[go: up one dir, main page]

WO2012081020A1 - Procédé et appareil pour l'ablation d'occlusion - Google Patents

Procédé et appareil pour l'ablation d'occlusion Download PDF

Info

Publication number
WO2012081020A1
WO2012081020A1 PCT/IL2011/050058 IL2011050058W WO2012081020A1 WO 2012081020 A1 WO2012081020 A1 WO 2012081020A1 IL 2011050058 W IL2011050058 W IL 2011050058W WO 2012081020 A1 WO2012081020 A1 WO 2012081020A1
Authority
WO
WIPO (PCT)
Prior art keywords
occlusion
generally tubular
diameter
tubular inner
outer member
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IL2011/050058
Other languages
English (en)
Inventor
Avraham Rapaport
Gilad Cibulski
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PERFLOW MEDICAL Ltd
Original Assignee
PERFLOW MEDICAL 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 PERFLOW MEDICAL Ltd filed Critical PERFLOW MEDICAL Ltd
Publication of WO2012081020A1 publication Critical patent/WO2012081020A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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
    • 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
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • 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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • 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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2217—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions single wire changing shape to a gripping configuration

Definitions

  • the invention relates generally to the field of medical devices, specifically to medical devices that are useful in treating stroke, and more particularly to a device aiding in retrieval of an occlusion.
  • Stroke is a leading cause of disability, death and health care expenditure.
  • Most strokes are ischemic, i.e. caused by a decrease in the blood supply to a portion of the brain due to a clot obstructing the flow of blood.
  • a total or hemodynamically significant occlusion of a cerebral artery in an acute ischemic stroke is mostly due to thrombus formation, an embolus, and/or other unwanted matter.
  • tissue ischemia laack of oxygen and nutrients
  • the organ most sensitive to ischemia is the brain. Ischemia will rapidly progress to tissue infarction (cell death) if the occlusion of blood flow persists.
  • occlusion As used herein is meant to include any partial or complete blockage of a blood vessel, as by thrombosis, embolism or gradual narrowing.
  • the functionally impaired region that surrounds the infarct core and is threatened by cell death has been termed the ischemic penumbra.
  • the ischemic penumbra although physiologically impaired, is potentially salvageable tissue, however the window of opportunity for recovery of the reversibly injured neurons in the ischemic penumbra is relatively short. Failure to timely restore blood flow triggers a biochemical and metabolic cascade ultimately leading to irreversible brain injury by progressive transformation of the ischemic penumbra into infarcted tissue, i.e. the infarct core expands as the penumbra tissue experiences necrosis.
  • t-PA tissue plasminogen activator
  • More recently percutaneous catheter-based technologies have been advanced, including: placing a microcatheter near the clot and infusing a thrombolytic agent in order to dissolve the clot; extracting the clot by distal embolectomy devices in which various wire corkscrews and baskets are advanced distally through the clot in order to capture it; and using proximal devices in which the clot is aspirated or captured and removed.
  • Other methods of removing or disrupting the clot include: facilitating fibrinolysis by an outside energy source such as ultrasound or laser energy; mechanical manipulation of the clot by primary angioplasty; and employing stents permanently or transiently are also widely used.
  • a key therapeutic goal of acute ischemic stroke treatment consists of re-establishment of arterial potency prior to cell death. The sooner arterial patency is achieved the greater the clinical benefit, therefore early restoration of blood flow in the affected territory of the brain may save brain tissue.
  • prompt action is required in the case of an occlusion to remove the occlusion, and preferably to maintain patency of blood flow sufficient to prevent cell death.
  • the present disclosure provides methods and apparatuses for enabling at least partial retrieval of the occlusion, while preferably sustaining patency through the occlusion.
  • This is accomplished in certain embodiments by providing an occlusion retrieval member constituted of a generally tubular inner member in communication with an outer member, the outer member arranged to meet the inner walls of the blood vessel at the occlusion.
  • the generally tubular inner member is arranged to provide and/or sustain at least partial patency of a small blood vessel exhibiting an occlusion.
  • the generally tubular inner member comprises a tubular body expandable from a small diameter state for manipulation adjacent, and/or through, the occlusion of the small blood vessel and a large diameter state, which may extend up to an at rest diameter state.
  • the at rest diameter state is less than the inner diameter of the blood vessel at the occlusion and preferably is less than 50% of the inner diameter of the blood vessel at the occlusion.
  • the occlusion retrieval member is particularly designed for use with small blood vessels, i.e. blood vessels of 5mm or less of inner diameter and may be constituted of an intracranial blood vessel.
  • the outer member is in one embodiment similarly constituted, however it is arranged to meet the inner walls of the body lumen at the occlusion, thereby enclosing at least a portion of the occlusion between the outer member and the generally tubular inner member. Removal of the occlusion retrieval member, with the occlusion securely contained therein, results in at least partial retrieval of the occlusion.
  • the present embodiments enable a device arranged to at least partially remove an occlusion occluding a small blood vessel, the device comprising: a generally tubular inner member; and an outer member in communication with the generally tubular inner member, wherein: the generally tubular inner member exhibits a small diameter state for manipulation to, and through, the occlusion of the small blood vessel, the generally tubular inner member expandable to a large diameter state, the outer diameter of the generally tubular member in the large diameter state being no more than an at rest diameter of the generally tubular inner member, wherein the at rest diameter of the generally tubular inner member is less than the inner diameter of the small blood vessel at the occlusion location; and the outer member exhibits a small diameter state for manipulation to, and through, the occlusion of the small blood vessel, the outer member expandable to a large diameter state wherein the inner diameter of the outer member in the large diameter state is greater than the outer diameter of the generally tubular inner member in the large diameter state, wherein at least a portion of
  • the outer diameter of the outer member in the large diameter state meets the inner walls of the small blood vessel at the occlusion location.
  • the at rest diameter of the generally tubular inner member is no more than 50% of the diameter of the small blood vessel at the occlusion location.
  • the generally tubular inner member and the outer member are removable from the body lumen, thus retrieving the occlusion.
  • the outer member exhibits a resting state, wherein the outer diameter of the outer member in the resting state is greater than the inner diameter of the small blood vessel.
  • the outer diameter of the outer member in the resting state is at least 0.5 millimeters greater than the inner diameter of the small blood vessel.
  • the outer diameter of the outer member in the resting state is 0.5 - 1.5 millimeters greater than the inner diameter of the small blood vessel.
  • the device comprises a distal filtering extension coupled to the distal end of the generally tubular inner member, the distal filtering extension arranged to meet the inner walls of the body lumen distal of the occlusion when the generally tubular inner member is large diameter state.
  • the generally tubular inner member comprises a first connecting portion, and wherein a proximal end of the outer member is connected to the generally tubular inner member via the first connecting portion.
  • the generally tubular inner member further comprises a second connecting portion, and wherein a distal end of the outer member is connected to the generally tubular inner member via the second connecting portion.
  • At least one of the generally tubular inner member and the outer member are constituted of self expanding braided filaments.
  • the device is constituted of braided filaments, and wherein the generally tubular inner member and the outer member are constituted of a single braid.
  • the small blood vessel is an intracranial blood vessel.
  • a method of occlusion retrieval comprising: providing an occlusion retrieval member exhibiting a generally tubular inner member and an outer member; manipulating the provided occlusion retrieval member in a small diameter state through a body lumen to, and through, an occlusion of a small blood vessel; expanding the generally tubular inner member of the provided occlusion retrieval member up to a large diameter state, the outer diameter of the generally tubular member in the large diameter state being no more than an at rest diameter of the generally tubular inner member, wherein the at rest diameter of the generally tubular inner member is less than the inner diameter of the small blood vessel at the occlusion location; expanding the outer member of the provided occlusion retrieval member up to a large diameter state wherein the inner diameter of the outer member is greater than the outer diameter of the generally tubular inner member in the large diameter state so as to contain at least a portion of the occlusion between the generally tubular inner member and the outer member; and withdrawing the provided
  • the expanding the outer member of the provided occlusion retrieval member up to a large diameter state comprises expanding the outer member so as to meet the inner walls of the small blood vessel at the occlusion location.
  • the at rest diameter of the generally tubular inner member is no more than 50% of the diameter of the small blood vessel at the occlusion location.
  • the outer member of the provided occlusion retrieval member exhibits a resting state, wherein the outer diameter of the outer member in the resting state is greater than the inner diameter of the small blood vessel at the occlusion location.
  • the outer diameter of the provided outer member in the resting state is at least 0.5 millimeters greater than the inner diameter of the small blood vessel at the occlusion location.
  • the outer diameter of the provided outer member in the resting state is 0.5 - 1.5 millimeters greater than the inner diameter of the small blood vessel at the occlusion location.
  • the method further comprises providing a distal filtering extension coupled to a distal end of the provided generally tubular inner member, the distal filtering extension arranged to meet the inner walls of the body lumen distal of the occlusion.
  • the generally tubular inner member of the provided occlusion retrieval member comprises a first connecting portion, and wherein a proximal end of the outer member of the occlusion retrieval member is connected to the generally tubular inner member via the first connecting portion.
  • the generally tubular inner member further comprises a second connecting portion, and wherein a distal end of the outer member is connected to the generally tubular inner member via the second connecting portion.
  • FIG. 1 illustrates a high level schematic diagram of a sectioned view of a first embodiment of a temporary endovascular conduit system, comprising a self expanding device;
  • FIG. 2 A - 2E illustrate high level schematic diagrams of partially sectioned views of the distal portion of the temporary endovascular perfusion conduit system of FIG. 1, showing sequential steps in the deployment of the self expanding device in a vessel according to an exemplary embodiment
  • FIG. 3 illustrates a high level schematic diagram of a partially sectioned view of the distal portion of the temporary endovascular perfusion conduit system of FIG. 1 and a delivery mechanism for intra-arterial administration of a medicament according to an exemplary embodiment
  • FIG. 4 illustrates a high level schematic diagram of a sectioned view of a second embodiment of a temporary endovascular conduit system, comprising an expanding device
  • FIGs. 5A - 5D illustrate high level schematic diagrams of partially sectioned views of the distal portion of the temporary endovascular perfusion conduit system of FIG. 4, showing sequential steps in the deployment of the expanding device in a vessel according to an exemplary embodiment
