WO2021108371A1 - Dispositifs, systèmes et procédés pour éliminer des caillots sanguins - Google Patents

Dispositifs, systèmes et procédés pour éliminer des caillots sanguins Download PDF

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Publication number
WO2021108371A1
WO2021108371A1 PCT/US2020/061958 US2020061958W WO2021108371A1 WO 2021108371 A1 WO2021108371 A1 WO 2021108371A1 US 2020061958 W US2020061958 W US 2020061958W WO 2021108371 A1 WO2021108371 A1 WO 2021108371A1
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WO
WIPO (PCT)
Prior art keywords
microcatheter
clot
distal
seal
blood vessel
Prior art date
Application number
PCT/US2020/061958
Other languages
English (en)
Inventor
Paul A. Spence
Paul KRELL
Joshua Benjamin
Original Assignee
Ischemicure Ltd
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 Ischemicure Ltd filed Critical Ischemicure Ltd
Publication of WO2021108371A1 publication Critical patent/WO2021108371A1/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, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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 the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system

Definitions

  • the present invention relates generally to medical and surgical devices and, more particularly, to devices, systems, and methods for removing blood clots during a catheter procedure.
  • Stroke is a sudden and often severely debilitating medical event for many people. Stroke can cause sudden death, and even survivors can lose the ability to speak, walk, feed, and care for themselves. These patients frequently need long term care and have limited life expectancy.
  • the most common cause of a stroke is an obstruction of an artery in the brain caused by lodgement of a blood clot.
  • the clot or embolus dislodges from a source such as the heart or an artery in the neck, and travels into a brain artery. As the artery narrows, the clot eventually becomes fixed or stuck in position. Flow ceases to the region of the brain beyond the obstruction and severe damage often occurs.
  • the brain is very unforgiving of lost blood flow. Many regions are supplied by only one source of blood, and the function of the brain is not replicated. Once a motor or speech area is lost, there is limited ability for other segments of the brain to take over the lost function.
  • a method of removing a clot from a blood vessel includes advancing, together and without substantial relative motion therebetween, to a position in the blood vessel distal to the clot, an inner microcatheter and an outer microcatheter disposed about the inner microcatheter.
  • the method further includes occluding the blood vessel distal to the clot by deploying a radially expandable distal seal disposed at a distal end portion of the inner microcatheter.
  • the clot is moved in a proximal direction by directing, into the vessel distal to the clot and through the inner microcatheter, a fluid at a positive pressure sufficient to move the clot.
  • the clot is captured and removed from the blood vessel.
  • the method may include various other optional features.
  • the outer microcatheter covers at least part of the distal seal
  • deploying the distal seal comprises moving the outer microcatheter proximally relative to the inner microcatheter to fully expose the distal seal.
  • Moving the outer microcatheter proximally relative to the inner microcatheter to fully expose the distal seal may further comprise holding the inner microcatheter stationary and withdrawing the outer microcatheter proximally.
  • Moving the outer microcatheter proximally relative to the inner microcatheter to fully expose the distal seal may further comprise holding the outer microcatheter stationary and advancing the inner microcatheter distally.
  • Moving the outer microcatheter proximally relative to the inner microcatheter to fully expose the distal seal may further comprise moving both the inner microcatheter distally and the outer microcatheter proximally.
  • the outer microcatheter may cover substantially all of the distal seal, and deploying the distal seal may comprise moving the outer microcatheter proximally relative to the inner microcatheter to fully expose the distal seal.
  • the method may include advancing a guidewire from proximal to the clot to distal to the clot, and advancing the inner microcatheter and the outer microcatheter may comprise advancing the inner microcatheter and the outer microcatheter along the guidewire.
  • the method may further include positioning an elongate intravascular element in the blood vessel on a proximal side of the clot, and advancing the guidewire may include advancing the guidewire through the elongate intravascular element.
  • Positioning the elongate intravascular element may comprise occluding the blood vessel proximal to the clot by expanding a radially expandable proximal seal extending from the elongate intravascular element.
  • Positioning the elongate intravascular element may comprise advancing a delivery catheter into the blood vessel and advancing the elongate intravascular element through the delivery catheter.
