US20140276403A1 - Ischemic stroke device - Google Patents
Ischemic stroke deviceDownload PDFInfo
- Publication number
- US20140276403A1 US20140276403A1US13/801,979US201313801979AUS2014276403A1US 20140276403 A1US20140276403 A1US 20140276403A1US 201313801979 AUS201313801979 AUS 201313801979AUS 2014276403 A1US2014276403 A1US 2014276403A1
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- Prior art keywords
- expandable member
- obstruction
- proximal
- interstices
- distal
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Links
- 208000032382Ischaemic strokeDiseases0.000titleclaimsabstractdescription9
- 210000004204blood vesselAnatomy0.000claimsdescription23
- 239000012634fragmentSubstances0.000claimsdescription13
- 230000017531blood circulationEffects0.000claimsdescription6
- 239000008177pharmaceutical agentSubstances0.000claimsdescription6
- 239000000463materialSubstances0.000claimsdescription5
- 210000005166vasculatureAnatomy0.000abstractdescription11
- 238000013151thrombectomyMethods0.000description14
- 238000000034methodMethods0.000description12
- 238000010586diagramMethods0.000description4
- 230000002792vascularEffects0.000description3
- 210000001367arteryAnatomy0.000description2
- 210000000601blood cellAnatomy0.000description2
- 208000007536ThrombosisDiseases0.000description1
- 239000000853adhesiveSubstances0.000description1
- 230000001070adhesive effectEffects0.000description1
- 230000003073embolic effectEffects0.000description1
- 238000013467fragmentationMethods0.000description1
- 238000006062fragmentation reactionMethods0.000description1
- 230000000977initiatory effectEffects0.000description1
- 238000012986modificationMethods0.000description1
- 230000004048modificationEffects0.000description1
- 229910001000nickel titaniumInorganic materials0.000description1
- 230000000717retained effectEffects0.000description1
- 238000005476solderingMethods0.000description1
Images
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
- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
- A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping 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
- A61B17/221—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
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
- A61B2017/22084—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
Definitions
- the present inventionrelates to an apparatus and method for increasing blood flow through an obstructed blood vessel and, more particularly relates to an apparatus and method for removal of at least a portion of an obstruction such as a clot from an obstructed blood vessel for treatment of ischemic stroke.
- a common treatment for ischemic strokeis the use of a thrombectomy device to physically remove an obstruction such as a blood clot from the affected artery.
- a thrombectomy devicetypically is advanced through a microcatheter into the vasculature, and is deployed into an obstruction or clot in the vasculature by pulling back on the microcatheter, allowing the thrombectomy device to capture at least a portion of the obstruction or clot, and the thrombectomy device is then retrieved by withdrawing the thrombectomy device into a catheter such as a guide catheter or an intermediate catheter.
- a balloon guide catheter or aspiration cathetermay be used. Aspiration is performed by attaching a syringe to a proximal end of the guide catheter and pulling a vacuum in the syringe, while simultaneously pulling the retrieving the thrombectomy device and the captured portion of the obstruction or clot into the guide catheter.
- a balloon guidemay be inflated just prior to retrieval of the thrombectomy device and the captured portion of the obstruction or clot in order to arrest blood flow. The thrombectomy device with the captured portion of the obstruction or clot is then pulled back into the balloon guide catheter.
- One embolic protection deviceincludes inner and outer tubular members and a flexible everting filter portion that is attached at one end to a distal end of the inner tubular member, and that is attached at a second end to a distal end of the outer tubular member, so that the inner and outer tubular members are movable relative to one another to position the filter portion within the body vessel.
- the filter portionis movable from a collapsed, everted configuration to an expanded, generally non-everted deployed configuration.
- the filter portionexpands radially outward to engage the filter body with an enclosing vessel wall, and also allows the passage of blood cells, while preventing the passage of captured emboli or thrombi through the filter portion.
- Another similar invertible filterincludes a guiding member configured to slidably engage a tubular filter portion that extends distally from the guiding member and is configured to evert to form a concave shape for capturing emboli, while allowing blood cells to pass through the filter portion.
- Another type of device for treating a vascular conditionincludes a graft, and first and second support members such as stents attached to distal and proximal regions of the graft.
- the first and second stentsare deployed distally and proximally of a vascular condition, and the graft can be everted to form a pocket to trap emboli during treatment of the vascular condition.
- Another deviceincludes a capturing section configured that can be inverted within a translating section by proximal movement of a leading wire when an open proximal end of the translating section engages resistance, and the size of the capturing section is reduced to enable the capturing section to re-enter a catheter.
- Another device for increasing blood flow through an obstructed blood vesselincludes an expandable member that is positioned within a blood vessel and radially adjacent to at least a portion of an obstruction, and that is expanded to bring at least a portion of the expandable member into contact with the obstruction.
- the expandable memberis made of a mesh having a plurality of interstices that allow one or more fragments of the obstruction to pass into and be retained within the expandable member when an outward radial force is exerted on the obstruction by the expandable member.
- the present inventionmeets these and other needs.
- the present inventionprovides for an apparatus and method for removal of at least a portion of an obstruction such as a clot from an obstructed blood vessel for treatment of a condition of a patient's vasculature such as ischemic stroke.
- the apparatus and method of the inventionhelps to reduce the risk of losing one or more pieces of an obstruction such as a clot during a thrombectomy procedure by providing a first or proximal expandable member that functions as a cover element that can evert to enfold and enclose a second or distal expandable member used to secure the obstruction or clot prior to pulling the secured obstruction or clot into a catheter for removal from the patient's vasculature.
