BSC USP 8,048,032
`Exhibit 1016
`
`Page 1 of 22
`
`(12)
`
`United States Patent
`Hermann et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,338,725 B1
`*J an. 15, 2002
`
`US006338725B1
`
`(54) LARGE-DIAMETER INTRODUCER SHEATH
`HAVING HEMOSTASIS VALVE AND
`REMOVABLE STEERING MECHANISM
`
`75
`(
`)
`
`Inventors: Geor e D. Hermann, Los Gatos;
`Kirstin Freislinger, Menlo Park;
`Steven W- Kima Cupertino; Jay A-
`Lenker, Laguna Beach; Michael A.
`Evans, Palo Alto, all of CA (US)
`(73> Aeelanee Medtrehle AVE, Inc-a Santa Rosa CA
`
`_
`( * ) Notice:
`
`(Us)
`
`_
`_
`_
`_
`SubJect to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U_S_C_ 154(k)) by 0 days_
`
`This patent is subject to a terminal dis-
`Clalmer'
`
`(21) Appl. No.: 09/158,777
`_
`(22) Flled:
`
`Sep‘ 23’ 1998
`Related US‘ Application Data
`
`(60) Continuation of application No. 08/735,401, ?led on Oct.
`21, 1996, now Pat. No. 5,843,031, which is a division of
`application N°~ O8/33Oa140a ?led on Oct- 24a 1994a now Pat-
`NO' 5599305‘
`(51) Int. Cl.7 ............................................. .. A61M 37/00
`(52) US. Cl. .............................. .. 604/95.04; 604/9601;
`6()4/164_()1; 604/16701; 604/523; 604/537;
`604/912
`(58) Field 61 Search ........................ .. 604/95, 164, 167,
`604/53, 200, 169, 170, 264, 256, 96, 101,
`912, 919, 523, 527, 526, 537, 16401, 16409,
`16412, 16413, 528; 251/1492, 1496,
`1491, 1494, 1495, 14911; 137/844
`
`(56)
`
`References Cited
`
`US. PATENT DOCUMENTS
`
`1/1978 Utsugi ......................... .. 128/4
`4,066,070 A
`4,129,129 A * 12/1978 Amrine ..................... .. 604/95
`4,177,814 A 12/1979 Knepshield et al. ...... .. 128/348
`4,411,655 A 10/1983 Schreck .................... .. 604/165
`4’475’548 A * 10/1984 Mum
`128/207'14
`4,586,923 A
`5/1986 Gould 6161. ................ .. 604/95
`(List continued on next page.)
`
`FOREIGN PATENT DOCUMENTS
`63333131 £ 1311335
`111111111: iil?iiii?l
`
`0 488 322 A1
`
`6/1992
`
`........ .. A61M/25/00
`
`0 596 172 A2 12/1992
`0 567 141
`10/1993
`
`........ .. A61M/25/01
`
`55
`
`EP
`
`EP
`EP
`
`(List continued on next page.)
`
`OTHER PUBLICATIONS
`Product label; ArroW International, Inc., Reading, Pennsyl
`vania 19605; super ArroW FlexTM.
`
`Primary Examiner—John G. Weiss
`Assistant Examiner—Joseph F. Weiss, Jr.
`(gigoitltlolrin?ybAgent, 0r Flrm—Sterne, Kessler, Goldstein
`
`(57)
`
`ABSTRACT
`
`A catheter introducing system includes an introducer cath
`eter comprising a ?exible sheath having a hemostasis valve
`and an obturator having a steering mechanism operated by
`a proximal actuator handle The Catheter introducer system
`Will usually be introduced With the obturator inside of the
`?exible sheath so that the obturator can effect steering by
`laterally delleetlhg the distal end at the eethhlhed sheath and
`obturator. Such catheter introducing systems are particularly
`useful for large diameter sheaths Which are not readily
`introduced over guide Wires. A ?rst exemplary hemostasis
`valve comprises a compressed foam insert having an axial
`lumen therein. A second exemplary hemostasis valve com
`prises an elastomeric insert Which receives and seals over
`the catheter.
`
`3,941,119 A
`
`3/1976 Corrales .................. .. 128/2 M
`
`10 Claims, 13 Drawing Sheets
`
`AA
`
`

