WO92/17118
`
`PCT /US92/02599
`
`- 27 -
`
`The apparatus of claim 6 wherein the
`8.
`positioning means includes means for selectively
`inflating and deflating the positioning balloons
`whereby the guiding catheter will move clockwise about
`the anchoring balloon when one of the positioning
`balloons is inflated, and the guiding catheter will
`move counterclockwise about the anchoring balloon when
`the other positioning balloon is inflated.
`9.
`The apparatus of claim 8 wherein the
`means for inflating and deflating the positioning
`balloons are operable syncronously so that when one of
`the balloons is being deflated the other is being
`inflated.
`The apparatus of claim 3 wherein the
`10.
`deposit removal tool includes an elongated shaft.
`11.
`The apparatus of claim 10 further
`comprising a positioning catheter carried within the
`guiding catheter, the positioning catheter being
`rotatable with respect to the guiding catheter and
`including an off-center lumen in which the shaft of
`the deposit removal tool is closely received, whereby
`rotation of the positioning catheter allows selective
`positioning of the deposit removal tool.
`12.
`The apparatus of claim 1 wherein the
`deposit removal tool includes a distal tip portion, an
`elongated shaft portion extending proximally from the
`tip, and a catheter disposed about the shaft portion,
`the catheter having a distal end adjacent the distal
`tip portion through which dislodged deposits and blood
`may be aspirated.
`13.
`The apparatus of claim 12 further
`comprising means for filtering and returning the
`aspirated blood to the patient.
`14.
`The apparatus of claim 1 wherein the
`deposit removal tool comprises a rotatable cutting
`
`IPR2020-01454 Page 00722
`
`

`

`W092/17118
`
`PCT/US92/02S99
`
`- 28 -
`
`device.
`The apparatus of claim 1 wherein the
`15.
`deposit removal tool comprises a rotatable abrading
`device.
`The apparatus of claim 1 wherein the
`16.
`deposit removal tool comprises an ultrasonic
`vibrations generator and a wire capable of conveying
`such ultrasonic vibrations connected to the generator
`and having a distal end locatable adjacent the aortic
`valve.
`The apparatus of claim 1 wherein the
`17.
`deposit removal tool comprises a high voltage power
`source and a pair of electrical discharge electrodes
`positionable adjacent the aortic valve.
`18.
`The apparatus of claim 1 wherein the
`deposit removal tool comprises a laser and an optical
`fiber connected to the laser.
`The apparatus of claim 4 including a
`19.
`collapsable guiding catheter insertion sleeve having a
`distal end portion attached to the intermediate
`portion of the circumferential band.
`20.
`The apparatus of claim 19 wherein the
`collapsable insertion sleeve is wider proximally than
`it is in its distal end portion, so that it receives
`the guiding catheter closely only in the distal end
`portion, allowing easy insertion and withdrawal of the
`guiding catheter through the insertion sleeve.
`21.
`The apparatus of claim 3 wherein the
`attachment means comprises first and second straps,
`each having a first end attached to the anchoring
`balloon and a second end attached to the guiding
`catheter, the straps being attached so that as the
`guiding catheter is rotated with respect to the
`anchoring balloon one of the straps will wind up on
`the guiding catheter and the other will unwind off the
`
`IPR2020-01454 Page 00723
`
`

`

`WO92/17118
`
`PCT/US92/02599
`
`29 -
`
`guiding catheter, causing the guiding catheter to move
`about the periphery of the anchoring balloon.
`22.
`The apparatus of claim 21 wherein the
`first strap comprises two such straps straddling the
`second strap.
`The apparatus of claim 1 wherein the
`23.
`anchoring balloon catheter includes an inflatable
`balloon having proximal and distal portions, the
`distal portion of the balloon being inflatable to a
`diameter larger than the proximal portion.
`24.
`The apparatus of claim 23 wherein the
`valve is of the type having multiple leaflets with
`superior and inferior surfaces, the distal and
`proximal portions of the balloon defining a shoulder
`that is engagable with the inferior surface of the
`valve leaflets to support the leaflets as deposits are
`removed from the superior surface thereof.
`25.
`The apparatus of claim 24 wherein the
`proximal portion of the balloon is generally elongated
`and cylindrical in shape and having an outer surface,
`the shoulder being formed by attaching a secondary
`distal balloon portion to the outer surface of the
`proximal balloon portion.
`26.
`The apparatus of claim 24 wherein the
`balloon has a longitudinal axis, the shoulder portion
`of the balloon being made of a stretchable material so
`that it can conform to the inferior surface of the
`leaflet, other portions of the balloon being
`constructed to be substantially non-stretchable in a
`direction perpendicular to the longitudinal axis.
`27.
`The apparatus of claim 1 wherein the
`anchoring balloon catheter comprises an inflatable
`helically coiled tube and securing means for securing
`windings of the helically coiled tube with respect to
`one another in a desired configuration.
`
`IPR2020-01454 Page 00724
`
`

