BSC USP 8,142,413
`Exhibit 1015
`
`Page 1 of 31
`
`I I I I I I I I I I I I I I I 0 I I I I I I I I I I I (cid:9)
`
`
`
`12 I I I I 2 I M I I I I I I I I I I I I I I I I I I I I I I I I I I
`
`(12) United States Patent
`Adams et al.
`
`(10) Patent No.: (cid:9)
`(45) Date of Patent: (cid:9)
`
`US 7,232,452 B2
`Jun. 19, 2007
`
`(54)
`
`DEVICE TO CREATE PROXIMAL STASIS
`
`(75)
`
`Inventors: Daniel 0. Adams, Long Lake, MN
`(US); Richard S. Kusleika, Eden
`Prairie, MN (US); Kent D. Anderson,
`Champlin, MN (US)
`
`(73)
`
`Assignee: ev3 Inc., Plymouth, MN (US)
`
`(* )
`
`Notice: (cid:9)
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 397 days.
`
`(21)
`
`Appl. No.: 10/194,355
`
`(22)
`
`Filed: (cid:9)
`
`Jul. 12, 2002
`
`(65)
`
`(51)
`
`(52)
`(58)
`
`(56)
`
`Prior Publication Data
`
`US 2004/0010280 Al (cid:9)
`
`Jan. 15, 2004
`
`(2006.01)
`
`Int. Cl.
`A61M 29/00 (cid:9)
` 606/200
`U.S. Cl. (cid:9)
` 606/194,
`Field of Classification Search (cid:9)
`606/127, 200, 159; 604/500
`See application file for complete search history.
`
`References Cited
`
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`
`(Continued)
`
`Primary Examiner (cid:9) Anhtuan T. Nguyen
`Assistant Examiner (cid:9) Elizabeth Houston
`(74) Attorney, Agent, or Firm (cid:9) Popovich, Wiles &
`O'Connell, P.A.
`
`(57) (cid:9)
`
`ABSTRACT
`
`A method and system of performing an intravascular pro-
`cedure at a treatment site in a vessel of a patient. A device
`creates a seal to prevent the flow of blood during the
`treatment of vascular disease. A seal may be formed between
`the distal inside diameter of a sheath or catheter such as a
`guide catheter as well as within a vessel, such as an artery
`or vein. An elongated device having a distal portion extend-
`ing from the catheter and having a fluid impermeable
`membrane disposed about at least the distal end of the device
`is used to seal the vessel. The system includes a device to
`occlude blood flow and a distal protection device to filter or
`remove embolic debris.
`
`22 Claims, 19 Drawing Sheets
`
`20
`
`16
`
`10
`
`16
`#11
`Aor
`(cid:9) A 74.
` 1 (cid:9)
`nA •
`
`Air/ Ar./../4/4/.//r/MMAAKKOM.ed
`
`15
`
`• • • •
`
`
`4sgatamg,
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`Page 2 of 31
`
`US 7,232,452 B2
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`
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`
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`
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`EP (cid:9)
`EP (cid:9)
`EP (cid:9)
`FR (cid:9)
`WO (cid:9)
`WO (cid:9)
`WO (cid:9)
`WO (cid:9)
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`WO (cid:9)
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`WO (cid:9)
`WO (cid:9)
`WO (cid:9)
`
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`
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`
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`
`* cited by examiner
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`606/170
`
`604/509
`604/509
`
`604/500
`
`128/898
`
`604/104
`
`606/194
`
`606/198
`
`
`
`604/96.01
`
`

`

`Page 3 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 1 of 19 (cid:9)
`
`US 7,232,452 B2
`
`(cid:9)
`

`

`Page 4 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 2 of 19 (cid:9)
`
`US 7,232,452 B2
`
`16
`
`Mg. 191
`
`(cid:9)
`

`

`Page 5 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 3 of 19 (cid:9)
`
`US 7,232,452 B2
`
`wig. 1 C
`
`6b (cid:9)
`
`)
`
`\6 (cid:9)
`
`a
`
`Sig. 1 D
`
`(cid:9)
`(cid:9)
`

