(12) United States Patent
`US 6,730,118 B2
`(10) Patent N0.:
`
`Spenser et al. May 4, 2004 (45) Date of Patent:
`
`
`USOO6730118B2
`
`(54)
`
`IMPLANTABLE PROSTHETIC VALVE
`
`(75)
`
`Inventors: Benjamin Spenser, Caesarea (IL);
`Netanel Benichu, Nir Etzion (IL);
`Assaf Bash, Givat Ada (IL); Avraham
`Zakai, Zichron Yaacov (IL)
`
`(73)
`
`Assignee:
`
`Percutaneous Valve Technologies,
`Inc., Fort Lee, NJ (US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`Appl. N0.:
`Filed :
`
`10/270,252
`
`Oct. 11, 2002
`Prior Publication Data
`
`US 2003/0114913 A1 Jun. 19, 2003
`
`Related U.S. Application Data
`
`Continuation-in-part of application No. 09/975,750, filed on
`Oct. 11, 2001.
`
`Int. Cl.7 ................................................... A61F 2/06
`U.S. Cl.
`...................................................... 623/124
`Field of Search ............................... 623/125, 1.24,
`623/11
`
`References Cited
`
`(63)
`
`(51)
`(52)
`(58)
`
`(56)
`
`U.S. PATENT DOCUMENTS
`Kischer
`Ersek
`Boretos et al.
`Klawitter
`RoyKlawitter el al.
`Black et al.
`Pietsch et al.
`Dzemeshkevich et a1.
`Gabbay
`Thuroff et al.
`Taheri
`Alonso
`
`12/1970
`4/1972
`5/1981
`2/1983
`9/1983
`8/1985
`8/1986
`2/1987
`9/1987
`7/1988
`5/1989
`7/1989
`7/1991
`
`3,548,417
`3,657,744
`4,265,694
`4,373,216
`4,406,022
`4,535,483
`4,605,407
`4,643,732
`4,692,164
`4,759,758
`4,829,990
`4,851,001
`
`5,032,128>3>3>3>>3>3>3>>>3>>>
`
`8/1991 Lane
`5,037,434 A
`1/1992 Bolz et a1.
`5,080,668 A
`2/1994 Trescony et al.
`5,282,847 A
`11/1994 Kusuhara
`5,360,444 A
`5/1995 Andersen et al.
`5,411,552 A
`. [/1996 Quijano et al.
`5,500,014 A
`8/1996 Stevens
`5,545,214 A
`11/1996 Vanney et al.
`5,571,175 A
`1/1997 Taheri et al.
`5,591,195 A
`3/1997 Trescony et al.
`5,607,464 A
`3/1997 Quijano et al.
`5,609,626 A
`' /1998 Leone et 81.
`5,728,068 A
`5/1998 Shaknovich ................ 606/198
`5,749,890 A *
`11/1998 Andersen et al.
`5,840,081 A
`1/1999 Bessler et al.
`5,855,601 A
`1/1999 Angell
`5,855,602 A
`10/2000 Williams et al.
`6,132,473 A
`9/2002 Schreck
`6,454,799 B1
`10/2002 Bailey
`6,458,153 B1
`6,482,228 B1 * 11/2002 Norred ...................... 623/217
`
`* cited by examiner
`
`Primary Examiner—Corrine McDermott
`Assistant Examiner—William H Matthews
`(74) Attorney, Agent, or Firm—William H. Dippert; Reed
`Smith LLP
`
`(57)
`
`ABSTRACT
`
`A valve prosthesis device is disclosed suitable for implan-
`tation in body ducts. The device comprises a support stent,
`comprised of a deployable construction adapted to be ini-
`tially crimped in a narrow configuration suitable for cath—
`eterization through the 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, and 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. The support stent
`is provided with a plurality of
`longitudinally rigid support beams of fixed length. 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 providing blockage to the reverse flow.
