitled “HEART
`VALVE”, describes a heart valve and a technique for effect-
`ing valve replacement or repair, which partially or com-
`pletely replaces the mitral
`(or tricuspid) valve with an
`autologous graft from the pericardium, fascia lata or even
`the dura mater, or a bovine or porcine pericardial or other
`synthetic sheet material equivalent thereof, preferably in a
`configuration which substantially restores
`the original
`anatomy of the heart, including chordae tendineae attached
`to adjacent papillary muscles of the heart. Most preferably,
`a section of the patient’s pericardium is cut to a shape
`including two leaflets, with each leaflet having a trabecu-
`lated tier of chordae tendineae terminating in a spear-shaped
`tab. The two leaflets are cut out as a single unit, and the two
`far ends are sutured together to yield a bileaflet valve having
`appended chordae and tabs.
`Machiraju does not address leaks that can occur around
`the implanted valve.
`Schreck in U.S. Pat. No. 6,454,799, entitled, “MINI-
`MALLY—INVASIVE HEART VALVES AND METHODS
`
`OF USE”, describes expandable heart valves for minimally
`invasive valve replacement surgeries. In a first embodiment,
`an expandable pre-assembled heart valve includes a plasti-
`cally-expandable annular base having a plurality of upstand-
`ing commissure posts. A tubular flexible member including
`a prosthetic section and a fabric section is provided, with the
`prosthetic section being connected to the commissure posts
`and defining leaflets therebetween, and the fabric section
`being attached to the annular base. In a second embodiment,
`an expandable heart valve includes an annular tissue-engag-
`ing base and a subassembly having an elastic wireform and
`a plurality of leaflets connected thereto. The annular base
`and subassembly are separately stored and connected just
`prior to delivery to the host annulus. Preferably the leaflet
`subassembly is stored in its relaxed configuration to avoid
`deformation of the leaflets. The expandable heart valves may
`be implanted using a balloon catheter. Preferably the leaflets
`of the heart valves are secured to the commissure regions of
`the expandable stents using a clamping arrangement
`to
`reduce stress.
`Schreck also does not address leaks that can occur around
`
`the implanted valve.
`Amplatz in U.S. Pat. No. 6,638,257, entitled, “INTRA-
`VASCULAR FLOW RESTRICTOR,” describes an intra-
`vascular flow restrictor that comprises a braided tubular
`structure designed to be placed in the main pulmonary artery
`for limiting blood pressure in the lungs. The braided struc-
`ture is designed to be collapsed for placement in a delivery
`catheter, but when it is ejected from the delivery catheter, it
`assumes a substantially larger diameter disk shaped device
`having one or more longitudinal channels or passways
`therethrough.
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`Amplatz also does not address leaks that can occur around
`the implanted valve. In addition, Amplatz’s braided struc-
`tures are of a shape and size not appropriate for paravalvular
`leak detection and sealing. Their geometry is designed for
`the conditions of the transceptal hole and not appropriate for
`valve leakage.
`Patent Application No.
`in U.S.
`al.
`Spenser
`et
`20030153974, entitled “IMPLANTABLE PROSTHETIC
`VALVE”, describe a prosthesis device suitable for implan-
`tation in body ducts. The device comprises a support stent
`bring comprised of a deployable construction adapted to be
`initially crimped in a narrow configuration suitable for
`catheterization through a body duct to a target location and
`adapted to be deployed by exerting substantially radial
`forces from within by means of a deployment device to a
`deployed state in the target location, the support stent bring
`provided with a plurality of longitudinally rigid support
`beams of fixed length, and (2) a valve assembly comprising
`a flexible conduit having an inlet end and an outlet, made of
`pliant material attached to the support beams providing
`collapsible slack portions of the conduit at the outlet. When
`flow is allowed to pass through the valve prosthesis device
`from the inlet to the outlet, the valve assembly is kept in an
`open position, whereas a reverse flow is prevented as the
`collapsible slack portions of the valve assembly collapse
`inwardly to provide blockage to the reverse flow.
`Spenser et al. also do not address leaks that can occur
`around the implanted valve.
`With regard to the general topic of prosthetic valves,
`implantation is currently done either through open heart
`surgery or by use of newer percutaneous methods, some of
`which are described in the patents mentioned above. With
`both methods paravalvular leaks are a known side effect.