`

`Page 6 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 4 of 19 (cid:9)
`
`US 7,232,452 B2
`
`10 (cid:9)
`
`20
`
`WO:IAMMIPM145////4
`
`Mg.
`
`12
`
`A
`
`A
`
`10 (cid:9)
`
`20
`r/4714 FA F (cid:9)
`Mei"; Vev4
`
`12
`
`A
`
`Mg. 2q
`
`10
`
`20
`
`r r vr4,,vnwier
`
`AIWA A.WAYAWAL
`
`Mg. 2C
`
`17 (cid:9)
`
`17
`
`(cid:9)
`(cid:9)
`

`

`Page 7 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 5 of 19 (cid:9)
`
`US 7,232,452 B2
`
`(cid:9)
`

`

`Page 8 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 6 of 19
`
`US 7,232,452 B2
`
`30
`
`33
`
`Mg. 3 ql
`
`Mg. 3C
`
`37c
`
`crnmArAwm.r.vm..T6-67-‘16-
`
`Mg. 3q
`
`
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`Page 9 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 7 of 19 (cid:9)
`
`US 7,232,452 B2
`
`31a
`
`10
`
`38a
`
`vi ArAPIrArAnirACIAIA/4/4/405/AW (cid:9)
`
`PirAPAPArAIA
`
`TrAr/ (cid:9)
`
`35
`
`• • I
`AFAW 4%M/
`
`// A
`
`30a
`
`33a
`
`14a (cid:9)
`
`45a
`
`Mg. 4I
`
`10
`
`30b
`
`4," ////WM (cid:9)
`
`/ArAWIAF/A
`
`mdurnA r
`.1/4/A7
`45b
`
`14b (cid:9)
`
`Mg. 4 iA
`
`38b
`
`45c
`
`30c
`
`AfAr. AP:4'4 WArArArArArArArA!
`
`•
`
`
`
`•••••n .111.111•n
`
`10 (cid:9)
`
`AV/ /AW
`14c (cid:9)
`Mg. 4C
`
`M ar./ A
`
`38c
`
`c (cid:9)
`35
`
`35
`
`(cid:9)
`

`

`Page 10 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 8 of 19 (cid:9)
`
`US 7,232,452 B2
`
`10
`F22=Z22:Zh2ZZZZ2222Z
`
`/50a
`
`56a
`
`(cid:9)7,43•0K
`
`53a
`
`750b
`
`55a
`
`51a
`Mg. 5j/I
`
`"Mi
`
`"Mb •IND
`
`55b
`
`56b
`Mg. 5q1
`
`

`

`Page 11 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 9 of 19 (cid:9)
`
`US 7,232,452 B2
`
`60a
`67a
`
`66a
`
`68a
`
`Mg. g 5 71 r
`
`69a
`
`Mg. 6'
`
`66a
`
`Mg. 6C
`
`67a
`
`(cid:9)
`

`

`Page 12 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 10 of 19 (cid:9)
`
`US 7,232,452 B2
`
`61d (cid:9)
`
`60d
`i/
`
`61d
`
`68d
`
`69d
`
`Mg. 6 CO
`
`760e
`
`61e
`
`68e
`
`i,
`
`60f
`
`61e
`
`_7\
`
`Mg. 6e
`
`69e
`
`Mg. 6,
`
`7
`
`69f
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`Page 13 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 11 of 19 (cid:9)
`
`US 7,232,452 B2
`
`770
`
`72 (cid:9)
`
`75
`
`71
`
`73
`75 7
`
`AMMO*
`
`73a
`
`70b
`Mg. 7,54
`
`N—„—, 75a
`70a
`
`70a
`
`70b
`
`70a
`
`70b
`
`Mg. 711
`
`Mg. 7C
`
`(cid:9)
`

`

`Page 14 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 12 of 19 (cid:9)
`
`US 7,232,452 B2
`
`80
`
`(
`
`, . ,, j
`
`1
`83
`
`Sig. 8
`
`91
`
`2\
`
`Mg. 9
`
`

`

`Page 15 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 13 of 19 (cid:9)
`
`US 7,232,452 B2
`
`
`/00 , _.,:i/g-. io10c
`
`/ (cid:9)
`
`N
`
`/
`
`106
`
`Mg. 10j4
`
`- - - _
`
`.... (cid:9)
`
`...• (cid:9)
`
`N.
`
`N...
`
`N.
`
`108
`n (cid:9)
`
`..0 (cid:9)
`/
`/
`
`I
`
`108b
`
`Mg. 103
`
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`Page 16 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
`
`Sheet 14 of 19 (cid:9)
`
`US 7,232,452 B2
`
`Mg. 11,gi
`
`110
`
`115
`
`111b
`
`113
`
`Mg. 119
`
`113a
`
`(cid:9)
`