`
`9 Claims, 53 Drawing Sheets
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 1 of 70
`
`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 1 of 70
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`US. Patent
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`May 4, 2004
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 2 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 2 of 70
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 3 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 3 of 70
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 4 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 4 of 70
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`US. Patent
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`May 4, 2004
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`US 6,730,118 B2
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`US. Patent
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`US 6,730,118 B2
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`FIG 60
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 6 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 6 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 7 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 8 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 8 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 9 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 9 of 70
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`US. Patent
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`US. Patent
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`US. Patent
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 13 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 13 of 70
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`US. Patent
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`US 6,730,118 132
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 14 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 14 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 15 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 15 of 70
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 17 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 17 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 18 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 18 of 70
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`US. Patent
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`May 4, 2004
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 19 of 70
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 20 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 20 of 70
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 21 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 21 of 70
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`US. Patent
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`May 4, 2004
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`US 6,730,118 B2
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`346
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 22 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 22 of 70
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`US. Patent
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`US. Patent
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`US. Patent
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`US. Patent
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 28 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 28 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 30 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 30 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 31 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 31 of 70
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`US. Patent
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`US. Patent
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 34 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 34 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 35 of 70
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 36 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 36 of 70
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`US. Patent
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`US. Patent
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 42 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 42 of 70
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`US. Patent
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 44 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 44 of 70
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`US. Patent
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 46 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 46 of 70
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 47 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 47 of 70
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`US. Patent
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`US. Patent
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`US. Patent
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 53 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 53 of 70
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`US. Patent
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`US 6,730,118 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 54 of 70
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`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 54 of 70
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`

`

`US 6,730,118 B2
`
`1
`IMPLANTABLE PROSTHETIC VALVE
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`This application is a continuation-in-part of co-pending
`US. patent application Ser. No. 09/975,750, filed Oct. 11,
`2001.
`
`FIELD OF THE INVENTION
`
`invention relates to implantable devices.
`The present
`More particularly, it relates to a valve prosthesis for cardiac
`implantation or for implantation in other body ducts.
`BACKGROUND OF THE INVENTION
`
`There are several known prosthetic valves that have been
`previously described. US. Pat. No. 5,411,552 (Andersen et
`a1.), entitled VALVE PROSTHESIS FOR IMPLANTATION
`IN THE BODY AND CATHETER FOR IMPLANTING
`SUCH VALVE PROSTHESIS, discloses a valve prosthesis
`comprising a stent made from an expandable cylinder-
`shaped thread structure comprising several spaced apices.
`The elastically collapsible valve is mounted on the stent with
`the commissural points of the valve secured to the projecting
`apices, which prevents the valve from turning inside out.
`Deployment of the valve can be achieved by using an
`inflatable balloon which in its deflated state is used to carry
`about it the valve structure to its position and, when inflated,
`deploys the stent in position to its final size. See, also, US
`Pat. No. (3,168,614 (Andersen et al.) entitled VALVE PROS-
`THESIS FOR IMPLANTATION IN THE BODY and US.
`Pat. No. 5,840,081 (Andersen et a1.), entitled SYSTEM
`AND METHOD FOR IMPLANTING CARDIAC
`VALVES.
`
`In PCT/EP97/07337 (Letac, Cribier et a1.), published as
`WO 98/29057, entitled VALVE PROSTHESIS FOR
`IMPLANTATION IN BODY CHANNELS,
`there is dis-
`closed a valve prosthesis comprising a collapsible valve
`structure and an expandable frame on which the valve
`structure is mounted The valve structure is composed of a
`valvular tissue compatible with the human body and blood,
`the valvular tissue being sufficiently supple and resistant to
`allow the valve structure to be deformed from a closed state
`to an opened state. The valvular tissue forms a continuous
`surface and is provided with guiding means formed or
`incorporated within, the guiding means creating stiflened
`zones which induce the valve structure to follow a patterned
`movement in its expansion to its opened state and in its
`turning back to its closed state, The valve structure can be
`extended to an internal cover which is fastened to the lower
`part of the valve structure to prevent regurgitation.
`There are several known methods currently used for
`replacing aortic valves and several types of artificial pros-
`thetic devices. Mechanical valves are commonly used in
`several different designs (single and double flap) manufac—
`tured by well-known companies such as St. Jude, Medtronic,
`Sulzer, and others. Some of the main disadvantages of these
`devices are:
`a need for permanent
`treatment of
`anticoagulants, noisy operation, and a need for a large-scale
`operation to implant.
`There is a wide range of biologically based valves made
`of natural valves or composed of biological materials such
`as pericardial tissue. These too are made and marketed by
`well-known companies such as Edwards Lifesciences,
`Medtronic, Sulzer, Sorin, and others.