`

`WO92/17118
`
`PCT/US92/02599
`
`- 30 -
`
`The apparatus of claim 27 wherein the
`28.
`securing means comprises a flexible skin attached to
`the turns of the coil.
`The apparatus of claim 1 further
`29.
`including a cardiopulmonary bypass system comprising a
`vein access catheter insertable into a vein to allow
`removal of blood therefrom, oxygenator means for
`oxygenating such blood, an artery access catheter
`insertable into an artery, and pump means for
`returning the blood through the artery access catheter
`to the artery.
`The apparatus of claim 29 wherein the
`30.
`anchoring balloon catheter includes a catheter having
`proximal and distal ends and a lumen, the lumen being
`open at the distal end of the catheter, the proximal
`end of the catheter lumen being operatively connected
`to the pump means so that when the anchoring balloon
`catheter is fixated across the aortic valve blood may
`be removed through such lumen and returned to the
`artery.
`The apparatus of claim 29 wherein the
`31.
`cardiopulmonary bypass system includes a filter and a
`heat exchanger through which the blood passes before
`it is returned to the artery.
`32.
`The apparatus of claim 29 further
`including a left ventricle access catheter insertable
`through the iliac vein, vena cava, through the right
`atrium and left atrium to the left ventricle, the left
`ventricle access catheter being operatively
`connectable to the pump means to allow blood flow from
`the left ventricle and its return to the artery.
`33.
`The apparatus of claim 32 wherein the
`vein access catheter and the left ventricle access
`catheter are arranged in one catheter.
`34.
`The apparatus of claim 33 wherein the
`
`IPR2020-01454 Page 00725
`
`

`

`W092/17118
`
`PCT/US92/02S99
`
`- 31
`
`vein access catheter and the left ventricle access
`catheter are arranged in a single lumen catheter
`having orifices in a wall thereof to define a distal
`end of the vein access catheter.
`35.
`The apparatus of claim 33 wherein the
`vein access catheter and the left ventricle access
`catheter are arranged in a double lumen catheter.
`The apparatus of claim 33 wherein the
`36,
`vein access catheter and the left ventricle access
`catheter are arranged in a co-axial double lumen
`catheter.
`The apparatus of claim 1 further
`37.
`including ultrasound transducing means disposed within
`the anchoring balloon for imaging the aortic valve,
`the location of the deposit removal tool, and the
`location of the deposits to be removed.
`38.
`The apparatus of claim 37 wherein the
`ultrasound transducing means comprises a phased array
`transducer comprised of an array of individual
`acoustic elements.
`39.
`The apparatus of claim 37 wherein the
`ultrasound transducing means comprises an echo
`transducer and a rotatable mirror element positionable
`in the anchoring balloon catheter.
`40.
`The apparatus of claim 37 wherein the
`anchoring balloon catheter includes a catheter lumen,
`the ultrasound transducing means being carried by a
`catheter positionable within the lumen of the
`anchoring balloon catheter and being movable distally
`and proximally within the lumen.
`41.
`The apparatus of claim 37 wherein the
`anchoring balloon catheter includes a central
`catheter, the ultrasound transducing means being
`carried by the central catheter.
`42.
`The apparatus of claim 3 wherein the
`
`IPR2020-01454 Page 00726
`
`

