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WO1999008744A1 - Procede distal de protection/lavage pour le traitement des vaisseaux sanguins - Google Patents

Procede distal de protection/lavage pour le traitement des vaisseaux sanguins Download PDF

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Publication number
WO1999008744A1
WO1999008744A1 PCT/US1998/016916 US9816916W WO9908744A1 WO 1999008744 A1 WO1999008744 A1 WO 1999008744A1 US 9816916 W US9816916 W US 9816916W WO 9908744 A1 WO9908744 A1 WO 9908744A1
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WO
WIPO (PCT)
Prior art keywords
balloon
vessel
treatment
treatment site
occluder
Prior art date
Application number
PCT/US1998/016916
Other languages
English (en)
Inventor
Alexander Shaknovich
Original Assignee
Alexander Shaknovich
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alexander Shaknovich filed Critical Alexander Shaknovich
Priority to AU89074/98A priority Critical patent/AU8907498A/en
Publication of WO1999008744A1 publication Critical patent/WO1999008744A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A61B2017/22002—Angioplasty, e.g. PCTA preventing restenosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22084—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts

Definitions

  • the present invention relates to a method and apparatus for treating an occluded vessel which permits aggressive treatment but protects against adverse clinical events by creating a temporary occlusion distal to the treatment site and by washing out the treatment site and proximal vessel to remove undesirable debris and soluble factors.
  • stenotic occluded
  • coronary arteries occluded
  • the detour is created by grafting a portion of a large vein of the subject, for example, the saphenous vein, to the diseased coronary artery to bypass the occlusion.
  • the graft itself becomes affected by atherosclerotic disease, and is partially (eventually completely, without treatment) occluded.
  • PTCA percutaneous transluminal coronary angioplasty
  • PTCA is not without risk.
  • an obstructive lesion must be debulked to permit introduction of the balloon, and the debulking procedure may release fragments of the lesion into the circulation. Such fragments can potentially result in morbidity or mortality, as they may travel either downstream, to cause an occlusion and tissue infarction, or upsteam (into the ascending aorta) to produce an embolic stroke.
  • Similar effects can result from soluble factors, which may promote thrombus formation, spasm, endothelial cell proliferation, or inflammation, released from normal or diseased tissues during a treatment procedure.
  • the present invention provides for a method and apparatus for treating a vessel occluded by an obstructive lesion which avoids the clinical consequences associated with lesion disruption by (i) creating a temporary obstruction distal to the treatment site, thereby protecting vessels and tissues which lie downstream (the
  • distal protection step washing out debris and chemicals by (a) introducing a wash solution into the treatment site and then (b) removing the wash solution at a location proximal to the treatment site (the "wash-out” step), thereby protecting upstream vessels and tissues.
  • the method of the invention may be used in conjunction with any technique which reduces the extent by which an obstructive lesion occludes a vessel, including, but not limited to, methods which dilate the vessel, debulk the lesion (mechanically, ultrasonically, enzymatically, etc.), and/or place a stent within the vessel.
  • the method of the invention provides a number of advantages. It may be used in the treatment of vessels having occluded portions of a wide range of length and severity, regardless of the presence of thrombus or caliber and quantity of distal branches of the target vessel. It may decrease the need for aggressive anticoagulation, use of platelet aggregation inhibitors, thrombolytic agents or vasodilators. Further, in specific non-limiting embodiments, the method of the invention may be practiced using conventional equipment routinely used by interventional cardiologists. The present invention also provides for a guiding catheter having an expandible portion at its distal end which prevents backflow of wash fluid during the wash-out step.
  • FIGURES 1-9 depict a non-limiting embodiment of the present invention, where the distal protection/wash-out method, using a guiding catheter having a distal expandible segment, is used in the dilatation treatment and scaffolding of a saphenous vein graft ("SVG"; 2) by-pass in a coronary artery (1) having an occlusion (3).