  • FIG. 6 illustrates a high level schematic diagram of a partially sectioned view of the distal portion of the temporary endovascular perfusion conduit system of FIG. 4 and a delivery mechanism for intra-arterial administration of a medicament according to an exemplary embodiment
  • FIG. 7A illustrates a high level schematic diagram of a sectioned view of an embodiment of a temporary endovascular perfusion conduit exhibiting a distal filtering extension member
  • FIG. 7B illustrates a high level schematic diagram of a sectioned view of an embodiment of a temporary endovascular perfusion conduit exhibiting a proximal securing member and a distal filtering extension member;
  • FIG. 8 illustrates a high level flow chart of a method of providing temporary endovascular perfusion
  • FIG. 9A illustrates a high level schematic diagram of a perspective view of an embodiment of an occlusion retrieval device comprising a generally tubular inner member and an outer member;
  • FIG. 9B illustrates a high level schematic diagram of a sectioned view of the occlusion retrieval device of FIG. 9A disposed within a body lumen at an occlusion;
  • FIGs. 10A - IOC illustrate a high level schematic diagram of a sectioned view of an embodiment of an occlusion retrieval device comprising a generally tubular inner member and an outer member constituted of a pair of self expanding meshes in communication at the proximal end thereof secured within a catheter, the various figures showing sequential steps in the deployment of the occlusion retrieval device within a body lumen at an occlusion according to an exemplary embodiment;
  • FIG. 11 illustrates a high level perspective view of an occlusion retrieval device wherein the generally tubular inner member and the outer member are constituted of a single mesh;
  • FIG. 12 illustrates a high level schematic diagram of a sectioned view of an embodiment of an occlusion retrieval device comprising a generally tubular inner member and an outer member and further comprising a distal filtering extension;
  • FIG. 13 illustrates a high level flow chart of a method of providing occlusion retrieval.
  • FIG. 1 illustrates a high level schematic diagram of a sectioned view of a first embodiment of a temporary endovascular conduit system, denoted temporary endovascular conduit system 50, deployed in an occlusion 10 occluding a body lumen 15.
  • Temporary endovascular conduit system 50 comprises: a catheter 40, exhibiting a proximal portion 60 and a distal portion 80; a hub 90; a pair of members 26 and 26A; a guide wire 30; and a self expanding device 20, exhibiting a proximal end 22 and a distal end 24, illustrated in a large diameter state.
  • the diameter of body lumen 15 in the area of occlusion 10 is denoted D2, and the inner diameter of self expanding device 20 in the large diameter state, denoted Dl, is preferably between 1/3 and 1/2 of D2.
  • Body lumen 15 is a small blood vessel, exhibiting an inner diameter D2 of 5mm or less, as described above.
  • providing a conduit exhibiting an inner diameter for blood flow of at least 1/3 of D2 allows a sufficient blood flow, in the absence of sufficient collateral flow from other arteries, to prevent or delay cell death, since this provides for a resultant stenosis of less than 75%.
  • Proximal end 22 of self expanding device 20 is positioned proximally to occlusion 10 and distal end 24 of self expanding device 20 is positioned distally to occlusion 10.
  • Self expanding device 20 in the large diameter state provides a conduit for limited blood flow from proximal end 22 to distal end 24.
  • the length of self expanding device 20 in the large diameter denoted L, is at least 5 times Dl .
  • length L is at least 10 times Dl .
  • length L is at least 15 times Dl .
  • length L is at least 20 times Dl .
  • length L is at least 30 times Dl .
  • length L is at least 14 times Dl .
  • Hub 90 is attached to proximal portion 60 of catheter 40.
  • members 26 and 26A are respectively connected to proximal end 22 and distal end 24 of self expanding device 20.
  • Members 26, 26A and guide wire 30 run through catheter 40 and hub 90 and out therefrom, and are provided to be long enough so as to be accessible.
  • the structure of self expanding device 20 can be of any kind, provided it is hollow, including, but not limited to, a tubular tube, a shield tube and a self expanding structure manufactured by any one of weaving, coiling, laser cutting and braiding a plurality of filaments.
  • self expanding device 20 is a self expandable braided tubular member, as illustrated.
  • the braid construction that forms self expanding device 20 can be produced from many different materials, including, but not limited to, metals, polymers and composites. More specifically, these materials can include cobalt-chrome alloys, stainless steel, nylon, and polyesters.
  • superelastic materials such as some nickel titanium alloys, are used.
  • a formulation of nickel titanium alloy comprising about 51% - 56% nickel and about 44% - 49% titanium is used.
  • each filament comprising self expanding device 20 has a round cross section, the diameter of the cross section usually ranging between about 0.0005 inches and 0.01 inches and optionally between 0.001 inches and 0.004 inches, and the number of filaments comprising the braided construction ranges between 4 and 288.
  • the filaments comprising self expanding device 20 are flat wires with non-circular cross sections, the number of filaments ranging between 8 and 64, optionally between 12 and 24.
  • the braiding angle is between 60° and 150°. In one particular embodiment the braiding angle is 90°.
  • the braiding pattern is a regular pattern known also as herringbone or 1x2 pattern.
  • a braiding pattern of lxl is used, with such a braiding pattern also known as a "one over one under" pattern.
  • self expanding device 20 is permeable to fluids.
  • the inner diameter of self expanding device 20 is in the small diameter state, denoted DO, when self expanding device 20 is held within catheter 40 as illustrated in FIG. 2 A described further below.
  • DO is between 0.5 mm and 1.5 mm, optionally between 0.8 mm and 1.2 mm and diameter Dl is between 0.8 mm and 2 mm, optionally between 1 mm and 1.5 mm.
  • the length of self expanding device 20 stays fixed when the diameter of self expanding device 20 changes, and in other embodiments, the length of self expanding device 20 is reduced when the inner diameter of self expanding device 20 increases.
  • self expanding device 20 is substantially not expanded or only slightly expands when elongated to length L.
  • the braid construction that forms self expanding device 20 is coated with a non-porous elastic material, illustrated in FIG. 3 as a coating 95. Coating over the porous braid construction of self expanding device 20 forms a solid tubular conduit within occlusion 10.
  • the elastic material can be any of a plurality of materials, including, but not limited to: polymers such as silicones, polyethers, polyurethanes, polyamides, hydrogels such as polyvinyl alcohol or polyvinyl pyrrolidone, and other polymers suitable for intravascular use; permeable, semi-permeable and non-permeable membranes; and expandable foams.
  • the elastic material is preferably formed into a fabric mesh and placed around self expanding device 20.
  • the elastic material is porous, preferably less permeable than self expanding device 20.
  • any particles from occlusion 10 which pass through the relatively small openings forming self expanding device 20 flow out therefrom, thereby avoiding harmful disruption of blood flow or occlusion of a vessel thereof.
  • Self expanding device 20 in the large diameter state provides and/or sustains a perfusion conduit exhibiting a minimum inner diameter Dl for sufficient blood flow to the region distal of occlusion 10 and from there to the affected area, thereby reducing the infarction rate of penumbral tissue.
  • the effective time window for performing endovascular attempts to remove or disrupt occlusion 10 is expanded. Shortening the length and/or increasing the hollow cross- section diameter of self expanding device 20 may result in greater cerebral blood flow to the region distal to occlusion 10 and from there to the affected area, resulting in a greater reduction in the infarction rate of penumbral tissue.
  • length L of self expanding device 20 in a maximum expanded state is provided to be as short as possible, while being longer than the length of occlusion 10, optionally between 2 mm and 40 mm longer than the length of occlusion 10, and the diameter of the hollow cross-section of self expanding device 20 in a maximum expanded state is provided to be between 1/3 and 1/2 of diameter D2 of body lumen 15, as described above.
  • length L is 20 mm, thereby extending 5 mm proximally of occlusion 10 and 5 mm distally of occlusion 10.
  • occlusion 10 is 20 - 30 mm long, length L between 40 mm and 50 mm, thereby extending between 5 mm and 15 mm proximally of occlusion 10 and between 5 mm and 15 mm distally of occlusion 10.
  • Self expanding device 20 provides enough radial force at diameters up to the unstressed maximum expanded state of 1/2 of D2 so as to prevent movement of self expanding device 20 in occlusion 10.
  • the inside diameter of self expanding device 20 in its maximum expanded state represents a conduit with a cross section of at least 0.685 mm 2 .
  • self expanding device 20 When self expanding device 20 is at its maximum expanded state it is considered to be at its resting state, since no radial expansion force is exhibited by self expanding device 20, in particular self expanding device 20 does not urge to expand beyond said second large diameter state. Thus, self expanding device 20 may exhibit outward radial force when within occlusion 10, until expansion has reached the unstressed maximum expanded state of 1/2 of D2. Once self expanding device 20 has reached the unstressed maximum expanded state of 1/2 of D2 minimal radial force is applied to occlusion 10. Furthermore no radial force is applied to the walls of body lumen 15 distally and proximally of occlusion 10.
  • Members 26, 26A are provided in order to facilitate the deployment of self expanding device 20 into occlusion 10, particularly aiding in control of localization and further procedures, and/or the ultimate retraction of self expanding device 20 therefrom.
  • Members 26 and 26A are in one embodiment each constituted of one of a flexible rod, a filament or a bundle of filaments.
  • the cross section of each of members 26 and 26A are on the same order as the cross section of guidewire 30, with guidewire 30 preferably being a 0.014" (0.3556 mm) guidewire known to the art exhibiting a cross-sectional area of less than 0.1 mm 2 .
  • stretching and compressing of self expanding device 20 is enabled by respectively relatively pulling and pushing members 26 and 26A to expand and decrease the length between proximal end 22 and distal end 24.
  • Stretching self expanding device 20 reduces its cross-sectional area and enables an operator to change the placement of self expanding device 20 easily.
  • Compressing self expanding device 20 enlarges its hollow cross-sectional area so as to allow more blood flow there through, as described above.
  • self expanding device 20 can be retracted into catheter 40 by pulling member 26 or by pulling and pushing members 26, 26A, respectively, and withdrawn from the patient body along with the retraction of catheter 40.
  • members 26,26A are inherently connected to self expanding device 20, i.e. members 26,26A are thin local elongated protrusions of self expanding device 20.
  • members 26,26A are thin local elongated protrusions of self expanding device 20.
  • withdrawal of self expanding device 20 comprises reduction in radial size to a size greater than the radial size of self expanding device when first delivered to occlusion 10.
  • radiopaque materials such as gold, platinum, or tungsten can be applied using various methods such as marker, electroplating, ion deposition, and coating.
  • self expanding device 20 is at least partially coated with a radiopaque polymer such as silicone mixed with tantalum powder thus providing visualization.
  • self expanding device 20 is secured in location within occlusion 10 by catheter 40 or by another anchoring means secured externally of the patient body, such as by members 26, 26A and 26B, to be described further below.
  • FIG. 2A illustrates high level schematic diagrams of partially sectioned views of the distal portion of temporary endo vascular conduit system 50 of FIG. 1, showing sequential steps in the deployment of self expanding device 20 within body lumen 15 across occlusion 10 according to an exemplary embodiment, the description of Figs. 2A - 2E being taken together.
  • self expanding device 20 is in a collapsed state, i.e. a small diameter state, and secured within catheter 40, and particulary in a distal portion of catheter 40.