`Polymer valves are new and are not yet in use, but several
`companies are in the process of developing such products. A
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`new type of prosthesis is being considered, based on artifi—
`cial polymer materials such as polyurethane.
`The present invention introduces several novel structural
`designs for implantable valves. An aspect of the present
`invention deals with the possibility of implanting the valve
`percutaneously, i.e., inserting the valve assembly on a deliv-
`ery device similar to a catheter, then implanting the valve at
`the desired location via a large blood vessel such as the
`femoral artery, in a procedure similar to other known inter-
`ventional cardiovascular procedures. The percutaneous
`deployment procedure and device has an impact on the
`product design in several parameters, some of which are
`explained hereinafter.
`The percutaneous implantation of medical devices and
`particularly prosthetic valves is a preferred surgical proce-
`dure for it involves making a very small perforation in the
`patient’s skin (usually in the groin or armpit area) under
`local anesthetic and sedation, as opposed to a large chest
`surgery incision, which requires general anesthesia, opening
`a large portion of the chest, and cardiopulmonary bypass.
`This percutaneous procedure is therefore considered safer.
`The present invention provides a series of new concepts
`in the field of aortic valves and other human valves.
`
`SUMMARY OF THE INVENTION
`
`
`
`it is therefore thus provided, in accordance with a pre-
`ferred embodiment of the present invention, a valve pros—
`thesis device suitable for implantation in body ducts, the
`device comprising:
`a support stent, comprised of a deployable construction
`adapted to be initially crimped in a narrow configura—
`ion suitable for catheterization through the body duct
`0 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
`arget location, the support stent provided with a plu-
`rality of longitudinally rigid support beams of fixed
`ength; and
`a valve assembly comprising a flexible conduit having an
`inlet end and an outlet, made ofpliant material attached
`0 the support beams providing collapsible slack por—
`ions of the conduit at the outlet,
`whereby when [low is allowed to pass through the valve
`arosthesis device from the inlet to the outlet the valve
`assembly is kept in an open position, whereas a reverse
`ow is prevented as the collapsible slack portions of the
`valve assembly collapse inwardly providing blockage
`0 the reverse flow.
`Furthermore,
`in accore ance with another preferred
`embodimen of the present
`invention,
`the support stent
`comprises an annular frame.
`Furthermore,
`in accore ance with another preferred
`embodimen of the present invention, said valve assembly
`has a tricuspid configuration.
`Furthermore,
`in accore ance with another preferred
`embodimen of the present invention, said valve assembly is
`made from 3iocompatible material.
`Furthermore,
`in accore ance with another preferred
`embodimen of the present invention, the valve assembly is
`made from aericardial tissue, or other biological tissue.
`Furthermore,
`in accorc ance with another preferred
`embodimen of the present invention, said valve assembly is
`made from 3iocompatible polymers.
`Furthermore,
`in accorc ance with another preferred
`embodimen of the present invention, the valve assembly is
`made from materials selected from the group consisting of
`polyurethane and polyethylene tereplitlialate (PET).
`
`
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 55 of 70
`
`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 55 of 70
`
`

`

`US 6,730,118 B2
`
`1 another preferrec
`he support beams are
`ially parallel so as to
`mbly.
`1 another preferrec
`he support beams are
`tching or tying of the
`
`1 another preferrec
`he support beams are
`nt.
`
`1 another preferrec
`said valve assembly is
`
`1 another preferrec
`said valve assembly is
`
`3
`in accordance wi
`Furthermore,
`1 another preferrec
`emboc iment of the present invention,
`said valve assembly
`comprises a main body made from PET (polyethylene
`polyurethane.
`tereph halate) and leaflets made from
`Furthermore,
`in accordance wi
`1 another preferrec
`embo iment of the present invention
`said support stent is
`made rom nickel titanium.
`Furthermore,
`in accordance wi
`embociment of the present invention,
`substantially equidistant and substan
`provide anchorage for the valve asse
`Furthermore,
`in accordance wi
`embociment of the present invention,
`provided with bores so as to allow sti
`valve assembly to the beams.
`Furthermore,
`in accordance wi
`emboc iment of the present invention,
`chemically adhered to the support ste
`Furthermore,
`in accordance wi
`emboc iment of the present invention,
`rivetec to the support beams.
