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WO2021207728A1 - Dispositif de protection embolique cérébrale - Google Patents

Dispositif de protection embolique cérébrale Download PDF

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Publication number
WO2021207728A1
WO2021207728A1 PCT/US2021/026851 US2021026851W WO2021207728A1 WO 2021207728 A1 WO2021207728 A1 WO 2021207728A1 US 2021026851 W US2021026851 W US 2021026851W WO 2021207728 A1 WO2021207728 A1 WO 2021207728A1
Authority
WO
WIPO (PCT)
Prior art keywords
base
embolic protection
patient
protection device
aortic arch
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/US2021/026851
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English (en)
Inventor
Kevin H. ROSENTHAL
Mariana Alvarez MACHADO
Varattavudh ASSAKUL
Pratik Pinal DOSHI
Anish Sanjay NIGADE
Kelly W. YANG
Eric S. RICHARDSON
John Kevin HARRISON
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Duke University
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Duke University
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Filing date
Publication date
Application filed by Duke University filed Critical Duke University
Publication of WO2021207728A1 publication Critical patent/WO2021207728A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0105—Open ended, i.e. legs gathered only at one side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0086—Pyramidal, tetrahedral, or wedge-shaped

Definitions

  • transcatheter aortic valve replacement For patients diagnosed with aortic stenosis who are not good candidates for open- heart valve replacement surgery (e.g., due to poor health), transcatheter aortic valve replacement (TAVR) is an increasingly popular procedure.
  • TAVR involves inserting a valve delivery system through either the left or right femoral artery and implanting a prosthetic valve via fluoroscopy. The patient is consciously sedated or under general anesthesia and typically spends one to two days in the hospital post procedure.
  • TAVR comes with its own set of risks. Patients undergoing TAVR often have heavily calcified native aortic valves and vasculature, which can come into contact with the valve delivery system and other catheters during the procedure, dislodging calcium and other emboli. The dislodged calcium and other emboli can clog any of the three great vessels (e.g., the brachiocephalic artery, the left common carotid artery, and the left subclavian artery) within the aortic arch that supply blood flow to the brain.
  • the brachiocephalic artery e.g., the brachiocephalic artery, the left common carotid artery, and the left subclavian artery
  • Similar problems can also occur to the renal arteries during medical procedures in which embolic material is likely to cause a blockage.
  • Cerebral embolic protection devices and methods of deployment of those cerebral embolic protection devices are provided.
  • a cerebral embolic protection device as described herein provides coverage that inhibits/deflects embolic material (e.g., debris, thrombi) from entering any of the three great vessels that lead to the brain within the aortic arch of the patient, reducing the likelihood of ischemia and/or stroke while allowing for adequate cerebral circulation.
  • embolic material e.g., debris, thrombi
  • the cerebral embolic protection device can be inserted and removed via a catheter to minimize damage to the aortic arch, surrounding tissue, and surrounding vasculature by only expanding to its pre-formed functional size while within the aortic arch of the patient. Furthermore, the cerebral embolic protection device deflects (rather than capturing and removing) debris, which further lowers the risk of releasing debris into cerebral circulation and lowers the risk of a build-up of collected debris that can occlude cerebral circulation within the three great vessels of the aortic arch.
  • a cerebral embolic protection device includes a structural frame and a porous mesh coupled to the structural frame.
  • the structural frame includes a proximal base, a distal base, and a longitudinal section connecting the proximal base to the distal base.
  • the structural frame is a shape-memory material.
  • the shape-memory material is nickel-titanium or cobalt-chromium.
  • the proximal base and the distal base are configured to expand radially for a secure fit within an aortic arch of a patient.
  • the porous mesh is made of at least one of nylon, polyurethane, polypropylene, PTFE, and siloxane.
  • the porous mesh when deployed into an aortic arch of a patient, the porous mesh is configured to be able to be positioned over an ostium of each of a brachiocephalic artery, a left common carotid artery, and a left subclavian artery within the aortic arch of the patient.
  • the porous mesh is semi-cylindrical.
  • the proximal base and the distal base are semi-annular.
  • the semi-cylindrical porous mesh covers between 72 ° to less than 360 ° radially along a length of the semi-cylindrical porous mesh.
  • the porous mesh is cylindrical.
  • the proximal base and the distal base are annular.
  • the distal base includes spiral rings.
  • the proximal base includes spiral rings.
  • the distal base includes a plurality of annular rings.
  • the proximal base comprises a plurality of annular rings.