`

`W092/17118
`
`PCT/US92/02S99
`
`- 32
`
`positioning means includes a pair of cords attached
`distally to the anchoring balloon, and pulleys mounted
`on the guiding catheter and the anchoring balloon, the
`cords being threaded through the pulleys so that
`pulling on a first of the cords and releasing the
`second cord will cause the guiding catheter to move
`clockwise about the anchoring balloon and, pulling the
`second cord and releasing the first cord will cause
`the guiding catheter to move counterclockwise about
`the anchoring balloon.
`43.
`The apparatus of claim 1 wherein the
`anchoring balloon catheter includes a catheter having
`a distal end and a lumen, the lumen being open at the
`distal end of the catheter, and has a check valve
`opening into the aorta.
`44.
`The apparatus of claim 1 wherein the
`anchoring balloon comprises an inflatable helically
`coiled tube defining a distally open lumen.
`45.
`The apparatus of claim 44 wherein the
`helically coiled tube includes a thin skin thereon to
`hold windings of the helically coiled tube in position
`with respect to one another.
`46.
`The apparatus of claim 45 wherein the
`anchoring balloon includes check valve means for
`permitting blood to flow through the lumen out of the
`heart's left ventricle and substantially preventing
`blood from flowing through such lumen back into the
`left ventricle.
`The apparatus of claim 46 wherein the
`47.
`check valve means is disposed on the skin of the
`helically coiled tube.
`48.
`The apparatus of claim 46 wherein the
`check valve means comprises a leaflet-type valve
`disposed across the lumen of the anchoring balloon.
`49.
`The apparatus of claim 48 wherein the
`
`IPR2020-01454 Page 00727
`
`

`

`WO92/17118
`
`PCT/US92/02599
`
`- 33 -
`
`leaflet-type valve is disposed across the lumen at the
`proximal end of the anchoring balloon.
`50.
`The apparatus of claim 44 further
`comprising a screw-type pump means disposed in the
`lumen for pumping blood across the aortic valve.
`51.
`The apparatus of claim 50 wherein the
`screw-type pump means comprises two or more screw-type
`pumps operating in parallel, each having an intake
`drawing blood distally from the lumen and an outlet
`discharging the blood proximally into the aorta.
`52.
`The apparatus of claim 50 further
`comprising a second screw-type pump means for
`withdrawing blood from ~djacent the deposit removal
`tool, and for filtering such blood and returning it to
`the aorta.
`The apparatus of claim 52 wherein the
`53.
`second screw-type pump means includes catheter means
`defining a blood flow path that is operatively
`isolated from the open lumen of the anchoring balloon
`and the first screw-type pump means, the catheter
`means including a distal end located adjacent the
`deposit removal tool and a proximal portion connected
`to an inlet of the second screw-type pump means, the
`second screw-type pump means further including an
`outlet to the aorta.
`54.
`The apparatus of claim 3 wherein the
`attachment means securing the tool to the anchoring
`balloon prevents any substantial movement of the
`guiding catheter with respect to the anchoring balloon
`catheter, the tool being positionable with respect to
`the aortic valve by rotating the. anchoring balloon
`catheter.
`Apparatus for in vivo removal of
`55.
`deposits from an aortic valve, comprising:
`an anchoring balloon catheter fixatable across
`
`IPR2020-01454 Page 00728
`
`

`

`WO92/17118
`
`PCT/US92/02599
`
`- 34 -
`
`the aortic valve;
`a deposit removal tool having an elongated shaft;
`a guiding catheter through which the tool may be
`advanced toward the aortic valve, the guiding catheter
`including a distal end portion;
`a circumferential band having first and second
`ends respectively attached to the anchoring balloon,
`and an intermediate portion operatively connected to
`the guiding catheter;
`a pair of positioning balloons interposed
`between the circumferential band and the anchoring
`balloon for selectively moving the guiding catheter
`about the anchoring balloon in response to inflation
`and deflation of the positioning balloons;
`means for selectively inflating and deflating
`the positioning balloons whereby the guiding catheter
`will move clockwise about the anchoring balloon when
`one of the positioning balloons is inflated, and the
`guiding catheter will move counterclockwise about the
`anchoring balloon when the other positioning balloon
`is inflated; and
`a positioning catheter carried within the
`guiding catheter, the positioning catheter being
`rotatable with respect to the guiding catheter and
`including an off-center lumen in which the shaft of
`the deposit removal tool is closely received, whereby
`rotation of the positioning catheter allows selective
`positioning of the deposit removal tool.
`56.
`A method of removing deposits from an
`aortic valve's superior surface, comprising;
`advancing an anchoring balloon through the aorta
`and positioning it across the aortic valve;
`inflating the anchoring balloon to fixate it
`with respect to the aorta and aortic valve; and
`operating a deposit removal tool secured to the
`
`IPR2020-01454 Page 00729
`
`