  • SVG saphenous vein graft
  • the SVG (2) has an occlusive obstructive lesion (4), having friable portions (12).
  • the first catheter (8) is advanced over the guide wire
  • the occluder balloon (9) is inflated, thereby creating a temporary obstruction to blood flow in the SVG (2; distal protection) and pressing the second guidewire (10) between the inflated occluder balloon (9) and the vessel wall. Also, the second catheter (6) is advanced over the guide wire (10) such that its uninflated treatment balloon (7) is placed within the obstructive lesion (4).
  • FIGURE 4 depicts a first treatment step in which the treatment balloon (7) has been inflated, thereby compressing a proximal portion of the obstructive lesion (4), and detaching several friable fragments (12), which move toward the inflated occluder balloon (9) (soluble factors would also be released, but are not shown).
  • FIGURE 5 depicts a second treatment step in which the treatment balloon (7), after having been deflated, is repositioned and re-inflated in a more distal location so as to compress the obstructive lesion (4) in the remainder of the diseased segment (20) of the SVG (2), thereby liberating additional friable fragments (12), which have accumulated on the proximal side of the inflated occluder balloon (9).
  • FIGURE 6 depicts a wash-out step, in which the treatment balloon (7) has been deflated and its guide wire (10) withdrawn from the patient, and the treatment balloon is positioned just proximal to the inflated occluder balloon (9).
  • Wash fluid (15; represented by arrows) is being infused through wire port of the treatment balloon catheter (6), and is carrying the detached friable fragments (12) (and any soluble factors) proximally.
  • the expandible portion (13) of the guiding catheter (5) is inflated and blocks the passage of these fragments and soluble factors into the proximal circulation (represented by curved arrows;22).
  • the exhausted wash fluid containing the debris from the procedure, including the detached friable fragments (12) and soluble factors is aspirated out of the treatment site through the distal tip of the guiding catheter (16).
  • the occluder balloon and the expandible portion of the guiding catheter are deflated, the treatment balloon and its catheter, and the occluder balloon and its catheter are withdrawn from the patient, leaving in place the guiding catheter and the first guide wire.
  • FIGURE 7 shows a scaffolding step, where a catheter having a distal balloon (17) carrying an expandible stent (18) is passed over the first guide wire (11) into the treatment site (over what had been the obstructive lesion, 4).
  • the balloon is expanded, thereby deploying the stent (18).
  • FIGURE 9 depicts the scaffolded treatment site (19). 4.
  • FIGURE 1 depicts a guiding catheter containing a treatment balloon catheter and an occluder balloon catheter in an occluded saphenous vein graft (SVG).
  • FIGURE 2 depicts positioning of the occluder balloon at a location distal to the treatment site.
  • FIGURE 3 depicts a distal protection step in which the occluder balloon is inflated, creating a temporary obstruction, and the treatment balloon is positioned within the obstructive lesion.
  • FIGURE 4 depicts a treatment step in which the treatment balloon is inflated to decrease the extent of occlusion, detaching friable fragments of the lesion which pass distally.
  • FIGURE 5 depicts a second treatment step in which a more distal portion of the diseased segment is opened by inflation of the treatment balloon.
  • FIGURE 6 depicts a wash-out step, in which wash fluid is perfused through the more distally located treatment balloon catheter (the balloon having been deflated), and passes retrogradely, where the debris-containing wash fluid is aspirated through the distal tip of the guiding catheter and out of the patient.
  • the guiding catheter has an expanded distal portion which blocks the wash fluid and debris from entering the proximal circulation.
  • FIGURE 7 shows a scaffolding step, where a balloon catheter carrying a stent is positioned within the treatment site.
  • FIGURE 8 shows a second scaffolding step where the stent is deployed.
  • FIGURE 9 shows the scaffolded SVG following treatment.
