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WO2016115533A1 - Ensemble cathéter à inversion du sens d'écoulement avec embase de détection d'emboles - Google Patents

Ensemble cathéter à inversion du sens d'écoulement avec embase de détection d'emboles Download PDF

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Publication number
WO2016115533A1
WO2016115533A1 PCT/US2016/013719 US2016013719W WO2016115533A1 WO 2016115533 A1 WO2016115533 A1 WO 2016115533A1 US 2016013719 W US2016013719 W US 2016013719W WO 2016115533 A1 WO2016115533 A1 WO 2016115533A1
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WO
WIPO (PCT)
Prior art keywords
catheter
imaging
balloon
blood
emboli
Prior art date
Application number
PCT/US2016/013719
Other languages
English (en)
Inventor
Bahram VARJAVAND
Original Assignee
Varjavand Bahram
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 Varjavand Bahram filed Critical Varjavand Bahram
Publication of WO2016115533A1 publication Critical patent/WO2016115533A1/fr

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Classifications

    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3613—Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/3137—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for examination of the interior of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00106—Sensing or detecting at the treatment site ultrasonic
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7545—General characteristics of the apparatus with filters for solid matter, e.g. microaggregates

Definitions

  • This invention relates to apparatus and methods for protecting against embolization during vascular interventions, such as carotid artery angioplasty and endarterectomy.
  • the apparatus and methods of the present invention induce substantially continuous retrograde flow through the internal carotid artery during treatment during an interventional procedure, without significant blood loss.
  • the apparatus includes a flow reversal catheter assembly provided with an emboli detection hub to detect emboli in the retrograde blood flow and help determine when it is safe to remove the apparatus.
  • Carotid artery stenoses typically manifest in the common carotid artery, internal carotid artery or external carotid artery as a pathologic narrowing of the vascular wall, for example, caused by the deposition of plaque, that inhibits normal blood flow.
  • Endarterectomy an open surgical procedure, traditionally has been used to treat such stenosis of the carotid artery.
  • emboli may be formed during the course of the procedure, and these emboli can rapidly pass into the cerebral vasculature and cause ischemic stroke.
  • Such emboli may be created, for example, when an interventional instrument, such as a guide wire or angioplasty balloon, is forcefully passed into or through the stenosis, as well as after dilatation and deflation of the angioplasty balloon or stent deployment. Because such instruments are advanced into the carotid artery in the same direction as blood flow, emboli generated by operation of the instruments are carried directly into the brain by antegrade blood flow.
  • an interventional instrument such as a guide wire or angioplasty balloon
  • Solano et al. U.S. Pat. No. 4,921,478 describes cerebral angioplasty methods and devices wherein two concentric shafts are coupled at a distal end to a distally-facing funnel-shaped balloon.
  • a lumen of the innermost shaft communicates with an opening in the funnel-shaped balloon at the distal end, and is open to atmospheric pressure at the proximal end.
  • the funnel-shaped balloon is deployed proximally (in the direction of flow) of a stenosis, occluding antegrade flow.
  • An angioplasty balloon catheter is passed through the innermost lumen and into the stenosis, and then inflated to dilate the stenosis.
  • the patent states that when the angioplasty balloon is deflated, a pressure differential between atmospheric pressure and the blood distal to the angioplasty balloon causes a reversal of flow in the vessel that flushes any emboli created by the angioplasty balloon through the lumen of the innermost catheter.
  • EP Publication No. 0 427 429 describes use of a separate balloon to occlude the ECA prior to crossing the lesion in the ICA.
  • that publication discloses that flow reversal occurs only when the dilatation balloon in the ICA is deflated.
  • the occlusion balloons on the guide catheter and in the ECA are inflated to block antegrade blood flow to the brain.
  • the dilation balloon then is deflated, the dilation catheter is removed, and blood is aspirated from the ICA to remove emboli.
  • the occlusion balloons are not inflated until after inflation of the dilation balloon. Microemboli generated during advancement of the dilation catheter into the stenosed segment may therefore be carried by retrograde blood flow into the brain before dilation, occlusion, and aspiration are even attempted.
  • Imran U.S. Pat. No. 5,833,650 describes a system for treating stenoses that comprises three concentric shafts.
  • the outermost shaft includes a proximal balloon at its distal end that is deployed proximal of a stenosis to occlude antegrade blood flow.
  • a suction pump then draws suction through a lumen in the outermost shaft to cause a reversal of flow in the vessel while the innermost shaft is passed across the stenosis.
  • a distal balloon on the innermost shaft is deployed to occlude flow distal to the stenosis.