  • the method may further comprise applying suction in the blood vessel proximal to the clot.
  • a system for removing a blood clot from a blood vessel of a patient.
  • the system may comprise a guidewire; an inner microcatheter disposed about the guidewire, the inner microcatheter comprising a radially expandable distal seal at a distal end portion thereof; an outer microcatheter disposed about the inner microcatheter; and an elongate intravascular element disposed about the outer microcatheter, the elongate intravascular element comprising a radially expandable proximal seal deployable from a distal end thereof.
  • the system may further comprise a delivery catheter disposed about the elongate intravascular element.
  • the outer microcatheter may at least partially cover the distal seal.
  • a system for removing a blood clot from a blood vessel of a patient, comprising: an elongate intravascular element including a radially expandable proximal seal disposed at a distal end thereof; wherein the proximal seal has a longitudinal length that is substantially greater than an expanded diameter of the proximal seal.
  • a system for removing a blood clot from a blood vessel of a patient includes an elongate intravascular element comprising a radially expandable proximal seal disposed at a distal end thereof; wherein a distal end portion of the proximal seal comprises a trumpet opening.
  • a system for removing a blood clot from a blood vessel of a patient includes: an elongate intravascular device comprising a distal seal disposed on a distal end portion thereof; wherein the distal seal is radially expandable to a diameter greater than the relaxed internal diameter of the blood vessel containing the blood clot to separate the clot from an interior wall surface of the blood vessel.
  • a system for removing a blood clot from a blood vessel of a patient comprises: an elongate intravascular device comprising a distal seal disposed on a distal end portion thereof; wherein the distal seal comprises a generally flexible membrane supported by one or more longitudinally spaced-apart hoop frames.
  • a system for removing a blood clot from a blood vessel of a patient comprises: an elongate intravascular device comprising a distal seal disposed on a distal end portion thereof; wherein the distal seal comprises a generally flexible membrane, a proximal portion of which is supported by a radially expanding stent.
  • a system for removing a blood clot from a blood vessel of a patient comprises: an elongate intravascular device comprising a distal seal disposed on a distal end portion thereof; wherein the distal seal comprises a generally flexible membrane, substantially the entire length of which is supported by a radially expanding stent.
  • Figure 1 is a schematic representation of a patient illustrating the use of an example clot removal system to remove a clot from a blood vessel in the patient’s brain.
  • Figures 1 A-1 E are longitudinal cross-sectional views schematically illustrating a clot removal system in accordance with one illustrative embodiment being used to dislodge and remove a blood clot.
  • Figures 2A and 2B are longitudinal cross-sectional views schematically illustrating another embodiment being used to dislodge and remove a blood clot.
  • Figures 3A-3D are longitudinal cross-sectional views schematically illustrating another embodiment being used to dislodge and remove a blood clot.
  • Figures 4A and 4B are longitudinal cross-sectional views schematically illustrating another embodiment being used to dislodge and remove a blood clot.
  • Figures 5A-5D are longitudinal cross-sectional views schematically illustrating another embodiment being used to dislodge and remove a blood clot.
  • Figures 6A-6D are longitudinal cross-sectional views schematically illustrating another embodiment being used to dislodge and remove a blood clot.
  • Figures 7A and 7B are longitudinal cross-sectional views schematically illustrating another embodiment being used to dislodge and remove a blood clot.
  • Figures 8A-8C are longitudinal cross-sectional views schematically illustrating another embodiment being used to dislodge and remove a blood clot.
  • Figures 9A-9C are longitudinal cross-sectional views schematically illustrating other embodiments being used to dislodge and remove blood clots.
  • Figure 1 is a schematic representation of a patient and portions of the vascular system of the patient, partially cross sectioned, and further illustrating a manner of using an example clot removal system 2 to remove a clot from a blood vessel in the patient’s brain. It will be appreciated that although exemplary embodiments are described herein in connection with removing clots from blood vessels in brains, some embodiments according to at least some aspects of the present disclosure may be used in procedures for removing obstructions from vessels in other body parts.
  • Figures 1A-1 E illustrate an obstruction or blood clot 10 in a blood vessel 12 having an interior wall surface 12a.