- the first or proximal expandable membercovers over not only the captured obstruction or clot, but also portions of the obstruction or clot which may be only partially captured, such as a portion of the obstruction stuck to or extending from the outside of the second or distal expandable member, to help to prevent the clot from being scraped off when the clot is pulled into a catheter.
- the close proximity of the first and second expandable membersalso allows the captured obstruction or clot to be covered almost immediately, which also can help to reduce the possibility of fragmentation of the obstruction or clot.
- a telescoping support member connected to the first or proximal expandable memberalso allows a user to initiate the process of causing the first or proximal expandable member to evert to enfold and enclose the second or distal expandable member used to secure the obstruction or clot.
- the present inventionaccordingly provides for an apparatus and method for removal of at least a portion of an obstruction from an obstructed blood vessel for treatment of ischemic stroke.
- the apparatusincludes a telescoping support member, a first or proximal expandable member connected to the telescoping support member, and a second or distal expandable member connected to the first or proximal expandable member.
- the telescoping support memberincludes an outer tubular shaft and an inner elongate member that extends through and is slidable within the outer tubular shaft.
- the first or proximal expandable memberhas a proximal end that is attached to a distal end of the outer tubular shaft of the telescoping support member, and a distal end of the first or proximal expandable member is attached to a distal portion of the inner elongate member.
- the first or proximal expandable memberpreferably has a radially compressed configuration and a radially expanded configuration, as well as a longitudinally extended configuration with proximal and distal ends of the first or proximal expandable member disposed at opposing ends of the first or proximal expandable member, and an everted configuration with the distal end of the first or proximal expandable member withdrawn within the tubular body of the first or proximal expandable member and adjacent to the proximal end of the first or proximal expandable member.
- the second or distal expandable memberpreferably has a closed distal end and a closed proximal end, and a tubular mesh body extending between the proximal and distal ends of the second or distal expandable member, and is configured to be deployed into an obstruction within the blood vessel.
- the closed proximal end of the second or distal expandable memberpreferably also is permanently joined to the distal end of the inner elongate member of the telescoping support member.
- the second or distal expandable memberalso preferably has a radially compressed configuration and a radially expanded configuration, and the tubular mesh body of the second or distal expandable member preferably is configured to radially expand into contact with at least a portion of the obstruction or clot such that a portion of the obstruction or clot is dislodged to enhance blood flow through the blood vessel.
- the tubular mesh bodyincludes a plurality of interstices, at least a portion of which are adapted to allow passage of at least one dislodged portion of the obstruction therethrough in a radial direction into the tubular mesh body.
- the tubular body of the first or proximal expandable memberincludes a plurality strands defining a plurality of interstices therebetween.
- the tubular body of the first or proximal expandable memberincludes a radiopaque band permanently attached to the distal end of the first or proximal expandable member.
- the tubular mesh body of the second or distal expandable membercomprises a plurality of strands, and the plurality of strands may form first and second meshes.
- each of the plurality of strandsis oriented in at least one of a helical, longitudinal, and radial direction with respect to the tubular mesh body.
- the second or distal expandable memberis at least partially constructed of a self-expanding material, and the second or distal expandable member is configured to dislodge the obstruction by fracturing a portion of the obstruction or by extruding a portion of the obstruction.
- the second or distal expandable memberincludes at least one radiopaque portion.
- the second or distal expandable memberis at least partially adapted to elute a pharmaceutical agent.
- the pharmaceutical agentis adapted to at least partially lyse the at least one fragment.
- the tubular mesh body of the second or distal expandable memberincludes a distal portion and a proximal portion, the distal portion of the tubular mesh body being formed of a first mesh, and the proximal portion of the tubular mesh body being made of a second mesh having a plurality of second interstices, at least one of the second interstices being adapted to selectively allow passage of at least one fragment therethrough.
- the first meshis formed integrally with the second mesh.
- at least one of the first intersticesis defined by a plurality of first strands, and at least one of the plurality of first strands is adapted to penetrate into the obstruction to longitudinally separate the at least one fragment from a remaining portion of the obstruction.
- At least one of the second intersticesis defined by a plurality of second strands, at least one of the plurality of second strands is adapted to break the at least one fragment into a plurality of subfragments, and at least one of the second interstices is adapted to selectively allow passage therethrough of at least one subfragment to release the at least one subfragment from the second or distal expandable member.
- at least one of the plurality of second intersticesis smaller than at least one of the plurality of first interstices.
- a size of at least one of the plurality of second intersticesis chosen on the basis of an allowable particulate size of the blood vessel.
- the tubular mesh body of the second or distal expandable memberis configured to compress at least a portion of the obstruction against a vessel wall of the blood vessel.
- movement of the inner elongate member in a proximal direction relative to the outer tubular shaft of the telescoping support membermoves the first or proximal expandable member between the longitudinally extended configuration and the everted configuration such that the first or proximal expandable member covers, enfolds or envelopes the second or distal expandable member.
- FIG. 1is an elevational, schematic diagram of the apparatus of the invention disposed within a patient's vasculature, showing the first and second expandable members in radially expanded configurations within the vasculature, with an obstruction or clot captured within the second or distal expandable member, according to the invention.