  • Autologous blood taken from a femoral artery using an extracorporeal blood pump is infused through a central lumen of the innermost catheter to provide continued antegrade blood flow distal to the distal balloon.
  • the third concentric shaft which includes an angioplasty balloon, is then advanced through the annulus between the innermost and outermost catheters to dilate the stenosis.
  • the device of the Imran patent appears to suffer the drawback of potentially dislodging emboli that are carried into the cerebral vasculature.
  • flow reversal in the vasculature distal to the distal balloon ceases, and the blood perfused through the central lumen of the innermost shaft establishes antegrade flow.
  • emboli are generated during deployment of the distal balloon, those emboli will be carried by the perfused blood directly into the cerebral vasculature, and again pose a risk of ischemic stroke.
  • reperfusion of blood under pressure through a small diameter catheter may contribute to hemolysis and possible dislodgment of emboli.
  • Another drawback of the above mentioned and other known flow reversal systems is their inability to detect when most or all of the emboli have been captured and indicate when it is safe to remove the system.
  • the existing systems are designed to be removed upon completion of a therapeutic treatment of a blood vessel.
  • any additional emboli that may be formed upon removal of the system when antegrade blood flow is restored may pose a risk for passing to the cerebral vasculature.
  • the method may comprise occluding a blood vessel of a patient at a first location, the blood vessel having an antegrade blood flow direction and a retrograde flow direction; initiating blood flow in the blood vessel in the retrograde flow direction by withdrawing blood from the blood vessel distal to the first location; performing a therapeutic treatment of the blood vessel; detecting the presence or absence of emboli in the withdrawn blood; providing a signal indicating the presence or absence of emboli in the withdrawn blood; filtering any emboli from the withdrawn blood after detecting the presence or absence of emboli in the withdrawn blood; returning the filtered withdrawn blood to the patient; and restoring blood flow in the blood vessel in the antegrade flow direction after performing the therapeutic treatment if the signal indicates the absence of emboli in the withdrawn blood.
  • the method may further comprise occluding the blood vessel of the patient at a second location before initiating blood flow in the blood vessel in the reverse flow direction.
  • the first location may be in the common carotid artery.
  • the first location may be in the common carotid artery and the second location may be in the external carotid artery.
  • the method may further comprise inserting a first balloon catheter to the first location and wherein occluding a vessel of the patient at the first location may comprise inflating a first balloon of the first balloon catheter at the first location.
  • occluding the blood vessel of the patient at the second location may comprise inflating a second balloon of the first balloon catheter at the second location.
  • the method may further comprise inserting a second balloon catheter into the first balloon catheter and wherein occluding the blood vessel of the patient at the second location may comprise inflating a second balloon of the second balloon catheter at the second location.
  • the method may further comprise attaching an imaging probe to the first balloon catheter.
  • the imaging probe may be a transcranial Doppler probe or a light scattering probe.
  • the first balloon catheter may be configured to position the imaging probe to image blood flow in a catheter hub of the first balloon catheter.
  • the catheter assembly may comprise a catheter hub with a distal port, a filter port, a lumen between the distal port and the filter port, the lumen containing an imaging zone, an imaging port configured to position an imaging probe to image the imaging zone; a catheter body with a proximal end and a distal end, wherein the proximal end is attached to the distal port of the catheter hub; and a filter configured to be in fluid communication with the filter port, comprising a filter inlet, a filter outlet, and filter element therebetween.
  • the catheter body may be a multi-lumen catheter body.
  • the catheter hub may further comprise a first working port with a first working lumen, and the catheter body may comprise a first lumen in fluid communication with the first working lumen.
  • the catheter hub may further comprise a proximal balloon port and a proximal occlusion balloon attached to the catheter body, wherein the proximal balloon port may be in fluid communication with the proximal occlusion balloon.
  • the catheter body may comprise a distal working opening in communication with the working lumen, and the proximal occlusion balloon may be located proximal to the distal working opening.
  • the catheter assembly may further comprise a distal occlusion balloon and wherein the catheter hub may further comprise a distal balloon port.
  • the distal occlusion balloon may be attached to the catheter body, wherein the distal balloon port may be in fluid communication with the distal occlusion balloon.
  • the distal occlusion balloon may be slidably positionable relative to the catheter body.
  • the catheter hub may further comprise a window structure between the imaging zone and the imaging port.