  • Self expanding device 20 is pre-loaded or back- loaded onto guidewire 30 while secured within catheter 40.
  • Guidewire 30 is manipulated through body lumen 15 from an entry site, such as the femoral artery, to the region of body lumen 15 occluded by occlusion 10.
  • a distal tip 32 of guidewire 30 is advanced across occlusion 10 using appropriate guidewire and crossing techniques known in the art. Once distal tip 32 of guidewire 30 passes through the distal end of occlusion 10, catheter 40 is advanced through occlusion 10.
  • a micro catheter can be used to visualize the patency of both the vasculature proximal to occlusion 10 and the vasculature distal to occlusion 10 using conventional radiographic techniques, prior to advancing catheter 40 over guidewire 30.
  • FIG. 2B temporary endovascular conduit system 50 comprising catheter 40 constraining self expanding device 20 is advanced through occlusion 10, with distal portion 80 of catheter 40 and distal end 24 of self expanding device 20 extending distally of occlusion 10.
  • a radiographic solution may be injected through hub 90 of FIG. 1 prior to advancing temporary endovascular conduit system 50 into occlusion 10, thus after the positioning of catheter 40 across occlusion 10 the length of occlusion 10 can be determined, thereby allowing an operator to determine the desired positions of distal end 24 and proximal end 22 of self expanding device 20.
  • determining of the length of occlusion 10 is performed prior to inserting temporary endovascular conduit system 50 in the patient body, thus enabling the operator to choose a specific self expanding device 20 with desired final length and expanded large diameter.
  • Various methods can be applied to visualize proximal end 22 and distal end 24 of self expanding device 20 under fluoroscopy, as described above in relation to FIG. 1.
  • catheter 40 is partially retracted from restraining self expanding device 20, while members 26, 26A are held in place, thereby partially releasing self expanding device 20 from catheter 40 through distal portion 80. Due to self expanding properties the exposed part of self expanding device 20 automatically performs an outward radial expansion and preferably forms into a generally circular configuration.
  • inner diameter D 1 of self expanding device 20 in the large diameter state is no greater than twice, optionally no greater than 1.5 times, and further optionally no greater than 1.2 times the inner diameter DO of self expanding device 20 in the small diameter state when held within catheter 40.
  • catheter 40 is retracted until self expanding device 20 is fully released.
  • Self expanding device 20 expands to its large diameter state, presenting a conduit for blood flow through occlusion 10.
  • Catheter 40 may be fully retracted from the patient body.
  • guidewire 30 remains positioned in occlusion 10 to provide guidance for maneuvering medical means to the site of occlusion 10.
  • guidewire 30 is removed from the patient body and member 26 and/or member 26A provides guidance for maneuvering medical means to the site of occlusion 10, thus enabling extended medical procedures without the need of guidewire 30.
  • Temporary endo vascular conduit system 50 can be fully retracted out of the patient body, whenever necessary. In one embodiment this is accomplished by expanding the length of self expanding device 20 by manipulation of members 26, 26 A thereby reducing the diameter of self expanding device 20. Once the diameter of self expanding device 20 has been reduced, catheter 40 is preferably advanced over self expanding device 20 while self expanding device 20 is held in the small diameter state by members 26, 26A, and catheter 40 containing therein self expanding device 20 is then removed from the patient body. Alternatively, catheter 40 is held stationary and self expanding device 20 in the small diameter state is withdrawn from the area of occlusion 10 towards distal portion 80 of catheter 40, and then drawn within catheter 40. In an alternative embodiment, self expanding device 20 is maintained in the small diameter state by the manipulation of members 26, 26A and removed from the patient body by further manipulation of members 26, 26A.
  • self expanding device 20 may be collapsed and returned within catheter 40, numerous deployments of self expanding device 20 at various locations may be performed as a single endovascular procedure.
  • a member 26B constituted of one of a flexible rod, a filament or a bundle of filaments is attached to proximal end 22 of self expanding device 20.
  • Member 26B can be produced by many different techniques, including but not limited to looping, tying, stitching, interweaving, gluing, welding and soldering, to one or more locations within proximal end 22.
  • member 26B is looped into the collapsible braided construction of proximal end 22 and thus reduces the diameter of self expanding device 20 while tensioned.
  • Self expanding device 20 can be retracted into catheter 40 by tensioning holding member 26B and advancing distal portion 80 of catheter 40 from proximal end 22 to distal end 24 of self expanding device 20.
  • a stopper 27 with an outer diameter fits into the inner diameter of catheter 40 and facilitates deployment of self expanding device 20 into occlusion 10 since stopper 27 is in contact with proximal end 22 of self expanding device 20 when retracting catheter 40 out of its position across occlusion 10.
  • FIG. 3 illustrates a high level schematic diagram of a partially sectioned view of the distal portion of temporary endo vascular conduit system 50 of FIG. 1 and a delivery mechanism 70 for intra-arterial administration of t-PA according to an exemplary embodiment, with device 20 illustrated with coating 95.
  • Coating 95 is in some embodiments non-permeable, and in other embodiments permeable.
  • Self expanding device 20 is shown in its large diameter state, i.e. its fully expanded uncompressed state, inside occlusion 10, thereby sustaining at least some blood flow through occlusion 10, as described above.
  • penumbral tissue preservation is facilitated, thereby prolonging the time window for any effective catheter based recanalization procedure, as described above.
  • temporary endo vascular conduit system 50 is temporarily deployed, so as to supply oxygenated blood to the ischemic penumbrae, and thereafter removed prior to any endovascular procedure for attempting to remove or disrupt occlusion 10, and optionally redeployed between repeated procedures for attempting to remove or disrupt occlusion 10.
  • temporary endovascular conduit system 50 is deployed prior to any endovascular procedure for recanalization of lumen 15, and self expanding device 20 remains expanded inside occlusion 10 during the procedure, thereby maintaining blood flow during the procedure.
  • coating 95 is permeable, and thus allows for the passage of a fluid from delivery mechanism 70 to occlusion 10.
  • delivery mechanism 70 is preferably delivered to be within self expanding device 20 optionally formed of a mesh exhibiting openings such that fluid exiting delivery mechanism 70 is received to the circumference of self expanding device 20 deployed across occlusion 10.
  • catheter 40 is used as a passage of a fluid from outside of the body to the occlusion site eliminating the need for delivery mechanism 70.
  • Delivery mechanism 70 is manipulated through body lumen 15 from an entry site, such as the femoral artery, to a region proximal to occlusion 10.
  • delivery mechanism 70 can be manipulated over guidewire 30.
  • guidewire 30 has also been removed, or in the embodiment in which temporary endo vascular conduit system 50 has not been removed, as illustrated, delivery mechanism 70 can be manipulated over a dedicated additional guidewire and/or through a guiding catheter, or by using any other technique known in the art.
  • Delivery mechanism 70 administers a drug such as a neuro-protective agent, or a thrombolytic agent such as t-PA or any other antithrombotic agent into occlusion 10, thus breaking down occlusion 10.
  • a drug such as a neuro-protective agent, or a thrombolytic agent such as t-PA or any other antithrombotic agent into occlusion 10, thus breaking down occlusion 10.
  • other means of removing or disrupting occlusion 10 such as: thrombolytic agent infusing techniques; distal or proximal embolectomy devices; various wire corkscrews and baskets; clot capturing devices; and clot aspiration and removing devices, can be used.
  • occlusion 10 Other methods of removing or disrupting occlusion 10, such as: facilitating fibrinolysis by an outside energy source such as ultrasound or laser energy; and mechanical manipulation of occlusion 10 by primary angioplasty and/or by employing stents permanently or transiently, may be used.
  • an outside energy source such as ultrasound or laser energy
  • mechanical manipulation of occlusion 10 by primary angioplasty and/or by employing stents permanently or transiently may be used.
  • FIG. 4 illustrates a high level schematic diagram of a sectioned view of a second embodiment of a temporary endovascular perfusion conduit system, denoted temporary endovascular perfusion conduit system 150, deployed in an occlusion 10 occluding a body lumen 15.
  • Temporary endovascular perfusion conduit system 150 comprises: a catheter 40, exhibiting a proximal portion 60 and a distal portion 80; a hub 90; a pair of members 126 and 126A; and an expanding device 120, exhibiting a proximal end 122 and a distal end 124, illustrated in a large diameter state.
  • a guide wire 30 is also provided.
  • the diameter of body lumen 15 in the area of occlusion 10 is denoted D2, and the inner diameter of expanding device 120 in the large diameter state denoted Dl, is between 1/3 and 1/2 of D2.
  • D2 The diameter of body lumen 15 in the area of occlusion 10
  • Dl the inner diameter of expanding device 120 in the large diameter state
  • Dl the inner diameter of expanding device 120 in the large diameter state
  • Advantageously providing a conduit exhibiting an inner diameter for blood flow of at least 1/3 of D2 allows a sufficient blood flow, in the absence of sufficient collateral flow from other arteries, to prevent or delay cell death since this provides for a resultant stenosis of less than 75%.
  • Proximal end 122 of expanding device 120 is positioned proximally to occlusion 10 and distal end 124 of expanding device 120 is positioned distally to occlusion 10.
  • Expanding device 120 in the large diameter state provides a conduit for limited blood flow from proximal end 122 to distal end 124.
  • the length of expanding device 120 in the large diameter is at least 5 times Dl .
  • length L is at least 10 times Dl .
  • length L is at least 15 times Dl .
  • length L is at least 20 times Dl .
  • length L is at least 30 times Dl .
  • length L is at least 14 times Dl .
  • Hub 90 is attached to proximal portion 60 of catheter 40.
  • members 126 and 126 A are respectively connected to one or both of proximal end 122 and distal end 124 of expanding device 120.
  • member 126 is connected to proximal end 122 of expanding device 120 and member 126A is connected to distal end 124 of expanding device 120, as will be described further hereinto below.
  • Members 126 and 126 A and guide wire 30 run through catheter 40 and hub 90 and out therefrom, and are provided to be long enough so as to be accessible.
  • the structure of expanding device 120 can be of any kind, providing it is hollow, including, but not limited to, a tubular tube, a shield tube and a self expanding structure manufactured by weaving, braiding, laser cutting, or by coiling a filament.
  • Optionally expanding device 120 is a self expandable coiled tubular member, as illustrated, formed by winding a filament spirally and closely over a predetermined diameter and arranged such that when in a fully expanded state each wind is in contact with an adjacent wind, thereby forming a solid tubular shape.
  • the coil forming expanding device 120 can be produced from many different materials, including, but not limited to, metals, polymers and composites. More specifically, these materials can include cobalt-chrome alloys, stainless steel, nylon, and polyesters.
  • superelastic materials such as some nickel titanium alloys, are used.
  • a formulation of nickel titanium alloy comprising about 51% - 56% nickel and about 44% - 49% titanium is used.
  • expanding device 120 is not self-expandable, but is instead balloon- expandable, shape memory altered by temperature change or externally stretchable without limitation.
  • the filament comprising expanding device 120 has a round cross section, the diameter of the cross section usually ranging between about 0.001 inches and 0.006 inches and optionally between 0.001 inches and 0.0035 inches.
  • the filament comprising expanding device 120 is a flat wire with a non-circular cross section.