- FIG. 2is an elevational, schematic diagram similar to FIG. 1 , showing the first or proximal expandable member beginning to evert to enfold and cover the second or distal expandable member as the second or distal expandable member is drawn into the first or proximal expandable member.
- FIG. 3is an elevational, schematic diagram similar to FIG. 2 , showing the first or proximal expandable member everted to enfold and cover the second or distal expandable member, which has been drawn into the first or proximal expandable member.
- FIG. 4is an enlarged cross-sectional view similar to FIG. 3 .
- FIG. 5is an elevational, schematic diagram similar to FIG. 3 , showing the first and second expandable members with the captured obstruction or clot being retrieved and withdrawn into a catheter.
- the present inventionprovides for an apparatus 10 having a proximal end 12 and a distal end 14 , for removal of at least a portion of an obstruction 16 , such as a clot, for example, from an obstructed blood vessel in a patient's vasculature 18 , such as for treatment of ischemic stroke, for example.
- an obstruction 16such as a clot, for example, from an obstructed blood vessel in a patient's vasculature 18 , such as for treatment of ischemic stroke, for example.
- the apparatusincludes a telescoping support member 20 , including an outer tubular shaft 22 having a distal end 24 , and an inner elongate member or core advancement wire 26 having a distal end 28 and a proximal portion 30 , and extending through the outer tubular shaft and slidable within the outer tubular shaft.
- the apparatusalso includes a first, proximal expandable member or cover element 32 having a proximal end 34 and a distal end 36 , and a tubular body 38 extending between the proximal and distal ends of the first or proximal expandable member.
- the proximal end of the first or proximal expandable memberis preferably permanently attached to the distal end of the outer tubular shaft of the telescoping support member, and the distal end of the first or proximal expandable member is preferably permanently attached to a distal portion 40 of the inner elongate member or core advancement wire.
- the first or proximal expandable memberhas a radially expanded configuration configured to engage the inner surface of a blood vessel in the patient's vasculature, as shown in FIGS. 1-4 , and a radially compressed configuration, such as when the first or proximal expandable member is disposed within and constrained by an introducer or delivery catheter 42 having an inner lumen (not shown).
- the first or proximal expandable memberpreferably is dimensioned to fit within the inner lumen of the catheter in the radially compressed configuration, and is configured to be constrained from expanding when the first or proximal expandable member is contained within the catheter.
- the first or proximal expandable memberin the radially expanded configuration, preferably also has a longitudinally extended configuration with the proximal and distal ends of the first or proximal expandable member disposed at opposing ends of the first or proximal expandable member, and an everted configuration, best shown fully in FIG. 4 , with the distal end of the first or proximal expandable member withdrawn within the tubular body of the first or proximal expandable member adjacent to the proximal end of the first or proximal expandable member.
- the tubular body of the first or proximal expandable memberpreferably includes a plurality strands of material 48 forming a proximal braided portion of the apparatus, defining a plurality of interstices 50 therebetween.
- the first or proximal expandable memberalso preferably includes at least one radiopaque portion, such as a radiopaque band 52 that is permanently attached to the distal end of the first or proximal expandable member.
- the apparatusalso includes a second, distal expandable member 54 at the distal end of the apparatus, that is configured to be deployed into an obstruction or clot within the blood vessel in the patient's vasculature.
- the second or distal expandable memberpreferably includes a closed distal end 56 a closed proximal end 58 , and a tubular mesh body 60 extending between the proximal and distal ends of the second or distal expandable member.
- the closed proximal end of the second or distal expandable memberpreferably is permanently joined to the distal end of the inner elongate member of the telescoping support member, such as by soldering, for example, although the second or distal expandable member may alternatively be permanently joined to the distal end of the inner elongate member of the telescoping support member by other similar suitable means, such as by adhesive or by heat shrinkable tubing, or combinations thereof, for example.
- the tubular mesh body of the second, distal expandable memberpreferably is configured to radially expand into contact with at least a portion of the obstruction or clot in the blood vessel, such that a portion of the obstruction is dislodged to enhance blood flow through the blood vessel.
- the tubular mesh bodypreferably includes a plurality of interstices 62 , and at least a portion of the interstices preferably are configured to allow passage of at least one dislodged portion of the obstruction therethrough in a radial direction into the tubular mesh body.
- the tubular mesh bodycan be formed to include a plurality of strands 63 forming first and second meshes, wherein each of the strands may be oriented in at least one of a helical, longitudinal, and radial direction with respect to the tubular mesh body.
- the second or distal expandable memberis configured to dislodge the obstruction or clot by fracturing a portion of the obstruction, by extruding a portion of the obstruction, or a combination thereof.
- the second or distal expandable memberis at least partially constructed of a superelastic and/or self-expanding material, such as a nickel-titanium alloy which has been memory-shaped into an expanded condition and is compressed into a collapsed condition before use.
- the second or distal expandable memberis constrained in the compressed condition by the introducer or delivery catheter, and preferably self-expands into the expanded condition upon removal from the introducer or delivery catheter.
- the second or distal expandable membermay also include one or more radiopaque portions, such as one or more additional radiopaque bands, for example.
- the second or distal expandable memberis at least partially adapted to elute a pharmaceutical agent, such as a pharmaceutical agent designed to at least partially lyse the obstruction or fragment of the obstruction.
- the tubular mesh bodymay include a first mesh in a distal portion of the tubular mesh body having a plurality of first interstices, and a second mesh in a proximal portion of the tubular mesh body being made of having a plurality of second interstices, with at least one of the second interstices being configured to selectively allow passage of at least one fragment therethrough.