  • the catheter hub may further comprise an imaging stop structure between the imaging zone and the imaging port to restrict distal displacement of an imaging probe.
  • the catheter assembly may further comprise an imaging probe configured to be removably coupled to the imaging port.
  • the catheter assembly may further comprise an imaging probe fixedly coupled to the imaging port.
  • the imaging probe may comprise a distal end configured to be coupled to the imaging port, and a proximal end configured to be removably coupled to an imaging base unit.
  • the imaging probe may be an ultrasound probe.
  • the imaging probe may be a Doppler probe.
  • the catheter assembly may further comprise an imaging base unit. In some of these variations, the imaging base unit may be configured to output real-time quantification of emboli in the imaging zone of the catheter hub.
  • the catheter assembly may further comprise an infusion catheter with a proximal end configured to attach to the filter outlet and a distal end configured for insertion into a blood vessel.
  • the imaging system may comprise a connector body comprising a first Luer lock, a second Luer lock, a lumen therebetween and containing an imaging zone, an imaging port configured to receive and lock a transcranial Doppler probe to image the imaging zone.
  • the treatment method may comprise initiating retrograde blood flow along a vascular segment using a catheter system to withdraw blood from the vasculature segment; performing a therapeutic procedure on the vascular segment; imaging blood within the catheter system to detect emboli; providing a real-time visual signal of the presence or absence of emboli within the blood in the catheter system; and confirming the real-time visual signal for the absence of emboli before restoring antegrade blood flow along the vascular segment.
  • the method may further comprise occluding a first location of the vascular segment using a first occluding element of the catheter system.
  • the method may further comprise occluding a second location of the vascular segment using a second occluding element of the catheter system.
  • the method may further comprise filtering the blood for emboli after providing the real-time visual signal; and returning the filtered blood to the patient.
  • the method may further comprise coupling a transcranial Doppler probe to the catheter system.
  • the method may further comprise locking the transcranial Doppler probe the catheter system using a universal clamp.
  • FIGS. 1A and IB are schematic views of previously known emboli protection systems
  • FIG. 2 is a partial schematic view of an illustrative variation of a catheter assembly in situ
  • FIG. 3 is a partial schematic view of another illustrative variation of a catheter assembly in situ.
  • FIG. 4 is a schematic view of an illustrative variation of a catheter hub.
  • FIG. 5A and 5B are schematic perspective and superior views of a system with the imaging housing and emboli filter.
  • FIGS. 1A and IB drawbacks of previously known emboli removal catheters are described with reference to performing percutaneous angioplasty of stenosis S in common carotid artery CCA.
  • FIG. 1A drawbacks associated with naturally-aspirated emboli removal systems, such as described in the above-mentioned patent to Solano and European Patent
  • emboli E generated while passing guide wire 20 or catheter 11 across stenosis S may be carried irretrievably into the cerebral vasculature before flow in the vessel is reversed and directed into the aspiration lumen of emboli removal catheter 16 by opening the proximal end of the aspiration lumen to atmospheric pressure.
  • natural-aspiration may not remove an adequate volume of blood to retrieve even those emboli that have not yet been carried all the way into the cerebral vasculature.
  • FIG. IB system 17 described in the above-mentioned patent to Imran is shown.
  • deployment of distal balloon 18, and ejection of blood out of the distal end of the inner catheter may dislodge emboli from the vessel wall distal to balloon 18.
  • the introduction of antegrade flow through inner catheter 19 is expected only to exacerbate the problem by pushing the emboli further into the cerebral vasculature.
  • positive suction in the Imran system may remove emboli located in the confined treatment field defined by the proximal and distal balloons, such suction is not expected to provide any benefit for emboli dislodged distal of distal balloon 18.
  • the apparatus and methods of the present invention induce substantially continuous retrograde flow through the internal carotid artery during treatment during an interventional procedure, without significant blood loss.
  • a flow reversal catheter assembly is provided with an emboli detection hub that employs ultrasonic interrogation of the blood aspirated through a catheter body in order to detect emboli.
  • emboli used herein includes both macroemboli and microemboli.
  • the catheter assembly of the present invention comprises a catheter hub, a catheter body and a filter.
  • FIG. 2 shows a partial catheter assembly 20 comprising a catheter body 21 having a lumen and proximal occlusion balloon 22.
  • a guide wire or second catheter 25 having distal occlusion balloon 26 disposed on its distal end is slidably positionable relative to the catheter body 21.
  • antegrade blood flow is stopped when both proximal occlusion balloon 22 in the CCA and distal occlusion balloon 26 are deployed.