  • the present invention provides for a method of treating a vessel occluded by an obstructive lesion at a treatment site comprising (i) creating a temporary obstruction distal to the treatment site; (ii) decreasing the extent that the obstructive lesion occludes the vessel; and (iii) washing out debris and soluble factors by (a) introducing a wash solution into the treatment site and then (b) removing the wash solution carrying debris and soluble factors at a location proximal to the treatment site.
  • proximal and distal refer to a directionality established by the actual or intended introduction of the elements disclosed into a subject, wherein the direction moving away or further from the point of introduction in the subject is “distal” and the direction moving toward or nearer the point of introduction is “proximal”.
  • proximal refers to a directionality established by the actual or intended introduction of the elements disclosed into a subject, wherein the direction moving away or further from the point of introduction in the subject is “distal” and the direction moving toward or nearer the point of introduction is “proximal”.
  • a catheter is inserted into the femoral artery of a subject via an access site in the groin, but one end of the catheter is held by an operator, and then the inserted tip of the catheter is passed through the femoral artery and into the aorta, the inserted tip is the distal tip of the catheter and the operator is holding the proximal end of the catheter, and the inserted tip is being moved distally.
  • the catheter is withdrawn
  • target vessel desirably lacks major proximal side branches which would provide alternate routes for dispersal of fragments or flow of wash fluid.
  • the method of the invention would operate at a site essentially having boundaries defined by the target vessel walls, the distally located temporary obstruction, and a more proximally located catheter through which exhausted wash fluid is withdrawn.
  • Small branch vessels may arise from the target vessel provided that passage of lesion fragments or wash fluid into said vessel(s) would not be associated with a substantial likelihood of clinically adverse consequences.
  • a preferred target vessel is a saphenous vein by-pass graft bridging an occluded portion of a coronary artery, although any vessel or conduit in the body may serve as a target vessel provided that it meets the abovementioned structural constraints.
  • Obstructive lesions according to the invention may be, for example but not by way of limitation, atherosclerotic, fibrotic, malignant or infectious in character.
  • the obstruction may lie within the target vessel and/or in or around the walls of the vessel.
  • the treatment site is defined as that location in which a procedure which may liberate lesion fragments or soluble factors is performed. It typically, but not always, would comprise all or a portion of the obstructive lesion associated with vessel occlusion.
  • a vessel is defined as being "occluded” herein if the lumen of the vessel is decreased, by an obstructive lesion, relative to its natural diameter absent the obstructive process.
  • occlusion need not, and preferably, is not, complete, so as to permit passage of the temporary obstructive element to a location distal to the lesion.
  • the temporary obstructive element may be placed within or even proximal to the lesion, provided that it lies distal to the treatment site.
  • the temporary obstruction may be created by a temporary obstructive element (hereafter, the "occluder") which may exist in a passive or an activated configuration.
  • the occluder In its passive configuration, the occluder may be introduced into the target vessel and into or past the occluded region of the vessel. When activated, however, the occluder expands to a diameter which substantially occludes the passage of fluid past it, but it must be able to be returned to a passive configuration so as to permit withdrawal from the patient.
  • the occluder preferably is comprised at the distal end of a catheter.
  • the occluder is a balloon, but any reversible means of expansion may be used to achieve the activated configuration, including a nitinol wire, or mechanical means.
  • the occluder may incorporate means for passive or active perfusion of the distal vessel, so as to avoid infarction, such as a conduit which would allow blood or other perfusate to pass from the area proximal to the expanded occluder to the area distal to it, such as small holes in the shaft of a catheter attached to the occluder proximal to and distal to the occluder element, which preferably are of a size or material which would prevent or inhibit passage of debris or soluble factors past the expanded occluder into the distal vessel.
  • the occluder may be a compliant PTCA balloon. Over-the-wire or monorail, but not perfusion, balloons may be used as occluders.
  • the size of the occluder balloon is chosen so that complete occlusion may be effected distal to the treatment site at very low pressures, optimally less than two atmospheres, in order to minimize the risk of injury to the region of the vessel where temporary obstruction is effected.