`

`W092/17118
`
`PCT /US92/02599
`
`- 35 -
`
`anchoring balloon to remove the deposits.
`57.
`The method of claim 56 including the
`step of advancing the deposit removal tool through the
`aorta after the anchoring balloon has been inflated.
`58.
`The method of claim 57 wherein the
`step of advancing the deposit removal tool comprises
`advancing the tool through a catheter that has~its
`distal end secured with respect to the anchoring
`balloon.
`The method of claim 56 wherein the
`59.
`step of advancing the anchoring balloon includes the
`step of simultaneously advancing the deposit removal
`tool and the anchoring balloon through the aorta.
`60.
`The method of claim 56 including the
`steps of withdrawing blood through a lumen of the
`anchoring balloon catheter, utilizing a pump if
`necessary, oxygenating such blood if necessary, and
`then returning such blood to an artery.
`61.
`The method of claim 56 further
`comprising withdrawing blood adjacent the deposit
`removal tool.
`The method of claim 61 further
`62.
`comprising filtering such blood and returning it to an
`artery.
`The method of claim 56 further
`63.
`comprising the steps of advancing a blood removal
`catheter through the vena cava to the right atrium and
`through the atrial septum to the left atrium and into
`the left ventricle, and then removing blood from the
`left ventricle through such catheter and returning
`such blood to an artery while the anchoring balloon is
`positioned across the aortic valve.
`64.
`The method 0£ claim 56 further
`comprising the steps of providing cardiopulmonary
`bypass support by inserting a vein access catheter
`
`IPR2020-01454 Page 00730
`
`

`

`W092/17118
`
`!>CT /US92/02599
`
`- 36 -
`
`into an artery, withdrawing blood through the vein
`access catheter, oxygenating the blood and returning
`it to the artery through the artery access catheter.
`65.
`The method of claim 56 further
`comprising the step of imaging the area adjacent the
`anchoring balloon.
`66.
`The method of claim 65 wherein the
`imaging step comprises radiographic imaging.
`67.
`The method of claim 65 wherein the
`imaging step includes imaging with ultrasound
`utilizing an ultrasound transducer carried by the
`anchoring balloon.
`68.
`A method of removing deposits from the
`aortic valve of a heart, comprising;
`advancing a deflated, furled anchoring balloon
`through the aorta and positioning it across the aortic
`valve, the anchoring balloon including a collapsable
`guiding catheter sheath;
`inflating the anchoring balloon to fixate it
`with respect to the aorta and aortic valve; and
`advancing a guiding catheter and a deposit
`removal tool through the guiding catheter sheath after
`the anchoring balloon has been inflated; and
`operating the deposit removal tool secured to
`the anchoring balloon to remove the deposits.
`69.
`The method of claim 68 further
`comprising withdrawing blood from the left ventricle
`of the heart through a catheter, and returning such
`blood to the aorta.
`
`IPR2020-01454 Page 00731
`
`

`

`W092/17118
`
`PCT/US92/02599
`
`1 /36
`
`I
`
`5
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00732
`
`

`

`W092/17118
`
`PCT /US92/02599
`
`2/36
`
`/0
`
`-
`4Z
`
`41
`40
`/S
`
`L.Y.
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00733
`
`

`

`pCT/US92/02599
`
`W092f17ll8
`
`3/36
`
`IZ
`
`sueSTITUTE SHEET
`
`IPR2020-01454 Page 00734
`
`

`

`WO 92/17118
`
`PCT/US92/02599
`
`4/36
`
`70
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00735
`
`

`

`WO 92/17118
`
`PCT /US92/02599
`
`5/36
`
`IZ
`
`/3 -
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00736
`
`

`

`WO92/17118
`
`PCT /US92/02599
`
`6/36
`
`7
`
`l 45
`4347 1
`
`8
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00737
`
`

`

`WO92/17118
`
`7/36
`
`PCT /US92/02599
`
`60
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00738
`
`

`

`W092/17118
`
`PCT/US92/02599
`
`8/36
`
`1o!B
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00739
`
`

`

`WO 92/17118
`
`PCT /US92/02599
`
`9/36
`
`~
`I~ 4'.
`
`10.
`
`?4
`\
`
`€£)
`
`44
`
`Z3.
`-?c
`77
`'f
`is.1,e
`
`,,e
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00740
`
`

`

`WO 92/17118
`
`PCT /l'S92/02599
`
`10/36
`
`6tJ -·
`
`.5()
`
`~ 46
`12 t:::lf.
`42·~~ 'Jt9.12t:::I/,
`suesmuTE.SHEET.
`
`IPR2020-01454 Page 00741
`
`

`

`WO 92/17118
`
`PCT /US92/02599
`
`11136
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00742
`
`

`

`WO92/17118
`
`PCT/VS92/02599
`
`12/36
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00743
`
`

