BSC USP 8,142,413
`Exhibit 1038
`
`Page 1 of 67
`
`111111
`
`1111111111111111111111111111111111111111111111111111111111111111111111111111
`US 20020165598Al
`
`(19) United States
`(12) Patent Application Publication
`Wahr et al.
`
`(10) Pub. No.: US 2002/0165598 Al
`Nov. 7, 2002
`( 43) Pub. Date:
`
`(54) EMBOLI PROTECTION DEVICES AND
`RELATED METHODS OF USE
`
`(75)
`
`Inventors: Dennis W. Wahr, Ann Arbor, MI (US);
`Thomas V. Ressemann, St. Cloud, MN
`(US); Peter T. Keith, St. Paul, MN
`(US); David J. Blaeser, Champlin, MN
`(US)
`
`Correspondence Address:
`FINNEGAN,HENDERSON,FARABOW,
`GARRETT &
`DUNNERLLP
`1300 I STREET, NW
`WASHINGTON, DC 20005 (US)
`
`(73) Assignee: Velocimed
`
`(21) Appl. No.:
`
`09/845,162
`
`(22) Filed:
`
`May 1, 2001
`
`Publication Classification
`
`(51)
`
`Int. CI? .................................................... A61M 29/00
`
`(52) U.S. Cl. ........................................... 623/1.11; 606/194
`
`(57)
`
`ABSTRACT
`
`An evacuation sheath assembly and method of treating
`occluded vessels which reduces the risk of distal emboliza(cid:173)
`tion during vascular interventions is provided. The evacua(cid:173)
`tion sheath assembly includes an elongated tube defining an
`evacuation lumen having proximal and distal ends. A pro xi(cid:173)
`mal sealing surface is provided on a proximal portion of the
`tube and is configured to form a seal with a lumen of a
`guided catheter. A distal sealing surface is provided on a
`distal portion of the tube and is configured to form a seal
`with a blood vessel. A method of treatment of a blood vessel
`using the evacuation sheath assembly includes advancing
`the evacuation sheath assembly into the blood vessel
`through a guide catheter. Prior to advancing a device across
`a stenosis to be treated, normal antegrade blood flow in the
`blood vessel proximate to the stenosis is stopped. While
`blood flow is stopped, the stenosis is treated. Retrograde
`blood flow is induced within the blood vessel to carry
`embolic material dislodged during treating into the evacu(cid:173)
`ation sheath assembly.
`
`160
`
`

`

`Page 2 of 67
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`Patent Application Publication Nov. 7, 2002 Sheet 48 of 48
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`Page 50 of 67
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`US 2002/0165598 Al
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`Nov. 7, 2002
`
`1
`
`EMBOLI PROTECTION DEVICES AND RELATED
`METHODS OF USE
`
`DESCRIPTION OF THE INVENTION
`
`[0001] 1. Field of the Invention
`
`[0002] The present invention relates to apparatus and
`methods used to prevent the introduction of emboli into the
`bloodstream during and after surgery performed to reduce or
`remove blockage in blood vessels.
`
`BACKGROUND OF THE INVENTION
`
`[0003] Narrowing or occlusion of blood vessels, such as
`the walls of an artery, inhibit normal blood flow. Such
`blockages, whether partial or full, can have serious medical
`consequences, depending upon their location within a
`patient's vascular system. Narrowing or blockage of the
`coronary vessels that supply blood to the heart, a condition
`known as atherosclerosis, may cause damage to the heart.
`Heart attacks (myocardial infarction) may also result from
`this condition. Other vessels are also prone to narrowing,
`including carotids, renals, cerebrals, and other peripheral
`arteries.
`
`[0004] Various surgical procedures are currently used to
`reduce or remove the blockage in blood vessels. Such
`procedures include balloon angioplasty, which involves
`inserting a balloon catheter into the narrowed or occluded
`area, expanding the balloon in the narrow or occluded area,
`and if necessary, placing a stent in the now expanded area to
`keep it open. Another common procedure used is atherec(cid:173)
`tomy where the lesion is cut away and removed from the
`vessel, or abrasively ground, sending the small particulates
`downstream. Other endovascular procedures make use of
`thrombectomy, drug delivery, radiation, stent-grafts, and
`various diagnostic devices.