`

`Page 17 of 31
`
`U.S. Patent (cid:9)
`
`Jun. 19, 2007
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`US 7,232,452 B2
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`Page 18 of 31
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`U.S. Patent (cid:9)
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`Jun. 19, 2007
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`U.S. Patent (cid:9)
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`Jun. 19, 2007
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`U.S. Patent (cid:9)
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`Jun. 19, 2007
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`Page 21 of 31
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`U.S. Patent (cid:9)
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`Jun. 19, 2007
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`Sheet 19 of 19 (cid:9)
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`US 7,232,452 B2
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`Page 22 of 31
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`US 7,232,452 B2
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`1
`DEVICE TO CREATE PROXIMAL STASIS
`
`FIELD OF THE INVENTION
`
`This invention relates to a device, a system, and a method 5
`for treating vascular disease. In particular, this invention
`relates to the occlusion of blood flow through a stenotic
`region and treatment of the region.
`
`BACKGROUND OF THE INVENTION (cid:9)
`
`10
`
`Atherosclerosis or vascular disease is the leading cause of
`death in the world today. It is a disease of the arteries
`whereby deposits (plaque) build up over time in the walls of
`the arteries, restricting oxygenated blood flow to vital organs 15
`such as the heart, brain and other bodily tissue. A number of
`medical procedures have been developed to treat vascular
`disease such as Coronary Artery By-Pass Grafting (CABG)
`and Percutaneous Balloon Angioplasty (PTCA) and Stent-
`ing. These procedures are intended to restore normal flow 20
`through the arteries.
`In the case of CABG, the saphenous vein is harvested
`from the leg and used as a conduit to by-pass blood flow
`from the aorta to a point distal to an obstruction in a coronary
`artery. After a number of years, these grafts become dis-
`25
`eased, and treatment of the graft is needed to improve blood
`flow. Treatment of these degenerated grafts with PTCA or
`Stenting is associated with a high incidence of embolic
`material (vessel deposits) released distally. This can result in
`a no-flow condition and myocardial infarction. Similarly, 30
`treatment of carotid arteries and renal arteries by PTCA and
`Stenting can cause release of embolic material. In the case
`of the carotid artery, emboli released can result in a stroke.
`In the case of the renal artery, emboli release can result in the
`renal infarct and reduced renal function. There is a risk of 35
`embolic material being released with any balloon expansion
`or passage of a treatment device through a diseased section
`of a vessel, with undesirable results to the patient. Thus, it
`is highly desirable to prevent embolic material from being
`released during treatment of vascular disease.
`The use of embolic protection devices has recently
`improved the outcome for treatment of these diseased grafts
`and arterial restrictions. There are two major approaches to
`embolic protection. In either case the devices are delivered
`to the area of treatment in the conventional means through 45
`a guide catheter or elongated sheath.
`The first approach involves crossing the obstruction or
`diseased vessel with a deflated balloon affixed to the distal
`end of a hollow guidewire. The balloon segment is placed
`distal to the arterial segment to be treated, and the balloon so
`is inflated to occlude flow of blood in the vessel. The PTCA
`or Stenting treatment is then performed over the hollow wire
`and any embolic material is prevented from moving beyond
`the distal occlusion balloon. After completion of the treat-
`ment, a suction catheter is placed into the vessel such that the 55
`distal tip is near the balloon. Suction is applied to the
`catheter tip and embolic material is removed from the vessel.
`The second approach involves a filter mounted on a
`guidewire and sheathed in a delivery catheter. The sheathed
`filter is placed in the artery distal to the treatment site. The 60
`filter is then deployed through the sheath and expands
`outward adjacent the vessel wall to channel blood flow into
`the filter. The treatment device is then advanced over the
`guidewire, and any emboli generated during treatment is
`directed by the blood flow into the filter. The filter retains 65
`embolic material greater in size than the filter pore size.
`After treatment, a recovery catheter is advanced distally to
`
`40
`
`2
`a location proximal to the filter and the filter pulled proxi-
`mally. The filter closes and/or the filter is drawn completely
`into a lumen of the retrieval catheter. The system with
`captured emboli is then withdrawn from the body.
`A balloon occlusion approach can be problematic because
`no blood is flowing through the vessel during use of the
`treatment device and ischemia can develop quickly, particu-
`larly in saphenous vein grafts. The procedure must be
`conducted swiftly to prevent undue patient pain. There is
`also no assurance that all trapped emboli are removed by
`suction.
`A filter approach can be problematic because particles
`smaller than the filter pore size will pass through the filter
