USOO7604612B2
`
`US 7,604,612 B2
`(10) Patent No.:
`(12) United States Patent
`
`Ressemann et al.
`(45) Date of Patent:
`Oct. 20, 2009
`
`(54) EMBOLI PROTECTION DEVICES AND
`RELATED METHODS OF USE
`
`
`FOREIGN PATENT DOCUlVIENTS
`0 427 429 Al
`5/1991
`
`EP
`
`(75)
`
`Inventors: Thomas V Ressemann, St. Cloud, MN
`(US); Steven S Hackett, Maple Grove,
`MN (US); Andrew J Dusbabek,
`Dayton, MN (US); Dennis W VVahr,
`anetonka’
`(US)
`(73) Assignee: St. Jude Medical, Cardiology Division,
`Inc., St. Paul, MN (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 15403) by 560 days.
`
`(Continued)
`
`OTHER PUBLICATIONS
`Kachel, Reiner, M.D., “Results ol‘BalloonAngioplasty in the Carotid
`Alterles’
`J‘ hndovas Mfg” 1996’ 3:22-30
`(Continued)
`
`Primary Examiner Nicholas D Lucchesi
`1453175711777 ExamineriTheodore J Stigell
`(74) Attorneu Agent, or FirmgO’Melveny & Myers LLP
`
`(21) Appl. No.: 10/214,712
`
`(57)
`
`ABSTRACT
`
`An evacuation sheath assembly and method of treating
`occluded vessels which reduces the risk of distal emboliza-
`tion during vascular interventions is provided. The evacua-
`tion sheath assembly includes an elongated tube defining an
`evacuation lumen having proximal and distal ends. A proxi-
`inal sealing surface is provided 011 a proximal portion of the
`tube and is configured to form a seal with a lumen ot'a guided
`catheter. A distal sealing surface is provided 011 a distal por-
`tion of the tube and is configured to form a seal With a blood
`vessel. Obturator assemblies and infusion catheter assem-
`blies are provided to be used with the evacuation sheath
`assembly. A method oftreatment of a blood vessel using the
`evacuation sheath assembly includes advancing the evacua-
`tion sheath assembly into the blood vessel through a guide
`catheter. Normal antegrade blood [low in the blood vessel
`proximate to the steno sis is stopped and the stenosis is treated.
`Retrograde blood flow is induced Within the blood vessel to
`carry embolic material dislodged during treating into the
`evacuation sheath assembly. If necessary to increase retro-
`grade flow,
`the coronary sinus may be at least partially
`.
`.
`.
`occluded. Alternatively, antegrade flow may be permitted
`While flow is occluded at the treatment s1te.
`
`(22)
`( 65)
`‘
`
`Flled:
`
`Aug. 9’ 2002
`Prior Publication Data
`'
`US 2003/0050600 A1
`Mar. 13, 2003
`
`(51)
`
`Int. Cl-
`(200601)
`A61M 29/00
`(52) U.S. Cl.
`................................................. 604/101.01
`(58) Field of Classification Search ,,,,,,,,,,,, 604/ 101 .04,
`604/284, 524, 96,013 10101, 1010340105,
`604/1020140203a 103.0@103.08; 606/191,
`606/194
`See application file for complete search history.
`
`(56)
`
`'1‘
`*
`
`References Cited
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`A
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`4 921 478 A
`
`(Continued)
`
`15 Claims, 73 Drawing Sheets
`
`
`
`Page 1
`
`Medtronic Exhibit 1408
`
`Page 1
`
`Medtronic Exhibit 1408
`
`

`

`US 7,604,612 132
`
`Page 2
`
`U.S. PATENT DOCUMENTS
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`
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`
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`
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`
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`
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`
`Page 2
`
`Medtronic Exhibit 1408
`
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`
`Medtronic Exhibit 1408
`
`

`

`US 7,604,612 132
` Page 3
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`'
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`
`'
`
`W0
`“’0
`W0
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`“70
`W0
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`WO
`
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`
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`
`W0
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`W0
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`WO
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`
`\VO 00/54673
`WO 00/56391 A1
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`\VO 00/76390 A2
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`* cited by examiner
`
`Page 3
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`Medtronic Exhibit 1408
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`Medtronic Exhibit 1408
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`US Patent
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`Oct. 20, 2009
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`Sheet 1 0f 73
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`US 7,604,612 B2
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`US Patent
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`Oct. 20, 2009
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`Sheet 2 0f 73
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`US 7,604,612 B2
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`US Patent
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`Oct. 20, 2009
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`Sheet 3 0f 73
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`US 7,604,612 B2
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`Oct. 20, 2009
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`US Patent
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`Sheet 5 0f 73
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`US 7,604,612 B2
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`US Patent
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`US Patent
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`Sheet 7 0f 73
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`Oct. 20, 2009
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`Oct. 20, 2009
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`Oct. 20, 2009
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`US 7,604,612 B2
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`1
`ENIBOLI PROTECTION DEVICES AND
`RELATED METHODS OF USE
`
`
`
`DESCRIPTION OF THE INVENTION
`
`This application is related to US application Ser. No.
`09/940,986, filedAug. 29, 2001, and US. application Ser. No.
`09/845,162, filed May 1, 2001, both of which are incorpo-
`rated herein by reference.
`FIETD OF THE INVENTION
`
`The present invention relates to apparatus and methods
`used to prevent the introduction of emboli into the blood—
`stream during and after surgery performed to reduce or
`remove blockage in blood vessels.
`
`
`BACKGROUND OF THE INVENTION
`
`5
`
`10
`
`15
`
`35
`
`Narrowing or occlusion of blood vessels, such as the walls 20
`of an artery,
`inhibit normal blood flow. Such blockages,
`whether partial or full, can have serious medical conse-
`quences, depending upon their location within a patient’s
`vascular system. Narrowing or blockage of the coronary ves—
`sels that supply blood to the heart, a condition known as 25
`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.
`Various surgical procedures are currently used to reduce or 30
`remove the blockage in blood vessels. Such procedures
`include balloon angioplasty, which involves inserting a bal—
`loon 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 atherectomy 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 40
`devices.
`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), 45
`however, is also susceptible to becoming occluded in a man-
`ner similar to that of the bypassed vessel. In such a case,
`angioplasty (with or without the use 0 fa stent) oratherectomy
`is often used on the SVG to remove or reduce the blockage.
`Each of the above described procedures carries with it the
`risk that some of the treated plaque will be disrupted, result-
`ing 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 55
`high risk of this result, but such problems are also encoun—
`tered in the other types of procedures mentioned, such as
`carotids, or native coronary arteries, particularly those whose
`lesions include thrombus.
`Several systems to prevent emboli being released into the 60
`bloodstream during such procedures have been tried. ()ne
`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 65
`or occluded area to a position downstream of the blockage.
`The balloon is inflated. the blockage is reduced or removed.
`
`anO
`
`2
`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 sys-
`tem 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 pass—
`ing 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 dis-
`turbed during this passage which forms emboli prior to infla—
`tion ofthe 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 downstream 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 prob-
`lematic.
`
`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 (down-
`stream) 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 ofthe 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 proce-
`dure, 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 ofemboli, 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 pro-
`cedure and may contribute to generalized vasospasm of the
`distal coronary tree.
`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 in erventions. There is also a
`need for a system which reduces he amount of time that total
`occlusion of the blood flow is necessary.
`
`SUMMARY OF THE INVENTION
`
`
`
`In accordance with the invention, methods and 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 mini-
`mal amount of time and capture particulate matter created
`during each step ofthe surgical process.
`According to one aspect of the invention, the finalized
`claims will be summarized here.
`
`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