  • the blood vessel 12 can comprise a proximal portion 11 and a distal portion 13, and can contain the blood clot 10 in the vessel between the portions 11, 13.
  • the vessel 12 may be, for example, an artery in a patient’s brain.
  • an illustrative embodiment or example of a clot removal system 2 includes an elongate intravascular element, such as a suction catheter 14.
  • the suction catheter 14 can comprise a distal end portion 15, which may be generally circular in cross section.
  • the distal end portion 15 can comprise a mouth or proximal seal 16.
  • the proximal seal 16 can be funnel-shaped and/or can be radially expandable.
  • the proximal seal 16 may include a stent or stent like structure which can self-expand, such as upon being advanced distally from a delivery catheter 8.
  • a user inserts the distal end 15 of the suction catheter 14 in its unexpanded form into the blood vessel 12 through the proximal portion 11.
  • the suction catheter 14 may be positioned near the clot 10 (e.g., proximal to the clot 10) by inserting it through the delivery catheter 8 extending to near the clot via the vascular system of the patient (see, e.g., Figure 1).
  • the proximal seal 16 can be expanded radially to contact the interior wall surface 12a of the blood vessel 12 and create a seal against fluid flow near the proximal side of the blood clot 10.
  • proximal seal 16 includes an open distal end portion 16a, which may be configured to receive the clot 10 therethrough.
  • the proximal seal 16 may be disposed at the distal end of a proximal seal wire, which is advanced through the suction catheter 14.
  • the proximal seal 16 may be deployed from the distal end portion 15 of the suction catheter 14 by relative motion of the proximal seal 16 in the distal direction.
  • the proximal seal 16 may be advanced distally through the stationary suction catheter 14, the suction catheter 14 may be withdrawn from the stationary proximal seal 16, or both the suction catheter 14 and the proximal seal 16 may be moved in opposite directions.
  • an elongate intravascular element such as a guidewire 36
  • an elongate intravascular element such as a guidewire 36
  • an elongate intravascular element such as an outer microcatheter 26, and an elongate intravascular element, such as an inner microcatheter 27, may be advanced together over the guidewire 36 to a location distally beyond the clot 10.
  • the inner microcatheter 27 may be positioned within the outer microcatheter 26 before the microcatheters 26, 27 are inserted into the vascular system of the patient.
  • the inner microcatheter 27 and the outer microcatheter 26 may be advanced together (e.g., simultaneously and/or without substantial relative motion between them) until they reach the location distally beyond the clot 10.
  • the outer microcatheter 26 and the inner microcatheter 27 are disposed coaxially about the guidewire 36, with the inner microcatheter 27 disposed radially between the guidewire 36 and the outer microcatheter 26. Accordingly, the outer microcatheter 26 has a larger diameter than the inner microcatheter 27, and the inner microcatheter 27 has a larger diameter than the guidewire 36.
  • the inner microcatheter 27 can comprise a thin, radially expandable, and flexible distal seal 20 at its distal end portion 27a.
  • the distal seal 20 may comprise a membrane constructed of polytetrafluoroethylene (PTFE), or other biocompatible, thin, strong, and flexible material.
  • PTFE polytetrafluoroethylene
  • the outer microcatheter 26 Prior to deployment of the distal seal 20, the outer microcatheter 26 at least partially covers the inner microcatheter 27, such as when the outer microcatheter 26 and the inner microcatheter 27 are advanced together over the guidewire 36 distally beyond the clot 10.
  • the outer microcatheter 26 covers substantially all of the inner microcatheter 27 that extends distally beyond the suction catheter 14, and the outer microcatheter 26 covers substantially the entire collapsed (unexpanded) distal seal 20 along the inner microcatheter 27. Covering substantially the entire collapsed distal seal 20 with the outer microcatheter 26 may prevent snagging, unraveling, or damage to the distal seal 20 as the outer microcatheter 26 and inner microcatheter 27 are advanced.
  • An alternative embodiment in which the outer microcatheter 26 covers only a portion of the inner microcatheter 26 is shown in Figures 2A and 2B and is described below.
  • the distal seal 20 may be deployed.