  • the aspiration lumen of catheter body 21 is connected to an infusion catheter, disposed, for example, in the patient's femoral vein.
  • the present invention provides substantially continuous retrograde blood flow through the ICA while preventing blood from flowing retrograde in the ECA and antegrade into the ICA, thereby preventing emboli from being carried into the cerebral vasculature. Because the apparatus and methods of the present invention "recycle" emboli-laden blood from the arterial catheter through the blood filter and to the venous return catheter, the patient experiences significantly less blood loss.
  • Catheter assembly 30 comprises catheter body 31 having an aspiration lumen, a proximal occlusion balloon 32 and a distal occlusion balloon 36 attached to the catheter body 31.
  • antegrade blood flow is stopped when both proximal occlusion balloon 32 in the CCA and distal occlusion balloon 36 are deployed.
  • the aspiration lumen of catheter body 31 is connected to an infusion catheter to induce substantially continuous flow of blood between the treatment site and the patient's venous vasculature. Any emboli dislodged by advancing a guide wire or angioplasty catheter 33 across stenosis S causes the emboli to be aspirated by catheter body 31.
  • the catheter assembly 20, 30 further includes a catheter hub 40 connected to the catheter body 21, 31.
  • the catheter hub may have a rigid plastic smooth body hermetically sealing blood from the environment. It may be formed of a biocompatible thermoplastic and integrally molded as a one piece for simple, disposable use and for ease of manufacturing.
  • the catheter hub may be preinstalled as part of a complete reverse flow catheter assembly or installed into a preexisting assembly prior to being coupled to the patient.
  • catheter hub 40 comprises a distal port 42 attached to a proximal end 50 of the catheter body, a filter port 44, a lumen between the distal port 42 and the filter port 44, and an imaging port 46 comprising an inner chamber.
  • the lumen contains an imaging zone 48, wherein the imaging port 46 is configured to position an imaging probe (not shown) to image the imaging zone 48.
  • An imaging stop structure between the imaging zone 48 and the imaging port 46 restricts displacement of the imaging probe.
  • the imaging probe may be a reusable, conventional ultrasound probe or Doppler probe, and may optionally include a protective sheath.
  • the imaging probe may have a distal end configured to be removably coupled (such as by universal clamp, rubber band, press-fitting, or tab or groove design) or fixedly coupled (such as by glue or sonic- welding) to the imaging port 46, and a proximal end configured to be removeably coupled to an imaging base unit (not shown).
  • the imaging base unit is configured to output real-time quantification of emboli in the imaging zone 48 of the catheter hub 40.
  • the catheter hub 40 may further include a window structure of appropriate material and thickness between the imaging zone 48 and the imaging port 46 in order to transmit sufficient acoustic signal from the imaging probe to the retrograde blood to be interrogated for emboli.
  • the catheter hub 40 or just the imaging port 46 of the hub may be made from a transparent material.
  • Properly coupling the acoustic waves between the imaging probe and the retrograde blood may further comprise an acoustic dampening material and an ultrasonic coupling gel in the inner chamber of the imaging port 46.
  • the dampening material may be of sufficient thickness and dampening coefficient to eliminate background noise from the received signal picked up by the imaging probed. It may, for example, comprise a commercially available UV "cure-in- place" urethane acrylate A60 durometer gasket material.
  • the catheter hub may have an imaging port, or an adapter for the imaging port, that is sized and configured to accommodate other types of imaging probes.
  • an imaging port for an intravascular ultrasound probe will be smaller in size than that for a transcranial Doppler probe.
  • the catheter body 21, 3 l is multi-luminal and has a distal end and a proximal end 50 attached to the distal port 42 of the catheter hub 40.
  • Catheter hub 40 further includes a working port 52 with a first working lumen that is in fluid communication with a first lumen and first working opening of the catheter body. Guide wires, angioplasty catheters and other interventional instruments may be inserted into the working port 52 and advanced through the first lumen and first working opening of the catheter body in order to perform a therapeutic treatment on the blood vessel.
  • the catheter hub also includes a proximal balloon port 54 that is in fluid communication with the proximal occlusion balloon 22, 32 attached to the catheter body 21, 31 proximal to the distal working opening.
  • Catheter hub 40 may optionally include a distal balloon port 56 to be in fluid communication with distal occlusion balloon 36 attached to catheter body 31 of the catheter assembly 30 shown in FIG. 3.
  • the catheter assembly 20, 30 may further comprise a filter (not shown) and an infusion catheter (not shown).
  • the filter is configured to be in fluid communication with the filter port 44 and comprises a filter inlet, a filter outlet and a filter element therebetween.
  • the infusion catheter has a proximal end configured to attach to the filter outlet and a distal end configured for insertion into a blood vessel.