`

`WO 92/17118
`
`PCT/US92/02599
`
`13/36
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00744
`
`

`

`WO92/17118
`
`PCT /US92/02S99
`
`14/36
`
`40
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00745
`
`

`

`WO 92/17118
`
`PCT/US92/02599
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00746
`
`

`

`WO92/J7118
`
`PCT/US92/02599
`
`16/36
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00747
`
`

`

`W092/17118
`
`PCT /US92/02599
`
`17/36
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00748
`
`

`

`WO 92/17118
`
`PCT/US92/02599
`
`18/36
`
`O,UGENAT/Jf PUHP FILTER
`t!L'
`!Q7
`(2ff
`~
`
`Ht:AT
`£XCHANG
`/08
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00749
`
`

`

`W092/17118
`
`PCT/US92/02599
`
`19/36
`
`OQGENATIJf PUHP FILTER
`/05
`&,_b
`!f2_7
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00750
`
`

`

`WO 92/17118
`
`PCT /US92/02599
`
`20/36
`
`FILTER.
`&-7
`
`//0
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00751
`
`

`

`WO 92/17118
`
`PCT /US92/02599
`
`21/36
`
`/0
`
`0,UGD/An
`/05
`
`PIIHP FILTER
`&_7
`/06
`
`-
`
`//0
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00752
`
`

`

`WO92/17118
`
`PCT/US92/02S99
`
`22/36
`
`OQGENA
`105
`
`PUHP FILTER
`!£27
`/Ob
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00753
`
`

`

`W092/17118
`
`PCT/US92/02599
`
`23/36
`
`c5
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00754
`
`

`

`W092/17118
`
`PCT /US92/02S99
`
`24/36
`
`ZI
`
`ZJ
`
`Z7
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00755
`
`

`

`WO92/17118
`
`PCT/US92/02599
`
`25/36
`
`ZI
`
`zz
`
`ZJ
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00756
`
`

`

`WO 92/17118
`
`PCT/US92/02599
`
`26/36
`
`ZI
`z3-({;i-zz
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00757
`
`

`

`W092/17118
`
`27/36
`
`PCT /US92/02599
`
`t
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00758
`
`

`

`WO92/17118
`
`PCT/US92/02599
`
`28/36
`
`rtJ t/tTR/IJlJI/NP HAC6?N£ to-,____
`TO SCKEWPUHP /Jf/Vll--.Jllia.ll
`11.~~~
`7-5-{}
`7,9--{t
`~:=::----
`80
`
`: 11
`
`/tJ'j
`
`//0
`CENl'A1~
`BLOOP
`PUMP
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00759
`
`

`

`W092/17118
`
`PCT /US92/02599
`
`70
`
`{,0 -
`
`29/36
`
`/0
`
`0
`0
`
`ry3Z
`-33
`
`/0
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00760
`
`

`

`WO 92/17118
`
`PCT/US92/02599
`
`30/36
`
`JO
`
`55
`
`SUBSilTUTE SHEET
`
`IPR2020-01454 Page 00761
`
`

`

`W092/17118
`
`31/36
`
`pCT/US92/02599
`
`/0
`
`I !4~
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00762
`
`

`

`WO92/17118
`
`32/36
`
`PCT/US92/02S99
`
`10
`
`4Z
`
`33
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00763
`
`

`

`WO 92117118
`
`PCT/US92/02599
`
`33/36
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00764
`
`

`

`WO92/17118
`
`PCT/US92/02S99
`
`34/36
`
`140
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00765
`
`

`

`W092/17118
`
`PCT/US92/02599
`
`35/36
`
`llL7RA'St'N/C
`. VI/JKATIOAIS
`GENERATO~
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00766
`
`