  • the coil forming expanding device 120 is coated with a non-porous elastic material. Coating over the porous coil will form a solid tubular conduit within occlusion 10.
  • the elastic material can be any of a plurality of materials, including, but not limited to: polymers such as silicone, polyethers, polyurethanes, polyamides, hydrogels such as polyvinyl alcohol or polyvinyl pyrrolidone, and other polymers suitable for intravascular use; permeable, semi-permeable and non-permeable membranes; and expandable foams.
  • the elastic material is formed into a fabric mesh and placed around expanding device 120.
  • the elastic material is porous, preferably less permeable than expanding device 120.
  • Expanding device 120 in the large diameter state provides and sustains a conduit exhibiting an inner diameter Dl for sufficient blood flow to the region distal of occlusion 10 and from there to the affected area, thereby reducing the infarction rate of penumbral tissue.
  • the effective time window for performing endovascular attempts to remove or disrupt occlusion 10 is expanded. Shortening the length and/or increasing the hollow cross-section diameter of expanding device 120 may result in greater cerebral blood flow to the region distal to occlusion 10 and from there to the affected area, resulting in a greater reduction in the infarction rate of penumbral tissue.
  • length L of expanding device 120 in a maximum expanded state is provided to be as short as possible, while being longer than the length of occlusion 10, optionally between 2 mm and 40 mm longer than the length of occlusion 10, and the diameter of the hollow cross-section of expanding device 120 in a maximum expanded state is provided to be between 1/3 and 1/2 of diameter D2 of body lumen 15, as described above.
  • length L is 20 mm, thereby extending 5mm proximally of occlusion 10 and 5mm distally of occlusion 10.
  • length L between 40mm and 50mm, thereby extending between 5mm and 15mm proximally of occlusion 10 and between 5mm and 15mm distally of occlusion 10.
  • Expanding device 120 provides enough radial force at diameters up to the unstressed maximum expanded state of 1/2 of D2 so as to prevent movement of expanding device 120 in occlusion 10.
  • the inside diameter of expanding device 120 in its maximum expanded state represents a conduit with a cross section of at least 0.685 mm 2 .
  • expanding device 120 may exhibit outward radial force when within occlusion 10, until expansion has reached the unstressed maximum expanded state of 1/2 of D2.
  • Once expanding device 120 has reached the unstressed maximum expanded state of 1/2 of D2 minimal radial force is applied to occlusion 10. Furthermore no radial force is applied to the walls of body lumen 15 distally and proximally of occlusion 10.
  • the hollow cross-sectional area of expanding device 120 is small enough so as to allow simultaneous use of expanding device 120 and a device for dislodging, removing and/or dissolving the clot, as will be described below in relation to FIG. 6.
  • expanding device 120 is secured in location within occlusion 10 by catheter 40 or by another anchoring means secured externally of the patient body, such as by members 126, 126A or 126B to be described further below
  • Optional members 126,126A are provided in order to facilitate the deployment of expanding device 120 into occlusion 10 particularly aiding in control of localization and further procedures, and/or the ultimate retraction of expanding device 120 therefrom.
  • Members 126 and 126 A are in one embodiment each constituted of one of a flexible rod, a filament or a bundle of filaments.
  • the cross section of each of members 126 and 126 A are on the same order as the cross section of guidewire 30, with guidewire 30 preferably being a 0.014" (0.3556 mm) guidewire known to the art exhibiting a cross-sectional area of less than 0.1 mm 2 .
  • stretching and compressing of expanding device 120 is enabled by respectively relatively pulling and pushing members 126 and 126 A to expand and decrease the length between proximal end 122 and distal end 124.
  • Stretching expanding device 120 reduces its cross-sectional area and enables an operator to change the placement of expanding device 120 easily.
  • Compressing expanding device 120 enlarges its hollow cross-sectional area so as to allow more blood flow there through, as described above.
  • expanding device 120 can be retracted into the catheter 40 using members 126, 126A and withdrawn from the patient body along with the retraction of catheter 40.
  • members 126,126A are inherently connected to expanding device 120, i.e. members 126,126A are thin local elongated protrusions of expanding device 120.
  • members 126,126A are thin local elongated protrusions of expanding device 120.
  • withdrawal of expanding device 120 comprises reduction in radial size to a size greater than the radial size of expanding device when first delivered to occlusion 10.
  • radiopaque materials such as gold, platinum, or tungsten can be applied using various methods such as marker, electroplating, ion deposition, and coating.
  • expanding device 120 is coated with a radiopaque polymer such as silicone mixed with tantalum powder.
  • FIG. 5A illustrates high level schematic diagrams of partially sectioned views of the distal portion of temporary endovascular perfusion conduit system 150 of FIG. 4, showing sequential steps in the deployment of expanding device 120 within body lumen 15 across occlusion 10 according to an exemplary embodiment, the description of Figs. 5A - 5D being taken together.
  • expanding device 120 is in a collapsed state, i.e. a small diameter state, and secured within catheter 40, and particularly in a distal portion of catheter 40. Expanding device 120 is pre-loaded or back- loaded onto guidewire 30 while secured within catheter 40.
  • Guidewire 30 is manipulated through body lumen 15 from an entry site, such as the femoral artery, to the region of body lumen 15 occluded by occlusion 10.
  • a distal tip 32 of guidewire 30 is advanced across occlusion 10 using appropriate guidewire and crossing techniques known in the art. Once distal tip 32 of guidewire 30 passes through the distal end of occlusion 10, catheter 40 is advanced through occlusion 10.
  • a micro catheter can be used to visualize the patency of both the vasculature proximal to occlusion 10 and the vasculature distal to occlusion 10 using conventional radiographic techniques, prior to advancing catheter 40 over guidewire 30.
  • FIG. 5B temporary endovascular conduit system 150 comprising catheter 40 constraining expanding device 120 is advanced through occlusion 10, with distal portion 80 of catheter 40 and distal end 124 of expanding device 120 extending distally of occlusion 10.
  • a radiographic solution may be injected through hub 90 of FIG. 4 prior to advancing temporary endovascular conduit system 150 into occlusion 10, thus after the positioning of catheter 40 across occlusion 10 the length of occlusion 10 can be determined, thereby allowing an operator to determine the desired positions of distal end 124 and proximal end 122 of expanding device 120.
  • determining of the length of occlusion 10 is performed prior to inserting temporary endovascular conduit system 150 in the patient body, thus enabling the operator to choose a specific expanding device 120 with a desired final length and expanded large diameter.
  • Various methods can be applied to visualize proximal end 122 and distal end 124 of expanding device 120 under fluoroscopy, as described above in relation to FIG. 4.
  • catheter 40 is partially retracted from expanding device 120 while members 126,126A are held in place, thereby partially releasing expanding device 120 from catheter 40 through distal portion 80.
  • expanding device 120 is self expandable, due to self expanding properties the exposed part of expanding device 120 automatically performs an outward radial expansion and preferably forms into a generally circular configuration.
  • inner diameter Dl of expanding device 120 in the large diameter state is no greater than twice, optionally no greater than 1.5 times, and further optionally no greater than 1.2 times the inner diameter of expanding device 120 in the small diameter state when held within catheter 40, denoted DO.
  • catheter 40 is retracted until expanding device 120 is fully released. Expanding device 120 expands to its large diameter state presenting a conduit for blood flow through occlusion 10. Catheter 40 may be fully retracted from the patient body. In one embodiment guidewire 30 remains positioned in occlusion 10 to provide guidance for maneuvering medical means to the site of occlusion 10. In another embodiment guidewire 30 is removed from the patient body and member 126 and/or member 126A provides guidance for maneuvering medical means to the site of occlusion 10, thus enabling extended medical procedures without the need of a guide wire 30.
  • Temporary endovascular perfusion conduit system 150 can be fully retracted out of the patient body, whenever necessary. In one embodiment this is accomplished by expanding the length of expanding device 120 by manipulation of members 126, 126A thereby reducing the diameter of expanding device 120. Once the diameter of expanding device 120 has been reduced, catheter 40 is preferably advanced over expanding device 120 while expanding device 120 is held in the small diameter state by members 126, 126A, and catheter 40 containing therein expanding device 120 is then removed from the patient body. Alternatively, catheter 40 is held stationary and expanding device 120 in the small diameter state is withdrawn from the area of occlusion 10 towards proximal end 80 of catheter 40, and then drawn within catheter 40. In an alternative embodiment, expanding device 120 is maintained in the small diameter state by the manipulation of members 126, 126A and removed from the patient body by further manipulation of members 126, 126A.
  • expanding device 120 may be collapsed and returned within catheter 40, numerous deployments of expanding device 120 at various locations may be performed as a single endovascular procedure.
  • expanding device 120 can be retracted into catheter 40 by a holding member 126B by tensioning holding member 26B and advancing distal portion 80 of catheter 40 from proximal end 122 to distal end 124 of expanding device 120.
  • a stopper 27 exhibiting an outer diameter fits into the inner diameter of catheter 40 and facilitates the deployment of expanding device 120 into occlusion 10 by keeping stopper 27 in constant contact against the proximal end 122 of expanding device 120 and pushing it gradually during the retraction of catheter 40 out of its position across occlusion 10.
  • FIG. 6 illustrates a high level schematic diagram of a partially sectioned view of the distal portion of temporary endovascular perfusion conduit system 150 of FIG. 4 and a delivery mechanism 70 for intra-arterial administration of t-PA according to an exemplary embodiment.
  • Expanding device 120 is shown in its large diameter state, i.e. its fully expanded state, inside occlusion 10, thereby sustaining at least some blood flow through occlusion 10, as described above. Expanding device 120 urges towards the at rest state, which thus represents a maximum for the large diameter state.
  • penumbral tissue preservation is facilitated, thereby prolonging the time window for any effective catheter based recanalization procedure, as described above.
  • temporary endo vascular perfusion conduit system 150 is temporarily deployed, so as to supply oxygenated blood to the ischemic penumbrae, and thereafter removed prior to any endovascular procedure for attempting to remove or disrupt occlusion 10, and optionally redeployed between repeated procedures for attempting to remove or disrupt occlusion 10.
  • temporary endovascular perfusion conduit system 150 is deployed prior to any endovascular procedure for attempting to remove or disrupt occlusion 10, and expanding device 120 remains expanded inside occlusion 10 during the procedure, thereby maintaining blood flow during the procedure.
  • expanding device 120 is permeable, and thus allows for the passage of a fluid from delivery mechanism 70 to occlusion 10.
  • delivery mechanism 70 is preferably delivered to be within expanding device 120 optionally formed as a spiral winding wherein successive turns are not in contact with previous turns thus forming a structure such that fluid exiting delivery mechanism 70 is received to the circumference of expanding device 120 deployed across occlusion 10.
  • catheter 40 is used as a passage of a fluid from outside of the body to the occlusion site eliminating the need for delivery mechanism 70.
  • Delivery mechanism 70 is manipulated through body lumen 15 from an entry site, such as the femoral artery, to a region proximal to occlusion 10.
  • delivery mechanism 70 can be manipulated over guidewire 30.