`and may cause embolic events or consequence, particularly
`in the brain. There is also no assurance that trapped emboli
`will not be squeezed through the filter mesh during recovery.
`Recent clinical trials show that both types of embolic
`protection devices reduce the occurrence of embolic events
`by about half in the case of saphenous vein grafts. Clinical
`trials currently are assessing the benefit in carotid and other
`arterial treatments.
`Unfortunately, these approaches to embolic protection do
`not eliminate embolic events entirely because passage of the
`protection device or the catheter delivering the device across
`the diseased section of the vessel or lesion can dislodge
`embolic material prior to deployment of the device. Thus, it
`would be highly desirable to use a device or method that
`would prevent release of embolic material during passage of
`the embolic protection system through the vessel lesion to
`the deployment location. One prior art attempt to solve this
`problem is disclosed in U.S. Pat. No. 6,348,062 (Hopkins et
`al.). In this approach a PTCA balloon is inflated proximal to
`the treatment site (lesion) to create stasis in the vessel.
`Emboli liberated on lesion crossing cannot be transported
`distally because there is no flow. A distal protection filter is
`then deployed and flow in the vessel is re-established. Any
`emboli created during lesion crossing by the distal protec-
`tion device are prevented from flowing distally. The disad-
`vantages of this system are that a treatment balloon must be
`advanced into the vessel prior to creating stasis, and
`advancement of this balloon may liberate emboli. Further,
`initial treatment with a balloon is not appropriate therapy for
`all procedures. For example, it may be more appropriate to
`initially debulk a vessel using atherectomy or thrombectomy
`by methods commonly used in the art. Finally, it is known
`that even passage of a guidewire can liberate emboli, espe-
`cially in saphenous vein grafts. Placement of a balloon
`catheter requires pre-placement of a guidewire in this prior
`art approach.
`
`SUMMARY OF THE INVENTION
`
`This invention is a device and a method that creates a seal
`to prevent the flow of blood during the treatment of vascular
`disease. A seal may be formed between the distal inside
`diameter of a sheath or catheter such as a guide catheter and
`within a vessel, such as an artery or vein. An elongated
`device having a distal portion extending from the catheter
`and having a fluid impermeable membrane disposed about at
`least the distal end of the device is used to seal the vessel.
`This invention is also a system in which the device occludes
`blood flow and includes a distal protection device which is
`deployed to filter or remove embolic debris.
`In one aspect, this invention is a method of performing an
`intravascular procedure at a treatment site in a vessel of a
`patient. The method includes providing a sealing device
`having proximal and distal ends, a distal sealing portion and
`
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`Page 23 of 31
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`US 7,232,452 B2
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`3
`a proximal sealing portion and having a lumen extending
`therethrough. The method further includes introducing a
`guide catheter into the vessel, advancing the guide catheter
`through the vessel until a distal end of the guide catheter is
`at a desired location proximal of the treatment site, intro-
`ducing the sealing device into a lumen of the guide catheter,
`advancing the sealing device through the lumen of the guide
`catheter until the distal sealing portion extends from the
`distal end of the guide catheter, and occluding the flow of
`blood through the vessel with the sealing device. After blood
`flow has been occluded the method includes advancing a
`distal protection device through the lumens of the guide
`catheter and the sealing device and through the vessel to a
`location distal to the treatment site, deploying the distal
`protection device, withdrawing the distal sealing portion of
`the sealing device into the guide catheter, advancing a
`vascular treatment device through the guide catheter to the
`treatment site, and performing the intravascular procedure
`with the treatment device.
`The distal sealing portion of the sealing device may be
`expandable from a delivery configuration to a deployed
`configuration. The proximal sealing portion of the sealing
`device may have a first diameter and the distal sealing
`portion may have a second diameter when extended from the
`distal end of the guide catheter, the second diameter being
`larger that the first diameter. The sealing device may com-
`prise metal wire, which may comprise nitinol. The sealing
`device may also have a control element connected adjacent
`at least one of the distal and proximal ends of the sealing
`device, and this control element may be a wire or a tube.
`The control element may comprise an elongate proximal
`portion of the sealing device having a length sufficient to
`extend outside the patient during advancement of the sealing
`device. The sealing device may comprise a flexible mem-
`brane. The distal sealing portion of the sealing element may
`comprise a flexible membrane which is folded into the
`lumen of the sealing device, wherein the sealing device
`further includes a deployment member, and wherein the step
`of occluding the flow of blood comprises advancing the
`deployment member through the lumen of the sealing device