`

`WO92/17118
`
`PCT/US92/02599
`
`36/36
`
`#/Gh'
`VOlTAG£
`.SOURCE
`
`SUBSTITUTE SHEET
`
`IPR2020-01454 Page 00767
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US92/02599
`
`CLASSIFICATION OF SUBJECT MATI'ER
`A.
`:A61B 17/20; A61M 31/00,29/00; A61D 1/02
`IPC(5)
`:604/96,22,53; 606/159; 606/194
`US CL
`According to International Patent Classification (IPC) or to both national classification and IPC
`B.
`FIELDS SEARCHED
`Minimum documentation searched (classification system followed by classification symbols)
`
`U.S. : 604/95,97-99,101,103,104,113,128,171,173,264,280,283,
`604/28,49-52; 606/160,167-171,180,191-192
`Documentation searched other than minimum documentation to the extent that such documents arc included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
`NONE.
`
`c. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category*
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`See Attached Sheet.
`
`[!I Further documents arc listed in the continuation of Box C. □ Sec patent family annex.
`
`•
`"A"
`
`"E"
`"L"
`
`·o·
`
`Special ca&qoriea of cited d a
`documentdefiaaiasdao paenllllllle ofdaoartwbida ii DOt-.lcred
`to be pm of particalar relcnace
`eufier docummt pablilbed Oil or after the Mea IElionaJ filiq dale
`docummt wlucll may throw ~ Oil priority claim(■) or wbich i■
`cited to .cablilh tbc publication date of modler' ciwioa or ocher
`■peciaJ ,_ (• lpeCified)
`document referrias to u oral di■cJoaure. - • exhibition or other
`
`•p•
`
`documentpablilbed prior to lbc. --.:mtiaaal filins datc but la&er than
`tbc priority date claimed
`Date of the actual completion of the international search
`
`16JULY 1992
`
`Name and mailing address of the ISA/
`Commiuioncr of Patenta and Trademarb
`Box PCT
`Washington. D.C. -20231
`Facsimile No. NOT APPLICABLE
`Form PCTllSA/210 (second sheet)(July 1992)-k
`
`-
`
`"T"
`
`lallerdoc:trmmtpubliallcdafter tbcinloa UOMl "iliDc dale or priority
`dale and DOt ill c:oaflic:& wida tbc application butcillld to undenlaDd the
`prillciple or lbeory IIDdertyillr tbc ilavealioll
`
`·x·
`
`•y•
`
`·a:·
`
`document of particular relevaace; tbc claimed iavcaboll cannot be
`COMidered newel or-be-ider'ed to involve m illveDtiveatep
`when dae documcat i■ talccD alone
`
`document of particalar relevuce; the claimed iavealioa cannot be
`iaveaave aq, wbm the document ia
`-ider'ed to iavolve •
`combiaed wida ODO or more odaerauc:ll doc,
`• ■ucb. combilllltion
`bem, obvioul to • perWOll lkilJed ill die ut
`
`dOClmlmt---ofdao-pMeatfamily
`
`Date of mailing of the international search report
`
`,-
`
`/" -
`
`j 5SEP 19~~
`Authorized offi:/f,/~...&,-a_~_
`
`RONALD S
`
`Telenhone No.
`
`GHT, JR.
`no3l 3os-2113 l'
`
`c:> Q._.
`
`IPR2020-01454 Page 00768
`
`

`

`INTERNAJ'.IONAL SEARCH REPORT
`
`.lmemational application No.
`PCT/US92/02S99
`
`C (Continuation). ~CUMENTS CONSIDERED TO BE RELEVANT
`
`Category*
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`X.P
`
`X
`
`X
`
`X,P
`
`X.E
`
`X
`
`A,P
`
`A
`
`A
`
`A
`
`A
`
`US,A 5,009,659 (HAMLIN ET AL) 23 APRIL 1991 (SEE ENTIRE DOCUMENT)
`
`1-3,10,12-15,43,54
`
`us.A 4,894,051 (SHIBER) 16 JANUARY 1990 (SEE COL. 6, LINES 8-10)
`
`1-3, 10, 12,14-18
`
`US,A 4,979,951 (SIMPSON) 25 DECEMBER 1990 (SEE ENTIRE DOCUMENT)
`
`1-3, 10, 12, 14
`
`US,A 5,092,873 (SIMPSON ET AL) 03 MARCH 1992 (SEE ENTIRE DOCUMENT)
`
`1-3, 10, 12, 14, 23-24
`
`US,A 5,100,424 (JANG ET AL) 31 MARCH 1992 (SEE ENTIRE DOCUMENT)
`
`1-3, 10, 12, 15, 37, 40,
`41
`
`US,A 4,784,636 (RYDELL) 15 NOVEMBER 1988 (SEE ENTIRE DOCUMENT)
`
`1-3, 10, 12-14 43, 54
`
`US,A 5,078,722 (STEVENS) 07 JANUARY 1992 (SEE ENTIRE DOCUMENT)
`
`PROGRESS IN CARDIOLOGY, JULY 1990, (SHAWL ET AL), PERCUTANEOUS
`CARDIOPULMONARY BYPASS SUPPORT IN THE CATHETERIZATION
`LABORATORY: TECHNIQUE AND COMPLICATIONS, PP. 195-203.
`
`S0-53
`
`29-36
`
`INTERNATIONAL JOURNAL OF CARDIAC IMAGING, VOLUMN 4, NOS. 2-4
`1989, (BOM ET AL), EARLY AND RECENTINTRALUMINAL ULTRASOUND
`DEVICES, PP. 79-88. (SEE ENTIRE DOCUMENT)
`
`1-13:312, 14.37.40.41
`8-39
`
`US,A 4,785,795 (SINGH)·22 NOVEMBER 1988 (SEE FIGURES 3 AND 4)
`
`23,24
`
`US,A 4,762,130 (FOGARTY ET AL) 09 AUGUST 1988 (SEE ENTIRE DOCUMENT)
`
`27 ,28,44,45
`
`US,A 3,438,375 (ERICSON) 15 APRIL 1969 (SEE ENTIRE DOCUMENT)
`
`27,28,44,45
`
`X,P
`
`us.A 5,026,367 (LECKRONE ET AL) 25 JUNE 1991 (SEE ENTIRE DOCUMENT)
`
`1-3,18
`
`Form PCT/ISA/210 (continuation of second sheet)(July 1992)1'r
`
`IPR2020-01454 Page 00769
`
`