`

`Page 2 of 22
`
`US 6,338,725 B1
`Page 2
`
`US. PATENT DOCUMENTS
`
`4,589,868 A * 5/1986 Dretler ...................... .. 604/96
`4,610,674 A * 9/1986 511111149191
`604/282
`4,634,432 A
`1/1987 Kocak -------- --
`604/167
`4,643,194 A
`2/1987 Fogarty e191-
`128/668
`4,673,393 A * 6/1987 Suzuki @191- -
`604/167
`47156360 A * 12/1987 Akui e1 91- ---- --
`604/256
`47236936 A * 2/1988 Buchbinden e191-
`604/95
`4,815,478 A * 3/1989 Buchbinder e1 a1~
`- 604/170
`4,946,133 A * 8/1990 Johnson et a1. ..
`251/1491
`
`4,960,410 A * 10/1990 Pinchuk - - - - - - - -
`49766688 A 12/1990 Rosenblum
`4,983,165 A
`1/1991 Loiterman
`4,985,022 A
`1/1991 Feamot er a1-
`5,019,040 A
`5/1991 Itaoka e191- --
`5,055,101 A * 10/1991 MCCOY ---------- --
`5,057,084 A * 10/1991 Ensminger er a1- -
`5,066,285 A 11/1991 Hillstead ---------- --
`5,069,217 A 12/1991 Fleischhackenlr-
`5,098,412 A
`3/1992 shill -------- --
`5,104,389 A
`4/1992 Dem @191-
`5,109,830 A
`5/1992 Cho - - - - - - - - - -
`5,125,893 A * 6/1992 Dryden
`5,127,626 A
`7/1992 Hilal e191
`5,147,315 A * 9/1992 W61>61 . . . . . . .
`5,167,636 A 12/1992 Clement
`5,180,376 A
`1/1993 P16611611 . . . . .
`
`- - - - -~ 604/96
`604/95
`604/95
`604/282
`604/95
`604/95
`604/167
`604/164
`128/657
`604/280
`604/264
`- - - -- 128/4
`---- -- 604/56
`-- 251/149-1
`. . . .. 604/164
`604/167
`. . . .. 604/282
`
`- - - ~137/844
`5205325 A * 4/1993 Piper - - - - - -
`-- 604/256
`5,207,656 A
`5/1993 Kranys
`5,215,537 A
`6/1993 Lynn @191
`-- 604/244
`604/43
`5,221,255 A
`6/1993 Mahurkar et a1.
`.. 604/282
`5,221,270 A * 6/1993 Parker ..... ..
`.. 604/213
`5,222,948 A
`6/1993 A1161111 6161.
`5,226,899 A
`7/1993 L66 6161. ................. .. 604/282
`5,242,425 A
`9/1993 W11116 6161. .............. .. 604/256
`5,273,546 A 12/1993 M6L611g111111 6161.
`.. 604/167
`5,275,152 A
`1/1994 K1611161 6161. ............... .. 128/4
`5,279,596 A
`1/1994 Castaneda et a1. ........ .. 604/282
`5,279,597 A
`1/1994 Dassa et al. .............. .. 604/283
`
`2/1994 Adair ....................... .. 604/164
`5,284,474 A
`5,300,033 A * 4/1994 M11161 ...................... .. 604/167
`5,300,034 A
`4/1994 Behnke et a1_ _________ " 604/167
`5,300,048 A * 4/1994 D16W66,J1.6161. .
`604/280
`5,324,262 A * 6/1994 18166116116161. .... ..
`604/96
`5,325,850 A * 7/1994 01116116161.
`.. 128/200.26
`5,334,185 A
`8/1994 G166y 6161. .............. .. 604/164
`5,338,313 A
`8/1994 M611611611616161. ...... .. 604/209
`5,364,357 A * 11/1994 A666 .............. ..
`.. 604/96
`5,380,304 A
`1/1995 P611161 ............ ..
`.604/282
`5,383,852 A
`1/1995 SteVenS_Wright _
`u 604/95
`
`.604/282
`5,403,292 A * 4/1995 Ju .................. ..
`604/96
`5,456,665 A * 10/1995 116616116161
`604/96
`.
`5,460,608 A * 10/1995 L6d1116161
`604/95
`5,462,527 A 10/1995 s16v6116-W11g1116161.
`5,467,763 A * 11/1995 M6M611611 6161. ........ .. 600/201
`5,484,425 A
`1/1996 18166116116161. ........... .. 604/282
`5,496,294 A * 3/1996 H61g61116111616161. .... .. 604/282
`5,513,628 A * 5/1996 (361666161. ......... .. 128/200.26
`5,514,236 A * 5/1996 Av611611616161. ......... .. 156/154
`5,520,644 A * 5/1996 11111611 ............. ..
`.. 604/95
`5,569,200 A * 10/1996 01116116 6161.
`604/96
`5,584,821 A * 12/1996 11611116 6161.
`604/280
`5,599,325 A * 2/1997 In 6161. ...... ..
`604/282
`5,630,806 A * 5/1997 1116g61<1 6161. .
`604/282
`5,676,659 A 6 10/1997 McGurk ______ __
`_604/282
`5,725,513 A * 3/1998 In 6161. ...... ..
`604/280
`5,782,817 A * 7/1998 Franzel et a1_ _
`_604/256
`
`.. 604/96
`5,807,328 A * 9/1998 13116666 .......... ..
`604/95
`5,865,800 A * 2/1999 M116161116161. ..
`5,895,377 A * 4/1999 81111111 6161. .............. .. 604/256
`
`FOREIGN PATENT DOCUMENTS
`
`W0
`W0
`W0
`W0
`
`WO 94/01169
`W0 94/11057
`W0 94/21165
`W0 96/13228
`
`1/1994
`5/1994
`9/1994
`5/1996
`
`........ .. A61M/39/00
`A61M/37/00
`.. A61B/5/04
`........... .. A61F/2/06
`
`* cited by examiner
`
`