- the first meshcan be formed integrally with the second mesh, for example.
- At least one of the first intersticesmay be defined by a plurality of first strands, in which case at least one of the plurality of first strands may be adapted to penetrate into the obstruction to longitudinally separate the at least one fragment from a remaining portion of the obstruction.
- At least one of the second intersticesmay be defined by a plurality of second strands, in which case at least one of the plurality of second strands may be adapted to break one or more fragments of the obstruction or clot into a plurality of subfragments, and at least one of the second interstices may be adapted to selectively allow passage of at least one subfragment therethrough to be released from the second or distal expandable member.
- one or more of the plurality of second intersticescan be smaller than one or more of the plurality of first interstices, and the size of one or more of the plurality of second interstices may be chosen on the basis of an allowable particulate size of the blood vessel.
- the tubular mesh bodymay also be configured to compress at least a portion of the obstruction against a vessel wall of the blood vessel
- the proximal braided portionstarts to evert, initiating covering the distal element, much like pulling a sock over a foot, so that movement of the inner elongate member in a proximal direction relative to the outer tubular shaft of the telescoping support member moves the first or proximal expandable member between the longitudinally extended configuration and the everted configuration, so that the first or proximal expandable member covers, envelopes or enfolds the second or distal expandable member as shown in FIG.
- any of the obstruction that may be only partially captured in the second or distal expandable membersuch as a portion of the obstruction stuck to or extending from the outside of the second or distal expandable member, for example, so that the second or distal expandable member and captured obstruction material can be withdrawn and retrieved into a catheter, as is illustrated in FIG. 5 .
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Abstract
Description
- The present invention relates to an apparatus and method for increasing blood flow through an obstructed blood vessel and, more particularly relates to an apparatus and method for removal of at least a portion of an obstruction such as a clot from an obstructed blood vessel for treatment of ischemic stroke.
- A common treatment for ischemic stroke is the use of a thrombectomy device to physically remove an obstruction such as a blood clot from the affected artery. One such thrombectomy device typically is advanced through a microcatheter into the vasculature, and is deployed into an obstruction or clot in the vasculature by pulling back on the microcatheter, allowing the thrombectomy device to capture at least a portion of the obstruction or clot, and the thrombectomy device is then retrieved by withdrawing the thrombectomy device into a catheter such as a guide catheter or an intermediate catheter. To prevent the loss of the captured portion of the obstruction or clot when the thrombectomy device is being retrieved, a balloon guide catheter or aspiration catheter may be used. Aspiration is performed by attaching a syringe to a proximal end of the guide catheter and pulling a vacuum in the syringe, while simultaneously pulling the retrieving the thrombectomy device and the captured portion of the obstruction or clot into the guide catheter. A balloon guide may be inflated just prior to retrieval of the thrombectomy device and the captured portion of the obstruction or clot in order to arrest blood flow. The thrombectomy device with the captured portion of the obstruction or clot is then pulled back into the balloon guide catheter.
- One embolic protection device is known that includes inner and outer tubular members and a flexible everting filter portion that is attached at one end to a distal end of the inner tubular member, and that is attached at a second end to a distal end of the outer tubular member, so that the inner and outer tubular members are movable relative to one another to position the filter portion within the body vessel. The filter portion is movable from a collapsed, everted configuration to an expanded, generally non-everted deployed configuration. The filter portion expands radially outward to engage the filter body with an enclosing vessel wall, and also allows the passage of blood cells, while preventing the passage of captured emboli or thrombi through the filter portion.
- Another similar invertible filter is known that includes a guiding member configured to slidably engage a tubular filter portion that extends distally from the guiding member and is configured to evert to form a concave shape for capturing emboli, while allowing blood cells to pass through the filter portion.
- Another type of device for treating a vascular condition is known that includes a graft, and first and second support members such as stents attached to distal and proximal regions of the graft. The first and second stents are deployed distally and proximally of a vascular condition, and the graft can be everted to form a pocket to trap emboli during treatment of the vascular condition.
- Another device is known that includes a capturing section configured that can be inverted within a translating section by proximal movement of a leading wire when an open proximal end of the translating section engages resistance, and the size of the capturing section is reduced to enable the capturing section to re-enter a catheter.
- Another device for increasing blood flow through an obstructed blood vessel is known that includes an expandable member that is positioned within a blood vessel and radially adjacent to at least a portion of an obstruction, and that is expanded to bring at least a portion of the expandable member into contact with the obstruction. The expandable member is made of a mesh having a plurality of interstices that allow one or more fragments of the obstruction to pass into and be retained within the expandable member when an outward radial force is exerted on the obstruction by the expandable member.
- However, whenever a captured obstruction or clot is retrieved into any type of catheter there is always a risk of some or all of the obstruction or clot being released into a patient's vasculature. In many cases some or all of the obstruction or clot is captured on the outside of the thrombectomy device. As the thrombectomy device is pulled back into a catheter, some or all of the obstruction or clot may be scraped off, sending one or more pieces of the obstruction or clot downstream to another artery, after which one or more dislodged pieces of the obstruction or clot will then need to be removed, adding to the length of time and complexity of the procedure. Smaller pieces of the clot also may go further downstream to smaller vessels that are not accessible with current thrombectomy devices.