  • a length of the longitudinal section of the structural frame is equal to or greater than a length of an aortic arch of a patient.
  • the cerebral embolic protection device further includes a second longitudinal section connecting the proximal base and the distal base. In some cases, the proximal base and the distal base are equally spaced from one another. In some cases, the cerebral embolic protection device further includes a third longitudinal section connecting the proximal base and the distal base. In some cases, the cerebral embolic protection device further includes a fourth longitudinal section connecting the proximal base and the distal base. In some cases, the structural frame is configured to provide 360 ° rotation about a roll axis.
  • the device is configured to be placed within a delivery sheath of a catheter and deployed into an aortic arch of a patient. In some cases, the device is configured to be retracted back into the delivery sheath of the catheter. In some cases, the device is attached to the delivery sheath via a flexible tethering wire.
  • a method of using a cerebral embolic protection device includes inserting, via one of a brachiocephalic artery, a left subclavian artery, and a descending aorta of a patient, a catheter into an aortic arch of a patient; deploying, via the catheter, the cerebral embolic protection device into the aortic arch of the patient; and positioning the cerebral embolic protection device over entries to three great vessels that lead to a brain within the aortic arch of the patient.
  • the method further incudes retracting the cerebral embolic protection device into a delivery sheath of the catheter.
  • the deploying of the cerebral embolic protection device into the aortic arch of the patient includes drawing back a delivery sheath of the catheter from the distal base to the proximal base; and allowing the distal base and the proximal base to expand radially for a secure fit within the aortic arch of the patient.
  • the positioning of the cerebral embolic protection device over the ostium of each of the brachiocephalic artery, the left common carotid artery, and the left subclavian artery within the aortic arch of the patient includes rotating the cerebral embolic protection device.
  • Figure 1A illustrates a cylindrical mesh, single-sectioned annular base cerebral embolic protection device.
  • Figure IB illustrates a semi-cylindrical mesh, single-sectioned annular base cerebral embolic protection device.
  • Figure 1C illustrates a semi-cylindrical mesh, single-sectioned semi-annular base cerebral embolic protection device.
  • Figure 2A illustrates a cylindrical mesh, double-sectioned annular base cerebral embolic protection device.
  • Figure 2B illustrates a cylindrical mesh, quadruple-sectioned annular base cerebral embolic protection device.
  • Figure 2C illustrates a semi-cylindrical mesh, triple-sectioned annular base cerebral embolic protection device.
  • Figure 2D illustrates a semi-cylindrical mesh, triple-sectioned semi-annular base cerebral embolic protection device.
  • Figures 3A-3C illustrate roll-axis rotation of a cylindrical mesh, single-sectioned spiral-annular base cerebral embolic protection device.
  • Figures 4A-4D illustrate deployment of a semi-cylindrical mesh, single-sectioned annular base cerebral embolic protection device within an aortic arch of a patient.
  • Figure 4E illustrates the completed deployment of a cylindrical mesh, single- sectioned annular base cerebral embolic protection device within an aortic arch of a patient.
  • Figures 5A-5D illustrate deployment of a cylindrical mesh, single-sectioned spiral-annular base cerebral embolic protection device within an aortic arch of a patient.
  • Figure 6 illustrates a method of deploying a cerebral embolic protection device within an aortic arch of a patient.
  • Figure 7A illustrates a cylindrical mesh, split-sectioned annular base cerebral embolic protection device.
  • Figure 7B illustrates a cylindrical mesh, split-sectioned annular base cerebral embolic protection device within an aortic arch of a patient.
  • Figure 8A illustrates a semi-cylindrical mesh, split-sectioned annular base cerebral embolic protection device.
  • Figure 8B illustrates a semi-cylindrical mesh, split-sectioned annular base cerebral embolic protection device within an aortic arch of a patient.
  • Cerebral embolic protection devices and methods of deployment of those cerebral embolic protection devices are provided.
  • a cerebral embolic protection device as described herein provides coverage that inhibits/deflects embolic material (e.g., debris, thrombi) from entering any of the three great vessels that lead to the brain within the aortic arch of the patient, reducing the likelihood of ischemia and/or stroke while allowing for adequate cerebral circulation.
  • embolic material e.g., debris, thrombi
  • semi-cylindrical refers to an open-ended semi-cylinder (i.e., a semi-tubular) that includes material that covers between 72 ° to ⁇ 360 ° radially along the length of the semi-cylinder.