`

`US. Patent
`
`Jan. 15, 2002
`
`Sheet 1 0f 13
`
`US 6,338,725 B1
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`22
`
`/'0
`
`
`
`{6
`
`FIG.1
`
`28
`
`Pageaofzz
`
`Page 3 of 22
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`U.S. Patent
`
`Jan. 15,2002
`
`Sheet 1 0f 13
`
`US 6,338,725 B1
`
`22
`
`/'O
`
`

`

`US. Patent
`
`Jan. 15, 2002
`
`Sheet 2 0f 13
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`US 6,338,725 B1
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`
`
`
`FIG. 2
`
`Page4of22
`
`Page 4 of 22
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`U.S. Patent
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`Jan. 15,2002
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`Sheet 2 0f 13
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`US 6,338,725 B1
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`FIG. 2
`
`

`

`Page 5 of 22
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`U.S. Patent
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`Jan. 15,2002
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`Sheet 3 0f 13
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`US 6,338,725 B1
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`“Kw/2%.
`
`\ii'lh'lqll'i V1
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`

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`U
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`M4whS
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`Page 6 of 22
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`U.S. Patent
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`Jan. 15, 2002
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`Sheet 4 0f 13
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`US 6,338,725 B1
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`On
`
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`Q
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`

`

`Page 7 of 22
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`U.S. Patent
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`Jan. 15,2002
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`Sheet 5 0f 13
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`US 6,338,725 B1
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`FIG. 7
`
`Q)
`(I)
`m _
`
`5O
`5
`
`FIG. 8
`
`

`

`US. Patent
`
`Jan. 15, 2002
`
`Sheet 6 0f 13
`
`US 6,338,725 B1
`
`mmON
`
`
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`mm
`
`Km
`
`mm.\\
`
`0.o_n_
`
`PageBof22
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`Page 8 of 22
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`U.S. Patent
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`Jan. 15,2002
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`Sheet 6 0f 13
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`US 6,338,725 B1
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`FIG. 9
`
`
`
`

`

`US. Patent
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`Jan. 15, 2002
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`Sheet 7 0f 13
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`US 6,338,725 B1
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`OF.07..
`
`Pagerf22
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`Page 9 of 22
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`

`

`US. Patent
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`Jan. 15, 2002
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`Sheet 8 0f 13
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`US 6,338,725 B1
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`IO\
`
`18
`
`
`
`Page 100f22
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`Page 10 of 22
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`Sheet 8 0f 13
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`US 6,338,725 B1
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`FIG. 11B
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`

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`Sheet 10 0f 13
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`Page 120f22
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`Sheet 11 0f 13
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`US 6,338,725 B1
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`7s
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`