`

`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`1111111111111111 IIIIII IIIII 1111111111111111111111111111111111111111 IIIII IIII IIIIIII IIII IIII IIII
`
`( 43) International Publication Date
`6 December 2007 (06.12.2007)
`
`(51) International Patent Classification:
`A61F 2124 (2006.01)
`
`PCT
`
`(10) International Publication Number
`WO 2007/138572 A2
`(74) Agents: G.E. EHRLICH (1995) LTD. et al.; 11 Men(cid:173)
`achem Begin Street, 52521 Ramat Gan (IL).
`
`(21) International Application Number:
`PCT /IL2007 /000615
`
`(22) International Filing Date:
`
`21 May 2007 (21.05.2007)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/809,848
`60/814,572
`60/832,162
`60/832,142
`60/860,805
`
`1 June 2006 (01.06.2006) us
`19 June 2006 (19.06.2006) us
`21 July 2006 (21.07.2006) us
`21 July 2006 (21.07.2006) us
`24 November 2006 (24.11.2006) us
`
`(71) Applicant (for all designated States except US): _MOR
`RESEARCH APPLICATIONS LTD. [IL/IL]; 20 HaM(cid:173)
`agshimim Street, Kiryat-Matalon, 49170 Petach-Tikva
`(IL).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH,
`CN, CO, CR, CU, CZ, DE, DK, DM, 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, MG, MK, MN, MW, MX, MY,
`MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS,
`RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, TJ, TM, TN,
`TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`(84) Designated States (unless othenvise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, MT, NL, PL,
`PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM,
`GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Published:
`without international search report and to be republished
`upon receipt of that report
`
`(72) Inventor; and
`(75) Inventor/Applicant (for US only): ORLOV, Boris
`[IL/IL]; 26 Netiv Ofakim, 34467 Haifa (IL).
`
`For two-letter codes and other abbreviations, refer to the "Guid(cid:173)
`ance Notes on Codes and Abbreviations" appearing at the begin(cid:173)
`ning of each regular issue of the PCT Gazette.
`
`---iiiiiiiiiiiiiii
`iiiiiiiiiiiiiii -
`---
`
`iiiiiiiiiiiiiii
`
`--iiiiiiiiiiiiiii
`
`iiiiiiiiiiiiiii
`
`M
`t-
`
`"' Q0
`~ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
`~ i:::: (54) Title: METHODS AND DEVICES FOR TREATMENT OF CARDIAC VALVES
`0
`(57) Abstract: Disclosed are methods for treatment of cardiac valve including augmenting a cardiac leaflet with the help of a ring
`0
`M associated with a membrane. Also disclosed are methods for treatment of cardiac valves including augmenting the tissue surrounding
`O a cardiac valve, for example with the help of a tubular or annular implant, allowing relocation of the valve. In embodiments, the
`> methods of the present invention improve leaflet coaptation, which in embodiments is useful for treating conditions such as ischemic
`
`~ mitral regurgitation. Also disclosed are devices useful for implementing the methods of the present invention.
`
`IPR2020-01454 Page 00770
`
`