  • cylindrical refers to an open-ended cylinder (i.e., tubular) that includes material that covers 360 ° radially along the length of the cylinder.
  • annular refers to a ring-like shape that includes material that covers 360 ° radially.
  • semi-annular refers to an incomplete ring-like shape that includes material that covers between 72 ° to less than 360 ° radially.
  • a cerebral embolic protection device includes a structural frame and a porous mesh coupled to the structural frame.
  • the structural frame can be made out of a shape memory material that is pre-formed to an approximate shape of an aortic arch of a patient so that when deployed within the aortic arch of the patient, the cerebral embolic protection device can expand for a secure fit within the aortic arch of the patient.
  • the cerebral embolic protection device is slightly larger than the aortic arch of the patient to provide the secure fit, however, it should be understood that the shape memory material and size are selected to not damage the aortic arch (or any other tissue surrounding the aortic arch) once expanded within the aortic arch.
  • the pre-formed shape of the structural frame is 60 to 70 millimeters in length; the diameter of the distal base (or the proximal base in cases where the cerebral embolic protection device is inserted via the brachiocephalic artery) is 29 to 33 millimeters; and the diameter of the proximal base (or the distal base in cases where the cerebral embolic protection device is inserted via the brachiocephalic artery) is 26 to 30 millimeters.
  • these sizes and ranges may be altered as needed for other populations.
  • the described cerebral embolic protection device is suitable for protection of the renal arteries with appropriate adjustments to size and ranges.
  • the cerebral embolic protection device can be implemented as a renal embolic protection device by appropriate sizing.
  • the shape memory material can be nickel-titanium and/or cobalt-chromium.
  • the cross-sectional diameter of the shape memory material can be 0.1 to 0.85 millimeters.
  • the porous mesh can be made of at least one of nylon, polyurethane, polypropylene, PTFE, and/or siloxane.
  • the thickness of the porous mesh can be 0.019 to 0.13 millimeters.
  • the pore diameter of the porous mesh can be 70 microns with an open area percentage of 49%. In some cases, the open area percentage is between 40% to 60%.
  • the pore diameter of the porous mesh can be smaller or larger based on cerebral perfusion requirements.
  • the cerebral embolic protection device can be inserted and removed (e.g., through one of the brachiocephalic artery, the left subclavian artery, or the descending aorta) via a catheter to minimize damage to the aortic arch, surrounding tissue, and surrounding vasculature by only expanding to its functional size while within the aortic arch of the patient and collapsing back into the catheter before being removed from the aortic arch of the patient.
  • the cerebral embolic protection device deflects (rather than capturing and removing) debris, which further lowers the risk of releasing debris into cerebral circulation and lowers the risk of a build-up of collected debris that can occlude cerebral circulation within the three great vessels of the aortic arch.
  • FIG 1A illustrates a cylindrical mesh, single-sectioned annular base cerebral embolic protection device.
  • a cerebral embolic protection device 100 includes a structural frame 110 and a porous mesh 120 coupled to the structural frame 110.
  • the structural frame 110 includes a proximal base 112, a distal base 114, and a longitudinal section 116 connecting the proximal base 112 to the distal base 114.
  • the proximal base 112 and the distal base 114 are annular, there is a single longitudinal section 116, and the porous mesh 120 is cylindrical (hence why this example is called a cylindrical mesh, single-sectioned annular base cerebral embolic protection device).
  • Figure IB illustrates a semi-cylindrical mesh, single-sectioned annular base cerebral embolic protection device.
  • a cerebral embolic protection device 130 includes a structural frame 140 and a porous mesh 150 coupled to the structural frame 140.
  • the structural frame 140 includes a proximal base 142, a distal base 144, and a longitudinal section 146 connecting the proximal base 142 to the distal base 144.
  • the proximal base 142 and the distal base 144 are annular, there is a single longitudinal section 146, and the porous mesh 150 is semi-cylindrical.
  • FIG. 1C illustrates a semi-cylindrical mesh, single-sectioned semi-annular base cerebral embolic protection device.
  • a cerebral embolic protection device 160 includes a structural frame 170 and a porous mesh 180 coupled to the structural frame 170.
  • the structural frame 170 includes a proximal base 172, a distal base 174, and a longitudinal section 176.
  • the proximal base 172 and the distal base 174 are semi-annular, there is a single longitudinal section 176, and the porous mesh 180 is semi-cylindrical.
  • FIG. 2A illustrates a cylindrical mesh, double-sectioned annular base cerebral embolic protection device.