  • the occluder is placed sufficiently distally to permit treatment of the entire length of the obstructive lesion, such that the occluder, when activated (i.e., expanded), lies within a relatively disease free segment of the target vessel distal to the obstructive lesion.
  • Contrast agent may be injected into the target vessel in order to confirm that obstruction with the activated occluder is complete.
  • a larger diameter occluder may be needed if the initial occluder (for example a balloon inflated to low pressure) does not prevent contrast agent from passing distal to the activated occluder.
  • the extent that the obstructive lesion occludes the target vessel may be decreased by any means known in the art, including, but not limited to, dilatation using a balloon or equivalent instrument, placement of a stent, or debulking.
  • Debulking may be performed mechanically, ultrasonically, chemically or enzymatically; suitable agents which may be used include but are not limited to heparin, hirudin, hirudin-related peptides including Hirulog, anti-platelet agents including Reopro, and thrombolytics such as tissue plasminogen activator, streptokinase, urokinase, and thromboplastin.
  • the step of decreasing the extent of occlusion is referred to herein as the treatment step (and was referred to in priority application no. 60/055,834 was the "pre-treatment step").
  • Preferably stent placement is performed after an obstructive lesion has been treated and after the wash-out procedure has been completed, as a separate "scaffolding step".
  • Stents which may be used according to the invention include but are not limited to Palmaz-Schatz, Gianturco-Roubin, Cook, AVE, Strecker, Wiktor, Wallsten and Cordis stents. Stents which are expandible by ancillary means or self- expanding stents may be used.
  • balloon-expandible stents may be delivered on deployment balloons of the same diameter (when expanded) as, or smaller diameter than, the treatment balloon.
  • self-expanding stents desirably have a diameter, in their expanded configuration, which does not exceed that of the treatment balloon used to dilate the target vessel at the treatment site.
  • post-deployment expansion of stents may be performed with balloon(s) preferably of the same diameter as, or of smaller diameter than, the treatment balloon at a maximal pressure below that used during pre-treatment.
  • the treatment balloon may be used as the deployment balloon for a biliary Palmz stent.
  • the occluder and any elements used in the treatment step are brought into proximity to the lesion by a guiding catheter, which may be of a length which reaches and may optionally enter the ostium of the target vessel, of an inner diameter which may accomodate simultaneously or sequentially the occluder and treatment elements, and of an outer diameter to permit safe passage to the desired location.
  • a guiding catheter which may be of a length which reaches and may optionally enter the ostium of the target vessel, of an inner diameter which may accomodate simultaneously or sequentially the occluder and treatment elements, and of an outer diameter to permit safe passage to the desired location.
  • 9F and 1 OF guiding catheters may be used.
  • Side holes in the guiding catheter are desirably avoided to facilitate effective removal of exhausted wash fluid.
  • the inner diameter may be in the range of from 0.8 to 1.6 millimeters, and preferably from 0.9 to 1.3 millimeters.
  • a guiding catheter having a modified distal end which may adopt an activated expanded configuration which prevents the proximal passage of exhausted wash fluid (backflow), as illustrated in FIGURE 6, may desirably be used.
  • such an expanded configuration may be achieved by a balloon or other mechanical element.
  • the expandible element may be comprised in the distal 50 millimeters of the guiding catheter, and may itself have a length of, preferably, 5 to 35 millimeters, and more preferably from 9 to 30 millimeters, and the diameter of the expandible element, in expanded configuration, for coronary artery and saphenous vein graft applications, may range from 2.0 to 6.0 millimeters and preferably from 3.0 to 5.0 millimeters, inclusive.
  • the occluder and the treatment elements are preferably, but not necessarily, introduced into the target vessels and through the guiding catheter over separate guide wires.
  • one guide wire used to position treatment elements, remains trapped between the vessel wall and the activated occluder (for example, during treatment), and is then withdrawn to a location proximal to the activated occluder prior to the wash-out step.
