1 IIIII IIIIIIII III
`
`IIIII IIIII IIIIII IIII IIII IIII
`USOO7422579B2
`US007422579B2
`
`(12) United States Patent
`(12) United States Patent
`Wahr et al.
`Wahr et al.
`
`(10) Patent No.:
`(10) Patent No.:
`(45) Date of Patent:
`(45) Date of Patent:
`
`US 7422,579 B2
`US 7,422,579 B2
`Sep. 9, 2008
`Sep. 9, 2008
`
`(54) EMBOLI PROTECTION DEVICES AND
`(54) EMBOLI PROTECTION DEVICES AND
`RELATED METHODS OF USE
`RELATED METHODS OF USE
`
`(75) Inventors: Dennis W. Wahr, Ann Arbor, MI (US);
`(75)
`Inventors: Dennis W. Wahr, Ann Arbor, MI (US);
`Thomas V. Ressemann, St. Cloud, MN
`Thomas V. Ressemann, St. Cloud, MN
`(US); Peter T. Keith, St. Paul, MN (US);
`(US); Peter T. Keith, St. Paul, MN (US);
`David J. Blaeser, Champlin, MN (US);
`David J. Blaeser, Champlin, MN (US);
`Michael Berman, Minnetonka, MN
`Michael Berman, Minnetonka, MN
`(US)
`(US)
`
`(*) Notice:
`(*) Notice:
`
`(73) Assignee: St. Jude Medical Cardiology Divison,
`(73) Assignee: St. Jude Medical Cardiology Divison,
`Inc., Maple Grove, MN (US)
`Inc., Maple Grove, MN (US)
`Subject to any disclaimer, the term of this
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 619 days.
`U.S.C. 154(b) by 619 days.
`(21) Appl. No.: 09/845,162
`Appl. No.: 09/845,162
`(21)
`(22) Filed:
`May 1, 2001
`May 1, 2001
`Filed:
`(22)
`
`(65)
`(65)
`
`Prior Publication Data
`Prior Publication Data
`US 20O2/O165598A1
`Nov. 7, 2002
`US 2002/0165598 Al
`Nov. 7, 2002
`
`(51) Int. Cl.
`Int. Cl.
`(51)
`(2006.01)
`A6M 3L/00
`A61M 31/00
`(2006.01)
`(52) U.S. Cl. ...................................................... 604/SO9
`(52) U.S. Cl.
`604/509
`(58) Field of Classification Search ................... 604/21,
`(58) Field of Classification Search
`604/21,
`604/27, 28, 35, 93.01, 96.01, 101.01, 101.05,
`604/27, 28, 35, 93.01, 96.01, 101.01, 101.05,
`604/104, 118, 119, 158, 164.01, 164.05,
`604/104, 118, 119, 158, 164.01, 164.05,
`604/164.13, 165.01, 264
`604/164.13, 165.01, 264
`See application file for complete search history.
`See application file for complete search history.
`References Cited
`References Cited
`U.S. PATENT DOCUMENTS
`U.S. PATENT DOCUMENTS
`
`(56)
`(56)
`
`4/1987 Daniels et al.
`4,655,746 A
`4, 1987 Daniels et al. ................ 604/53
`4,655,746 A
`604/53
`9/1987 Wilcox
`4,696,668 A
`9, 1987 Wilcox
`4,696,668 A
`4,784,636 A 1 1/1988 Rydell ......................... 604/22
`11/1988 Rydell
`4,784,636 A
`604/22
`4,883,460 A
`11/1989 Zanetti
`4,883,460 A 11, 1989 Zanetti ........
`... 604/22
`604/22
`4,921,478 A
`4,921.478 A
`5/1990 Solano et al. ................. 604/53
`5/1990 Solano et al.
`604/53
`
`138
`138
`
`134
`
`134b
`
`
`
`132
`
`140
`
`146a
`E.
`
`142
`
`EN4
`
`148
`
`106
`
`110
`
`120
`
`
`
`15
`15
`
`EP
`EP
`
`5,011,488 A
`5,011,488 A
`
`4, 1991 Ginsburg .................... 606, 159
`4/1991 Ginsburg
`606/159
`(Continued)
`(Continued)
`FOREIGN PATENT DOCUMENTS
`FOREIGN PATENT DOCUMENTS
`0 427 429 A2
`5/1991
`O 427 429 A2
`5, 1991
`(Continued)
`(Continued)
`OTHER PUBLICATIONS
`OTHER PUBLICATIONS
`Theron, Jacques, G., MD, "Carotid Artery Stenosis: Treatment with
`Theron, Jacques, G., MD, "Carotid Artery Stenosis: Treatment with
`Protected Balloon Angioplasty and Stent Placement.” Radiology, vol.
`Protected Balloon Angioplasty and Stent Placement," Radiology, vol.
`201, No. 3, Dec. 1996, pp. 627-636.
`201, No. 3, Dec. 1996, pp. 627-636.
