(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2004/0010280 A1
`(43) Pub. Date:
`Jan. 15, 2004
`Adams et al.
`
`US 20040010280A1
`
`(54) DEVICE TO CREATE PROXIMAL STASIS
`(76) Inventors: Daniel O. Adams, Long Lake, MN
`(US); Richard S. Kusleika, Eden
`Prairie, MN (US); Kent D. Anderson,
`Champlin, MN (US)
`Correspondence Address:
`Terry L. Wiles
`Popovich & Wiles, PA
`Suite 1902, IDS Center
`80 South 8th Street
`Minneapolis, MN 55402-2111 (US)
`(21) Appl. No.:
`10/194,355
`(22) Filed:
`Jul. 12, 2002
`Publication Classification
`
`(51) Int. Cl. ................................................. A61M 29/00
`
`
`
`(52) U.S. Cl. .............................................................. 606/194
`
`(57)
`
`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.
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`US 2004/0010280 A1
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`Jan. 15, 2004
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`DEVICE TO CREATE PROXIMAL STASIS
`
`FIELD OF THE INVENTION
`0001. This invention relates to a device, a system, and a
`method 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
`0002 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 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 Stenting. These procedures are intended to
`restore normal flow through the arteries.
`0003. In the case of CABG, the Saphenous vein is har
`Vested 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 diseased, 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, 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 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.
`0004. 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
`a guide catheter or elongated sheath.
`0005 The first approach involves crossing the obstruc
`tion 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 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 comple
`tion of the treatment, a Suction catheter is placed into the
`vessel such that the distal tip is near the balloon. Suction is
`applied to the catheter tip and embolic material is removed
`from the vessel.
`0006 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 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 treat
`ment is directed by the blood flow into the filter. The filter
`retains embolic material greater in size than the filter pore
`size. After treatment, a recovery catheter is advanced distally
`to a location proximal to the filter and the filter pulled
`proximally. 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.
`0007. 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,
`particularly 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.
`0008 A filter approach can be problematic because par
`ticles Smaller than the filter pore Size will pass through the
`filter and may cause embolic events or consequence, par
`ticularly in the brain. There is also no assurance that trapped
`emboli will not be Squeezed through the filter mesh during
`recovery.
`0009 Recent clinical trials show that both types of embo
`lic 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.
`0.010
`Unfortunately, these approaches to embolic protec
`tion do not eliminate embolic events entirely because pas
`Sage 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 pas
`Sage 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 PTCAballoon is inflated
`proximal to the treatment site (lesion) to create Stasis in the
`vessel. Emboli liberated on lesion crossing cannot be trans
`ported distally because there is no flow. A distal protection
`filter is then deployed and flow in the vessel is re-estab
`lished. Any emboli created during lesion crossing by the
`distal protection device are prevented from flowing distally.
`The disadvantages 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
`0011. 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
`
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`US 2004/0010280 A1
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`Jan. 15, 2004
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`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.
`0012. In one aspect, this invention is a method of per
`forming 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 a proximal Sealing portion and having a lumen
`extending therethrough. The method further includes intro
`ducing 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, introducing 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 por
`tion 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.
`0013 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 initinol. 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.
`0.014. 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 membrane. 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 posi
`tioned adjacent the distal Sealing portion.
`0.015 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.
`0016. In another aspect, this invention is a method of
`occluding the flow of blood in a vessel of a patient com
`prising introducing an elongate sheath into the vessel, the
`sheath having an inner wall defining a lumen extending
`therethrough, 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
`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
`the wall of the vessel to occlude blood flow.
`0017. 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 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.
`0018. 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
`proximal 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.
`0019. In another aspect, this invention is a system for
`protecting a patient from emboli released during an intra
`vascular 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
`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
`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.
`0020. In another aspect, this invention is a system for
`protecting a patient from emboli released during an intra
`
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`US 2004/0010280 A1
`
`Jan. 15, 2004
`
`vascular 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
`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
`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
`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
`Second Section being biased radially outwardly, the proximal
`Sealing means comprising the Second Section. The distal
`Sealing means may comprise a Self-expanding metal.