  • the distal seal 20 may be exposed by moving the outer microcatheter 26 proximally relative to the inner microcatheter 27 and/or the moving the inner microcatheter 27 distally relative to the outer microcatheter 26. This may be accomplished by holding the inner micro catheter 27 stationary and withdrawing the outer micro catheter 26 proximally and/or by holding the outer micro catheter 26 stationary and advancing the inner micro catheter 27 distally, or by moving the microcatheters 26, 27 in opposite directions.
  • the outer micro catheter 26 may remain in a position generally proximal to the seal 20 as illustrated in Figure 1 D, or it may be further withdrawn.
  • the distal seal 20 may be radially expandable to seal against the interior wall surface 12a of the vessel 12 distal to the clot 10. Accordingly, the seal 20 may help protect against broken pieces of clot 10 or emboli traveling distally, such as into the brain of the patient.
  • the proximal end of the seal 20 may be open.
  • the seal 20 may be generally flexible, which may facilitate the seal 20 conforming to and sealing against the interior wall surface 12a of the vessel 12.
  • the distal seal 20 may be constructed in various manners, such as those described elsewhere herein and in the ’985 Publication.
  • the distal seal 20 may be constructed with a supporting structure, such as the stent 20d shown in Figure 9C, arranged to radially expand the distal seal 20 self expanding manner when it is exposed.
  • the open proximal end of the distal seal 20 may be connected to the inner micro catheter 27 by one or more tethers 25, which may aid in maintaining the distal seal 20 in the desired configuration and/or which may prevent inversion of the distal seal 20 if the inner microcatheter 27 is pulled proximally.
  • the tethers 25 may be integrally formed with the seal 20, or may be separate and then suitably attached to the seal 20 and the inner micro catheter 27.
  • the clot 10 is substantially contained within a sealed volume of the vessel 12 between the distal seal 20 on the distal side of the clot 10 and the proximal seal 16 on the proximal side of the clot.
  • a pressure source/control 22 may provide and/or control suction and/or positive fluid pressure to various components of the system 2.
  • the inner micro catheter 27 may comprise one or more holes or perforations 23 of any desired number, shape, and/or configuration for infusing a fluid.
  • the perforation(s) 23 may be located proximal to the attachment point of the distal seal 20 to the inner microcatheter 27 so that they are generally within the distal seal 20.
  • the perforations 23 may allow fluid communication between an interior of the inner microcatheter 27 and the environment surrounding the inner microcatheter 27, such as within the distal seal 20 and/or within the vessel 12 distal to the clot 10.
  • the pressure source/control 22 may be operatively coupled to supply positive pressure via the inner microcatheter 27 and the perforations 23.
  • the pressure source/control 22 and the inner microcatheter 27 may deliver a pressurized fluid (e.g., a liquid, a gas, or a combination of liquid and gas), such as carbon dioxide (CO2) 19 via the perforation(s) 23.
  • a pressurized fluid e.g., a liquid, a gas, or a combination of liquid and gas
  • CO2 carbon dioxide
  • Other fluids that may be supplied by the pressure source/control 22 via the perforation(s) 23 include any biocompatible liquids and/or biocompatible gasses (e.g., air, oxygen, or anesthetic gasses). Fluids may include medications, which may aid in dilating the vessel 12 and/or dissolving the clot, and/or may protect the brain, for example.
  • Applying positive pressure within the distal seal 20 via the perforations 23 may aid in expanding the distal seal 20 and/or in creating a sealed engagement of the distal seal 20 against the interior wall surface 12a of the vessel 12.
  • applying positive pressure within the vessel 12 distal to the clot 10 may aid in freeing the clot 10 from its lodged location against the interior wall surface 12a of the vessel 12 and/or may push the clot 10 in a proximal direction to the open distal end portion 16a of the suction catheter 14.
  • the positive pressure at which the fluid e.g., CO2 19
  • the fluid e.g., CO2 19
  • the pressure source/control 22 may apply suction pressure, such as via the suction catheter 14.
  • suction may be applied via the suction catheter 14 when the guidewire 36 is being advanced past the clot 10 and/or when positive pressure is being applied via the perforations 23.
  • the pressure delivered through the perforation(s) 23 and/or the suction applied via the suction catheter 14 may be continuous (constant) or pulsed (cycled) at one or more desired frequencies and amplitudes of pressure, such as controlled by the pressure source/control 22.