  • a cerebral embolic protection device 200 includes a structural frame 210 and a porous mesh 202 coupled to the structural frame 210.
  • the structural frame 210 includes a proximal base 212, a distal base 214, and two longitudinal sections 216, 218 connecting the proximal base 212 to the distal base 214.
  • the proximal base 212 and the distal base 214 are annular, there are two longitudinal sections 216, 218, and the porous mesh 202 is cylindrical (hence why this example is called a cylindrical mesh, double- sectioned annular base cerebral embolic protection device).
  • the longitudinal sections 216, 218 are equally spaced from one another (e.g., 180 ° apart). Furthermore, even though the two longitudinal sections 216, 218 are illustrated as being on a top (e.g., 216) and a bottom (e.g., 218), due to the cylindrical shape of the porous mesh 202 around the structural frame 210, the two longitudinal sections 216, 218 may be oriented at any radial position as the cerebral embolic protection device 200 provides rotational symmetry.
  • FIG. 2B illustrates a cylindrical mesh, quadruple-sectioned annular base cerebral embolic protection device.
  • a cerebral embolic protection device 220 includes a structural frame 230 and a porous mesh 222 coupled to the structural frame 230.
  • the structural frame 230 includes a proximal base 232, a distal base 234, and four longitudinal sections 236, 238, 240, 242 connecting the proximal base 232 to the distal base 234.
  • the proximal base 232 and the distal base 234 are annular, there are four longitudinal sections 236, 238, 240, 242, and the porous mesh 222 is cylindrical.
  • the longitudinal sections 236, 238, 240, 242 are equally spaced from one another (e.g., 90 ° apart).
  • FIG. 2C illustrates a semi-cylindrical mesh, triple-sectioned annular base cerebral embolic protection device.
  • a cerebral embolic protection device 250 includes a structural frame 260 and a porous mesh 252 coupled to the structural frame 260.
  • the structural frame 260 includes a proximal base 262, a distal base 264, and three longitudinal sections 266, 268, 270 connecting the proximal base 262 to the distal base 264.
  • the proximal base 262 and the distal base 264 are annular, there are three longitudinal sections 266, 268, 270, and the porous mesh is semi-cylindrical.
  • the longitudinal sections 266, 268, 270 are equally spaced from one another (e.g., 120 ° apart).
  • FIG. 2D illustrates a semi-cylindrical mesh, triple-sectioned semi-annular base cerebral embolic protection device.
  • a cerebral embolic protection device 280 includes a structural frame 290 and a porous mesh 282 coupled to the structural frame 290.
  • the structural frame 290 includes a proximal base 292, a distal base 294, and three longitudinal sections 296, 298, 299 connecting the proximal base 292 to the distal base 294.
  • the proximal base 292 and the distal base 294 are semi-annular, there are three longitudinal sections 296, 298, 299, and the porous mesh is semi-cylindrical.
  • the longitudinal sections 296, 298, 299 are equally spaced from one another (e.g., 120 ° apart).
  • a structural frame (e.g., 110, 140, 170, 210, 230, 260, and/or 290) contains one or more radio-opaque markers for positioning the device while the device is imaged under fluoroscopy. This can be particularly useful when the porous mesh (e.g., 120, 150, 180, 202, 222, 252, and/or 282) is semi-cylindrical.
  • the structural frame is coupled to the porous mesh by threading/suturing the porous mesh to the structural frame.
  • the structural frame is coupled to the porous mesh via an adhesive.
  • the structural frame is coupled to the porous mesh via a thermal bond.
  • an embolic protection device can be used to protect renal arteries of a patient via access through the descending aorta (e.g., in medical procedures in which it is advantageous to protect the renal arteries from embolic material).
  • FIG. 3A-3C illustrate roll-axis rotation of a cylindrical mesh, single-sectioned spiral-annular base cerebral embolic protection device.
  • a cerebral embolic protection device 300 includes a structural frame 310 and a porous mesh 320 coupled to the structural frame 310.
  • the structural frame 310 includes a proximal base 312, a distal base 314, and a longitudinal section 316 connecting the proximal base 312 to the distal base 314.
  • the proximal base 312 is annular
  • the distal base 314 is made of spiral rings (i.e., the distal base is made up of a plurality of spiral-shaped rings), there is single longitudinal section 316, and the porous mesh 320 is cylindrical.
  • the proximal base 312 is made of spiral rings.
  • the distal base 314 is made of a plurality of annular rings.
  • the proximal base 312 is made of a plurality of annular rings.