`0021. In another aspect, this invention is a system for
`protecting a patient from emboli released during an intra
`vascular 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
`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
`is extended from the distal end of the guide catheter, a
`delivery catheter having distal and proximal ends and a
`lumen, the delivery catheter being sized to be delivered
`through the lumens of the guide catheter and Sealing device
`to a location in the vessel where its distal end is distal to the
`treatment Site, and an elongate Support member carrying an
`embolic protection device, the elongate Support member and
`embolic protection device being sized to be slideably
`accommodated within the lumen of the delivery catheter, the
`embolic protection device being expandable from a delivery
`configuration when contained within the delivery catheter to
`a deployed configuration when extended from the distal end
`of the delivery catheter.
`0022. In another aspect, this invention is a method of
`performing an intravascular procedure at a treatment Site in
`a vessel of a patient comprising providing a Sealing device
`having proximal and distal ends, a distal Sealing portion and
`a proximal Sealing portion and having a lumen extending
`therethrough, introducing a guide catheter into the vessel,
`the guide catheter having proximal and distal ends and a
`lumen and a valve connected at the proximal end for opening
`and closing the lumen of the guide catheter to fluid flow,
`advancing the guide catheter through the vessel until the
`distal end of the guide catheter is at a desired location
`proximal of the treatment Site, introducing the Sealing device
`into the 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, blocking antegrade blood flow through the vessel
`with the Sealing device, opening the valve on the guide
`catheter to create retrograde blood flow through the vessel,
`after antegrade blood flow has been blocked 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.
`0023. In another aspect, this invention is a method of
`performing an intravascular procedure at a treatment Site in
`a vessel of a patient comprising providing a Sealing device
`having proximal and distal ends, a distal Sealing portion and
`a proximal Sealing portion and having a lumen extending
`therethrough, introducing a guide catheter into the vessel,
`the guide catheter having proximal and distal ends and a
`lumen and a Suction device connected to the lumen, advanc
`ing the guide catheter through the vessel until the distal end
`of the guide catheter is at a desired location proximal of the
`treatment Site, introducing the Sealing device into the 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,
`blocking antegrade blood flow through the vessel with the
`Sealing device, operating the Suction device to create retro
`grade blood flow through the vessel, after antegrade blood
`flow has been blocked 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, with
`drawing 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 per
`forming the intravascular procedure with the treatment
`device.
`In another aspect, this invention is a system for
`0024.
`creating retrograde flow of blood in a vessel of a human
`vascular System comprising a catheter having proximal and
`distal ends and a lumen and a valve connected at the
`proximal end for opening and closing the lumen of the
`catheter to fluid flow, and a Sealing device having a proximal
`Sealing portion and a distal Sealing portion and a lumen, the
`proximal 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.
`0025. In another aspect, this invention is a system for
`creating retrograde flow of blood in a vessel of a human
`vascular System comprising a catheter having proximal and
`distal ends and a lumen, a Suction device connected to the
`lumen of the catheter, and a Sealing device having a proxi
`mal Sealing portion and a distal Sealing portion and a lumen,
`the proximal 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.
`0026. In another aspect, this invention is a method of
`delivering an embolic protection device to a desired location
`distal to 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 a proximal Sealing
`
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`US 2004/0010280 A1
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`Jan. 15, 2004
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`portion and having a lumen extending therethrough, intro
`ducing 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, introducing 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, occluding the flow
`of blood through the vessel with the Sealing device, and after
`blood flow has been occluded advancing a distal protection
`device through the lumens of the guide catheter and the
`Sealing device and through the vessel to the desired location
`distal to the treatment site.
`0027. In another aspect, this invention is a method of
`occluding the flow of blood in a vessel of a patient com
`prising providing a Sealing device having proximal and
`distal ends, a distal Sealing portion and a proximal Sealing
`portion and having a lumen extending therethrough, intro
`ducing 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, introducing the Sealing device into a lumen of the guide
`catheter, and 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 expands
`to Seal against a wall of the vessel.
`BRIEF DESCRIPTION OF THE DRAWINGS
`0028 FIG. 1A is a side view in partial cross-section of
`one embodiment of the device of this invention and the
`delivery system used to deliver it. FIG. 1B is a detail view
`showing deployment of another embodiment of the device
`of this invention within a saphenous vein graft; FIG. 1C is
`an illustrative view of deployment of another embodiment of
`the device of this invention in a carotid artery, and FIG. 1D
`is a perspective view of an introducer used to load the guide
`Seal into the System.
`0029 FIGS. 2A to 2F are detailed illustrative views of
`the System of this invention, showing deployment of the
`guide Seal and a distal protection device within a vessel.