`

`WO 2007/138572
`
`1
`
`PCT/IL2007 /000615
`
`METHODS AND DEVICES FOR TREATMENT OF CARDIAC VALVES
`
`5
`
`RELATED APPLICATIONS
`
`The present application gams benefit of the filing dates of US patent
`
`application Nos. 60/809,848 filed 1 June 2006; 60/814,572 filed 19 June 2006;
`
`60/832,142 filed 21 July 2006; 60/832,162 filed 21 July 2006 and 60/860,805 filed 24
`
`November 2006 all which are incorporated by reference as if fully set forth herein.
`
`FIELD AND BACKGROUND OF THE INVENTION
`
`The present invention relates to the field of surgery and especially to methods
`
`and devices useful for augmenting cardiac valve leaflets or in augmenting tissue
`
`surrounding a cardiac valve, for example to allow relocation of the intact cardiac
`
`15
`
`valve. Embodiments of the teachings of the present invention allow, for example,
`
`improving leaflet coaptation, for example in order to
`
`treat
`
`ischemic mitral
`
`regurgitation.
`
`The human heart 10, depicted in cross sectional long axis view in Figure 1, is
`
`a muscular organ that pumps deoxygenated blood through the lungs to oxygenate the
`
`20
`
`blood and pumps oxygenated blood to the rest of the body by rhythmic contractions of
`
`four chambers.
`
`After having circulated in the body, deoxygenated blood from the body enters
`
`the right atrium 12 through the vena cava 14. Right atrium 12 contracts, pumping the
`
`blood through a tricuspid valve 16 into the right ventricle 18. Right ventricle 18
`
`25
`
`contracts, pumping the blood through the pulmonary semi-lunar valve 20 into the
`
`pulmonary artery 22 which splits to two branches, one for each lung. The blood is
`
`oxygenated while passing through the lungs and reenters the heart to the left atrium
`
`24.
`
`Left atrium 24 contracts, pumping the oxygenated blood through the mitral
`
`30
`
`valve 26 into the left ventricle 28. Left ventricle 28 contracts, pumping the
`
`oxygenated blood through the aortic semi-lunar valve 30 into the aorta 32. From aorta
`
`32, the oxygenated blood is distributed to the rest of the body.
`
`IPR2020-01454 Page 00771
`
`

`

`WO 2007/138572
`
`2
`
`PCT /IL2007 /000615
`
`Physically separating left ventricle 28 and right ventricle 18 is interventricular
`
`septum 33. Physically separating left atrium 24 and right atrium 12 is an interatrial
`
`septum.
`Mitral valve 26, depicted in Figure 2A (top view) and in Figure 2B ( cross
`
`5
`
`sectional long axis view) is defined by an approximately circular mitral annulus 34
`
`that defines a mitral lumen 36. Attached to the periphery of mitral annulus 34 is an
`
`anterior leaflet 38 and a smaller posterior leaflet 40, leaflets 38 and 40 joined at
`
`commissures 41. Each leaflet is between about 0.8 and 2.4 mm thick and composed of
`
`1 0
`
`three layers of soft tissue.
`The typical area of mitral lumen 36 in a healthy adult is between 4 and 6 cm2
`while the typical total surface area of leaflets 38 and 40 is approximately 12 cm2
`Consequently and as depicted in Figure 2B, leaflets 38 and 40 curve downwards into
`
`•
`
`left ventricle 28 and coapt to accommodate the excess leaflet surface area, producing
`
`a coaptation surface 42 that constitutes a seal. The typical length of coaptation surface
`
`15
`
`42 in a healthy heart 10 of an adult is approximately 7-8 mm.
`
`The bottom surface of anterior leaflet 38 and posterior leaflet 40 are connected
`
`to papillary muscles 44 at the bottom of left ventricle 28 by posterior chordae 46 and
`
`anterior chordae 48.
`
`During diastole, left atrium 24 contracts to pump blood downwards into left
`
`20
`
`ventricle 28 through mitral valve 26. The blood flows through mitral lumen 36
`
`pushing leaflets 38 and 40 downwards into left ventricle 28 with little resistance.
`
`During systole left ventricle 28 contracts to pump blood upwards into aorta 32
`
`through aortic semi-lunar valve 30. Mitral annulus 34 contracts pushing leaflets 38
`
`and 40 inwards and downwards, reducing the area of mitral lumen 36 by about 20% to
`
`25
`
`30% and increasing the length of coaptation surface 42. The pressure of blood in left
`
`ventricle 28 pushes against the bottom surfaces of leaflets 38 and 40, tightly pressing
`
`leaflets 38 and 40 together at coapt