  • two Choice PTTM wires are used to facilitate retraction of the wire trapped by the occluder.
  • the means of treatment could use the shaft of a catheter attached to the occluder as a guide, (e.g. if the occluder is attached to a hollow wire, a "balloon on the wire"), only a single guide wire would be necessary.
  • the wash solution may be any physiologically compatible fluid, including but not limited to normal saline, Ringer's solution, etc., and may comprise one or more other compounds, including, but not limited to, contrast agent(s), anticoagulant agent(s) and/or enzyme(s), antibiotic(s), vasoactive substance(s), and so forth.
  • exhaust wash fluid Once it has been used to wash the treatment site, it is referred to as "exhausted wash fluid".
  • the object of the treatment step is not only to decrease the extent of vessel occlusion, but also to dislodge, express, and liberate from the vessel walls any friable and/or non-solid material which may cause distal embolization or no reflow. Accordingly, treatment is preferably vigorous and uses aggressive measures.
  • a balloon at the treatment site may be inflated up and down the treatment site to relatively high pressure, for example, 12-16 atmospheres; where a subsequent scaffolding step is planned, these treatment step inflation pressures are desirably equal to the pressure the operator intends to use for high-pressure post-deployment stent dilatation. Multiple overlapping inflations may be necessary. The duration of each inflation is desirably limited to the time required to achieve full balloon expansion in order to minimize overall ischemic time.
  • treatment should involve not only the most severely occluded portion of the target vessel, but any contiguous or non-contiguous less severely affected portion as well. Treatments, including distal protection and wash-out steps, may be performed sequentially in the same target vessel.
  • the method of the invention may be used in the treatment of a subject having a saphenous vein graft (SVG), which had been placed in a by-pass procedure to treat an occluded coronary artery, but which is now itself partially occluded.
  • SVG saphenous vein graft
  • the following procedure may be used to dilate the occluded portion of the SFG (the target vessel), using the distal protection/wash-out method of the invention, and then to place a stent in the SVG to maintain its patency.
  • Equipment used in the procedure may include (i) a 9F guiding catheter;
  • a first guide wire over which may be passed
  • a first balloon catheter wherein the balloon will serve as the occluder (and is hereafter referred to as the "occluder balloon” or “occluder"), attached to a means of inflating the occluder balloon
  • a second guide wire over which may be passed
  • a second balloon catheter wherein the balloon will be used in a treatment step (and is referred to hereafter as the "treatment balloon") to dilate the occluded portion of the SVG, attached to a means of inflating the treatment balloon.
  • the proximal end of the second balloon catheter may be attached to a Y-adapter, one arm of which may be attached to a three-way stopcock which may be connected to (i) a small (e.g., 3-5cc) saline-filled syringe and (ii) a larger (10-20 cc) syringe containing wash fluid.
  • the guiding catheter may comprise, at its proximal end, an attachment site for a means for removing exhausted wash fluid, such as an empty 20-30 cc syringe (henceforth, the "aspiration syringe").
  • Another separate piece of equipment may be a stent mounted on the balloon (henceforth, the "deployment balloon") of a third balloon catheter, and a third guide wire which may be used for introduction of the guiding catheter.
  • the guiding catheter may be passed, over the third guide wire, into the femoral artery of the subject and passed through the aorta and into the SVG, to a position proximal to the occluded segment, and the third guide wire may then be withdrawn once the guiding catheter is in position. Then, the first and second guide wires may be passed through the guiding catheter to traverse the occluded SVG segment.
  • first and second balloon catheters may be passed into and through the guiding catheter either simultaneously, as is shown in FIGURE 1, or sequentially (e.g., first the first balloon catheter comprising the occluder, and then the second balloon catheter comprising the treatment balloon).
  • the catheter bearing the occluder balloon is advanced over the first guide wire so that the occluder balloon is in a position which is distal to the intended treatment site, which preferably constitutes all or most of the diseased segment of the SVG.