  • the cerebral embolic protection device 300 can rotate about the roll axis 330.
  • This roll axis 330 rotation allows for a device to be positioned and/or moved over an ostium of each of a brachiocephalic artery, a left common carotid artery, and a left subclavian artery within an aortic arch of a patient without damaging the aortic arch or the ostium of each of the arteries, as is described in more detail below with respect to Figures 4A-6.
  • any cerebral embolic protection device having annular, semi-annular, a plurality of annular rings, or spiral ring bases provide the ability to rotate 360 ° about the roll axis when inside the aortic arch of a patient without damaging the aortic arch or the ostium of each of the arteries.
  • the rotational symmetry provided allows for the longitudinal section 316 to be oriented at any radial position as illustrated in Figures 3A-3C.
  • Figures 4A-4D illustrate deployment of a semi-cylindrical mesh, single-sectioned annular base cerebral embolic protection device within an aortic arch of a patient.
  • Figure 4E illustrates the completed deployment of a cylindrical mesh, single-sectioned annular base cerebral embolic protection device within an aortic arch of a patient.
  • Figure 6 illustrates a method 600 of deploying a cerebral embolic protection device within an aortic arch of a patient. Referring to Figure 4A and Figure 6, a catheter 400 is inserted (602), via a left subclavian artery 402, into the aortic arch 404 of a patient.
  • the catheter 400 is inserted (602), via the brachiocephalic artery 406, into the aortic arch 404 of the patient; in some cases, the catheter 400 is inserted (602), via a descending aorta 408, into the aortic arch 404 of the patient.
  • the catheter 400 is further inserted and/or positioned (603) past an ostium 407 of a brachiocephalic artery 406 (e.g., towards the ascending aorta 412).
  • the catheter is further inserted and/or positioned (603) past an ostium 403 of the left subclavian artery 402 (e.g., towards the descending aorta 408).
  • a cerebral embolic protection device is deployed (604) when a delivery sheath 415 of the catheter 400 is drawn back, exposing a distal base 432 of the cerebral embolic protection device 420 into the aortic arch 404 of the patient.
  • the cerebral embolic protection device 420 is positioned (606) (e.g., from the distal base 432 to the proximal base 434) over an ostium 407, 419, 403 of each of the brachiocephalic artery 406, the left common carotid artery 418, and the left subclavian artery 402 within the aortic arch 404 of the patient.
  • deployment (604) of the cerebral embolic protection device 420 is complete when delivery sheath 415 is pulled back into the entry artery (e.g., the left subclavian artery 402, the descending aorta 408, or the brachiocephalic artery 406).
  • the proximal base 434 remains connected to the catheter 400 by a flexible tethering wire 416.
  • the packing density factor percentage of the delivery sheath 415 is between 50% to 70%.
  • the deploying (604) and the positioning (606) is accomplished, at least in part, because as the delivery sheath 415 is drawn back (e.g., from the distal base 432 to the proximal base 434) and due to the shape memory material of the structural frame 430, the structural frame 430 is allowed to expand (radially for the distal base 432 and the proximal base 434) for a secure fit within the aortic arch 404 of the patient.
  • the porous mesh 422, 423 covers the ostium 407, 419, 403 of each of the arteries 406, 418, 402 within the aortic arch 404 of the patient, allowing for adequate blood flow to the brain while deflecting any embolic material (e.g., debris, thrombi) that may be dislodged during the TAVR procedure from traveling with the blood flow into brain and instead directing any embolic material into the descending aorta 408.
  • embolic material e.g., debris, thrombi
  • the proximal base 434 and the distal base 432 are both are both annular and there is a single longitudinal section 436.
  • these features 432, 434, 436 of the structural frame 430 provide for simple rotation about a roll axis of the cerebral embolic protection device 420, which can also assist in positioning (606) of the porous mesh 422, 423 of the cerebral embolic protection device 420 over the ostium 407, 419, 403 of each of the arteries 406, 418, 402 within the aortic arch.
  • the ability to rotate the cerebral embolic protection device 420 about the roll axis allows for a semi-cylindrical shape of the porous mesh 422, reducing the amount of material needed to be packed into the delivery sheath 415 of the catheter 400, which can further reduce the size of the delivery sheath 415 of the catheter 400 and decrease the chances of unwanted damage to the surrounding tissue, including but not limited to, the entry artery (e.g., the left subclavian artery 402, the descending aorta 408, or the brachiocephalic artery 406) and the aortic arch 404 of the patient.