`One way to approach the leak problem is to identify the leak
`location and repair it. Another approach is to equip the
`prosthesis with means to prevent the leak (“self-sealing”
`prosthesis). Both these approaches are encompassed by the
`present invention.
`Percutaneous introduction of medical devices is a pre-
`ferred surgical procedure for it involves making only a very
`small perforation in the patient’s skin (usually in the groin
`or armpit area) under local anesthetic sedation. In contrast,
`surgical placement involves a large chest, surgical incision
`and requires general anesthesia, to expose a large portion of
`a patient’s thoracic region. Percutaneous introduction is
`therefore considered safer and less invasive.
`
`Percutaneous introduction of a leak detection and repair
`device or of a self-sealing valve resembles other known
`interventional cardiologic procedures. The percutaneous
`deployment procedure and device has an impact on several
`parameters of the product design, some of which are
`explained hereinafter.
`In summary, the present invention provides new concepts
`of percutaneous paravalvular repair,
`including means for
`identifying the leak location, repair techniques, and means
`for leak prevention that can be engineered into the prosthesis
`valve itself.
`
`SUMMARY OF THE INVENTION
`
`In accordance with a preferred embodiment of the present
`invention, a catheter-delivered device is provided for locat-
`ing cavities occurring between a prosthetic valve and the
`wall of the body vessel where the valve is implanted, the
`cavities producing paravalvular leaks during diastole. The
`device comprises at least one of a plurality of flexible wires,
`the wire having attached to it a balloon, wherein the balloon
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`US 7,276,078 B2
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`3
`is pulled by the leak through the cavity and wherein the wire
`then serves to mark the cavity location.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, a spacing element is
`provided to maintain the wires adjacent to the wall of the
`body vessel.
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a catheter-delivered
`stent for sealing cavities occurring between a prosthetic
`valve and the wall of the body vessel where the valve is
`implanted, the cavities producing paravalvular leaks during
`diastole. The stent, which is delivered via a guidewire to the
`cavity and held in place in the cavity by friction, comprises
`a support structure and an impermeable membrane,
`the
`membrane preventing the pas sage of fluids through the stent,
`thereby sealing the cavity.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the sealing stent is
`balloon-expandable and the membrane comprises a tab
`spring-hinged to the inside of the stent lumen and sized to
`occlude the lumen when closed. The tab is held open by the
`stent balloon during insertion and springs closed when the
`balloon is removed after the stent is expanded.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the sealing stent is
`self-expandable, wherein the membrane is a material cov-
`ering at least one end of the stent.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the stent is comprised
`of shape memory material.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the material is nitinol.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the stent is covered on
`its external walls with hooks comprised of shape memory
`material and which extend, upon insertion of the stent, into
`adjacent body vessel walls.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the distal end of the
`stent-delivery catheter is substantially perpendicular to the
`wall of the vessel at a point inside the cavity and the stent
`guidewire terminates in an anchoring mechanism that is
`inserted through the catheter and into the vessel wall,
`anchoring itself in the vessel wall and providing greater
`anchorage for the stent.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the anchoring mecha-
`nism is a hook comprised of shape memory material that is
`compressed for catheter delivery into the vessel wall, where-
`upon the hook extends out, anchoring the guidewire into the
`vessel wall.
`
`in accordance with another preferred
`Furthermore,
`embodiment of the present invention, the anchoring mecha-
`nism is a threaded point that is threaded into the vessel wall
`anchoring the guidewire into the vessel wall.
`Also provided in accordance with a preferred embodiment
`of the present invention,
`is a device for sealing cavities
`occurring between a prosthetic valve and the wall of the
`body vessel where the valve is implanted,
`the cavities
`producing paravalvular leaks during diastole. The device
`comprises a first guidewire threaded through the cavity, a
`second guidewire slidably coupled to the first guidewire and
`inserted such that the slidable coupling is moved to a desired
`point in the cavity, a first catheter inserted over the first
`guidewire to the point
`in the cavity, a second catheter
`inserted over the second guidewire to the desired point in the
`cavity, a first component of a two-component biological
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`adhesive inserted through the first catheter to the desired
`point, a second component of the two-component adhesive
`inserted through the second catheter to the desired point, the
`two components thereby mixing to form a plug that seals the
`cavity.