  • the occluder balloon is then inflated at a pressure high enough to effect complete occlusion, but low enough to minimize or avoid injury to local vessel walls (which may be part of the SVG or the coronary artery to which the graft was anastomosed); this pressure is preferably less than 2 atmospheres.
  • the second guide wire becomes trapped between the expanded occluder and the vessel wall. Contrast injection into the SVG may be used to confirm that the vessel is completely occluded.
  • the treatment balloon may be advanced over the second guide wire, and inflated and deflated so as to dilate the segment of the SVG occluded by disease.
  • the inflations and deflations may be performed multiple times and at different positions along the diseased SVG (the entire area constituting the treatment site).
  • the inflations are at relatively high pressures, such as 12-16 atmospheres.
  • friable fragments of the SVG wall and lesions associated with it may be broken free and pass distally, until they are stopped from progressing further by the activated occluder balloon.
  • the treatment balloon may be advanced distally over the second guide wire until it reaches the activated occluder. Then, the second guide wire may be pulled out of the treatment balloon (past the activated occluder balloon) and its attached catheter. To avoid entraining air during the wire pull out, saline from the small syringe connected to the stopcock attached to the Y adapter may be flushed through the Y-adapter, which comprises an O-ring which is partially open. Once the second guide wire is completely out of the treatment balloon, the O-ring of the Y adapter may be tightened, and the stopcock may be turned off to the treatment balloon.
  • the treatment site is perfused as the operator flushes the wash fluid (via the 10-20 cc syringe attached to the stocpcock attached to the Y adapter) through the wire port of the treatment balloon catheter and, simultaneously, the operator or an assistant aspirates exhausted wash fluid via the guiding catheter tip and into an aspiration syringe.
  • the treatment balloon catheter is withdrawn first, followed by deflation and removal of the occluder balloon catheter, with the first guide wire remaining in place across the treatment site of the SVG.
  • the catheter bearing, at its distal end, the deployment balloon may then be passed over the first guide wire, and the stent positioned and deployed into the treatment site.
  • the entire treatment site is scaffolded by the placement of one or more stent.

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Abstract

La présente invention concerne un procédé et un appareil destinés au traitement des vaisseaux sanguins obstrués par une lésion obstructive, et permettant d'empêcher la survenue des conséquences cliniques associées aux ruptures des lésions par la création d'une obstruction temporaire (9) à distance de la zone de traitement, de manière à protéger les vaisseaux et les tissus se trouvant en aval. Les débris et les facteurs solubles (12) sont ensuite éliminés en introduisant une solution de lavage (15) dans la zone de traitement, cette solution étant retirée par la suite au niveau d'une région se trouvant à distance de la zone de traitement, protégeant ainsi les vaisseaux et les tissus en aval.