  • Some example embodiments may utilize suction only, positive pressure only, or both suction and positive pressure.
  • the pressure source/control 22 may comprise an electronically controlled pump, which may be configured with various control algorithms.
  • the pressure source/control 22 may be configured to avoid suction of blood beyond a predetermined amount.
  • the pressure source/control 22 may be configured to recognize when a clot 10 has been captured in the proximal seal 16.
  • the pressure source/control 22 may be configured to limit positive pressure and/or suction within predetermined limits.
  • the pressure source/control 22 may be configured to minimize the introduction of air into the clot removal system 2.
  • pressure source/control 22 is not specifically described in connection with each embodiment described herein, it will be appreciated that any embodiment described herein may include components for providing positive and/or negative pressure and one or more controls associated therewith, such as pressure source/control 22.
  • FIGS 2A and 2B show an alternative illustrative embodiment or example of a clot removal system 2a.
  • Clot removal system 2a is generally similar to clot removal system 2, includes similar components, and is used in a similar manner; however, in clot removal system 2a the outer microcatheter 27 covers only a portion of the inner microcatheter 26, such as when the outer microcatheter 26 and the inner microcatheter 27 are advanced together over the guidewire 36 distally beyond the clot 10.
  • the outer microcatheter 27 at least partially covers the tethers 25 but does not cover the unexpanded distal seal 20 while the outer microcatheter 26 and the inner microcatheter 27 are initially advanced together over the guidewire 36 distally beyond the clot 10.
  • the delivery catheter 8, the suction catheter 14, the proximal seal 16, and the guidewire 36 are utilized in a manner similar to that describe above with respect to clot removal system 2.
  • the outer microcatheter 26 and the inner microcatheter 27 are advanced together over the guidewire 36 with the unexpanded distal seal 20 at least partially exposed. Then, referring to Figure 2B, the outer microcatheter 26 may be moved distally with respect to the inner microcatheter 27 to expose the tethers 25.
  • the distal seal 20 is expanded and the clot 10 is removed in a manner similar to that described above with respect to clot removal system 2.
  • FIGS 3A-3D show an alternative illustrative embodiment or example of a clot removal system 2b.
  • Clot removal system 2b is generally similar to clot removal system 2, includes similar components, and is used in a similar manner; however, clot removal system 2b may not include components positioned distal to the clot 10.
  • clot removal system 2b utilizes suction applied by the suction catheter 14 to draw the clot 10 into the proximal seal 16.
  • the clot 10 is approached by the suction catheter 14, which may extend through the delivery catheter 8.
  • the open distal end portion 16a of the proximal seal 16 is positioned proximal to the clot 10, and the proximal seal 16 is expanded.
  • suction catheter 14 may be held stationary while the delivery catheter 8 is withdrawn, allowing the proximal seal 16 to expand radially.
  • the proximal seal 16 has a longitudinal length between the distal end portion 15 of the suction catheter 14 and the open distal end portion 16a of the proximal seal 16 that is greater than the interior diameter of the vessel 12. In some embodiments, the length of the proximal seal 16 may be several times the diameter of the vessel 12.
  • the proximal seal 16 is constructed from a flexible membrane supported by a self-expanding stent-like structure or stent.
  • the proximal seal 16 may be in its radially contracted configured when it is within the deliver catheter 8, and proximal seal 16 may self-expand as it is advanced distally out of the delivery catheter 8.
  • the elongated portion of the proximal seal 16 may be generally cylindrical, and the proximal portion may taper generally in a funnel shape to about the interior diameter of the delivery catheter 8.
  • suction may be applied via the suction catheter 14 using the pressure source/control 22, which may draw the clot 10 into the proximal seal 16. Because the proximal seal 16 in this embodiment is longer than the clot 10, the clot 10 may be drawn fully within the proximal seal 16.