`in accordance with another preferred
`Furthermore,
`embodiment of the present invention, the device is adapted
`to apply an adhesive with more than two components.
`Furthermore,
`in accordance with another preferred
`embodiment of the present
`invention,
`instead of two
`guidewires and two catheters,
`a
`single catheter and
`guidewire are used for delivery, with the catheter comprising
`two lumens, each lumen providing delivery for one of the
`two-component adhesive components, and the catheter ter-
`minates in a mixer that forces the components to mix when
`they exit the catheter in the cavity, thereby creating the plug
`that seals the cavity.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, instead of two-com-
`ponent adhesive components being delivered via the cath-
`eters, a radiation-cured adhesive is delivered via one of the
`catheters and a radiation source is delivered via the other
`
`catheter, wherein the radiation source is applied to the
`adhesive to create the plug in the cavity.
`Also provided in accordance with a preferred embodiment
`of the present invention is a catheter-delivered assembly for
`sealing cavities occurring between a prosthetic valve and the
`wall of the body vessel where the valve is implanted, the
`cavities producing paravalvular leaks during diastole. The
`assembly is delivered via guidewire to the cavity and
`comprises two sealing stents connected by a suture, the
`suture running back up the catheter,
`the sealing stents
`comprising a stent structure and sealing membrane. One
`stent of the assembly is inserted underneath the cavity and
`the other stent is inserted inside the cavity, the membranes
`preventing the passage of fluids through the stent, thereby
`sealing the cavity and each stent helping anchor the other in
`place.
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a prosthetic valve with
`integrated sealing ring attached to the outside wall, the ring
`having a circumference greater than that of the valve and
`elastically conforming to seal cavities between the valve and
`the wall of the body vessel where the valve is implanted, the
`cavities producing paravalvular leaks during diastole.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the ring comprises a
`balloon.
`
`in accordance with another preferred
`Furthermore,
`embodiment of the present invention, the ring comprises a
`plurality of spring-wire tabs mounted adjacent
`to one
`another around the circumference of the valve and covered
`
`with an impermeable membrane. The tabs are folded against
`the body of the valve during catheter delivery, and, upon
`egress from the catheter, the tabs spring out to form the
`sealing ring.
`in accordance with another preferred
`Furthermore,
`embodiment of the present invention, the ring comprises a
`plurality of impermeable tabs mounted adjacent
`to one
`another around the circumference of the valve, and further
`comprises a balloon under the tabs. The tabs are folded down
`on the deflated balloon during catheter delivery, and, upon
`egress from the catheter, the balloon is inflated, thereby
`opening the tabs to form the sealing ring.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the ring comprises a
`plurality of impermeable tabs mounted adjacent
`to one
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`US 7,276,078 B2
`
`5
`another around the circumference of the valve, each tab
`spring-hinged to the valve. The tabs are folded against the
`body of the valve during catheter delivery, and, upon egress
`from the catheter, the tabs spring out to form the sealing ring.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the ring comprises at
`least one of a plurality of flexible, self-expanding sealing
`elements comprised of self-expanding mesh covered with an
`impermeable membrane.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the ring comprises at
`least one of a plurality of flexible, self-expanding sealing
`elements comprised of self-expanding mesh covered with an
`impermeable membrane.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the sealing ring com-
`prises modified struts of the stent, the modification com-
`prising geometrical constraints that, upon expansion of the
`stent, cause the struts to bend out from the stent body,
`thereby creating the sealing ring.
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a prosthetic valve with
`integrated sealing means,
`the sealing means comprising
`sutures attached around the perimeter of the valve and
`extending back out of the body. Patches can be pushed down
`the sutures and attached to the point where the suture is
`attached to the valve, thereby sealing any cavity existing
`between the valve and the wall of the body vessel where the
`valve is implanted, the cavities producing paravalvular leaks
`during diastole.
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a catheter-delivered
`prosthetic valve with integrated sealing means, the sealing
`means comprising an elastic stent that is first deployed and
`inside which the valve is deployed. The elastic stent seals
`any cavity existing between the valve and the wall of the
`body vessel where the valve is implanted,
`the cavities
`producing paravalvular leaks during diastole.