PCT/US1998/016916 1997-08-15 1998-08-14 Procede distal de protection/lavage pour le traitement des vaisseaux sanguins WO1999008744A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU89074/98A AU8907498A (en) 1997-08-15 1998-08-14 A distal protection/wash-out method for treating vessels

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5583497P 1997-08-15 1997-08-15
US60/055,834 1997-08-15

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Publication Number Publication Date
WO1999008744A1 true WO1999008744A1 (fr) 1999-02-25

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PCT/US1998/016916 WO1999008744A1 (fr) 1997-08-15 1998-08-14 Procede distal de protection/lavage pour le traitement des vaisseaux sanguins

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Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1031330A3 (fr) * 1999-02-24 2000-12-27 Cordis Corporation Stent avec bifurcation à flexibilité axiale
WO2001070325A3 (fr) * 2000-03-21 2002-06-13 Advanced Cardiovascular System Systeme de protection contre l'embolie
EP1218054A4 (fr) * 1999-07-14 2003-02-12 Richard R Heuser Dispositif de prevention d'embolies
US6746476B1 (en) 1997-09-22 2004-06-08 Cordis Corporation Bifurcated axially flexible stent
WO2004047682A3 (fr) * 2002-11-27 2004-08-05 Bolton Medical Inc Prothese vasculaire pour le traitement d'anevrysmes aortiques abdominaux, a l'aide d'une technique laparoscopique/effractive et endovasculaire combinee, et systeme de pose permettant de liberer une prothese equipee de protheses endovasculaires d'ancrage
US6843802B1 (en) 2000-11-16 2005-01-18 Cordis Corporation Delivery apparatus for a self expanding retractable stent
EP1518515A1 (fr) * 2003-08-29 2005-03-30 Cordis Neurovascular, Inc. Stent auto-expansible et Système de mise en place d'un stent pour traitement de sténose vasculaire
US6887268B2 (en) 1998-03-30 2005-05-03 Cordis Corporation Extension prosthesis for an arterial repair
US6942692B2 (en) 2000-11-16 2005-09-13 Cordis Corporation Supra-renal prosthesis and renal artery bypass
US7029493B2 (en) 2002-01-25 2006-04-18 Cordis Corporation Stent with enhanced crossability
EP1738692A1 (fr) * 2001-05-01 2007-01-03 St. Jude Medical, Cardiology Division, Inc. Dispositif de protection contre les emboles
US7166120B2 (en) 2002-07-12 2007-01-23 Ev3 Inc. Catheter with occluding cuff
US7229472B2 (en) 2000-11-16 2007-06-12 Cordis Corporation Thoracic aneurysm repair prosthesis and system
US7232452B2 (en) 2002-07-12 2007-06-19 Ev3 Inc. Device to create proximal stasis
US7267685B2 (en) 2000-11-16 2007-09-11 Cordis Corporation Bilateral extension prosthesis and method of delivery
US7300459B2 (en) 2002-10-17 2007-11-27 Heuser Richard R Stent with covering and differential dilation
US7314483B2 (en) 2000-11-16 2008-01-01 Cordis Corp. Stent graft with branch leg
US7326237B2 (en) 2002-01-08 2008-02-05 Cordis Corporation Supra-renal anchoring prosthesis
US7374560B2 (en) 2001-05-01 2008-05-20 St. Jude Medical, Cardiology Division, Inc. Emboli protection devices and related methods of use
US7374567B2 (en) 2006-01-25 2008-05-20 Heuser Richard R Catheter system for connecting adjacent blood vessels
US7402141B2 (en) 2003-08-27 2008-07-22 Heuser Richard R Catheter guidewire system using concentric wires
US7500988B1 (en) 2000-11-16 2009-03-10 Cordis Corporation Stent for use in a stent graft
US7604612B2 (en) 2001-05-01 2009-10-20 St. Jude Medical, Cardiology Division, Inc. Emboli protection devices and related methods of use
US8603064B2 (en) 2008-09-22 2013-12-10 Covidien Lp Double balloon catheter and methods for homogeneous drug delivery using the same
US20220183818A1 (en) * 2019-02-20 2022-06-16 Tissueguard Gmbh Device and assemblies for oriented transport, microscopic investigation and oriented ejection of a tissue graft or implant