  • guidewire 30 has also been removed, or in the embodiment in which temporary endovascular perfusion conduit system 150 has not been removed, as illustrated, delivery mechanism 70 can be manipulated over a dedicated additional guidewire and/or through a guiding catheter, or by using any other technique known in the art.
  • Delivery mechanism 70 administers a drug such as a neuro-protective agent, or a thrombolytic agent such as t- PA, or any other antithrombotic agent, into occlusion 10, thus breaking down occlusion 10.
  • a drug such as a neuro-protective agent, or a thrombolytic agent such as t- PA, or any other antithrombotic agent
  • Delivery mechanism 70 administers a drug such as a neuro-protective agent, or a thrombolytic agent such as t- PA, or any other antithrombotic agent, into occlusion 10, thus breaking down occlusion 10.
  • a drug such as a neuro-protective agent, or a thrombolytic agent such as t- PA, or any other antithrombotic agent
  • thrombolytic agent infusing techniques such as: thrombolytic agent infusing techniques; distal or proximal embolectomy devices; various wire corkscrews and baskets; clot capturing devices; and clot aspiration and
  • occlusion 10 Other methods of removing or disrupting occlusion 10, such as: facilitating fibrinolysis by an outside energy source such as ultrasound or laser energy; and mechanical manipulation of occlusion 10 by primary angioplasty and/or by employing stents permanently or transiently, may be used.
  • an outside energy source such as ultrasound or laser energy
  • mechanical manipulation of occlusion 10 by primary angioplasty and/or by employing stents permanently or transiently may be used.
  • FIG. 7A illustrates a high level schematic diagram of a sectioned view of an embodiment of a temporary endovascular perfusion conduit 220 exhibiting a distal filtering extension member 240, coupled to distal end 24 of self expanding device 20 via transition portion 230.
  • Self expanding device 20 is substantially as described above in relation to FIG. 1, exhibiting an inner diameter between 1/3 and 1/2 of D2, i.e. the diameter of body lumen 15 in the area of occlusion 10.
  • distal filtering extension member 240 is sized so as to meet the inner walls of lumen 15 in the area distal of occlusion 10.
  • distal filtering extension member 240 is arranged to be at the resting state for diameters of 0.25 mm - 1.5 mm larger than the inner walls of lumen 15 in the area distal of occlusion 10, thus ensuring that distal filtering extension member 240 meets the inner walls of lumen 15 and further optionally provides a securing or anchoring functionality.
  • Transition portion 230 is optionally a flared portion, and both transition portion 230 and distal filtering extension member 240 may be provided in a single integrated braid using an appropriately shaped mandrel, as described in U.S Patent S/N 7,093,527 issued August 22, 2006 to Rapaport et al, entitled “Method and Apparatus for Making Intraluminal Implants and Construction Particularly Useful in such Method and Apparatus", the entire contents of which is incorporated herein by reference.
  • distal filtering extension member 240 is arranged to trap particles greater than a predetermined size.
  • the predetermined size is 500 microns.
  • the predetermined size is 350 microns.
  • the predetermined size is 200 microns, and in yet another embodiment the predetermined size is 80 microns.
  • transition portion 230 and distal filtering extension member 240 are of a different element than that of temporary endovascular perfusion conduit 220, such as of silicon or rubber.
  • the distal portion of distal filtering extension member 240 may be open, may exhibit a filter, or be closed in the area opposing transition portion 230 without exceeding the scope.
  • the filter of distal filtering extension member 240 may be more or less permeable than the walls of temporary endovascular perfusion conduit 220 without exceeding the scope.
  • FIG. 7B illustrates a high level schematic diagram of a sectioned view of an embodiment of a temporary endovascular perfusion conduit 320 exhibiting distal filtering extension member 240 coupled to distal end 24 of self expanding device 20 via transition portion 230, and further exhibiting a proximal securing member 330 coupled to proximal end 22 of self expanding device 20 via a transition portion 340.
  • Self expanding device 20 is substantially as described above in relation to FIG. 1, exhibiting an inner diameter between 1/3 and 1/2 of D2, i.e. the diameter of body lumen 15 in the area of occlusion 10 and distal filtering extension member 240 is substantially as described above in relation to FIG. 7A.
  • Proximal securing member 330 is preferably sized so as to meet the inner walls of lumen 15 in the area proximal of occlusion 10, thus occlusion 10 is completely encased by the combination of self expanding device 20, distal filtering extension member 240 and proximal securing member 330.
  • proximal securing member 330 is arranged to be at resting state for diameters of 0.25 mm - 1.5 mm larger than the inner walls of lumen 15 in the area proximal of occlusion 10, thus ensuring that proximal securing member 330 meets the inner walls of lumen 15, thus securing particles detached from occlusion 10 to flow out therefrom, thereby avoiding harmful disruption of blood flow or occlusion of a vessel thereof, and optionally providing a securing or anchoring functionality.
  • Transition portion 340 is preferably a flared portion, and both transition portion 340 and proximal securing member 340 may be provided in a single integrated braid using an appropriately shaped mandrel, as described in U.S Patent S/N 7,093,527 incorporated above by reference.
  • FIG. 8 illustrates a high level flow chart of a method for providing temporary endovascular perfusion.
  • an expandable tubular body is provided, preferably selected so as to exhibit a small diameter state and a large diameter state.
  • the expandable tubular body exhibits a diameter in the large diameter state no more than 50% of the diameter of a target blood vessel at the sight of the occlusion.
  • the large diameter state of the expandable tubular body may exhibit a diameter of up to the at rest state diameter of the expandable tubular body.
  • the length of the expandable tubular body of stage 1000 is selected so as to be at least 14 times the inner diameter of the expandable tubular body in the large diameter state.
  • the inner diameter of the expandable tubular body of stage 1000 in the large diameter state is selected so as to be no greater than twice the diameter of the expandable tubular body of stage 1000 in the small diameter state.
  • the inner diameter of the small diameter state may not be inherent, and in an exemplary embodiment is defined by the parameters of the delivery catheter, such as catheter 40.
  • stage 1030 the expandable tubular body of stage 1000 is advanced in the small diameter state through the occlusion.
  • a distal portion or a tip of the catheter is first broached through the occlusion thereby opening and/or widening a passage therethrough, later to be occupied and sustained by the expandable tubular body, as the catheter is further advanced.
  • the expandable tubular body is manipulated through the body and advanced through the occlusion while loaded onto the distal portion of a delivery catheter, such as catheter 40.
  • stage 1040 the advanced tubular body of stage 1030 is expanded to the large diameter state, thus providing a conduit through the expanded tubular body to maintain blood flow patency through the occlusion.
  • the expansion be complete to the at rest state diameter, and the only requirement is that sufficient blood flow patency is restored by providing blood flow of at least 25% of the unoccluded blood flow volume.
  • the advanced tubular body of stage 1030 occupies the widened passage opened by the catheter that first broached through the occlusion so no additional radial force is supplied by the expanded tubular body to the occlusion, thus preventing unintended and uncontrolled break up.
  • a medicament is delivered to the occlusion.
  • the tubular body is permeable by the medicament when in the large diameter state and thus the medicament is delivered through the tubular body to the occlusion surrounding the tubular body.
  • a distal filtering extension is provided distal of the tubular body of stage 1000, the distal filtering extension being expanded to meet the blood vessel walls distal of the occlusion.
  • the distal filtering extension traps any dislodged fragments of the occlusion.
  • the tubular body is contracted, preferably to the small diameter state, and withdrawn from the blood vessel.
  • FIG. 9A illustrates a high level schematic diagram of a perspective view of an embodiment of an occlusion retrieval device 420 comprising a generally tubular inner member 425 in communication with an outer member 430, wherein generally tubular inner member 425 is illustrated without limitation as self expanding device 20 as described above
  • FIG. 9B illustrates a high level schematic diagram of a sectioned view of occlusion retrieval device 420 shown disposed within body lumen 15 at occlusion 10, FIGs. 9A and 9B being described together.
  • Occlusion retrieval device 420 is in all respects similar to self expanding device 20 of FIG.
  • outer member 430 constituted of an additional braid external to that of generally tubular inner member 425, the additional braid of outer member 430 constituted of a plurality of filaments 435.
  • outer diameter D3 of outer member 430 in an at rest state is 0.5 mm - 1.5 mm larger than diameter D2 of the inner walls of body lumen 15 in the area of occlusion 10.
  • outer diameter D3 in the at rest state is 4 mm, which is 1 mm larger than the inner walls D2 of body lumen 15
  • the pressure applied to the inner walls of body lumen 15, applied at each contact point of outer member 430 with the inner walls of body lumen 15, is at least 15,000 pascals.
  • this is at least 2.5 times greater than the local pressure applied by a standard stent for recanalization procedure and/or occlusion retrieval of the prior art, thus preferably ensuring contact between a portion of filaments 435 and the inner walls of body lumen 15.
  • Outer member 430 is in one embodiment an open braid constituted of filaments 435 and thus expands to trap within holes 440 of outer member 430 portions 470 of occlusion 10.
  • the largest open dimension of each hole 440 is about 0.9 millimeters
  • the number of holes/ cm 2 is about 80
  • the length of each filament 435 per area of outer member 430 is about 200 mm/cm 2
  • the amount of actual filament 430 surface area per surface area of the outer member 430 is about 30 mm/cm 2 .
  • the hole size is significantly smaller than the equivalent dimension of a stent for recanalization procedure and/or occlusion retrieval of the prior art, thus limiting the amount of occlusion 10 which is dislodged, and the number of holes per cm 2 is significantly greater than stents for recanalization procedure and/or occlusion retrieval of the prior art thus ensuring greater surface contact between occlusion retrieval 430 and occlusion 10.
  • the ratio of actual filament 435 surface over the total body area of outer member 430 is less than 90%. Occlusion 10 is trapped between generally tubular inner member 425 and outer member 430, and thus breakup of occlusion 10 is prevented.
  • each filament 435 of outer member 430 is constituted of a spring alloy wire material such as cobalt-chrome alloys, stainless steel, and nickel titanium alloys.
  • the diameter of each filament constituting outer member 430 is between 40 microns - 65 microns.
  • At least one filament 435 of outer member 430 is constituted of a radiopaque material such as gold, platinum, or tungsten wire that is visible under fluoroscopy.
  • a length LI of outer member 430 is between 10 mm - 20 mm less than a length L2 of self expanding device 20.
  • proximal end 432 of outer member 430 is connected to a proximal connecting portion 460 of generally tubular inner member 425 and distal end 434 of outer member 430 is connected to distal connecting portion 450 of generally tubular inner member 425.
  • outer member 430 is a self expanding device, as described above in relation to self expanding device 20. In one embodiment outer member 430 is thus retrieved responsive to the action of member 26 as described above in relation to FIGs. 1 and 2D. In another embodiment additional members similar to members 26 and 26A are provided associated with outer member 430, thereby allowing independent stretching and compressing of outer member 430.
  • Portions 470 of occlusion 10 are trapped within holes 440 of outer member 430 and are furthermore trapped between outer member 430 and generally tubular inner member 425, as an inner diameter D5 of outer member 430 in the large diameter state, i.e. when expanded within body lumen 15, is greater than outer diameter D4 of generally tubular inner member 425.