  • the delivery catheter 8 and the suction catheter 14 may be withdrawn proximally, carrying the clot 10 with them. Because the proximal seal 16 is longer than the clot 10 and the clot is fully within the proximal seal, the risk of inadvertently leaving pieces of the clot in the vessel 12 as the catheters 8, 14 are withdrawn may be reduced. [0059] It will be appreciated that detailed features of the proximal seal 16 described in connection with this illustrative embodiment may be used in connection with other embodiments, such as the clot removal system 2 described above.
  • FIGS 4A and 4B show an alternative illustrative embodiment or example of a clot removal system 2c.
  • Clot removal system 2c is generally similar to clot removal system 2b, includes similar components, and is used in a similar manner; however, clot removal system 2c includes a proximal seal 16b having a radially outwardly extending distal opening (“trumpet opening”) 16c.
  • the proximal seal 16b may be elongated, generally cylindrical, self expanding, and may be constructed similar to the proximal seal 16 described above.
  • the trumpet opening 16c may be a short portion at the distal end that has a larger diameter than the elongated main portion of the proximal seal 16b.
  • clot removal system 2c may be utilized in a manner similar to clot removal system 2b.
  • the trumpet opening 16c of proximal seal 16b may facilitate a more effective sealing engagement between the proximal seal 16b and the interior wall surface 12a of the vessel 12 because the distal-most edge presses radially outward into the vessel 12.
  • the trumpet opening 16c may facilitate easier and/or more complete capture of the clot 10 because the outwardly extending trumpet opening 16c may serve to funnel the clot 10 into the main portion of the proximal seal 16b.
  • a trumpet opening 16c may be utilized in connection with other embodiments, such as embodiments including components positioned distal to the clot 10.
  • FIGs 5A-5D show an alternative illustrative embodiment or example of a clot removal system 2d.
  • Clot removal system 2d is generally similar to clot removal system 2, includes similar components, and is used in a similar manner; however, clot removal system 2d may not include one or both of the microcatheters 26, 27. Instead, referring to Figure 5A, clot removal system 2d may include an elongate intravascular element, such as a guidewire 18, extended through a suction catheter 14, which may extend through a delivery catheter 8.
  • the guidewire 18 may include the distal seal 20 at its distal end portion 18a.
  • the distal seal 20 may be radially expanded. Referring to Figure 5C, positive pressure via the perforations 23 and/or suction via the suction catheter 14 may be used to move the clot 10 into the proximal seal 16.
  • the guidewire 18 may be withdrawn proximally to pull the proximal portion of the distal seal 20 into the proximal seal 16 of the suction catheter 14, which may capture the clot 10 therein for removal from the vessel 12.
  • Figures 6A-6D
  • FIGS 6A-6D show an alternative illustrative embodiment or example of a clot removal system 2e.
  • Clot removal system 2e is generally similar to clot removal system 2, includes similar components, and is used in a similar manner; however, clot removal system 2e may not include the outer microcatheter 26.
  • positive pressure via the perforations 23 and/or suction via the suction catheter 14 may be used to move the clot 10 into the proximal seal 16.
  • the microcatheter 27 and/or the guidewire 36 may be withdrawn proximally to pull the proximal portion of the distal seal 20 into the proximal seal 16 of the suction catheter 14, which may capture the clot 10 therein for removal from the vessel 12.
  • FIGS 7A and 7B show an alternative illustrative embodiment or example of a clot removal system 2f.
  • Clot removal system 2f is generally similar to clot removal system 2, includes similar components, and is used in a similar manner; however, clot removal system 2f may comprise an elongate intravascular element, such as a guidewire 36a, with an attached distal seal 20 coupled to an elongate intravascular element , such as a microcatheter 27a, by tethers 25.
  • the guidewire 36a and the microcatheter 27a may be advanced together to position the distal seal 20 distal to the clot 10. Then, the distal seal 20 may be expanded, such as by the infusion of fluid via the open distal tip 27b of the microcatheter 27a.
  • the microcatheter 27a may include holes or perforations similar to perforations 23 in place of or in addition to its open distal tip 27b.
  • positive pressure via the microcatheter 27a and/or suction via the suction catheter 14 may be used to move the clot 10 into the proximal seal 16.
  • the microcatheter 27a and/or the guidewire 36a may be withdrawn together proximally to pull the proximal portion of the distal seal 20 into the proximal seal 16 of the suction catheter 14, which may capture the clot 10 therein for removal from the vessel 12.