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`US. Patent
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`Sheet 12 0f 13
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`Sheet 13 0f 13
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`m:
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`Page 16 of 22
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`US 6,338,725 B1
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`1
`LARGE-DIAMETER INTRODUCER SHEATH
`HAVING HEMOSTASIS VALVE AND
`REMOVABLE STEERING MECHANISM
`
`This application is a continuation of application Ser. No.
`08/735,401, ?led on Oct. 21, 1996, now US. Pat. No.
`5,843,031 Which is a divisional of application Ser. No.
`08/330,140, ?led Oct. 24, 1994, now US. Pat. No. 5,599,
`305 and are hereby incorporated by reference for all pur
`poses.
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention relates generally to apparatus and
`methods for introducing devices to target locations Within
`body lumens and cavities. In particular, the present invention
`relates to introducing catheters and methods Which are used
`to provide large-diameter access lumens to target locations
`disposed along or at the distal end of tortuous paths.
`Introducer sheaths and catheters are commonly used to
`provide endoluminal and/or percutaneous access to remote
`target locations in a variety of medical procedures, including
`intravascular procedures, laparoscopic procedures, and other
`minimally invasive procedures. Of speci?c interest to the
`present invention, the endovascular placement of vascular
`grafts for the treatment of abdominal aortic aneurysms has
`been proposed, Where the graft may be inserted into the aorta
`via an antegrade or retrograde arterial approach. Such endo
`vascular graft placement Will require the use of a relatively
`large graft placement catheter, typically having an outer
`diameter in the range from 4 mm to 10 mm. Such large
`placement catheters Will require correspondingly large intro
`ducing catheters or sheaths, typically having an internal
`lumen diameter Which is at least slightly larger than the outer
`diameter of the placement catheter. The placement and use
`of such large-diameter introducing catheters or sheaths Will
`be problematic in several respects.
`In particular, the antegrade path into the subclavian artery,
`through the aortic arch, and into the thoracic aorta is quite
`tortuous. While the path can be readily negotiated by con
`ventional intravascular guide Wires, such guide Wires have
`very small diameters and are not suf?ciently strong to permit
`introduction of a large diameter introducing sheaths there
`over. To overcome this problem, it Would be possible to
`employ an introducing sheath having an integral steering
`mechanism. Such sheaths could be introduced around even
`the very tight curves encountered in the transition from the
`subclavian artery to the aortic arch. The incorporation of a
`steering mechanism, hoWever, necessarily reduces the
`lumen area of the sheath Which is ultimately available for
`accommodating the graft-placement catheter.
`Other problems Which arise When introducing sheaths are
`used for aortic access include the design of the hemostasis
`valve. The hemostasis valve must be able to accommodate
`very small devices, such as guide Wires, as Well as the very
`large graft-placement catheter. The body of the sheath must
`have a very thin Wall (to maximiZe available area in the
`access lumen), and a very smooth lumen to permit the
`passage of the graft-placement catheters Without sticking or
`constriction of the catheter. Additionally, placement of vas
`cular grafts through an introducing sheath located in the
`abdominal aorta is further made dif?cult by the relatively
`high blood ?oW rate through the aorta. Moreover, the ability