  • the aspiration lumen of catheter body 21 , 31 is in fluid communication with the infusion catheter, which may be disposed, for example, in the patient's femoral vein.
  • aspirated blood flows through the catheter body proximal end 50 and through the lumen between the distal port 42 and filter port 44 of the catheter hub 40 where it is imaged for emboli in the imaging zone 48 by an imaging probe.
  • the retrograde blood then flows through the filter port 44 to the filter where any emboli is captured, the infusion catheter and into the blood vessel (e.g., femoral vein). In this manner a substantially continuous flow of blood is induced between the treatment site and the patient's vasculature.
  • any emboli dislodged during treatment or after treatment (e.g., when the balloon of angioplasty catheter 23, 33 is deflated) will be aspirated by the catheter body, imaged by the emboli detection catheter hub, and filtered by the filtering element before being returned to the patient.
  • the proximal occlusion balloon 22, 32 and the distal occlusion balloon 26, 36 may be deflated to restore blood flow in the antegrade direction and the catheter assembly safely removed.
  • FIGS. 5A and 5B depict another variation of the system, comprising a catheter hub 100, imaging housing 102 and an emboli filter 104.
  • the imaging housing 102 is in fluid communication with the side port 106 of the catheter 100 via connector tubing 108
  • the emboli filter 104 is in fluid communication with the imaging housing 102 via a second connector tubing 110.
  • either or both of the connecting tubes 108, 1 10 may be eliminated and the imaging housing 102 and/or the emboli filter 104 may be configured to directly couple to the side port 106 and/or imaging housing 102, for example.
  • the catheter hub 100 comprises a working port 1 12 into which a catheter 1 14 or other tool may be inserted.
  • the side port 106 of the catheter hub 100 is in fluid communication with the distal end 116 of the imaging housing 102, either directly or via connector tubing 108.
  • the proximal end 1 18 of the imaging housing is in fluid communication with the distal end 120 of the emboli filter 104.
  • the imaging port 122 of the imaging housing 102 may be similarly configured as imaging port 46 described herein.
  • the catheter assembly described here may be used in a treatment method for a patient.
  • the treatment method may comprise initiating retrograde blood flow along a vascular segment using a catheter system to withdraw blood from the vasculature segment.
  • a therapeutic procedure such as angioplasty or stenting, may be performed on the vascular segment.
  • Blood within the catheter system is imaged using a transcranial Doppler probe, for example, to detect emboli.
  • the probe may be locked to the catheter system using a universal clamp.
  • a real-time visual signal of the presence or absence of emboli within the blood in the catheter system is provided, and the real-time visual signal for the absence of emboli before restoring antegrade blood flow along the vascular segment is confirmed.
  • the blood may be filtered for emboli after providing the real-time visual signal and the filtered blood may be returned to the patient.
  • the method may further comprise occluding first and second locations of the vascular segment using first and second occluding elements, respectively, of the catheter system.
  • the method may comprise occluding a blood vessel of a patient at a first location (e.g., common carotid artery) by inserting a first balloon catheter to the first location and inflating a first balloon of the first balloon catheter at the first location, the blood vessel having an antegrade blood flow direction and a retrograde flow direction. Blood flow in the blood vessel is initiated in the retrograde flow direction by withdrawing blood from the blood vessel distal to the first location. A therapeutic treatment (e.g., angioplasty, stenting) is performed on the blood vessel.
  • a therapeutic treatment e.g., angioplasty, stenting
  • the presence or absence of emboli in the withdrawn blood is detected and a signal indicating the presence or absence of emboli in the withdrawn blood is provided.
  • Emboli from the withdrawn blood may be filtered after detecting the presence or absence of emboli in the withdrawn blood, and the filtered withdrawn blood may be returned to the patient. Blood flow may be restored in the blood vessel in the antegrade flow direction after performing the therapeutic treatment if the signal indicates the absence of emboli in the withdrawn blood.
  • the method may further comprise occluding the blood vessel of the patient at a second location (e.g., external carotid artery) by inflating a second balloon of the first balloon catheter at the second location before initiating blood flow in the reverse flow direction.
  • occlusion at the second location may comprise inserting a second balloon catheter into the first balloon catheter and inflating a second balloon of the second balloon catheter at the second location, as shown in FIG. 2.
  • An imaging probe e.g., transcranial Doppler probe, light scattering probe
  • the imaging system may comprise a connector body comprising a first Luer lock, a second Luer lock, and a lumen therebetween and containing an imaging zone.
  • An imaging port is configured to receive and lock a transcranial Doppler probe to image the imaging zone.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