`to push the folded membrane out of the lumen of the sealing
`device. There may be at least one flow window between the
`lumen of the sealing device and an exterior surface of the
`sealing device. When the distal sealing portion is expandable
`from a delivery configuration to a deployed configuration,
`there may be a means to delay expansion of the distal sealing
`portion of the sealing device and this means may include
`longitudinal restraining elements positioned adjacent the
`distal sealing portion.
`The step of advancing the sealing device may comprise
`inflating a balloon portion of a balloon catheter in the lumen
`of the sealing device until the sealing device is secured to the
`balloon catheter and then advancing the balloon catheter
`through the lumen of the guide catheter. The sealing device
`also may include means to bias the proximal sealing portion
`outwardly to seal against the lumen of the guide catheter,
`and this biasing means may comprise a spring wire, open
`cell foam, or a locally thinned portion of the proximal
`sealing portion. When the treatment site is located adjacent
`an ostium of the vessel, the distal sealing portion of the
`sealing device may be provided with a first section with a
`first diameter sized to seal the vessel proximal to the ostium
`and a second section with a second larger diameter.
`In another aspect, this invention is a method of occluding
`the flow of blood in a vessel of a patient comprising
`introducing an elongate sheath into the vessel, the sheath
`having an inner wall defining a lumen extending there-
`
`2
`
`25
`
`30 (cid:9)
`
`4
`through, advancing the sheath through the vessel until a
`distal end of the sheath is at a desired location in the vessel,
`introducing a sealing device into the lumen of the sheath, the
`sealing device having a proximal sealing portion which seals
`5 against the inner wall of the sheath and a self-expanding
`distal sealing portion and having a lumen extending there-
`through, and advancing the sealing device through the
`lumen of the sheath until the distal sealing portion extends
`from a distal end of the sheath and expands to seal against
`10 the wall of the vessel to occlude blood flow.
`In another aspect, this invention is a sealing device for use
`in combination with a catheter to occlude fluid flow through
`a body lumen comprising an elongate body having a distal
`sealing portion and a proximal sealing portion and a lumen
`15 extending therethrough, the proximal sealing portion being
`sized to seal against a lumen of the catheter and the distal
`sealing portion being sized to seal against the body lumen
`when the distal sealing portion is extended from a distal end
`of the catheter.
`In another aspect, this invention is a system for occluding
`the flow of blood in a vessel of a human vascular system
`comprising a catheter having proximal and distal ends and a
`lumen, and a sealing device having a proximal sealing
`portion and a distal sealing portion and a lumen, the proxi-
`mal sealing portion being sized to seal against the lumen of
`the catheter and the distal sealing portion being sized to seal
`against the wall of the vessel when the distal sealing portion
`is extended from the distal end of the catheter.
`In another aspect, this invention is a system for protecting
`a patient from emboli released during an intravascular
`procedure performed at a treatment site in a vessel of a
`patient comprising a guide catheter having proximal and
`distal ends and a lumen, a sealing device having a distal
`35 sealing portion and a proximal sealing portion and a lumen,
`the proximal sealing portion being sized to seal against the
`lumen of the guide catheter and the distal sealing portion
`being sized to seal against the wall of the vessel at a location
`proximal to the treatment site when the distal sealing portion
`40 is extended from the distal end of the guide catheter, and a
`distal protection device sized to be delivered through the
`lumens of the guide catheter and sealing device to a location
`in the vessel distal to the treatment site.
`In another aspect, this invention is a system for protecting
`45 a patient from emboli released during an intravascular
`procedure performed at a treatment site in a vessel of a
`patient comprising a guide catheter having proximal and
`distal ends and a lumen, a sealing device having a lumen and
`having a proximal portion including proximal sealing means
`so for sealing against the lumen of the guide catheter and a
`distal portion including distal sealing means for sealing
`against the wall of the vessel at a location proximal to the
`treatment site when the distal portion is extended from the
`distal end of the guide catheter and a distal protection device
`55 sized to be delivered through the lumens of the guide
`catheter and sealing device to a location in the vessel distal
`to the treatment site. The proximal sealing means may
`comprise a spring wire or open cell foam. A distance
`between a wall of the lumen of the sealing device and an
`60 exterior surface of a first section of the proximal portion
`defines a first wall thickness and a distance between the wall
`of the lumen of the sealing device and an exterior surface of
`a second section of the proximal portion defines a second
`wall thickness which is less than the first wall thickness, the
`65 second section being biased radially outwardly, the proximal
`sealing means comprising the second section. The distal
`sealing means may comprise a self-expanding metal.
`
`