`to anchor the vascular graft Within the aorta and/or adjoining
`iliac arteries can be problematic and require additional
`devices Which are dif?cult to provide through the limited
`area of the access lumen.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`For these reasons, it Would be desirable to provide
`improved catheter introducing systems and methods, includ
`ing catheter sheaths, sheath steering mechanisms, hemosta
`sis valves, and the like, Which overcome at least some of the
`de?ciencies described above. The introducing sheaths
`should have a large lumen diameter, typically being at least
`4 mm, to accommodate large diameter graft-placement
`catheters, should have good hoop strength to avoid kinking
`or collapse of the sheath When bent around tight curves, and
`should have good column and tensile strengths to avoid
`deformation When the graft-placement catheter is passed
`through the lumen. The sheath steering mechanisms should
`provide for a high degree of lateral de?ection at the distal
`end of the sheath but should not take up lumen area Which
`is necessary for subsequent passage of large diameter cath
`eters. The hemostasis valves should be able to accommodate
`both small diameter devices, such as guide Wires, and the
`large diameter catheters While still maintaining a tight seal
`around the catheter to prevent leakage.
`2. Description of the Background Art
`A steerable sleeve for use in combination With a ?exible
`catheter is described in DE 39 20 707. US. Pat. No.
`4,976,688 shoWs a steerable sheath structure. European
`Patent Application 488 322 shoWs a tubular device having a
`variable curvature controlled by differential pressure. Other
`catheter- and device-steering mechanisms are described in
`US. Pat. Nos. 5,109,830; 5,098,412; 5,019,040; 4,983,165;
`4,066,070; and 3,941,119.
`A large-diameter introducer sheath having metal-ribbon
`reinforcement and a proximal hemostasis valve is described
`in US. Pat. No. 5,180,376. Devices covered by the ’376
`patent are sold by ArroW International, Inc., Reading, Pa.
`19605, under the name super ArroW FlexTM percutaneous
`sheath introducer set With integral side port/hemostasis
`valve. Other reinforced tubular catheter designs are
`described in US. Pat. Nos. 5,279,596; 5,275,152; 5,226,
`899; 5,221,270; 5,221,255; 5,069,217; 4,985,022; and 4,411,
`655.
`US. Pat. No. 5,207,656, discloses a hemostasis valve
`having a foam member for sealing against a catheter passed
`therethrough. The foam member has a lubricant absorbed in
`an open-cell foam structure. US. Pat. No. 4,475,548, dis
`closes a foam sealing member for use in an endotracheal
`tube. European patent application 567,141 describes a trocar
`valve assembly Which may include a ?exibly resilient mate
`rial for reception of an instrument passed through the valve.
`Other hemostasis and similar valve structures are described
`in US. Pat. Nos. 5,338,313; 5,300,034; 5,279,597; 5,242,
`425; 5,222,948; 5,215,537; 5,167,636; 5,127,626; 5,104,
`389; and 4,177,814.
`
`SUMMARY OF THE INVENTION
`The present invention provides apparatus and methods for
`placement of a ?exible introducer sheath at a target location
`in a body lumen or cavity. Placement of the ?exible sheath
`is usually percutaneous, i.e., through a puncture or incision
`in the patient’s skin, and endoluminal i.e., through a body
`lumen or cavity Which has been accessed through the
`percutaneous puncture site. An exemplary use of the appa
`ratus and methods of the present invention is placement of
`a ?exible sheath through the subclavian or brachial arteries,
`through the aortic arch, and into the abdominal aorta for the
`delivery of a vascular graft intended for treatment of an
`abdominal aneurysm. The apparatus and methods of the
`present invention, hoWever, are not limited to use in such
`graft placement procedures and may ?nd additional uses in
`
`