`
`[0005] Another alternative is bypass surgery in which a
`section of vein is removed from, for example, the patient's
`leg, e.g., a saphenous vein, to be used as a graft to form a
`pathway to bypass the occluded area. The saphenous vein
`graft (SVG), however, is also susceptible to becoming
`occluded in a manner similar to that of the bypassed vessel.
`In such a case, angioplasty (with or without the use of a
`stent) or atherectomy is often used on the SVG to remove or
`reduce the blockage.
`
`[0006] Each of the above described procedures carries
`with it the risk that some of the treated plaque will be
`disrupted, resulting in embolic particulates released in the
`bloodstream. These emboli, if allowed to flow through the
`vascular system, may cause subsequent infarctions or
`ischemia in the patient. SVGs treated by angioplasty or
`atherectomy carry a particularly high risk of this result, but
`such problems are also encountered in the other types of
`procedures mentioned, such as carotids, or native coronary
`arteries, particularly those whose lesions include thrombus.
`
`[0007] Several systems to prevent emboli being released
`into the bloodstream during such procedures have been
`tried. One system uses a balloon to totally occlude the artery
`distal (downstream) to the area of blockage to be treated. In
`this system, a guidewire with a balloon is introduced into the
`narrowed or occluded area, and passes through the narrowed
`or occluded area to a position downstream of the blockage.
`The balloon is inflated, the blockage is reduced or removed,
`
`and then the blood proximal to the balloon is withdrawn
`from the blood vessel to remove any particles or emboli
`which have resulted from the reduction of the blockage.
`While this system has shown a decrease in emboli related
`complications in patients undergoing such treatments, the
`event rate remains significant. One particular problem with
`this system is passing the guidewire and balloon through the
`narrowed or occluded area prior to occlusion with the
`balloon, creating the risk that emboli will be produced as the
`balloon passes through the blockage. Thus, any particulate
`or plaque disturbed during this passage which forms emboli
`prior to inflation of the balloon is free to flow through the
`vascular system, increasing the risk for
`infarction or
`ischemia. Also, any debris or particulate matter which
`gathers around the edges of the balloon may slip down(cid:173)
`stream during deflation and retrieval of the balloon. In
`addition, this system requires that blood flow be totally
`occluded in the vessel for relatively prolonged intervals that
`may induce adverse cardiac events. Although this may not
`be a problem clinically, many patients perceive the occlusion
`of blood flow for this period of time as problematic.
`
`[0008] Another system used to prevent emboli being
`released into the bloodstream during surgical intervention is
`a filter. As with the occlusion balloon, the filter must pass
`through the narrowed or occluded area and is deployed distal
`(downstream) to the blockage. The filter then catches any
`particulate material generated during the removal of the
`blockage. The filter offers the benefit that blood flow is not
`totally occluded. However, because the filter must pass
`through the blockage, it suffers from the same drawback as
`the previous system-risk of the creation of emboli during
`passage of the filter through the blockage. In addition, it is
`difficult to deploy the filter securely against the walls of the
`vessel to prevent flow around the filter and any debris or
`particulate matter which gathers around the edges of the
`filter may slip downstream during its retrieval. Also, in order
`to allow blood flow during the procedure, the pores of the
`filter should be at least 100 microns in diameter. The
`majority of emboli have a diameter between about 40
`microns and about 100 microns. Thus, the filter will not
`catch the majority of emboli, which may flow downstream
`and cause a infarction or ischemia. The filter also cannot
`prevent the passage of certain neurohumoral or vasoactive
`substances which are released into the blood during the
`procedure and may contribute to generalized vasospasm of
`the distal coronary tree.
`
`[0009] Thus, there is a need for an improved system and
`method of treating occluded vessels which can reduce the
`risk of distal embolization during vascular interventions.
`There is also a need for a system which reduces the amount
`of time that total occlusion of the blood flow is necessary.