  • FIGS 8A-8C show an alternative illustrative embodiment or example of a clot removal system 2g.
  • Clot removal system 2g is generally similar to clot removal system 2d of Figures 5A-5D, includes similar components, and is used in a similar manner; however, clot removal system 2g may comprise a distal seal 20a configured to expand to a diameter substantially greater than the relaxed internal diameter of the vessel. In some circumstances, it may be beneficial to radially expand the vessel 12 to aid in separating the clot 10 from the interior wall surface 12a. Clot 10 inside a vessel 12 tends to become adherent to the vessel wall surface 12a. By radially expanding the vessel 12, at least part or even all of the clot 10 can be separated from the interior wall surface 12a.
  • the clot removal system 2g may include a guidewire 18 extended through a suction catheter 14 having a proximal seal 16, which may extend through a delivery catheter 8.
  • the guidewire 18 may include the distal seal 20a at its distal end portion 18a.
  • the distal seal 20a may be radially expanded. Positive pressure via the perforations 23 may expand the distal seal 20a and the adjacent portion of the vessel 12 radially outward. Because the distal seal 20a is configured to expand to a diameter greater than the relaxed internal diameter of the vessel 12, the expanded distal seal 20a may push the interior wall surface 12a of the vessel 12 away from the radially outward surfaces of the clot 10. Accordingly, the clot 10 may be released from the interior wall surface 12a of the vessel 12. [0076] Referring to Figure 8C, the distal seal 20a may be partially deflated, allowing the vessel 12 to return to approximately its relaxed diameter. The guidewire 18 may be withdrawn proximally to pull the proximal portion of the distal seal 20a into the proximal seal 16 of the suction catheter 14, which may capture the clot 10 therein for removal from the vessel 12.
  • any embodiment may include a distal seal that is capable of being radially expand to a diameter greater than the relaxed inner diameter of the vessel 12. This allows the distal seal to expand sufficiently to properly engage the interior wall surface 12a of the vessel 12 to create the fluid-tight interface for different sizes of vessels 12. Whether the distal seal is radially expanded substantially beyond the relaxed internal diameter of the vessel 12 as illustrated in Figure 8B and the extent of such expansion may be controlled during the procedure, such as by controlling the level of positive pressure of fluid supplied via the perforations 23.
  • FIGS 9A-9C illustrate example clot removal systems 2h, 2i, 2j, which include optional, alternative distal seal 20 supporting structures.
  • Clot removal systems 2h, 2i, 2j are generally similar to clot removal system 2d of Figures 5A-5D, include similar components, and are used in similar manners; however, the distal seals 20 in clot removal systems 2h, 2i, 2j comprise optional, alternative supporting structures.
  • these alternative distal seal 20 supporting structures may be used with distal seals 20 disposed on any elongate intravascular devices, including any clot removal systems described herein.
  • the distal seal 20, which may comprise a generally flexible membrane, is supported by one or more longitudinally spaced-apart hoop frames 20b.
  • the hoop frames 20b may be generally circular or generally elliptical in shape.
  • the hoop frames 20b may be initially configured in a collapsed configuration to allow the guidewire 18 and distal seal 20 to advance distally past the clot 10.
  • the hoop frames 20b may be allowed transition to the expanded configuration shown in Figure 9A, such as by unfolding in a self-expanding manner.
  • the proximal portion of the distal seal 20, which may comprise a generally flexible membrane, is supported by a stent-like structure or stent 20c, which may be arranged to radially expand less than the entire longitudinal length of the distal seal 20.
  • the proximal opening may be supported by a hoop frame 20b, which may be generally circular or generally elliptical.
  • the distal seal 20, which may comprise a generally flexible membrane may be supported by a stent-like structure or stent 20d, which may be arranged to radially expand substantially the entire longitudinal length of the distal seal 20.
  • the proximal opening may be supported by a hoop frame 20b, which may be generally circular or generally elliptical.
  • the hoop frames 20b, stent 20c, and/or stent 20d may be constructed from any suitable materials, such as shape memory alloys (e.g., Nitinol).
  • blood clot means any obstruction or clot material impeding the flow of blood in a blood vessel, regardless of the material forming the obstruction or the origin of the material.