`

`Page 17 of 22
`
`US 6,338,725 B1
`
`3
`a Wide variety of procedures, including laparoscopic and
`other minimally invasive procedures Where it is desired to
`introduce a large diameter sheath into a body cavity or
`lumen and subsequently steer or manipulate the distal end of
`the sheath to a target location Within the luminal cavity.
`In a ?rst aspect of the present invention, a catheter
`introducing system comprises a ?exible sheath having a
`proximal end, a distal end, and an access lumen extending
`therebetWeen. An obturator is removably received in the
`lumen of the ?exible sheath and includes a mechanism for
`laterally de?ecting at least a distal portion of the obturator.
`In this Way, the distal end of the ?exible sheath can be
`manipulated using the obturator to facilitate intravascular or
`other placement of the sheath. After the sheath has been
`introduced to the desired target location, the obturator may
`be WithdraWn, leaving the access lumen open to receive
`guide Wires, Working catheters, and the like. Since the siZe
`of the obturator is limited only by the area of the sheath
`access lumen, there is suf?cient available cross-sectional
`area for providing effective and efficient steering mecha
`nisms. In particular, it Will be possible to provide steering
`mechanisms Which are capable of inducing small-radius
`de?ections in the distal end of the sheath, typically as loW as
`one cm.
`In a second aspect of the present invention, a method for
`introducing a ?exible sheath to a target location in a body
`lumen comprises introducing the sheath to the lumen and
`advancing the sheath Within the lumen While laterally
`de?ecting at least a distal portion of an obturator Which is
`removably received in a lumen of the sheath. The obturator
`is removed from the sheath after the target location has been
`reached in order to provide the desired access lumen.
`Usually, the obturator Will be Within the sheath With its
`de?ectable distal end axially aligned With a distal portion of
`the sheath having enhanced ?exibility. Alternatively, the
`obturator could be advanced distally beyond the sheath,
`using the steering mechanism to reach the desired target
`location, With the sheath then being advanced over the
`obturator. The method is particularly useful for introducing
`the sheath into the subclavian, external carotid, axillary, or
`brachial arteries, through the aortic arch, and into the
`abdominal aorta, but can also be used for a variety of
`procedures as described above.
`In a third aspect of the present invention, an aortic
`introducer catheter comprises a ?exible sheath having a
`proximal end, a distal end, and an access lumen extending
`therebetWeen. The length betWeen the proximal and distal
`ends is in the range from 30 cm to 60 cm and the lumen
`diameter is in the range from 4 mm to 10 mm. Ahemostasis
`valve is secured to the proximal end of the sheath, and the
`aortic introducer catheter is particularly useful for providing
`an access lumen into the subclavian or brachial arteries,
`through the aortic arch, and into the abdominal aorta. The
`catheter preferably has a region of enhanced ?exibility over
`a distal length in the range from 5 cm to 15 cm so that it may
`be utiliZed in combination With a steerable obturator, as
`described above. The aortic introducer catheter may further
`comprise an expandable member, typically an in?atable
`balloon, located at from 1 cm to 10 cm from its distal end
`Where the expandable member can be used to partially
`occlude blood ?oW When expanded inside the aorta. The
`catheter may additionally or alternatively, include an
`expandable member, again typically an in?atable balloon, at
`its distal end, Where the distal expandable member can be
`used for anchoring an aortic prosthesis by internal expan
`sion.
`In a fourth aspect, the present invention provides a
`catheter sheath comprising a tubular inner liner having a
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`proximal end, a distal end, and a lumen therebetWeen. The
`inner liner Will preferably be formed from a lubricous
`material or have its inner lumen coated With a silicone gel or
`other lubricating material. Flat Wire helical coil is Wrapped
`over the exterior surface of the tubular inner liner, and the
`coil has spaced-apart adjacent turns. Plastic coating is
`formed over the helical coil and penetrates into the space
`betWeen the adjacent turns. The coating bonds to the inner
`liner to provide an integral structure having a thin Wall With
`controlled ?exibility. The sheath preferably has a region of
`enhanced ?exibility near its distal end, Where ?exibility can
`be controlled by utiliZing liner materials, plastic coating
`materials, or both, having loWer durometers near the distal
`end. Alternatively, the ?exibility can be controlled by uti
`liZing different helical coil materials or by modifying the
`spacing betWeen adjacent coil turns to enhance the ?exibil
`ity. The catheter sheaths Will also preferably have a soft tip
`over a distal length in the range from 2 mm to 10 mm. The
`soft tip Will usually be free from the helical coil and may
`optionally be formed from a material having a loWer durom
`eter.
`In a ?fth aspect of the present invention, a steerable
`obturator is provided comprising a ?exible body having a
`proximal end and a tapered distal end. A mechanism Will be
`provided in the body for laterally de?ecting at least a distal
`portion of the body. Typically, the lateral de?ection mecha