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`Page 24 of 31
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`US 7,232,452 B2
`
`
`
`5
`6
`In another aspect, this invention is a system for protecting
`flow has been blocked advancing a distal protection device
`a patient from emboli released during an intravascular
`through the lumens of the guide catheter and the sealing
`procedure performed at a treatment site in a vessel of a
`device and through the vessel to a location distal to the
`patient comprising a guide catheter having proximal and
`treatment site, deploying the distal protection device, with-
`distal ends and a lumen, a sealing device having a distal 5
`drawing the distal sealing portion of the sealing device into
`sealing portion and a proximal sealing portion and a lumen,
`the guide catheter, advancing a vascular treatment device
`the proximal sealing portion being sized to seal against the
`through the guide catheter to the treatment site, and per-
`lumen of the guide catheter and the distal sealing portion
`forming the intravascular procedure with the treatment
`being sized to seal against the wall of the vessel at a location
`device.
`o (cid:9)proximal to the treatment site when the distal sealing portion 1
`In another aspect, this invention is a system for creating
`is extended from the distal end of the guide catheter, a
`retrograde flow of blood in a vessel of a human vascular
`delivery catheter having distal and proximal ends and a
`system comprising a catheter having proximal and distal
`lumen, the delivery catheter being sized to be delivered
`ends and a lumen and a valve connected at the proximal end
`through the lumens of the guide catheter and sealing device
`for opening and closing the lumen of the catheter to fluid
`5 flow, and a sealing device having a proximal sealing portion
`to a location in the vessel where its distal end is distal to the 1
`and a distal sealing portion and a lumen, the proximal
`treatment site, and an elongate support member carrying an
`sealing portion being sized to seal against the lumen of the
`embolic protection device, the elongate support member and
`catheter and the distal sealing portion being sized to seal
`embolic protection device being sized to be slideably
`against the wall of the vessel when the distal sealing portion
`accommodated within the lumen of the delivery catheter, the
`
`o is extended from the distal end of the catheter. embolic protection device being expandable from a delivery 2
`In another aspect, this invention is a system for creating
`configuration when contained within the delivery catheter to
`retrograde flow of blood in a vessel of a human vascular
`a deployed configuration when extended from the distal end
`system comprising a catheter having proximal and distal
`of the delivery catheter.
`ends and a lumen, a suction device connected to the lumen
`In another aspect, this invention is a method of perform-
`5 of the catheter, and a sealing device having a proximal
`ing an intravascular procedure at a treatment site in a vessel 2
`sealing portion and a distal sealing portion and a lumen, the
`of a patient comprising providing a sealing device having
`proximal sealing portion being sized to seal against the
`proximal and distal ends, a distal sealing portion and a
`lumen of the catheter and the distal sealing portion being
`proximal sealing portion and having a lumen extending
`sized to seal against the wall of the vessel when the distal
`therethrough, introducing a guide catheter into the vessel,
`
`o sealing portion is extended from the distal end of the the guide catheter having proximal and distal ends and a 3
`catheter.
`lumen and a valve connected at the proximal end for opening
`In another aspect, this invention is a method of delivering
`and closing the lumen of the guide catheter to fluid flow,
`an embolic protection device to a desired location distal to
`advancing the guide catheter through the vessel until the
`a treatment site in a vessel of a patient. The method includes
`distal end of the guide catheter is at a desired location
`proximal of the treatment site, introducing the sealing device 3
`5 providing a sealing device having proximal and distal ends,
`a distal sealing po