  • outer diameter D4 of generally tubular inner member 425 is no greater than the at rest state diameter of generally tubular inner member 425. Retrieval of outer member 430, preferably in combination with retrieval of generally tubular inner member 425 thus removes portions 470 of occlusion 10 from body lumen 15.
  • generally tubular inner member 425 provides and/or sustains a conduit for blood passage having a diameter for sufficient blood flow to the region distal of occlusion 10, as described above in relation to self expanding device 20.
  • Production of occlusion retrieval device 420 is in one embodiment performed by braiding generally tubular inner member 425 with additional filaments coupled to inherent structural filaments of outer member 430.
  • the additional filaments will ultimately appear only in outer member 430.
  • Proximal connecting portion 460 of generally tubular inner member 425 is braided and then additional filaments are braided over generally tubular inner member 425 to form outer member 430.
  • the filaments of generally tubular inner member 425 and the additional filaments of outer member 430 are cut to lengths L2 and LI respectively or connected together to form distal connecting portion 450.
  • proximal connecting portion 460 As generally tubular inner member 425 is braided to proximal connecting portion 460, the additional filaments of outer member 430 are removed from the braiding machine, and generally tubular inner member 425 is braided to portion 450.
  • a tube with a desired length at the at rest state of outer member 430 and an inner diameter larger than that of generally tubular inner member 425 and an outer diameter of the desired diameter at the at rest state of outer member 430 is placed over the braided portion of generally tubular inner member 425.
  • the additional filaments of proximal connecting portion 460 are then braided over the tube to a desired length, the length defined at the resting state of outer member 430, and then braided to distal connecting portion 450.
  • the additional filaments of distal connecting portion 450 are then removed, and all filaments, including the filaments of generally tubular inner member 425 and the additional filaments are cut to lengths L2 and LI respectively or connected together to form distal connecting portion 450.
  • the connection between the filaments of generally tubular inner member 425 and the additional filaments in distal connecting portion 450 can be produced by many different techniques, including but not limited to braiding, looping, tying, stitching, interweaving, gluing, welding and soldering.
  • occlusion retrieval device 420 is a braided device, however this is not meant to be limiting in any way.
  • occlusion retrieval device 420 is manufactured by any one of weaving, coiling and laser cutting.
  • FIG. 10A illustrates a high level schematic diagram of a sectioned view of an embodiment of an occlusion retrieval device 520 comprising a generally tubular inner member 525 in communication with an outer member 530.
  • generally tubular inner member 525 is in all respects similar to self expanding device 20.
  • FIG. 10A illustrates occlusion retrieval device 520 in a collapsed state, i.e. a small diameter state, and secured within catheter 40 as described above in relation to FIG. 2A.
  • FIG. 10B illustrates a high level schematic diagram of a sectioned view of an embodiment of occlusion retrieval device 520 of FIG. 10A in a partially expanded state; and FIG.
  • IOC illustrates a high level schematic diagram of a sectioned view of occlusion retrieval device 520 of FIG. 10A in a large diameter state within body lumen 15 at occlusion 10.
  • FIGs. 10A, 10B and IOC will be described together for simplicity and clarity.
  • Occlusion retrieval device 520 is in all respects similar to occlusion retrieval device 420 of FIGs. 9A, 9B, except that, in one embodiment, the distal end 534 of outer member 530 is not connected distally to generally tubular inner member 525. A proximal end 532 of outer member 530 is thus connected to a proximal end 542 of generally tubular inner member 525 via a proximal connecting portion 550. In one embodiment distal end 534 of outer member 530 is open, i.e. it does not converge to meet a distal end 524 of self expanding device 20. In another embodiment distal end 534 of outer member 530 converges to meet distal end 524 of self expanding device 20.
  • outer member 530 is in one embodiment a self expanding device.
  • deployment catheter 40 is guided by guide wire 30 into occlusion 10 and retracted, as described above in relation to FIG. 2C, thereby releasing generally tubular inner member 525 and outer member 530.
  • generally tubular inner member 525 thus self expands towards the at rest state to achieve a large diameter state, with a maximum outer diameter equal to the at rest state diameter, and outer member 530 self expands to meet the inner walls of body lumen 15.
  • members 26 and 26A are utilized for stretching and compressing of generally tubular inner member 525
  • the same members, or additional members may be utilized for stretching and compressing outer member 530, as described above in relation to FIG. 9A.
  • outer member 530 preferably meets the inner wall of body lumen 15, and occlusion 10 is secured between outer member 530 and generally tubular inner member 525.
  • patency is ensured by generally tubular inner member 525.
  • Occlusion 10 experiences a large contact area with generally tubular inner member 525 and outer member 530, since portions of occlusion 10 are in communication with each of generally tubular inner member 525 and outer member 530.
  • any break up of occlusion 10 is limited by the outer surface of generally tubular inner member 525, which in an exemplary embodiment is constituted of an open braid.
  • a meshed braid exhibiting windows allows for increased contact area with occlusion 10, since constituent portions of occlusion 10 may partially penetrate into windows of the open braid of generally tubular inner member 525.
  • FIG. 11 illustrates a high level perspective view of an embodiment of an occlusion retrieval device 620 in a large diameter state within body lumen 15, occlusion retrieval device 620 comprising a generally tubular inner member 625 in communication with an outer member 630, wherein generally tubular inner member 625 and outer member 630 are constituted of a single mesh 640.
  • Production of occlusion retrieval device 620 is in one embodiment performed by braiding filaments over a mandrel exhibiting two diameters.
  • a first portion 650 of mesh 640 is formed by braiding filaments over a small diameter mandrel to form generally tubular inner member 625 and a second portion 660 of mesh 640 is formed by braiding filaments over a larger diameter mandrel to form outer member 630.
  • a connecting portion 670, wherein first portion 650 merges into second portion 660 of mesh 640 constitutes a proximal end 622 of generally tubular inner member 625 and a proximal end 632 of outer member 630.
  • second portion 660 of mesh 640 is rolled over first portion 650 of mesh 640 at connecting portion 670 to place outer member 630 over generally tubular inner member 625, thereby at least partially enclosing generally tubular inner member 625.
  • length LI of outer member 630 is between 10 mm - 20 mm less than the length L2 of generally tubular inner member 625.
  • FIG. 12 illustrates a high level schematic diagram of a sectioned view of an embodiment of an occlusion retrieval device 720 in a partially expanded state, occlusion retrieval device 720 comprising a generally tubular inner member 725 in communication with an outer member 730.
  • generally tubular inner member 725 is constituted of self expanding device 20.
  • Generally tubular inner member 725 further exhibits a distal filtering extension member 740, coupled to distal end 724 of generally tubular inner member 725 via a transition portion 750, as described above in relation to FIG. 7A.
  • distal filtering extension 740 is arranged to expand to meet the inner walls of body lumen 15 distal of occlusion 10.
  • Outer member 730 can be realized as any of outer members 430, 530 and 630 of FIGs 9A, 9B, 10A, 10B, IOC and 11, respectively.
  • axial motion of outer member 730 may break apart a portion, or portions, of occlusion 10.
  • Distal filtering extension member 740 is arranged to trap any portions of occlusion 10 which have been broken apart by outer member 730, thus not allowing any dislodged portions of occlusion 10 to enter the blood stream distal of distal filtering extension member 740.
  • distal filtering extension member 740 encloses occlusion 10 at its distal end, thereby assuring full removal of occlusion 10 as outer member 730 is retrieved from body lumen 15.
  • FIG. 13 illustrates a high level flow chart of a method of providing occlusion retrieval.
  • an occlusion retrieval member exhibiting a generally tubular inner member and an outer member is provided.
  • the outer member exhibits an at rest state diameter greater than the inner wall of the body lumen at the target occlusion, in a process known as over sizing.
  • the outer member exhibits an at rest state diameter 0.5 mm greater than that of the inner wall of the body lumen at the site of the occlusion.
  • the outer member exhibits an at rest state diameter 0.5 mm to 1.5 mm greater than that of the inner wall of the body lumen at the site of the occlusion.
  • the generally tubular inner member exhibits an at rest state wherein the outer diameter is no more than 50% of the diameter of the small blood vessel at the occlusion location, as described above in relation to FIG. 1.
  • the generally tubular inner member when allowed to expand urges towards the at rest state diameter, achieving a large diameter state, and exhibits minimal expansive force once expanded to the at rest state diameter.
  • stage 2010 the provided occlusion retrieval member of stage 2000 is manipulated in a small diameter state through a body lumen to, and through, an occlusion of small blood vessel.
  • the small blood vessel is an intracranial blood vessel.
  • stage 2020 the generally tubular inner member is expanded to a large diameter state, thereby preferably maintaining blood flow patency there through, as described above in relation to self expanding device 20.
  • generally tubular inner member achieves, or nearly achieves, an outer diameter equal to the at rest state diameter.
  • stage 2030 the outer member is expanded to meet the inner wall of the body lumen at the occlusion site. The occlusion occluding the small blood vessel is thus at least partially contained between the outer diameter of the generally tubular inner member and the inner walls of the outer member.
  • the outer member is provided with windows, and portions of the occlusion are further trapped within the windows of the outer member.
  • a distal filtering extension is provided for the generally tubular inner member of stage 2000, the distal filtering extension arranged to meet the inner walls of the body lumen distal of the occlusion when the generally tubular inner member is in the expanded state.
  • the distal filtering extension traps any dislodged fragments of the occlusion.
  • the generally tubular inner member and outer member are connected at proximal ends thereof via a first connecting portion.
  • the generally tubular inner member and outer member are further connected at distal ends thereof thereby at least partially encasing the occlusion.
  • stage 2070 the occlusion retrieval member is withdrawn from the body lumen, preferably in the expanded state, thereby retrieving the occlusion.
  • the large surface area provided by the combination of the generally tubular inner member and outer member ensures nearly complete withdrawal of the occlusion.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un dispositif conçu pour retirer au moins partiellement une occlusion occluant un petit vaisseau sanguin, le dispositif étant constitué d'un élément interne globalement tubulaire et d'un élément externe en communication avec l'élément interne globalement tubulaire. L'élément interne globalement tubulaire est expansible jusqu'à un état de grand diamètre qui n'est rien de plus qu'un état au repos et qui représente, dans un mode de réalisation, pas plus de 50% du diamètre du petit vaisseau sanguin à l'endroit de l'occlusion. L'élément externe globalement tubulaire est expansible jusqu'à un état de grand diamètre qui est plus grand que l'état de diamètre externe au repos de l'élément interne globalement tubulaire ; et dans un mode de réalisation, l'élément externe rencontre les parois internes du petit vaisseau sanguin à l'endroit de l'occlusion. Au moins une partie de l'occlusion est contenue entre l'élément interne globalement tubulaire dans l'état de grand diamètre et l'élément externe dans l'état de grand diamètre.
PCT/IL2011/050058 2010-12-12 2011-12-12 Procédé et appareil pour l'ablation d'occlusion Ceased WO2012081020A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US42217110P 2010-12-12 2010-12-12
US61/422,171 2010-12-12