  • elongate intravascular element means a wire, guidewire, catheter or microcatheter, or other similar device configured for insertion into and use within the vascular system of a patient.
  • catheter and microcatheter mean an elongate intravascular element having a longitudinal lumen extending therethrough, which may be used to convey fluid and/or other elongate intravascular elements, regardless of diameter.
  • positive pressure refers to a pressure that is greater than the pressure at the relevant location.
  • suction refers to a pressure that is less than the pressure at the relevant location. Accordingly, “positive pressure” and “suction” are relative terms that should be considered in the context of the pressure at the relevant location immediately before the “positive pressure” or “suction” is applied.
  • suction catheter refers to a catheter such as one having the structure and features as described herein, regardless of whether it is specifically configured to apply suction and regardless of whether it is used to apply suction in a particular procedure.

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  • Surgery (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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Abstract

L'invention concerne des systèmes, des dispositifs et des procédés pour éliminer un caillot sanguin (10) d'un vaisseau sanguin (12). Ceux-ci comprennent l'avancement, ensemble et sans mouvement relatif substantiel entre eux, jusqu'à une position dans le vaisseau sanguin (12) distale par rapport au caillot (10), un microcathéter interne (27) et un microcathéter externe (26) disposé autour du microcathéter interne (27). Le vaisseau sanguin (12) est occlus de manière distale par rapport au caillot (10) par déploiement d'un joint distal radialement extensible (20) disposé au niveau d'une partie d'extrémité distale (27a) du microcathéter interne (27). Le caillot (10) est déplacé dans une direction proximale par orientation, dans le vaisseau (12) de manière distale par rapport au caillot (10) et à travers le microcathéter interne (27), un fluide (19) à une pression positive suffisante pour déplacer le caillot (10). Le caillot (10) est capturé et éliminé du vaisseau sanguin (12).
PCT/US2020/061958 2019-11-27 2020-11-24 Dispositifs, systèmes et procédés pour éliminer des caillots sanguins WO2021108371A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11793532B2 (en) 2018-01-25 2023-10-24 Ischemicure Ltd. Devices, systems and methods to remove blood clots

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5728123A (en) * 1995-04-26 1998-03-17 Lemelson; Jerome H. Balloon actuated catheter
US20040015150A1 (en) * 1996-05-20 2004-01-22 Gholam-Reza Zadno-Azizi Method and apparatus for emboli containment
WO2009132858A2 (fr) * 2008-05-02 2009-11-05 Acandis Gmbh & Co. Kg Dispositif pour extraire des concrétions présentes dans des vaisseaux du corps
US20100145371A1 (en) * 1998-05-01 2010-06-10 Rosenbluth Robert F Embolectomy Catheters And Methods For Treating Stroke And Other Small Vessel Thromboembolic Disorders
US20180098778A1 (en) * 2016-10-06 2018-04-12 Mivi Neuroscience, Inc. Hydraulic displacement and removal of thrombus clots, and catheters for performing hydraulic displacement

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5728123A (en) * 1995-04-26 1998-03-17 Lemelson; Jerome H. Balloon actuated catheter
US20040015150A1 (en) * 1996-05-20 2004-01-22 Gholam-Reza Zadno-Azizi Method and apparatus for emboli containment
US20100145371A1 (en) * 1998-05-01 2010-06-10 Rosenbluth Robert F Embolectomy Catheters And Methods For Treating Stroke And Other Small Vessel Thromboembolic Disorders
WO2009132858A2 (fr) * 2008-05-02 2009-11-05 Acandis Gmbh & Co. Kg Dispositif pour extraire des concrétions présentes dans des vaisseaux du corps
US20180098778A1 (en) * 2016-10-06 2018-04-12 Mivi Neuroscience, Inc. Hydraulic displacement and removal of thrombus clots, and catheters for performing hydraulic displacement

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11793532B2 (en) 2018-01-25 2023-10-24 Ischemicure Ltd. Devices, systems and methods to remove blood clots
US11950795B1 (en) 2018-01-25 2024-04-09 Ischemicure Ltd. Devices, systems and methods to image blood clots

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