`nism Will comprise a pull Wire Which is attached off center
`at the distal end of the ?exible body. The pull Wire can be
`actuated by a handle secured to the proximal end of the body.
`The obturator Will preferably have a region of enhanced
`?exibility at its distal length, Where the region of enhanced
`?exibility may comprise a series of articulated elements.
`In a sixth aspect, the present invention provides a hemo
`stasis valve comprising a housing having an interior cavity
`and axially aligned inlet and outlet ports. A compressible
`insert is disposed Within the interior cavity of the housing
`and includes a polymeric foam body having an open axial
`lumen in an exterior geometry Which is similar to but larger
`than the interior cavity in the housing. By con?ning the foam
`insert Within the interior cavity of the housing, the open
`lumen Will be closed to provide a seal betWeen the axial
`lined ports of the housing. The circumference of the lumen,
`hoWever, Will be suf?ciently large to accommodate even
`large diameter catheters and devices subsequently intro
`duced through the valve. The particular advantage of this
`design is that the lumen in the foam insert Will not be
`stretched or torn as the catheter is being introduced there
`through. That is, the original cross-sectional circumference
`of the lumen Will remain even though the lumen has been
`collapsed by external compression. Preferably, the hemosta
`sis valve Will include a second valve element, such as a
`duckbill or slit disc structure to provide for hemostasis When
`no catheter or device is placed through the foam insert. The
`lumen of the foam insert Will also preferably be coated With
`a lubricant and optionally provided With a protective layer to
`further guard against tearing of the foam as the catheter is
`passed therethrough.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a prospective vieW of the catheter introducing
`system constructed in accordance With the principles of the
`present invention and including a ?exible sheath and an
`obturator having a laterally de?ectable distal end.
`FIG. 2 is a prospective vieW of the catheter introducing
`system of FIG. 1, shoWn With the obturator located in an
`axial lumen of the ?exible sheath, With a laterally de?ected
`distal end shoWn in broken line.
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`US 6,338,725 B1
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`5
`FIG. 3 is a partial cross-sectional vieW of a hemostasis
`valve mounted at the proximal end of the ?exible sheath of
`the catheter introducing system of FIG. 1.
`FIG. 4 is a cross-sectional vieW of a foam insert included
`in the hemostasis valve of FIG. 3.
`FIG. 5 is a partial cross-sectional vieW of the body of the
`?exible sheath of the catheter introducing system of FIG. 1.
`FIG. 6 is a side vieW of an alternate construction of the
`?exible sheath of the catheter introducing system of the
`present invention.
`FIG. 7 is a cross-sectional vieW taken along line 7—7 of
`FIG. 6.
`FIG. 8 is a proximal end vieW of a hemostasis valve on the
`?exible sheath of FIG. 6.
`FIG. 9 is a side vieW of the obturator of the catheter
`introducing system of FIG. 1 shoWn With portions broken
`aWay.
`FIG. 10 illustrates an alternative construction of the
`laterally de?ectable distal end of the obturator of FIG. 9.
`FIGS. 11A—11E illustrate use of the catheter introducing
`system of FIG. 1 for introducing a vascular graft through the
`subclavian artery, aortic arch, and abdominal aorta.
`FIG. 12 is a partial cross-sectional vieW of an alternative
`hemostasis valve Which can be mounted at the proximal end
`of the ?exible sheath of the catheter introducing system of
`FIG. 1.
`FIG. 13 is a front vieW of an elastomeric insert included
`in the hemostasis valve of FIG. 12.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`The present invention provides a catheter introducing
`system including both a large diameter sheath and a steer
`able obturator Which can be removably introduced into a
`central lumen of the sheath. The sheath is usually part of an
`introducer catheter having a hemostasis valve at its proximal
`end. The sheath and obturator are usually introduced
`together through a percutaneous access site to a desired
`target location Within a body lumen or cavity, With the
`steerable obturator being used to guide the sheath through a
`tortuous path such as in a blood vessel or Within an open
`body cavity, such as in an insuf?ated abdomen during a
`laparoscopic procedure. Alternatively, the obturator could be
`advanced distally beyond the sheath, With the sheath being
`subsequently advanced over the obturator. In either case, the
`obturator is removed after the sheath reaches the target
`location, providing an open access lumen for subsequent
`introduction of interventional or other catheters and devices.
`The catheter introducing system of the present invention is
`particularly useful for introducing large diameter interven
`tional catheters, especially into the brachial or subclavian
`arteries, through the aortic arch, and into the abdominal
`aorta, more especially for graft placement to treat abdominal
`aortic aneurysms.
`The sheath of the catheter introducing system Will pref
`erably include only a single lumen having a relatively large
`diameter, usually being at least 4 mm, preferably being from
`4 mm to 10 mm, and more preferably being from 5 mm to
`9 mm. For use in the exemplary aortic introducing catheter,