- It would be desirable to provide an apparatus and method for removal of at least a portion of an obstruction or clot from an obstructed blood vessel for treatment of ischemic stroke that provides a cover over the secured obstruction or clot prior to drawing the secured obstruction or clot into a catheter, in order to reduce the risk of the obstruction or clot being scraped off or otherwise losing one or more pieces of the obstruction or clot being retrieved during a thrombectomy procedure. The present invention meets these and other needs.
- Briefly and in general terms, the present invention provides for an apparatus and method for removal of at least a portion of an obstruction such as a clot from an obstructed blood vessel for treatment of a condition of a patient's vasculature such as ischemic stroke. The apparatus and method of the invention helps to reduce the risk of losing one or more pieces of an obstruction such as a clot during a thrombectomy procedure by providing a first or proximal expandable member that functions as a cover element that can evert to enfold and enclose a second or distal expandable member used to secure the obstruction or clot prior to pulling the secured obstruction or clot into a catheter for removal from the patient's vasculature. The first or proximal expandable member covers over not only the captured obstruction or clot, but also portions of the obstruction or clot which may be only partially captured, such as a portion of the obstruction stuck to or extending from the outside of the second or distal expandable member, to help to prevent the clot from being scraped off when the clot is pulled into a catheter. The close proximity of the first and second expandable members also allows the captured obstruction or clot to be covered almost immediately, which also can help to reduce the possibility of fragmentation of the obstruction or clot. A telescoping support member connected to the first or proximal expandable member also allows a user to initiate the process of causing the first or proximal expandable member to evert to enfold and enclose the second or distal expandable member used to secure the obstruction or clot.
- The present invention accordingly provides for an apparatus and method for removal of at least a portion of an obstruction from an obstructed blood vessel for treatment of ischemic stroke. The apparatus includes a telescoping support member, a first or proximal expandable member connected to the telescoping support member, and a second or distal expandable member connected to the first or proximal expandable member. The telescoping support member includes an outer tubular shaft and an inner elongate member that extends through and is slidable within the outer tubular shaft. The first or proximal expandable member has a proximal end that is attached to a distal end of the outer tubular shaft of the telescoping support member, and a distal end of the first or proximal expandable member is attached to a distal portion of the inner elongate member. The first or proximal expandable member preferably has a radially compressed configuration and a radially expanded configuration, as well as a longitudinally extended configuration with proximal and distal ends of the first or proximal expandable member disposed at opposing ends of the first or proximal expandable member, and an everted configuration with the distal end of the first or proximal expandable member withdrawn within the tubular body of the first or proximal expandable member and adjacent to the proximal end of the first or proximal expandable member. The second or distal expandable member preferably has a closed distal end and a closed proximal end, and a tubular mesh body extending between the proximal and distal ends of the second or distal expandable member, and is configured to be deployed into an obstruction within the blood vessel. The closed proximal end of the second or distal expandable member preferably also is permanently joined to the distal end of the inner elongate member of the telescoping support member. The second or distal expandable member also preferably has a radially compressed configuration and a radially expanded configuration, and the tubular mesh body of the second or distal expandable member preferably is configured to radially expand into contact with at least a portion of the obstruction or clot such that a portion of the obstruction or clot is dislodged to enhance blood flow through the blood vessel. In a presently preferred aspect, the tubular mesh body includes a plurality of interstices, at least a portion of which are adapted to allow passage of at least one dislodged portion of the obstruction therethrough in a radial direction into the tubular mesh body.
- In another presently preferred aspect, the tubular body of the first or proximal expandable member includes a plurality strands defining a plurality of interstices therebetween. In another presently preferred aspect, the tubular body of the first or proximal expandable member includes a radiopaque band permanently attached to the distal end of the first or proximal expandable member. In another presently preferred aspect, the tubular mesh body of the second or distal expandable member comprises a plurality of strands, and the plurality of strands may form first and second meshes. In another presently preferred aspect, each of the plurality of strands is oriented in at least one of a helical, longitudinal, and radial direction with respect to the tubular mesh body.
- In another presently preferred aspect, the second or distal expandable member is at least partially constructed of a self-expanding material, and the second or distal expandable member is configured to dislodge the obstruction by fracturing a portion of the obstruction or by extruding a portion of the obstruction.
- In another presently preferred aspect, the second or distal expandable member includes at least one radiopaque portion. In another presently preferred aspect, the second or distal expandable member is at least partially adapted to elute a pharmaceutical agent. In another presently preferred aspect, the pharmaceutical agent is adapted to at least partially lyse the at least one fragment. In another presently preferred aspect, the tubular mesh body of the second or distal expandable member includes a distal portion and a proximal portion, the distal portion of the tubular mesh body being formed of a first mesh, and the proximal portion of the tubular mesh body being made of a second mesh having a plurality of second interstices, at least one of the second interstices being adapted to selectively allow passage of at least one fragment therethrough. In another presently preferred aspect, the first mesh is formed integrally with the second mesh. In another presently preferred aspect, at least one of the first interstices is defined by a plurality of first strands, and at least one of the plurality of first strands is adapted to penetrate into the obstruction to longitudinally separate the at least one fragment from a remaining portion of the obstruction. In another presently preferred aspect, at least one of the second interstices is defined by a plurality of second strands, at least one of the plurality of second strands is adapted to break the at least one fragment into a plurality of subfragments, and at least one of the second interstices is adapted to selectively allow passage therethrough of at least one subfragment to release the at least one subfragment from the second or distal expandable member. In another presently preferred aspect, at least one of the plurality of second interstices is smaller than at least one of the plurality of first interstices. In another presently preferred aspect, a size of at least one of the plurality of second interstices is chosen on the basis of an allowable particulate size of the blood vessel. In another presently preferred aspect, the tubular mesh body of the second or distal expandable member is configured to compress at least a portion of the obstruction against a vessel wall of the blood vessel.