`
`SUMMARY OF THE INVENTION
`
`In accordance with the invention, methods and
`[0010]
`apparatuses for reducing or removing a blockage within a
`vessel without permitting embolization of particulate matter
`are provided. The methods and apparatuses occlude blood
`flow for a minimal amount of time and capture particulate
`matter created during each step of the surgical process.
`
`[0011] According to one aspect of the invention, a method
`of treatment of a blood vessel is provided. The method
`includes advancing an evacuation sheath assembly into the
`
`

`

`Page 51 of 67
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`US 2002/0165598 Al
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`Nov. 7, 2002
`
`2
`
`blood vessel, prior to advancing a device across a stenosis to
`be treated, stopping normal antegrade blood flow in the
`blood vessel proximate to the stenosis, treating the stenosis
`while blood flow is stopped, and inducing retrograde blood
`flow within the blood vessel to carry embolic material
`dislodged during treating into the evacuation sheath assem(cid:173)
`bly.
`
`[0012] According to another aspect of the invention, a
`method for treating a diseased blood vessel is provided. The
`method includes positioning a guide catheter proximate to
`the diseased blood vessel, positioning an evacuation sheath
`assembly within the diseased blood vessel, prior to advanc(cid:173)
`ing a device across a diseased area of the blood vessel,
`stopping normal antegrade blood flow in the blood vessel
`proximate to the diseased area, advancing a guidewire
`through the guide catheter and the evacuation sheath assem(cid:173)
`bly across the diseased area of the blood vessel while the
`blood flow is stopped, causing retrograde flow of blood
`within the diseased blood vessel to remove embolic debris
`dislodged by advancement of the guidewire, advancing an
`interventional catheter into the blood vessel to treat the
`diseased area of the blood vessel, and causing retrograde
`flow of blood within the vessel to remove embolic debris
`dislodged by advancement of the interventional catheter.
`
`[0013] According to another aspect of the present inven(cid:173)
`tion, a method of performing a procedure on a blood vessel
`is provided. The method includes positioning a guide cath(cid:173)
`eter proximate to the blood vessel, positioning an evacuation
`sheath assembly within the guide catheter, measuring pres(cid:173)
`sure in the blood vessel to obtain a first pressure measure(cid:173)
`ment, creating a seal between the evacuation sheath assem(cid:173)
`bly and the blood vessel, measuring pressure in the blood
`vessel to obtain a second pressure measurement, and com(cid:173)
`paring the first and second pressure measurements.
`
`[0014] According to yet another aspect of the invention, a
`method of isolating fluid communication between a catheter
`and a blood vessel to facilitate visualization of the blood
`vessel is provided. The method includes advancing a cath(cid:173)
`eter proximate to the blood vessel, advancing an evacuation
`sheath assembly including a sealing surface LAW OFFICES
`through the catheter and partially into the blood vessel,
`expanding the sealing surface to create a seal between the
`blood vessel and the evacuation sheath assembly thereby
`stopping normal blood flow in the vessel, and injecting
`contrast dye into the blood vessel while the normal blood
`flow is stopped.
`
`[0015] According to one aspect of the present invention,
`an evacuation sheath assembly is provided. The evacuation
`sheath assembly includes a tube having first and second
`lumens and first and second sealing surfaces, wherein the
`first lumen is an evacuation lumen configured to be placed
`in fluid communication with a bloodstream and wherein the
`second lumen is an inflation lumen in fluid communication
`with at least one of the first and second sealing surfaces, and
`a shaft in fluid communication with the inflation lumen and
`configured to connect to an inflation source.
`
`[0016] According to another aspect of the invention,
`evacuation sheath assembly is provided. The evacuation
`sheath assembly includes an elongated tube defining an
`expandable evacuation lumen having a compressed delivery
`configuration and an expanded operational configuration,
`
`and a first sealing surface configured to form a seal within
`a catheter and a second sealing surface configured to form a
`seal with a blood vessel.
`
`[0017] According to yet another aspect of the present
`invention, a combination for isolating fluid communication
`between a blood vessel and a catheter is provided. The
`combination includes a catheter having a lumen, and an
`evacuation sheath assembly configured to move within the
`lumen of the catheter and having an evacuation lumen and
`first and second sealing surfaces.