`0030 FIG. 3A is a perspective view of a device of this
`invention attached to a proximal control wire. FIG. 3B is a
`detail View showing a crimp tube that attaches the control
`wire and the proximal end of the guide seal; FIG.3C is a top
`view of an alternate attachment means, and FIG. 3D is a
`cross sectional view showing the attachment means of FIG.
`3C.
`0031 FIGS. 4A to 4C are side views of alternate embodi
`ments of the device of this invention showing means for
`Sealing the guide Seal within the lumen of the guide catheter.
`0032 FIGS. 5A and 5B are side views of the device of
`this invention provided with flow windows.
`0033 FIG. 6A is a side view of an embodiment of the
`device of this invention having a delayed expansion feature.
`FIGS. 6B and 6C are detail side views showing deployment
`of the guide seal of FIG. 6A from the distal end of the guide
`catheter. FIGS. 6D to 6F are side views of alternative
`embodiments of the device of this invention having a
`delayed expansion feature.
`0034 FIG. 7A is a side view of an alternate embodiment
`of the device of this invention connected to a tube at its
`
`proximal end and to a control wire at its distal end, and
`FIGS. 7B and 7C are end views illustrating the relative
`position of portions of the guide Seal.
`0035 FIGS. 8 and 9 are perspective views of further
`alternate embodiments of the device of this invention.
`0036 FIG. 10A is a side view of an alternate embodi
`ment of the device of this invention and FIG. 10B is a detail
`View showing attachment of polymeric membrane to the
`guide Seal frame wire.
`0037 FIG. 11A shows a side view of another embodi
`ment of the device of this invention and FIG. 11B shows a
`perspective view of a hypotube attached to the guide Seal.
`0038 FIG. 12A is a side view of a further alternate
`embodiment of the device having two control wires and
`FIG. 12B is a cross sectional view along line 12B-12B of
`FIG. 12A showing the distal connection of a control wire.
`0039 FIGS. 13A and 13B are cross sectional views of an
`alternative embodiment of the device of this invention
`having an everting guide Seal.
`0040 FIG. 14A is a side view of an alternative embodi
`ment of the device of this invention having a disc-shaped
`guide seal placed in the ostium of a vein, FIG. 14B is a end
`View showing the relative sizes of portions of the guide Seal,
`and FIG. 14C is a cross-sectional view showing the guide
`Seal and catheter placement relative to the Ostium of a vein.
`0041 FIG. 15 is a side view of an alternate embodiment
`of the device of this invention.
`0042 FIG. 16A is a cut away view and FIGS. 16B and
`16C are cross sectional views of an alternate embodiment of
`the device of this invention.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`0043. The terms “distal” and “proximal” as used herein
`refer to the relative position of the guidewire, catheters, and
`guide Seal in a lumen. “Proximal” refers to a location
`upstream and “distal” refers to a location downstream. Flow
`of blood through a lumen normally moves from the proximal
`to the distal portions of the device of this invention, how
`ever, the device interrupts this flow and a retrograde flow
`may be established.
`0044) The Figures describe various embodiments. Ele
`ments that vary from one embodiment to another but oth
`erwise are Similar in shape, Size, relative placement, or
`function are denoted by suffices “a”, “b”, “c”, etc., and may
`be referred to in a general way by a number without its
`Suffix.
`004.5 The present invention is a device for occluding
`blood flow in a vessel at a location proximal to a treatment
`Site in the vessel, thus preventing embolic material from
`moving distally in the vessel, prior to deployment of an
`embolic protection device positioned distally of the treat
`ment Site. The device includes a guide Seal that has a
`proximal portion that Seals within the lumen of a guide
`catheter and a distal portion that expands when deployed
`beyond the distal end of the guide catheter to Seal within a
`vessel So that a fluid tight Seal is obtained. The guide Seal
`stops blood flow through the vessel and is deployed without
`causing damage to the vasculature. A filtration device or
`
`Page 24
`
`Medtronic Exhibit 1435
`
`

`

`US 2004/0010280 A1
`
`Jan. 15, 2004
`
`other distal protection device can then be advanced through
`the guide Seal, down the vessel, and acroSS a lesion or
`Stenosis. Because of the occlusion by the guide Seal there is
`little or no flow through the stenotic site when it is being
`crossed by the distal protection device or its delivery cath
`eter. A proximal wire or other control means extends axially
`and controls actuation of the guide Seal by it