`Furthermore,
`in accordance wi
`emboc iment of the present invention,
`stitched to the support beams.
`Furthermore,
`in accordance wi
`1 another preferrec
`said beams are manu-
`emboc iment of the present invention,
`factured by injection using a mold, or by machining.
`Furthermore,
`in accordance wi
`1 another preferrec
`emboc iment of the present invention,
`said valve assembly is
`rolled
`over the support stent at the inlet.
`Furthermore,
`in accordance wi
`emboc iment of the present invention, said valve device is
`manufactured using forging or dipping techniques.
`Furthermore,
`in accordance wi
`1 another preferrec
`embo iment of the present invention,
`said valve assembly
`leaflets are longer than needed to exactly close the outlet,
`thus when they are in the collapsed sta
`e substantial portions
`of the leaflets fall on each other creat
`ing better sealing.
`Furthermore,
`in accordance wi
`1 another preferrec
`emboc iment of the present invention,
`said valve assembly is
`made ‘rom coils of a polymer, coated
`by a coating layer of
`same polymer.
`in accordance wi
`Furthermore,
`emboc iment of the present invention,
`urethane.
`in accordance wi
`Furthermore,
`] another preferree
`embo iment of the present invention
`, the support stent is
`provided with heavy metal markers so
`as to enable tracking
`ition and orientation.
`and determining the valve device pos
`Furthermore,
`in accordance wi
`1 another preferre
`embociment of the present invention, the heavy metal mark—
`iridium, or tantalum.
`ers are selected from gold, platinum,
`Furthermore,
`in accordance wi
`1 another preferre
`embociment of the present invention, the valve assembly
`leaflets are provided with radio-opaque material at the outlet,
`so as to help tracking the valve device operation in vivo.
`Furthermore,
`in accordance wi
`1 another preferrec
`embociment of the present
`invention, said radio-opaque
`material comprises gold thread.
`Furthermore,
`in accordance wi
`emboc iment of the present invention,
`support stent, when fully deployed is
`about 19 to about 25 mm.
`Furthermore,
`in accordance wi
`embociment of the present invention,
`support stent may be expanded from
`mm.
`
`
`
`
`4
`in accordance with another preferred
`Furthermore,
`embodiment of the present invention, the support beams are
`provided with bores and wherein the valve assembly is
`attached to the support beams by means of U-shaped rigid
`members that are fastened to the valve assembly and that are
`provided with extruding portions that fit into matching bores
`on the support beams.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention,
`the support beams
`comprise rigid support beams in the form of frame
`construction, and the valve assembly pliant material
`is
`inserted through a gap in the frame and a fastening rod is
`inserted through a pocket formed between the pliant material
`and the frame and holds the valve in position.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the main body of the
`valve assembly is made from coiled wire coated with
`coating material.
`in accordance with another preferred
`Furthermore,
`embodiment of the present invention, the coiled wire and the
`coating material is made from polyurethane.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, a strengthening wire is
`interlaced in the valve assembly at the outlet of the conduit
`so as to define a fault line about which the collapsible slack
`portion of the valve assembly may flap.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the strengthening wire
`is made from nickel titanium alloy.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, there is provided a
`valve prosthesis device suitable for implantation in body
`ducts, the device comprising a main conduit body having an
`inlet and an outlet and pliant leaflets attached at the outlet so
`that when a [low passes through the conduit from the inlet
`to the outlet the leaflets are in an open position allowing the
`flow to exit the outlet, and when the flow is reversed the
`leaflets collapse so as to block the outlet, wherein the main
`body is made from PET and collapsible leaflets are made
`form polyurethane.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, support beams made
`from polyurethane are provided on the main body and
`wherein the leaflets are attached to the main body at the
`support beams.
`in accordance with another preferred
`Furthermore,
`embodiment of the present invention, said support beams are
`chemically adhered to the main body.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, there is provided a
`valve prosthesis device suitable for implantation in body
`ducts, the device comprising:
`a support stent, comprised of a deployable construction
`adapted to be initially erimped in a narrow configura-
`tion suitable for catheterization through the 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 provided with a plu—
`rality of longitudinally rigid support beams of fixed
`length;
`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 por-
`tions of the conduit at the outlet; and
`substantially equidistant rigid support beams interlaced or
`attached to the slack portion of the valve assembly
`material, arranged longitudinally.