- In the method of the invention, movement of the inner elongate member in a proximal direction relative to the outer tubular shaft of the telescoping support member moves the first or proximal expandable member between the longitudinally extended configuration and the everted configuration such that the first or proximal expandable member covers, enfolds or envelopes the second or distal expandable member.
- Other features and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments in conjunction with the accompanying drawings, which illustrate, by way of example, the operation of the invention.
FIG. 1 is an elevational, schematic diagram of the apparatus of the invention disposed within a patient's vasculature, showing the first and second expandable members in radially expanded configurations within the vasculature, with an obstruction or clot captured within the second or distal expandable member, according to the invention.FIG. 2 is an elevational, schematic diagram similar toFIG. 1 , showing the first or proximal expandable member beginning to evert to enfold and cover the second or distal expandable member as the second or distal expandable member is drawn into the first or proximal expandable member.FIG. 3 is an elevational, schematic diagram similar toFIG. 2 , showing the first or proximal expandable member everted to enfold and cover the second or distal expandable member, which has been drawn into the first or proximal expandable member.FIG. 4 is an enlarged cross-sectional view similar toFIG. 3 .FIG. 5 is an elevational, schematic diagram similar toFIG. 3 , showing the first and second expandable members with the captured obstruction or clot being retrieved and withdrawn into a catheter.- Referring to the drawings, which are provided by way of example, and not by way of limitation, the present invention provides for an
apparatus 10 having aproximal end 12 and adistal end 14, for removal of at least a portion of anobstruction 16, such as a clot, for example, from an obstructed blood vessel in a patient'svasculature 18, such as for treatment of ischemic stroke, for example. - The apparatus includes a
telescoping support member 20, including an outertubular shaft 22 having adistal end 24, and an inner elongate member orcore advancement wire 26 having adistal end 28 and aproximal portion 30, and extending through the outer tubular shaft and slidable within the outer tubular shaft. The apparatus also includes a first, proximal expandable member orcover element 32 having aproximal end 34 and adistal end 36, and atubular body 38 extending between the proximal and distal ends of the first or proximal expandable member. The proximal end of the first or proximal expandable member is preferably permanently attached to the distal end of the outer tubular shaft of the telescoping support member, and the distal end of the first or proximal expandable member is preferably permanently attached to adistal portion 40 of the inner elongate member or core advancement wire. The first or proximal expandable member has a radially expanded configuration configured to engage the inner surface of a blood vessel in the patient's vasculature, as shown inFIGS. 1-4 , and a radially compressed configuration, such as when the first or proximal expandable member is disposed within and constrained by an introducer ordelivery catheter 42 having an inner lumen (not shown). The first or proximal expandable member preferably is dimensioned to fit within the inner lumen of the catheter in the radially compressed configuration, and is configured to be constrained from expanding when the first or proximal expandable member is contained within the catheter. - Referring to
FIG. 1 , in the radially expanded configuration, the first or proximal expandable member preferably also has a longitudinally extended configuration with the proximal and distal ends of the first or proximal expandable member disposed at opposing ends of the first or proximal expandable member, and an everted configuration, best shown fully inFIG. 4 , with the distal end of the first or proximal expandable member withdrawn within the tubular body of the first or proximal expandable member adjacent to the proximal end of the first or proximal expandable member. The tubular body of the first or proximal expandable member preferably includes a plurality strands ofmaterial 48 forming a proximal braided portion of the apparatus, defining a plurality ofinterstices 50 therebetween. The first or proximal expandable member also preferably includes at least one radiopaque portion, such as aradiopaque band 52 that is permanently attached to the distal end of the first or proximal expandable member. - The apparatus also includes a second, distal
expandable member 54 at the distal end of the apparatus, that is configured to be deployed into an obstruction or clot within the blood vessel in the patient's vasculature. The second or distal expandable member preferably includes a closed distal end56 a closedproximal end 58, and atubular mesh body 60 extending between the proximal and distal ends of the second or distal expandable member. The closed proximal end of the second or distal expandable member preferably is permanently joined to the distal end of the inner elongate member of the telescoping support member, such as by soldering, for example, although the second or distal expandable member may alternatively be permanently joined to the distal end of the inner elongate member of the telescoping support member by other similar suitable means, such as by adhesive or by heat shrinkable tubing, or combinations thereof, for example. - The tubular mesh body of the second, distal expandable member preferably is configured to radially expand into contact with at least a portion of the obstruction or clot in the blood vessel, such that a portion of the obstruction is dislodged to enhance blood flow through the blood vessel. The tubular mesh body preferably includes a plurality of