La présente invention concerne un appareil et des procédés de protection contre une embolisation au cours d'interventions vasculaires, telles qu'une angioplastie de la carotide et une endartériectomie. L'appareil et les procédés induisent un écoulement rétrograde sensiblement continu à travers la carotide interne pendant le traitement au cours d'une procédure d'intervention, sans perte de sang significative. L'appareil comprend un ensemble cathéter à inversion d'écoulement pourvu d'une embase de détection d'emboles destinée à détecter les emboles dans le flux sanguin rétrograde et à aider à déterminer le moment permettant un retrait de l'appareil en toute sécurité.
PCT/US2016/013719 2015-01-16 2016-01-15 Ensemble cathéter à inversion du sens d'écoulement avec embase de détection d'emboles WO2016115533A1 (fr)

Applications Claiming Priority (2)

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US201562104660P 2015-01-16 2015-01-16
US62/104,660 2015-01-16

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6582396B1 (en) * 1998-05-13 2003-06-24 Arteria Medical Science, Inc. Puncture resistant balloon for use in carotid artery procedures and methods of use
US20050154344A1 (en) * 2003-11-21 2005-07-14 Chang David W. Method and apparatus for treating a carotid artery
US20090024072A1 (en) * 2007-07-18 2009-01-22 Enrique Criado Methods and systems for establishing retrograde carotid arterial blood flow
US20120022426A1 (en) * 2007-03-05 2012-01-26 Pei Ho System and method for embolic protection
US20130317425A1 (en) * 2012-04-30 2013-11-28 BiO2 Medical, Inc. Multi-lumen central access vena cava filter apparatus for clot management and method of using same
US20140024955A1 (en) * 2012-07-17 2014-01-23 Michael Zhadkevich Carotid Artery Occluding Apparatus with First and Second Occluding Balloons
US20140052173A1 (en) * 2003-04-30 2014-02-20 Medtronic Vascular, Inc. Perivascular leak repair system

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6582396B1 (en) * 1998-05-13 2003-06-24 Arteria Medical Science, Inc. Puncture resistant balloon for use in carotid artery procedures and methods of use
US20140052173A1 (en) * 2003-04-30 2014-02-20 Medtronic Vascular, Inc. Perivascular leak repair system
US20050154344A1 (en) * 2003-11-21 2005-07-14 Chang David W. Method and apparatus for treating a carotid artery
US20120022426A1 (en) * 2007-03-05 2012-01-26 Pei Ho System and method for embolic protection
US20090024072A1 (en) * 2007-07-18 2009-01-22 Enrique Criado Methods and systems for establishing retrograde carotid arterial blood flow
US20130317425A1 (en) * 2012-04-30 2013-11-28 BiO2 Medical, Inc. Multi-lumen central access vena cava filter apparatus for clot management and method of using same
US20140024955A1 (en) * 2012-07-17 2014-01-23 Michael Zhadkevich Carotid Artery Occluding Apparatus with First and Second Occluding Balloons

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