`
`[0018] According to another aspect of the present inven(cid:173)
`tion, an evacuation LAW OFFICES sheath assembly com(cid:173)
`prises an elongated tube defining an evacuation lumen
`having proximal and distal ends, a proximal sealing surface
`at a proximal end of the tube configured to form a seal with
`a catheter, and a distal sealing surface configured to form a
`seal with a blood vessel.
`
`[0019] According to a further aspect of the present inven(cid:173)
`tion, an evacuation sheath assembly is provided. The evacu(cid:173)
`ation sheath assembly includes an elongated tube defining an
`evacuation lumen having open proximal and distal ends and
`an inflation lumen having an open proximal end and a closed
`distal end, and a first sealing region on a proximal portion of
`the evacuation lumen and a second sealing region on a distal
`portion of the evacuation lumen, wherein at least one of the
`first and second sealing regions is in fluid communication
`with the inflation lumen, and wherein the first sealing region
`is expandable to a first diameter and the second sealing
`region is expandable to a second diameter diJierent than the
`first diameter.
`
`[0020] According to another aspect of the present inven(cid:173)
`tion, an evacuation sheath assembly is provided and includes
`an elongated tube defining an inflation lumen and an
`expandable evacuation lumen having a compressed configu(cid:173)
`ration and an expanded configuration, and a plurality of
`expandable surfaces along a length of the tube, wherein a
`most proximal expandable surface forms a proximal sealing
`surface and wherein a most distal expandable surface forms
`a distal sealing surface, and wherein expansion of the
`plurality of expandable surfaces expands the evacuation
`lumen from the compressed configuration to the expanded
`configuration.
`
`[0021] According to another aspect of the present inven(cid:173)
`tion, an evacuation sheath assembly is provided. The evacu(cid:173)
`ation sheath assembly includes an elongated sheath defining
`an evacuation lumen having open proximal and distal ends,
`within the sheath is expandable from a delivery configura(cid:173)
`tion to an operational configuration, a proximal hollow shaft
`connected to a proximal end of the sheath, and an actuation
`wire connected to a distal end of the sheath, the actuation
`wire being movable within said shaft from a distal position
`to a proximal position to expand said sheath.
`
`[0022] According to one aspect of the present invention, a
`method of treatment of a blood vessel is provided. The
`method includes advancing a guide catheter proximate to the
`blood vessel, advancing an evacuation sheath assembly
`through the guide catheter and into the blood vessel while
`retaining a proximal portion of the evacuation sheath assem(cid:173)
`bly within the guide catheter, creating a first seal between the
`proximal portion of the evacuation sheath assembly and the
`guide catheter, creating a second seal between a distal
`
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`portion of the evacuation sheath assembly and the blood
`vessel, stopping normal antegrade blood flow within the
`blood vessel, treating a stenosis within the blood vessel,
`causing retrograde flow within the blood vessel to thereby
`remove embolic material dislodged during the treating and
`carried by the retrograde flow into the evacuation sheath
`assembly, and re-establishing normal antegrade blood flow
`within the blood vessel.
`[0023] According to another aspect of the present inven(cid:173)
`tion, an evacuation sheath assembly is provided. The evacu(cid:173)
`ation sheath assembly includes an elongated tube defining an
`expandable evacuation lumen having first a first delivery
`configuration and a second operational configuration, and a
`sealing surface on a distal portion of the evacuation lumen,
`the sealing surface having a non-sealing configuration that
`corresponds to the first delivery configuration and a sealing
`configuration that LAW OFFICES corresponds to the sec(cid:173)
`ond operational configuration, wherein the sealing configu(cid:173)
`ration is configured to create a seal with a blood vessel.
`[0024] According to another aspect of the present inven(cid:173)
`tion, an evacuation sheath assembly is provided. The evacu(cid:173)
`ation sheath assembly includes an elongated tube defining an
`evacuation lumen having open proximal and distal ends and
`an inflation lumen having an open proximal end and a closed
`distal end, at least one inflatable sealing surface in fluid
`communication with the inflation lumen, and a soft steerable
`tip on a distal end of the elongated tube.