interstices 62, and at least a portion of the interstices preferably are configured to allow passage of at least one dislodged portion of the obstruction therethrough in a radial direction into the tubular mesh body. The tubular mesh body can be formed to include a plurality ofstrands 63 forming first and second meshes, wherein each of the strands may be oriented in at least one of a helical, longitudinal, and radial direction with respect to the tubular mesh body. In a presently preferred aspect, the second or distal expandable member is configured to dislodge the obstruction or clot by fracturing a portion of the obstruction, by extruding a portion of the obstruction, or a combination thereof. In another presently preferred aspect, the second or distal expandable member is at least partially constructed of a superelastic and/or self-expanding material, such as a nickel-titanium alloy which has been memory-shaped into an expanded condition and is compressed into a collapsed condition before use. The second or distal expandable member is constrained in the compressed condition by the introducer or delivery catheter, and preferably self-expands into the expanded condition upon removal from the introducer or delivery catheter. The second or distal expandable member may also include one or more radiopaque portions, such as one or more additional radiopaque bands, for example. In another presently preferred aspect, the second or distal expandable member is at least partially adapted to elute a pharmaceutical agent, such as a pharmaceutical agent designed to at least partially lyse the obstruction or fragment of the obstruction. - The tubular mesh body may include a first mesh in a distal portion of the tubular mesh body having a plurality of first interstices, and a second mesh in a proximal portion of the tubular mesh body being made of having a plurality of second interstices, with at least one of the second interstices being configured to selectively allow passage of at least one fragment therethrough. The first mesh can be formed integrally with the second mesh, for example. At least one of the first interstices may be defined by a plurality of first strands, in which case at least one of the plurality of first strands may be adapted to penetrate into the obstruction to longitudinally separate the at least one fragment from a remaining portion of the obstruction. At least one of the second interstices may be defined by a plurality of second strands, in which case at least one of the plurality of second strands may be adapted to break one or more fragments of the obstruction or clot into a plurality of subfragments, and at least one of the second interstices may be adapted to selectively allow passage of at least one subfragment therethrough to be released from the second or distal expandable member. In another presently preferred aspect, one or more of the plurality of second interstices can be smaller than one or more of the plurality of first interstices, and the size of one or more of the plurality of second interstices may be chosen on the basis of an allowable particulate size of the blood vessel. The tubular mesh body may also be configured to compress at least a portion of the obstruction against a vessel wall of the blood vessel
- Referring to
FIGS. 2 and 3 , in the method of operation of the device of the invention, when the distal element is pulled back, the proximal braided portion starts to evert, initiating covering the distal element, much like pulling a sock over a foot, so that movement of the inner elongate member in a proximal direction relative to the outer tubular shaft of the telescoping support member moves the first or proximal expandable member between the longitudinally extended configuration and the everted configuration, so that the first or proximal expandable member covers, envelopes or enfolds the second or distal expandable member as shown inFIG. 4 , as well as any of the obstruction that may be only partially captured in the second or distal expandable member, such as a portion of the obstruction stuck to or extending from the outside of the second or distal expandable member, for example, so that the second or distal expandable member and captured obstruction material can be withdrawn and retrieved into a catheter, as is illustrated inFIG. 5 . - It will be apparent from the foregoing that while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.
Claims (21)
1. Apparatus for removal of at least a portion of an obstruction from an obstructed blood vessel for treatment of ischemic stroke, comprising:
a telescoping support member including an outer tubular shaft and an inner elongate member extending through said outer tubular shaft and slidable within said outer tubular shaft, said outer tubular shaft having a distal end, and said inner elongate member having a distal end and a proximal end;
a first expandable member having a proximal end and a distal end and a tubular body extending between the proximal and distal ends of the first expandable member, said proximal end of said first expandable member being attached to said distal end of said outer tubular shaft of said telescoping support member, and said distal end of said first expandable member being attached to a distal portion of said inner elongate member, said first expandable member having a radially compressed configuration and a radially expanded configuration, and said first expandable member having a longitudinally extended configuration with said proximal and distal ends of said first expandable member disposed at opposing ends of said first expandable member, and an everted configuration with said distal end of said first expandable member withdrawn within said tubular body of said first expandable member adjacent to said proximal end of said first expandable member; and
a second expandable member configured to be deployed into an obstruction within the blood vessel, said second expandable member having a closed distal end and a closed proximal end, and a tubular mesh body extending between the proximal and distal ends of the second expandable member, said closed proximal end of said second expandable member being permanently joined to said distal end of said inner elongate member of said telescoping support member, said tubular mesh body being configured to radially expand into contact with at least a portion of the obstruction such that a portion of the obstruction is dislodged to enhance blood flow through the blood vessel, said tubular mesh body including a plurality of interstices, at least a portion of the interstices being adapted to allow passage of at least one dislodged portion of the obstruction therethrough in a radial direction into the tubular mesh body.
2. The apparatus ofclaim 1 , wherein said tubular body of said first expandable member comprises a plurality strands defining a plurality of interstices therebetween.
3. The apparatus ofclaim 1 , wherein said tubular body of said first expandable member comprises a radiopaque band permanently attached to said distal end of said first expandable member.
4. The apparatus ofclaim 1 , wherein said tubular mesh body of said second expandable member comprises a plurality of strands.
5. The apparatus ofclaim 4 , wherein said plurality of strands form first and second meshes.
6. The apparatus ofclaim 4 , wherein each of said plurality of strands is oriented in at least one of a helical, longitudinal, and radial direction with respect to the tubular mesh body.
7. The apparatus ofclaim 1 , wherein said second expandable member is configured to dislodge the obstruction by fracturing a portion of the obstruction.
8. The apparatus ofclaim 1 , wherein said second expandable member is configured to dislodge the obstruction by extruding a portion of the obstruction.