`the sheath Will have a lumen diameter from 7 mm to 8 mm,
`and an outer diameter from 8 mm to 9 mm. In order to
`maximiZe available lumen area (Which is an objective of the
`design of the catheter introducing system), the sheath Will
`have a thin Wall, usually being from 0.25 mm to 1 mm. The
`sheath length Will vary depending on the intended use,
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`typically being from 30 cm to 60 cm. For use in the
`exemplary aortic introducer catheter, the sheath length Will
`be from 40 cm to 60 cm, usually being from 40 cm to 50 cm.
`The body of the ?exible sheath must have sufficient hoop
`strength in order to avoid kinking and collapse during use,
`even When the sheath is bent through a small radius curve,
`preferably as small as about 1 cm. The sheath must also have
`sufficient column strength so that it can be advanced through
`restricted passages (although the obturator present in the
`sheath lumen Will contribute signi?cantly to its effective
`column strength). To meet these mechanical requirements,
`the sheath of the present invention Will preferably be
`reinforced, such as by an imbedded metal coil, braid,
`?lament(s), or the like. In a preferred aspect of the present
`invention, as illustrated in the exemplary embodiments
`beloW, the sheath Will be reinforced With a helical coil
`formed from a ?at metal ribbon, usually a stainless steel
`ribbon The stainless steel ribbon preferably has a Width in
`the range from about 0.5 mm to 1.5 mm and a thickness in
`the range from about 0.08 mm to 0.15 mm. In a particularly
`preferred construction, the ribbon is Wrapped over an inner
`liner (as described beloW) having from 5 turns to 15 turns
`per centimeter, Wherein the spacing betWeen the adjacent
`turns is in the range from 0.5 mm to 1 mm.
`In the exemplary embodiment, the inner liner may be
`formed from a lubricous material, such as polytetra?uoreth
`ylene (PTFE), ?uorinated ethylenepropylene polymer
`(FEP), polyether block amide copolymer (pebax), polya
`mide (nylon), polyethylene, and the like. The tubular inner
`liner Will typically have a thickness in the range from about
`0.08 mm to 0.15 mm. The inner liner may also be formed
`from a non-lubricous material, such as a polyurethane,
`Where the inner lumen of the liner is coated With a lubri
`cating material, such as a silicone gel. Optionally, the
`lubricating layer may also be used With other, more lubri
`cous materials, in order to provide even greater lubricity for
`the introduction of instruments and devices through the
`sheath. The helical coil Will be Wrapped over the inner liner,
`and an outer plastic coating Will be melted or otherWise
`impregnated over the coil and into the space betWeen
`adjacent turns of the coil. The plastic coating is preferably
`composed of a material Which has elastic properties similar
`to those of the liner. Suitable materials include polyurethane,
`polyethylene (pebax), polyamide (nylon), and the like. The
`thickness of the coating measured from the inner liner to the
`exterior of the sheath is typically in the range from 0.8 mm
`to 0.15 mm. In a preferred construction, both the inner liner
`and the outer plastic coating are composed of polyurethane,
`and the lumen of the combined inner and outer liner assem
`bly is coated With a silicone, hydrophilic, or other lubricant.
`Such lubricating coatings are Well described in the patent
`literature. See, for example, US. Pat. No. 4,898,591, Which
`is incorporated herein by reference.
`In a preferred aspect of the present invention, the ?exible
`sheath Will have regions of differing ?exibility over its
`length, preferably having a region of enhanced ?exibility
`over a distal length in the range from about 5 cm to 15 cm,
`more preferably from 5 cm to 10 cm. Such enhanced
`?exibility may be achieved by increasing the spacing
`betWeen adjacent turns of the reinforcement coil (thus
`providing reduced reinforcement in the enhanced ?exibility
`region), utiliZing materials for the inner liner and/or outer
`plastic coating having loWer durometers, selectively reduc
`ing Wall thickness, or by other conventional techniques.
`The ?exible sheath of the catheter introducing system Will
`also preferably have a soft tip formed over the distal 2 mm
`to 10 mm of the sheath body. The soft tip may be formed by
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`Page 19 of 22
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`US 6,338,725 B1
`
`7
`terminating the reinforcement in the soft tip region. Addi
`tionally or alternatively, the softness of the tip can be
`enhanced by utilizing the same or different materials for the
`inner liner and/or outer coating, Where the materials have a
`loWer durometer in the soft tip region.
`The ?exible catheter sheath of the catheter introducing
`system may be fabricated by methods Well knoWn in the art.
`In an exemplary method, the inner layer is formed by
`Wrapping a strip of the desired plastic material, e.g., a
`polyurethane, over a mandril, typically a te?on rod having
`the desired ?nal inner lumen diameter. A stainless steel
`reinforcement ribbon is next Wrapped helically over the
`polyurethane. Next, another strip of the desired plastic
`coating material, e.g., polyurethane, is Wrapped over the
`stainless steel reinforcement. A shrink Wrap tube may then
`be placed over the entire assembly, and the assembly cured
`in an oven at a temperature suf?cient to melt both the inner
`layer material and outer layer plastic coating material an