`[0025] According to yet another aspect of the present
`invention, an evacuation sheath assembly includes an elon(cid:173)
`gated tube defining an evacuation lumen having open proxi(cid:173)
`mal and distal ends and an inflation lumen having an open
`proximal end and a closed distal end, and at least one
`inflatable sealing surface in fluid communication with the
`inflation lumen, wherein the open distal end of the evacu(cid:173)
`ation lumen is angled.
`[0026] According to another aspect of the present inven(cid:173)
`tion, an evacuation sheath assembly is provided and includes
`an elongated tube defining an evacuation lumen having open
`proximal and distal ends and an inflation lumen having an
`open proximal end and a closed distal end, and first and
`second sealing surfaces on the tube, wherein the open
`proximal end of the evacuation lumen is angled.
`[0027] According to a further aspect of the present inven(cid:173)
`tion, an evacuation sheath assembly includes an elongated
`tube defining an evacuation lumen having open proximal
`and distal ends and an inflation lumen having an open
`proximal end and a closed distal end, and at least one
`inflatable sealing surface in fluid communication with the
`inflation lumen, wherein the evacuation lumen is shorter
`than the inflation lumen.
`[0028] According to another aspect of the invention, an
`evacuation sheath assembly is provided and includes an
`elongated tube defining an evacuation lumen having open
`proximal and distal ends and an inflation lumen having an
`open proximal end and a closed distal end, and at least one
`inflatable sealing surface in fluid communication with the
`inflation lumen, wherein a proximal portion of the evacua(cid:173)
`tion lumen has a first diameter and a distal portion of the
`evacuation lumen has a second diameter larger than the first
`diameter.
`[0029] According to another aspect of the present inven(cid:173)
`tion, a method for treating a diseased blood vessel is
`
`provided. The method includes positioning a guide catheter
`within the ostium of a target vessel, advancing an evacuation
`sheath assembly through the guide catheter and beyond a
`major side branch of the target vessel, forming a first seal
`between the target vessel and a distal portion of the evacu(cid:173)
`ation sheath assembly forming a second seal between the
`catheter and a proximal portion of the evacuation sheath
`assembly, and advancing an interventional device through a
`lumen of the evacuation sheath assembly to treat the target
`vessel.
`
`[0030] Additional objects and advantages of the invention
`will be set forth in part in the description which follows, and
`in part will be obvious from the description, or may be
`learned by practice of the invention. The objects and advan(cid:173)
`tages of the invention will be realized and attained by means
`of the elements and combinations particularly pointed out in
`the appended claims.
`
`It is to be understood that both the foregoing
`[0031]
`general description and the following detailed description
`are exemplary and explanatory only and are not restrictive of
`the invention, as claimed.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0032] The accompanying drawings, which are incorpo(cid:173)
`rated in and constitute a part of this specification, illustrate
`several embodiments of the invention and together with the
`description, serve to explain the principles of the invention.
`In the drawings,
`[0033] FIG. 1A is a cross-sectional side view of a partial
`length evacuation sheath according to one embodiment of
`the present invention;
`
`[0034] FIG. 1B is a cross-sectional view of the partial
`length evacuation sheath taken along line 1B-1B of FIG.
`1A;
`[0035] FIG. 1C is a cross-sectional side view of an
`alternative embodiment of a partial length evacuation sheath
`according to one embodiment of the present invention;
`
`[0036] FIG. 1D is a cross-sectional view of the partial
`length evacuation sheath taken along line 1D-1D of FIG.
`1C;
`[0037] FIG. 2A is a cross-sectional side view of an
`expandable evacuation sheath, shown in an unexpanded
`state, according to another embodiment of the present inven(cid:173)
`tion;
`[0038] FIG. 2B is a cross-sectional view of the unex(cid:173)
`panded expandable evacuation sheath taken along line
`2B-2B of FIG. 2A;
`
`[0039] FIG. 2C is a cross-sectional side view of the
`expandable evacuation sheath of FIG. 2A in an expanded
`state;
`[0040] FIG. 2D is a cross-sectional view of the expanded
`expandable evacuation sheath taken along line 2D-2D of
`FIG. 2C;
`[0041] FIG. 2E is a cross-sectional view of the expanded
`evacuation sheath taken a long line 2E-2E of FIG. 2C.