`(Continued)
`(Continued)
`Primary Examiner Manuel Mendez
`Primary Examiner Manuel Mendez
`(74) Attorney, Agent, or Firm—O'Melveny & Myers LLP
`(74) Attorney, Agent, or Firm-O'Melveny & Myers LLP
`
`(57)
`(57)
`
`ABSTRACT
`ABSTRACT
`
`An evacuation sheath assembly and method of treating
`An evacuation sheath assembly and method of treating
`occluded vessels which reduces the risk of distal emboliza
`occluded vessels which reduces the risk of distal emboliza-
`tion during vascular interventions is provided. The evacua
`tion during vascular interventions is provided. The evacua-
`tion sheath assembly includes an elongated tube defining an
`tion sheath assembly includes an elongated tube defining an
`evacuation lumen having proximal and distal ends. A proxi
`evacuation lumen having proximal and distal ends. A proxi-
`mal sealing Surface is provided on a proximal portion of the
`mal sealing surface is provided on a proximal portion of the
`tube and is configured to form a seal with a lumen of a guided
`tube and is configured to form a seal with a lumen of a guided
`catheter. A distal sealing Surface is provided on a distal por
`catheter. A distal sealing surface is provided on a distal por-
`tion of the tube and is configured to form a seal with a blood
`tion of the tube and is configured to form a seal with a blood
`vessel. A method of treatment of a blood vessel using the
`vessel. A method of treatment of a blood vessel using the
`evacuation sheath assembly includes advancing the evacua
`evacuation sheath assembly includes advancing the evacua-
`tion sheath assembly into the blood vessel through a guide
`tion sheath assembly into the blood vessel through a guide
`catheter. Prior to advancing a device across a stenosis to be
`catheter. Prior to advancing a device across a stenosis to be
`treated, normal antegrade blood flow in the blood vessel
`treated, normal antegrade blood flow in the blood vessel
`proximate to the stenosis is stopped. While blood flow is
`proximate to the stenosis is stopped. While blood flow is
`stopped, the stenosis is treated. Retrograde blood flow is
`stopped, the stenosis is treated. Retrograde blood flow is
`induced within the blood vessel to carry embolic material
`induced within the blood vessel to carry embolic material
`dislodged during treating into the evacuation sheath assem
`dislodged during treating into the evacuation sheath assem-
`bly.
`bly.
`
`124 Claims, 48 Drawing Sheets
`124 Claims, 48 Drawing Sheets
`
`1D-
`
`13
`
`1349
`
`36
`136
`
`w132
`
`105
`
`110
`
`120
`
`:í%Ì/lJllÌ/í(%%Ì/l
`
`2,4744,
`
`3
`
`48
`146b
`
`
`
`92a
`
`31
`
`
`
`'1426
`
`0.
`
`137
`37
`
`1
`144
`
`EXHIBIT
`EXHIBIT
`
`1123
`1123
`
`IPR2020-01344
`
`Medtronic Ex-1123
`Medtronic v. Teleflex
`Page 1 of 67
`
`

`

`US 7422,579 B2
`US 7,422,579 B2
`Page 2
`Page 2
`
`U.S. PATENT DOCUMENTS
`U.S. PATENT DOCUMENTS
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`604/101.03
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`604/96
`5,573,508 A 1 1/1996 Thornton ..................... 604,96
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`5,749,888 A
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`606/194
`5,769,868 A
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`5,779,721 A
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`U.S. Patent
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`Sep. 9
`, 2008
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`Sheet 1 of 48
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`US 7422,579 B2
`
`
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`144
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`
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
`
`Sheet 2 of 48
`Sheet 2 of 48
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`U.S. Patent
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`Sep. 9, 2008
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`Sheet 3 of 48
`
`US 7422,579 B2
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`232
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`U.S. Patent
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`US 7422,579 B2
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`244
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
`
`Sheet 5 of 48
`Sheet 5 of 48
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`US 7,422,579 B2
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`US. Patent
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`Sep. 9, 2008
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`Sheet 6 0f 48
`
`US 7,422,579 B2
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`IPR2020-01344
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`IPR2020-01344
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 8 of 48
`Sheet 8 of 48
`
`US 7422,579 B2
`US 7,422,579 B2
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`195
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`FIG. 5A
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`
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 9 of 48
`Sheet 9 of 48
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`US 7,422,579 B2
`US 7422,579 B2
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
`
`Sheet 10 of 48
`Sheet 10 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 11 of 48
`Sheet 11 of 48
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`US 7,422,579 B2
`US 7422,579 B2
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`
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 12 of 48
`Sheet 12 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 13 of 48
`Sheet 13 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 14 of 48
`Sheet 14 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 15 of 48
`Sheet 15 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 16 of 48
`Sheet 16 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 17 of 48
`Sheet 17 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 18 of 48
`Sheet 18 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`
`IPR2020-01344
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 19 of 48
`Sheet 19 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`IPR2020-01344
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`U.S. Patent
`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 20 of 48
`Sheet 20 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`
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`IPR2020-01344
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 21 of 48
`Sheet 21 of 48
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`US 7422,579 B2
`US 7,422,579 B2
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`IPR2020-01344
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 22 of 48
`Sheet 22 of 48
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`US 7422,579 B2
`US 7,422,579 B2
`
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`Sep. 9, 2008
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`US 7422,579 B2
`US 7,422,579 B2
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`
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`Sep. 9, 2008
`Sep. 9, 2008
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`Sheet 24 of 48
`Sheet 24 of 48
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`US 7422,579 B2
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`U.S. Patent
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`Sep. 9, 2008
`Sep. 9, 2008
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`US 7422,579 B2
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`US 7,422,579 B2
`US 7422,579 B2
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`LL
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