Publications (1)

Publication Number Publication Date
WO2012081020A1 true WO2012081020A1 (fr) 2012-06-21

Family

ID=45496222

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2011/050058 Ceased WO2012081020A1 (fr) 2010-12-12 2011-12-12 Procédé et appareil pour l'ablation d'occlusion

Country Status (1)

Country Link
WO (1) WO2012081020A1 (fr)

Cited By (50)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8777976B2 (en) 2008-07-22 2014-07-15 Neuravi Limited Clot capture systems and associated methods
WO2014139845A1 (fr) * 2013-03-14 2014-09-18 Neuravi Limited Dispositif de retrait d'un caillot occlusif dans un vaisseau sanguin
US8852205B2 (en) 2011-03-09 2014-10-07 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
EP2923673A4 (fr) * 2012-11-23 2016-05-11 Venus Medtech Hangzhou Inc Filtre pour caillot sanguin et procédé d'utilisation associé
US9351749B2 (en) 2010-10-22 2016-05-31 Neuravi Limited Clot engagement and removal system
US9402707B2 (en) 2008-07-22 2016-08-02 Neuravi Limited Clot capture systems and associated methods
US9433429B2 (en) 2013-03-14 2016-09-06 Neuravi Limited Clot retrieval devices
WO2017009841A1 (fr) * 2015-07-16 2017-01-19 Perflow Medical Ltd. Appareil et procédé permettant l'élimination d'occlusion de vaisseau
US9642635B2 (en) 2013-03-13 2017-05-09 Neuravi Limited Clot removal device
US10201360B2 (en) 2013-03-14 2019-02-12 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US10265086B2 (en) 2014-06-30 2019-04-23 Neuravi Limited System for removing a clot from a blood vessel
US10285720B2 (en) 2014-03-11 2019-05-14 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
US10363054B2 (en) 2014-11-26 2019-07-30 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US10441301B2 (en) 2014-06-13 2019-10-15 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US10617435B2 (en) 2014-11-26 2020-04-14 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US10792056B2 (en) 2014-06-13 2020-10-06 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US10842498B2 (en) 2018-09-13 2020-11-24 Neuravi Limited Systems and methods of restoring perfusion to a vessel
US11147572B2 (en) 2016-09-06 2021-10-19 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US11253278B2 (en) 2014-11-26 2022-02-22 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
US11259824B2 (en) 2011-03-09 2022-03-01 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US11311304B2 (en) 2019-03-04 2022-04-26 Neuravi Limited Actuated clot retrieval catheter
US11395667B2 (en) 2016-08-17 2022-07-26 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
US11395669B2 (en) 2020-06-23 2022-07-26 Neuravi Limited Clot retrieval device with flexible collapsible frame
US11406416B2 (en) 2018-10-02 2022-08-09 Neuravi Limited Joint assembly for vasculature obstruction capture device
US11439418B2 (en) 2020-06-23 2022-09-13 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US11517340B2 (en) 2019-12-03 2022-12-06 Neuravi Limited Stentriever devices for removing an occlusive clot from a vessel and methods thereof
US11529495B2 (en) 2019-09-11 2022-12-20 Neuravi Limited Expandable mouth catheter
US11633198B2 (en) 2020-03-05 2023-04-25 Neuravi Limited Catheter proximal joint
US11712231B2 (en) 2019-10-29 2023-08-01 Neuravi Limited Proximal locking assembly design for dual stent mechanical thrombectomy device
US11717308B2 (en) 2020-04-17 2023-08-08 Neuravi Limited Clot retrieval device for removing heterogeneous clots from a blood vessel
US11730501B2 (en) 2020-04-17 2023-08-22 Neuravi Limited Floating clot retrieval device for removing clots from a blood vessel
US11737771B2 (en) 2020-06-18 2023-08-29 Neuravi Limited Dual channel thrombectomy device
US11759217B2 (en) 2020-04-07 2023-09-19 Neuravi Limited Catheter tubular support
US11779364B2 (en) 2019-11-27 2023-10-10 Neuravi Limited Actuated expandable mouth thrombectomy catheter
US11839725B2 (en) 2019-11-27 2023-12-12 Neuravi Limited Clot retrieval device with outer sheath and inner catheter
US11864781B2 (en) 2020-09-23 2024-01-09 Neuravi Limited Rotating frame thrombectomy device
US11871946B2 (en) 2020-04-17 2024-01-16 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US11872354B2 (en) 2021-02-24 2024-01-16 Neuravi Limited Flexible catheter shaft frame with seam
US11883043B2 (en) 2020-03-31 2024-01-30 DePuy Synthes Products, Inc. Catheter funnel extension
US11937839B2 (en) 2021-09-28 2024-03-26 Neuravi Limited Catheter with electrically actuated expandable mouth
US11937837B2 (en) 2020-12-29 2024-03-26 Neuravi Limited Fibrin rich / soft clot mechanical thrombectomy device
US11937836B2 (en) 2020-06-22 2024-03-26 Neuravi Limited Clot retrieval system with expandable clot engaging framework
US11944327B2 (en) 2020-03-05 2024-04-02 Neuravi Limited Expandable mouth aspirating clot retrieval catheter
US11974764B2 (en) 2021-06-04 2024-05-07 Neuravi Limited Self-orienting rotating stentriever pinching cells
US12011186B2 (en) 2021-10-28 2024-06-18 Neuravi Limited Bevel tip expandable mouth catheter with reinforcing ring
US12029442B2 (en) 2021-01-14 2024-07-09 Neuravi Limited Systems and methods for a dual elongated member clot retrieval apparatus
EP4181793A4 (fr) * 2020-07-17 2024-07-31 Squadra Lifesciences, Inc Systèmes et procédés de piégeage et/ou d'élimination de caillots pour obtenir une restauration de flux sanguin dans un vaisseau
US12064130B2 (en) 2021-03-18 2024-08-20 Neuravi Limited Vascular obstruction retrieval device having sliding cages pinch mechanism
US12076037B2 (en) 2011-03-09 2024-09-03 Neuravi Limited Systems and methods to restore perfusion to a vessel
US12502189B2 (en) 2024-04-23 2025-12-23 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040254633A1 (en) * 2003-06-10 2004-12-16 Avraham Rapaport Method and apparatus for making intraluminal implants and construction particularly useful in such method and apparatus
US20050059993A1 (en) * 2003-09-17 2005-03-17 Kamal Ramzipoor Embolectomy device
WO2007089897A2 (fr) * 2006-02-01 2007-08-09 The Cleveland Clinic Foundation procede et appareil d'amelioration de la circulation sanguine dans un vaisseau obstrue
US20070208371A1 (en) * 2000-06-29 2007-09-06 Concentric Medical, Inc. Devices and methods for removing obstructions from a patient and methods for making obstruction removing devices
EP1832240A2 (fr) * 2006-03-06 2007-09-12 Terumo Kabushiki Kaisha Cathéter d'athérectomie
US20090292307A1 (en) * 2008-05-22 2009-11-26 Nasser Razack Mechanical embolectomy device and method
WO2010146581A1 (fr) * 2009-06-15 2010-12-23 Perflow Medical Ltd. Procédé et appareil pour permettre un écoulement de sang à travers un vaisseau obstrué

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070208371A1 (en) * 2000-06-29 2007-09-06 Concentric Medical, Inc. Devices and methods for removing obstructions from a patient and methods for making obstruction removing devices
US20040254633A1 (en) * 2003-06-10 2004-12-16 Avraham Rapaport Method and apparatus for making intraluminal implants and construction particularly useful in such method and apparatus
US7093527B2 (en) 2003-06-10 2006-08-22 Surpass Medical Ltd. Method and apparatus for making intraluminal implants and construction particularly useful in such method and apparatus
US20050059993A1 (en) * 2003-09-17 2005-03-17 Kamal Ramzipoor Embolectomy device
WO2007089897A2 (fr) * 2006-02-01 2007-08-09 The Cleveland Clinic Foundation procede et appareil d'amelioration de la circulation sanguine dans un vaisseau obstrue
EP1832240A2 (fr) * 2006-03-06 2007-09-12 Terumo Kabushiki Kaisha Cathéter d'athérectomie
US20090292307A1 (en) * 2008-05-22 2009-11-26 Nasser Razack Mechanical embolectomy device and method
WO2010146581A1 (fr) * 2009-06-15 2010-12-23 Perflow Medical Ltd. Procédé et appareil pour permettre un écoulement de sang à travers un vaisseau obstrué