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`1 another preferrec
`
`
`
`1 another preferree
`said polymer is poly-
`
`1 another preferrec
`the diameter of saic
`in the range of from
`
`1 another preferrec
`the diameter of saic
`about 4 to about 25
`
`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 56 of 70
`
`Edwards Lifesciences Corporation, et al. Exhibit 1023, p. 56 of 70
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`

`

`US 6,730,118 B2
`
`5
`in accordance with another preferrec
`Furthermore,
`embodiment of the present invention, there is provided a
`crimping device for crimping the valve device describec
`above or in claim 1,
`the crimping device comprising a
`plurality of adjustable plates that resemble a typical SLR
`(Single Lens Reflex) camera variable restrictor, each pro-
`vided with a blade, that are equally dispersed in a radia
`symmetry but each plate moves along a line passing off an
`opening in the center, all plates equidistant from that center
`opening.
`in accordance with another preferrec
`Furthermore,
`embodiment of the present invention, the multiple plates are
`adapted to move simultaneously by means of a lever anc
`transmission.
`in accordance with another preferrec
`Furthermore,
`embodiment of the present invention, there is provided a
`method for deploying an implantable prosthetic valve device
`from the retrograde approach (approaching the aortic valve
`from the descending aorta) or from the antegrade approach
`(approaching the aortic valve from the left ventricle after
`performing a trans—septa] puncture) at
`the natural aortic
`valve position at
`the entrance to the left ventricle of a
`myocardium of a patient, the method comprising the steps
`of:
`
`
`
`(a) providing a balloon catheter having a proximal end
`and a distal end, having a first and second indepen-
`dently inflatable portions,
`the first inflatable portion
`located at the distal end of the catheter and the second
`inflatable portion adjacently behind the first inflatable
`portion;
`(b) providing a guiding tool for guiding the balloon
`catheter in the vasculature of the patient;
`(c) providing a deployable implantable valve prosthesis
`device adapted to be mounted on the second inflatable
`portion of the balloon catheter;
`(d)
`for
`the retrograde approach, guiding the balloon
`catheter through the patient’s aorta using the guiding
`tool, the valve device mounted over the second inflat-
`able portion of the balloon catheter until
`the first
`inflatable portion of the balloon catheter is inserted into
`the left ventricle, whereas the second inflatable portion
`of the balloon catheter is positioned at the natural aortic
`valve position;
`(e) for the antegrade approach, guiding the balloon cath—
`eter through the patient’s greater veins, right atrium,
`left atrium, and left ventricle using the guiding tool, the
`valve device mounted over the second inflatable por—
`tion of the balloon catheter until
`the first inflatable
`portion of the balloon catheter is inserted into the left
`ventricle, whereas the second inflatable portion of the
`balloon catheter is positioned at the natural aortic valve
`position;
`inflatable portion of the balloon
`inflating the first
`catheter so as to substantially block blood flow through
`the natural aortic valve and anchor the distal end of the
`balloon catheter in position;
`(g) inflating the second inflatable portion of the balloon
`catheter so as to deploy the implantable prosthetic
`valve device in position at
`the natural aortic valve
`position;
`(h) deflating the first and second inflatable portions of the
`balloon catheter; and
`(i) retracting the balloon catheter and removing it from the
`patient’s body.
`Furthermore,
`in accordance with another preferred
`embodiment of the present invention, the guiding tool com—
`prises a guide Wire.
`
`(f)
`
`6
`in accordance with another preferred
`Furthermore,
`embodiment of the present invention, there is provided a
`method for deploying an implantable prosthetic valve device
`at the natural aortic valve position at the entrance to the left
`ventricle of a myocardium of a patient, the method com-
`prising the steps of:
`(a) providing a balloon catheter having a proximal end
`and a distal end, having a first and second indepen-
`dently inflatable portions,
`the first inflatable portion
`located at the distal end of the catheter and the second
`inflatable portion adjacently behind the first inflatable
`portion;
`(b) providing a guiding tool for guiding the balloon
`catheter in the vasculature of the patient;
`(c) providing a deployable implantable val