9. The apparatus ofclaim 1 , wherein said second expandable member is at least partially constructed of a self-expanding material.
10. The apparatus ofclaim 1 , wherein said obstruction comprises a clot.
11. The apparatus ofclaim 1 , wherein said second expandable member includes at least one radiopaque portion.
12. The apparatus ofclaim 1 , wherein said second expandable member is at least partially adapted to elute a pharmaceutical agent.
13. The apparatus ofclaim 12 , wherein said pharmaceutical agent is adapted to at least partially lyse the at least one fragment.
14. The apparatus ofclaim 1 , wherein said tubular mesh body of said second expandable member includes a distal portion and a proximal portion, the distal portion of the tubular mesh body being formed of a first mesh, and the proximal portion of the tubular mesh body being made of a second mesh having a plurality of second interstices, at least one of the second interstices being adapted to selectively allow passage of at least one fragment therethrough.
15. The apparatus ofclaim 14 , wherein said first mesh is formed integrally with the second mesh.
16. The apparatus ofclaim 14 , wherein at least one of the first interstices is defined by a plurality of first strands, and at least one of the plurality of first strands is adapted to penetrate into the obstruction to longitudinally separate the at least one fragment from a remaining portion of the obstruction.
17. The apparatus ofclaim 14 , wherein at least one of the second interstices is defined by a plurality of second strands, at least one of the plurality of second strands is adapted to break the at least one fragment into a plurality of subfragments, and at least one of the second interstices is adapted to selectively allow passage therethrough of at least one subfragment to release the at least one subfragment from the second expandable member.
18. The apparatus ofclaim 14 , wherein at least one of the plurality of second interstices is smaller than at least one of the plurality of first interstices.
19. The apparatus ofclaim 14 , wherein a size of at least one of the plurality of second interstices is chosen on the basis of an allowable particulate size of the blood vessel.
20. The apparatus ofclaim 14 , wherein said tubular mesh body of said second expandable member is configured to compress at least a portion of the obstruction against a vessel wall of the blood vessel.
21. The apparatus ofclaim 1 , wherein movement of said inner elongate member in a proximal direction relative to said outer tubular shaft of the telescoping support member moves the first expandable member between said longitudinally extended configuration and said everted configuration such that said first expandable member covers/envelopes said second expandable member.
Priority Applications (13)
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|---|---|---|---|
| US13/801,979US20140276403A1 (en) | 2013-03-13 | 2013-03-13 | Ischemic stroke device |
| IN520DE2014IN2014DE00520A (en) | 2013-03-13 | 2014-02-25 | |
| AU2014201209AAU2014201209A1 (en) | 2013-03-13 | 2014-03-05 | Ischemic stroke device |
| KR1020140027549AKR102258237B1 (en) | 2013-03-13 | 2014-03-10 | Ischemic stroke device |
| CA2845439ACA2845439C (en) | 2013-03-13 | 2014-03-11 | Ischemic stroke device |
| EP15203260.3AEP3020344A1 (en) | 2013-03-13 | 2014-03-12 | Ischemic stroke device |
| EP14159071.1AEP2786717B1 (en) | 2013-03-13 | 2014-03-12 | Ischemic stroke device |
| DK14159071.1TDK2786717T3 (en) | 2013-03-13 | 2014-03-12 | Device for ischemic stroke |
| JP2014048677AJP6391951B2 (en) | 2013-03-13 | 2014-03-12 | Ischemic stroke device |
| CN201410092295.XACN104042304B (en) | 2013-03-13 | 2014-03-13 | Ishemic stroke device |
| BRBR102014005957-1ABR102014005957A2 (en) | 2013-03-13 | 2014-03-13 | Ischemic Stroke Device |
| US15/983,719US10687834B2 (en) | 2013-03-13 | 2018-05-18 | Ischemic stroke device |
| AU2018220106AAU2018220106A1 (en) | 2013-03-13 | 2018-08-23 | Ischemic stroke device |
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| Application Number | Priority Date | Filing Date | Title |
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| US13/801,979US20140276403A1 (en) | 2013-03-13 | 2013-03-13 | Ischemic stroke device |
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| EP (2) | EP3020344A1 (en) |
| JP (1) | JP6391951B2 (en) |
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| CN (1) | CN104042304B (en) |
| AU (2) | AU2014201209A1 (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| DK2786717T3 (en) | 2016-04-11 |
| EP2786717B1 (en) | 2016-01-13 |
| CA2845439A1 (en) | 2014-09-13 |
| EP2786717A3 (en) | 2014-11-19 |
| JP2014176660A (en) | 2014-09-25 |
| AU2018220106A1 (en) | 2018-09-13 |
| KR102258237B1 (en) | 2021-06-01 |
| IN2014DE00520A (en) | 2015-06-12 |
| BR102014005957A2 (en) | 2015-06-23 |
| EP2786717A2 (en) | 2014-10-08 |
| US20190133628A1 (en) | 2019-05-09 |
| CA2845439C (en) | 2021-04-06 |
| CN104042304B (en) | 2018-10-26 |
| AU2014201209A1 (en) | 2014-10-02 |
| EP3020344A1 (en) | 2016-05-18 |
| KR20140112415A (en) | 2014-09-23 |
| JP6391951B2 (en) | 2018-09-19 |
| US10687834B2 (en) | 2020-06-23 |
| CN104042304A (en) | 2014-09-17 |
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