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Cited By (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6436104B2 (en) 1996-01-26 2002-08-20 Cordis Corporation Bifurcated axially flexible stent
US6746476B1 (en) 1997-09-22 2004-06-08 Cordis Corporation Bifurcated axially flexible stent
US7842077B2 (en) 1997-09-22 2010-11-30 Cordis Corporation Bifurcated axially flexible stent
US6887268B2 (en) 1998-03-30 2005-05-03 Cordis Corporation Extension prosthesis for an arterial repair
EP1031330A3 (fr) * 1999-02-24 2000-12-27 Cordis Corporation Stent avec bifurcation à flexibilité axiale
EP1218054A4 (fr) * 1999-07-14 2003-02-12 Richard R Heuser Dispositif de prevention d'embolies
WO2001070325A3 (fr) * 2000-03-21 2002-06-13 Advanced Cardiovascular System Systeme de protection contre l'embolie
US6485500B1 (en) 2000-03-21 2002-11-26 Advanced Cardiovascular Systems, Inc. Emboli protection system
US7500988B1 (en) 2000-11-16 2009-03-10 Cordis Corporation Stent for use in a stent graft
US6942692B2 (en) 2000-11-16 2005-09-13 Cordis Corporation Supra-renal prosthesis and renal artery bypass
US7862609B2 (en) 2000-11-16 2011-01-04 Cordis Corporation Stent graft having a pleated graft member
US7229472B2 (en) 2000-11-16 2007-06-12 Cordis Corporation Thoracic aneurysm repair prosthesis and system
US7267685B2 (en) 2000-11-16 2007-09-11 Cordis Corporation Bilateral extension prosthesis and method of delivery
US6843802B1 (en) 2000-11-16 2005-01-18 Cordis Corporation Delivery apparatus for a self expanding retractable stent
US7314483B2 (en) 2000-11-16 2008-01-01 Cordis Corp. Stent graft with branch leg
US7422579B2 (en) 2001-05-01 2008-09-09 St. Jude Medical Cardiology Divison, Inc. Emboli protection devices and related methods of use
EP1738692A1 (fr) * 2001-05-01 2007-01-03 St. Jude Medical, Cardiology Division, Inc. Dispositif de protection contre les emboles
US7604612B2 (en) 2001-05-01 2009-10-20 St. Jude Medical, Cardiology Division, Inc. Emboli protection devices and related methods of use
US7374560B2 (en) 2001-05-01 2008-05-20 St. Jude Medical, Cardiology Division, Inc. Emboli protection devices and related methods of use
US7326237B2 (en) 2002-01-08 2008-02-05 Cordis Corporation Supra-renal anchoring prosthesis
US7029493B2 (en) 2002-01-25 2006-04-18 Cordis Corporation Stent with enhanced crossability
US7232452B2 (en) 2002-07-12 2007-06-19 Ev3 Inc. Device to create proximal stasis
US7166120B2 (en) 2002-07-12 2007-01-23 Ev3 Inc. Catheter with occluding cuff
US7887560B2 (en) 2002-07-12 2011-02-15 Ev3 Inc. Catheter with occluding cuff
US8721674B2 (en) 2002-07-12 2014-05-13 Covidien Lp Catheter with occluding cuff
US10136906B2 (en) 2002-07-12 2018-11-27 Covidien Lp Catheter with occluding cuff
US7300459B2 (en) 2002-10-17 2007-11-27 Heuser Richard R Stent with covering and differential dilation
WO2004047682A3 (fr) * 2002-11-27 2004-08-05 Bolton Medical Inc Prothese vasculaire pour le traitement d'anevrysmes aortiques abdominaux, a l'aide d'une technique laparoscopique/effractive et endovasculaire combinee, et systeme de pose permettant de liberer une prothese equipee de protheses endovasculaires d'ancrage
US7402141B2 (en) 2003-08-27 2008-07-22 Heuser Richard R Catheter guidewire system using concentric wires
EP1518515A1 (fr) * 2003-08-29 2005-03-30 Cordis Neurovascular, Inc. Stent auto-expansible et Système de mise en place d'un stent pour traitement de sténose vasculaire
US7374567B2 (en) 2006-01-25 2008-05-20 Heuser Richard R Catheter system for connecting adjacent blood vessels
US8603064B2 (en) 2008-09-22 2013-12-10 Covidien Lp Double balloon catheter and methods for homogeneous drug delivery using the same
US20220183818A1 (en) * 2019-02-20 2022-06-16 Tissueguard Gmbh Device and assemblies for oriented transport, microscopic investigation and oriented ejection of a tissue graft or implant

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