`[0042] FIG. 3A is cross-sectional side view of a full(cid:173)
`length evacuation sheath according to another embodiment
`of the present invention;.
`
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`[0043] FIG. 3B is cross-sectional view of the full-length
`evacuation sheath taken along line 3B-3B of FIG. 3A;
`[0044] FIG. 4A is cross-sectional side view of a guiding
`catheter/evacuation sheath combination according to yet
`another embodiment of the present invention;
`[004S] FIG. 4B is cross-sectional view of the guiding
`catheter/evacuation sheath combination taken along line
`4B-4B of FIG. 4A;
`
`[0046] FIG. SA is cross-sectional view of the partial
`evacuation sheath of FIGS. lA and lB deployed within a
`vessel;
`[0047] FIG. SB is cross-sectional view of the expandable
`evacuation sheath of FIGS. 2A-2D deployed within a vessel;
`[0048] FIG. SC is cross-sectional view of the full-length
`evacuation sheath of FIGS. 3A and 3B deployed within a
`vessel;
`
`[0049] FIG. SD is cross-sectional view of the guiding
`catheter/evacuation sheath combination of FIGS. 4A and
`4B deployed within a vessel;
`
`[OOSO] FIGS. 6A-6I are cross-sectional views of the partial
`length evacuation sheath of FIGS. 1A and lB as employed
`in a method according to one aspect of the present invention;
`
`[OOSl] FIGS. 7 A-71 are cross-sectional views of the
`expandable evacuation sheath of FIGS. 2A-2D as employed
`in a method according to another aspect of the present
`invention;
`
`[OOS2] FIGS. 8A-81 are cross-sectional views of the full(cid:173)
`length evacuation sheath of FIGS. 3A and 3B as employed
`in a method according to a further aspect of the present
`invention;
`
`[OOS3] FIGS. 9A-9H are cross-sectional views of the guid(cid:173)
`ing catheter/evacuation sheath of FIGS. 4A and 4B as
`employed in a method according to yet another aspect of the
`present invention;
`
`[OOS4] FIG. lOA is a cross-sectional side view of another
`embodiment of an evacuation sheath assembly enclosed in a
`delivery sheath and being delivered through a guiding
`catheter;
`
`[OOSS] FIG. lOB is a cross-sectional side view of a
`braided sheath forming an evacuation head of the evacuation
`sheath assembly of FIG. lOA in an unexpanded state with
`the delivery sheath removed;
`
`[OOS6] FIG. lOC is a cross-sectional side view of the
`braided sheath of FIG. lOB in the expanded state; and
`
`[OOS7] FIG. lOD is cross-sectional view of the guiding/
`evacuation lumen of the evacuation sheath assembly of
`FIGS. lOA-lOC deployed within a blood vessel.
`
`DESCRIPTION OF THE EMBODIMENTS
`
`[OOS8] Reference will now be made in detail to the present
`embodiments of the invention, examples of which are illus(cid:173)
`trated in the accompanying drawings. Wherever possible,
`the same reference numbers will be used throughout the
`drawings to refer to the same or like parts.
`
`[OOS9] The present invention provides a system and
`method for evacuating emboli, particulate matter, and other
`
`debris from a blood vessel, and particularly from an
`occluded blood vessel. As used herein, an "occlusion,
`""blockage," or "stenosis" refers to both complete and
`partial blockages of the vessels, stenoses, emboli, thrombi,
`plaque, debris and any other particulate matter which at least
`partially occludes the lumen of the blood vessel.
`
`[0060] Additionally, as used herein, "proximal" refers to
`the portion of the apparatus closest to the end which remains
`outside the patient's body, and "distal" refers to the portion
`closest to the end inserted into the patient's body.
`
`[0061] This method and apparatus are particularly suited
`to be used in diseased blood vessels that have particularly
`fragile lesions, or vessels whereby the consequences of even
`small numbers of small emboli may be clinically significant.
`Such blood vessels include diseased SVGs, carotid arteries,
`coronary arteries with thrombus, and renal arteries. How(cid:173)
`ever, it is cont