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a method for locating
`cavities between an implanted prosthetic valve and the wall
`of the body vessel where the valve is implanted, the cavities
`producing paravalvular leaks during diastole. The method
`comprises:
`inserting a balloon mounted on a flexible wire next to the
`valve,
`wherein the balloon is pulled by the leak through the
`cavity and wherein the wire then serves to mark the cavity
`location.
`
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a method for sealing
`cavities between an implanted prosthetic valve and the wall
`of the body vessel where the valve is implanted, the cavities
`producing paravalvular leaks during diastole. The method
`comprises:
`inserting an impermeable stent into the cavity,
`whereby the stent seals the cavity.
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a method for sealing
`cavities between an implanted prosthetic valve and the wall
`of the body vessel where the valve is implanted, the cavities
`producing paravalvular leaks during diastole. The method
`comprises:
`inserting a first guidewire into the cavity;
`running a loop attached to a second guidewire over the
`first guidewire to a point inside the cavity;
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`injecting one component of a two-component adhesive
`through a catheter over the first guidewire to the cavity; and
`injecting the second component of the two-component
`adhesive through a catheter over the second guidewire to the
`cavity,
`wherein the components combine to create an adhesive
`plug that seals the cavity.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, instead of the first
`adhesive component, a radiation-cured adhesive is injected
`and instead of the second adhesive component a radiation
`source is applied, thereby creating the adhesive plug.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, only one guidewire is
`used and the two components are inserted via separate
`lumens within a single catheter over the guidewire.
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a method for provid-
`ing integrated sealing capability in an implanted prosthetic
`valve and the wall of the body vessel where the valve is
`implanted, the cavities producing paravalvular leaks during
`diastole. The method comprises:
`providing an expandable elastic ring around the outside of
`the valve; and
`expanding the ring,
`wherein the ring seals any cavities.
`There is thus also provided in accordance with a preferred
`embodiment of the present invention, a method for sealing
`cavities between an implanted prosthetic valve and the wall
`of the body vessel where the valve is implanted, the cavities
`producing paravalvular leaks during diastole. The method
`comprises:
`inserting a sealing stent at the distal end of the cavity; and
`inserting a second sealing stent attached to the first stent
`into the cavity.
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`To better understand the present invention and appreciate
`its practical applications, the following Figures are provided
`and referenced hereafter. It should be noted that the Figures
`are given as examples only and in no way limit the scope of
`the invention as defined in the appended claims. Like
`components are denoted by like reference numerals.
`FIG. 1 illustrates an implanted valve with a cavity creat-
`ing a paravalvular leak and a device, in accordance with a
`preferred embodiment of the present invention, comprising
`a soft guidewire with an inflatable balloon and designed to
`identify the exact location of the paravalvular leak.
`FIGS. 2a and 2b depict a plurality of balloons on soft
`guidewires, in accordance with another preferred embodi-
`ment of the present invention, designed to identify paraval-
`vular leaks around an implanted valve.
`FIG. 3 illustrates a plurality of balloons on soft guidewires
`and kept along the perimeter of the blood vessel by a ring,
`in accordance with another preferred embodiment of the
`present invention, designed to identify paravalvular leaks
`around an implanted valve.
`FIGS. 4a to 40 depict the process, in accordance with
`another preferred embodiment of the present invention, of
`inserting a sealing stent over a guidewire to close a para-
`valvular leak.
`
`FIGS. 5a to 5d depict several types of sealing stents, in
`accordance with another preferred embodiment of the
`present invention.
`FIGS. 6a to 6d illustrate blocking a paravalvular leak with
`a sealing device,
`in accordance with another preferred
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`US 7,276,078 B2
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`7
`embodiment of the present invention, assisted by anchors,
`which attach the device to the aortic wall (or annulus).
`FIG. 7 illustrates an anchoring apparatus, in accordance
`with another preferred embodiment of the present invention,
`for achieving sealing as shown in FIG. 6, in this case by use
`of a screw, which is embedded into to the aortic wall (or
`annulus).
`FIGS. 8a to 8d depict a leak repair done, in accordance
`with another preferred embodiment of the present invention,
`using a two-component biological glue.
`FIG. 9 depicts a leak repair done, in accordance with
`another preferred embodiment of the present
`invention,
`using an ultra