Cited By (108)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10582939B2 (en) 2008-07-22 2020-03-10 Neuravi Limited Clot capture systems and associated methods
US9402707B2 (en) 2008-07-22 2016-08-02 Neuravi Limited Clot capture systems and associated methods
US11529157B2 (en) 2008-07-22 2022-12-20 Neuravi Limited Clot capture systems and associated methods
US8777976B2 (en) 2008-07-22 2014-07-15 Neuravi Limited Clot capture systems and associated methods
US9463036B2 (en) 2010-10-22 2016-10-11 Neuravi Limited Clot engagement and removal system
US11871949B2 (en) 2010-10-22 2024-01-16 Neuravi Limited Clot engagement and removal system
US10292723B2 (en) 2010-10-22 2019-05-21 Neuravi Limited Clot engagement and removal system
US11246612B2 (en) 2010-10-22 2022-02-15 Neuravi Limited Clot engagement and removal system
US12471941B2 (en) 2010-10-22 2025-11-18 Neuravi Limited Clot engagement and removal system
US9351749B2 (en) 2010-10-22 2016-05-31 Neuravi Limited Clot engagement and removal system
US10034680B2 (en) 2011-03-09 2018-07-31 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US10299811B2 (en) 2011-03-09 2019-05-28 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US9642639B2 (en) 2011-03-09 2017-05-09 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US8852205B2 (en) 2011-03-09 2014-10-07 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US10588649B2 (en) 2011-03-09 2020-03-17 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US10743894B2 (en) 2011-03-09 2020-08-18 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US12059164B2 (en) 2011-03-09 2024-08-13 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US11998223B2 (en) 2011-03-09 2024-06-04 Neuravi Limited Clot retrieval device for removing a clot from a blood vessel
US11259824B2 (en) 2011-03-09 2022-03-01 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US12076037B2 (en) 2011-03-09 2024-09-03 Neuravi Limited Systems and methods to restore perfusion to a vessel
US10952760B2 (en) 2011-03-09 2021-03-23 Neuravi Limited Clot retrieval device for removing a clot from a blood vessel
US10292722B2 (en) 2011-03-09 2019-05-21 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US9301769B2 (en) 2011-03-09 2016-04-05 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
EP2923673A4 (fr) * 2012-11-23 2016-05-11 Venus Medtech Hangzhou Inc Filtre pour caillot sanguin et procédé d'utilisation associé
US10792055B2 (en) 2013-03-13 2020-10-06 Neuravi Limited Clot removal device
US10080575B2 (en) 2013-03-13 2018-09-25 Neuravi Limited Clot removal device
US10517622B2 (en) 2013-03-13 2019-12-31 Neuravi Limited Clot removal device
US9642635B2 (en) 2013-03-13 2017-05-09 Neuravi Limited Clot removal device
US10201360B2 (en) 2013-03-14 2019-02-12 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US9433429B2 (en) 2013-03-14 2016-09-06 Neuravi Limited Clot retrieval devices
US10420570B2 (en) 2013-03-14 2019-09-24 Neuravi Limited Clot retrieval devices
US10390850B2 (en) 2013-03-14 2019-08-27 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US10588648B2 (en) 2013-03-14 2020-03-17 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
WO2014139845A1 (fr) * 2013-03-14 2014-09-18 Neuravi Limited Dispositif de retrait d'un caillot occlusif dans un vaisseau sanguin
US11871945B2 (en) 2013-03-14 2024-01-16 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US10610246B2 (en) 2013-03-14 2020-04-07 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US11937835B2 (en) 2013-03-14 2024-03-26 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US10675045B2 (en) 2013-03-14 2020-06-09 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
JP2018196762A (ja) * 2013-03-14 2018-12-13 ニューラヴィ・リミテッド 血管から閉塞血餅を除去するための血餅回収デバイス
US12402902B2 (en) 2013-03-14 2025-09-02 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
JP2020127771A (ja) * 2013-03-14 2020-08-27 ニューラヴィ・リミテッド 血管から閉塞血餅を除去するための血餅回収デバイス
US10357265B2 (en) 2013-03-14 2019-07-23 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US9445829B2 (en) 2013-03-14 2016-09-20 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US11839392B2 (en) 2013-03-14 2023-12-12 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US10278717B2 (en) 2013-03-14 2019-05-07 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US11547427B2 (en) 2013-03-14 2023-01-10 Neuravi Limited Clot retrieval devices
US11103264B2 (en) 2013-03-14 2021-08-31 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
JP2016513505A (ja) * 2013-03-14 2016-05-16 ニューラヴィ・リミテッド 血管から閉塞血餅を除去するための血餅回収デバイス
US10285720B2 (en) 2014-03-11 2019-05-14 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
US11484328B2 (en) 2014-03-11 2022-11-01 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
US11446045B2 (en) 2014-06-13 2022-09-20 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US10792056B2 (en) 2014-06-13 2020-10-06 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US10441301B2 (en) 2014-06-13 2019-10-15 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US10682152B2 (en) 2014-06-13 2020-06-16 Neuravi Limited Devices and methods for removal of acute blockages from blood vessels
US11076876B2 (en) 2014-06-30 2021-08-03 Neuravi Limited System for removing a clot from a blood vessel
US10265086B2 (en) 2014-06-30 2019-04-23 Neuravi Limited System for removing a clot from a blood vessel
US11944333B2 (en) 2014-06-30 2024-04-02 Neuravi Limited System for removing a clot from a blood vessel
US10363054B2 (en) 2014-11-26 2019-07-30 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US11712256B2 (en) 2014-11-26 2023-08-01 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US11857210B2 (en) 2014-11-26 2024-01-02 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US10617435B2 (en) 2014-11-26 2020-04-14 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US11253278B2 (en) 2014-11-26 2022-02-22 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
US11980379B2 (en) 2014-11-26 2024-05-14 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
US11129631B2 (en) 2015-07-16 2021-09-28 Perflow Medical Ltd. Apparatus and method for vessel occlusion removal
EP3622907A1 (fr) * 2015-07-16 2020-03-18 Perflow Medical Ltd. Appareil permettant l'élimination d'occlusion de vaisseau
US10376274B2 (en) 2015-07-16 2019-08-13 Perflow Medical Ltd. Apparatus and method for vessel occlusion removal
WO2017009841A1 (fr) * 2015-07-16 2017-01-19 Perflow Medical Ltd. Appareil et procédé permettant l'élimination d'occlusion de vaisseau
US11395667B2 (en) 2016-08-17 2022-07-26 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
US12133657B2 (en) 2016-09-06 2024-11-05 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US11147572B2 (en) 2016-09-06 2021-10-19 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US10842498B2 (en) 2018-09-13 2020-11-24 Neuravi Limited Systems and methods of restoring perfusion to a vessel
US11406416B2 (en) 2018-10-02 2022-08-09 Neuravi Limited Joint assembly for vasculature obstruction capture device
US11963693B2 (en) 2018-10-02 2024-04-23 Neuravi Limited Joint assembly for vasculature obstruction capture device
US11311304B2 (en) 2019-03-04 2022-04-26 Neuravi Limited Actuated clot retrieval catheter
US11969180B2 (en) 2019-03-04 2024-04-30 Neuravi Limited Actuated clot retrieval catheter
US11529495B2 (en) 2019-09-11 2022-12-20 Neuravi Limited Expandable mouth catheter
US12029864B2 (en) 2019-09-11 2024-07-09 Neuravi Limited Expandable mouth catheter
US12004731B2 (en) 2019-10-29 2024-06-11 Neuravi Limited Proximal locking assembly design for dual stent mechanical thrombectomy device
US11712231B2 (en) 2019-10-29 2023-08-01 Neuravi Limited Proximal locking assembly design for dual stent mechanical thrombectomy device
US11839725B2 (en) 2019-11-27 2023-12-12 Neuravi Limited Clot retrieval device with outer sheath and inner catheter
US11779364B2 (en) 2019-11-27 2023-10-10 Neuravi Limited Actuated expandable mouth thrombectomy catheter
US12023058B2 (en) 2019-12-03 2024-07-02 Neuravi Limited Stentriever devices for removing an occlusive clot from a vessel and methods thereof
US11517340B2 (en) 2019-12-03 2022-12-06 Neuravi Limited Stentriever devices for removing an occlusive clot from a vessel and methods thereof
US11633198B2 (en) 2020-03-05 2023-04-25 Neuravi Limited Catheter proximal joint
US11944327B2 (en) 2020-03-05 2024-04-02 Neuravi Limited Expandable mouth aspirating clot retrieval catheter
US11883043B2 (en) 2020-03-31 2024-01-30 DePuy Synthes Products, Inc. Catheter funnel extension
US11759217B2 (en) 2020-04-07 2023-09-19 Neuravi Limited Catheter tubular support
US12048446B2 (en) 2020-04-17 2024-07-30 Neuravi Limited Clot retrieval device for removing heterogeneous clots from a blood vessel
US11871946B2 (en) 2020-04-17 2024-01-16 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US11717308B2 (en) 2020-04-17 2023-08-08 Neuravi Limited Clot retrieval device for removing heterogeneous clots from a blood vessel
US11730501B2 (en) 2020-04-17 2023-08-22 Neuravi Limited Floating clot retrieval device for removing clots from a blood vessel
US12446908B2 (en) 2020-04-17 2025-10-21 Neuravi Limited Floating clot retrieval device for removing clots from a blood vessel
US11737771B2 (en) 2020-06-18 2023-08-29 Neuravi Limited Dual channel thrombectomy device
US12213691B2 (en) 2020-06-18 2025-02-04 Neuravi Limited Dual channel thrombectomy device
US11937836B2 (en) 2020-06-22 2024-03-26 Neuravi Limited Clot retrieval system with expandable clot engaging framework
US12419657B2 (en) 2020-06-23 2025-09-23 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
US11395669B2 (en) 2020-06-23 2022-07-26 Neuravi Limited Clot retrieval device with flexible collapsible frame
US11439418B2 (en) 2020-06-23 2022-09-13 Neuravi Limited Clot retrieval device for removing clot from a blood vessel
EP4181793A4 (fr) * 2020-07-17 2024-07-31 Squadra Lifesciences, Inc Systèmes et procédés de piégeage et/ou d'élimination de caillots pour obtenir une restauration de flux sanguin dans un vaisseau
US11864781B2 (en) 2020-09-23 2024-01-09 Neuravi Limited Rotating frame thrombectomy device
US11937837B2 (en) 2020-12-29 2024-03-26 Neuravi Limited Fibrin rich / soft clot mechanical thrombectomy device
US12029442B2 (en) 2021-01-14 2024-07-09 Neuravi Limited Systems and methods for a dual elongated member clot retrieval apparatus
US11872354B2 (en) 2021-02-24 2024-01-16 Neuravi Limited Flexible catheter shaft frame with seam
US12064130B2 (en) 2021-03-18 2024-08-20 Neuravi Limited Vascular obstruction retrieval device having sliding cages pinch mechanism
US11974764B2 (en) 2021-06-04 2024-05-07 Neuravi Limited Self-orienting rotating stentriever pinching cells
US11937839B2 (en) 2021-09-28 2024-03-26 Neuravi Limited Catheter with electrically actuated expandable mouth
US12011186B2 (en) 2021-10-28 2024-06-18 Neuravi Limited Bevel tip expandable mouth catheter with reinforcing ring
US12502189B2 (en) 2024-04-23 2025-12-23 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel

Similar Documents

Publication Publication Date Title
US11179253B2 (en) Method and apparatus for allowing blood flow through an occluded vessel
WO2012081020A1 (fr) Procédé et appareil pour l'ablation d'occlusion
CN111246811B (zh) 治疗血管闭塞的装置及方法
AU2016273879B2 (en) Devices and systems for thrombus treatment
US8486104B2 (en) Mechanical clot treatment device with distal filter
US9931495B2 (en) Devices and methods for vascular recanalization
US8568465B2 (en) Device for rechanneling a cavity, organ path or vessel
US11141178B2 (en) Systems, devices, and methods for obstruction retrieval and treatment
JP2011516183A (ja) 多効用マイクロカテーテルシステムおよび使用方法
CN115919412A (zh) 血管取栓装置
CN119587230A (zh) 一种支架植入系统
US20240358385A1 (en) Devices, systems, and methods for retrieval of material from vessel lumens
JP2020533049A (ja) カテーテル

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 11808948

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205N DATED 22/08/2013)

122 Ep: pct application non-entry in european phase

Ref document number: 11808948

Country of ref document: EP

Kind code of ref document: A1