  • the semi- cylindrical shape of the porous mesh 422 is enough to cover the superior side of the aortic arch
  • the cylindrical shape of the porous mesh 423 allows for protection of the entire aortic arch 404 from embolic material. Furthermore, the cylindrical shape of the porous mesh 423 allows for orientation-free deployment (604).
  • the method 600 described herein may be carried out using an external controller that allows a physician to move the delivery sheath within the aortic arch and includes a slider mechanism that allows the physician to draw back the delivery sheath 415 from the cerebral embolic protection device 420.
  • the TAVR procedure can be performed.
  • the method 600 can further include retracting (608) the cerebral embolic protection device 420 back into the delivery sheath 415 of the catheter 400; and removing, via the entry artery, the catheter 400 from the aortic arch 404 of the patient.
  • the retraction (608) can include using the flexible tethering wire 416 to pull the cerebral embolic protection device back into the delivery sheath 415. This first-in, last-out approach maximizes the amount of debris deflected by the cerebral embolic protection device, decreasing the chances of ischemia and/or stroke.
  • Figures 5A-5D illustrate deployment of a cylindrical mesh, single-sectioned spiral- annular base cerebral embolic protection device within an aortic arch of a patient.
  • a catheter 500 is inserted (602), via a left subclavian artery 502, a brachiocephalic artery 506, or a descending aorta 508, into the aortic arch 504 of a patient.
  • the catheter 500 is further inserted and/or positioned (603) past an ostium 507 of a brachiocephalic artery 506 (e.g., towards the ascending aorta 512).
  • the catheter is further inserted and/or positioned (603) past an ostium 503 of the left subclavian artery 502 (e.g., towards the descending aorta 508).
  • a cerebral embolic protection device is deployed (604) when a delivery sheath 515 of the catheter 500 is drawn back, exposing a distal base 532 of the cerebral embolic protection device 520 into the aortic arch 504 of the patient.
  • the cerebral embolic protection device 520 is positioned (606) (e.g., from the distal base 532 to the proximal base 534) over an ostium 507, 519, 503 of each of the brachiocephalic artery 506, the left common carotid artery 518, and the left subclavian artery 502 within the aortic arch 504 of the patient.
  • deployment (604) of the cerebral embolic protection device 520 is complete when delivery sheath 515 is pulled back into the entry artery (e.g., the left subclavian artery 502, the descending aorta 508, or the brachiocephalic artery 506).
  • the proximal base 534 remains connected to the catheter 500 by a tethering wire 516.
  • the tethering wire 516 is flexible.
  • the deploying (604) and/or the positioning (606) includes allowing the distal base 532 and the proximal base 534 to expand radially for a secure fit within the aortic arch 504 of the patient.
  • the radial expansion is provided for by the shape memory material of the structural frame 530; and the shape memory material of the structural frame 530 may be pre-formed to an approximate shape of the aortic arch 504 of the patient to provide that secure fit.
  • the porous mesh 522 covers the ostium 507, 519, 503 of each of the arteries 506, 518, 502 within the aortic arch 504 of the patient, allowing for adequate blood flow to the brain while deflecting any embolic material (e.g., debris, thrombi) that may be dislodged during the TAVR procedure from traveling with the blood flow into brain and instead directing any embolic material into the descending aorta 508.
  • embolic material e.g., debris, thrombi
  • the proximal base 534 is annular and the distal base 532 is spiral rings and there is a single longitudinal section 536.
  • these features 532, 534, 536 of the structural frame 530 provide for simple rotation about a roll axis of the cerebral embolic protection device 520, which can also assist in positioning (606) of the porous mesh 522 of the cerebral embolic protection device 520 over the ostium 507, 519, 503 of each of the arteries 506, 518, 502 within the aortic arch.
  • the TAVR procedure can be performed.
  • the method 600 can further include retracting (608) the cerebral embolic protection device 520 back into the delivery sheath 515 of the catheter 500; and removing, via the entry artery, the catheter 500 from the aortic arch 504 of the patient.
  • the retraction (608) can include using the tethering wire 516 to pull the cerebral embolic protection device back into the delivery sheath 515. This first-in, last-out approach maximizes the amount of debris deflected by the cerebral embolic protection device, decreasing the chances of ischemia and/or stroke.
  • FIG. 7A illustrates a cylindrical mesh, split-sectioned annular base cerebral embolic protection device.
  • a cerebral embolic protection device 700 includes a structural frame 710 and a porous mesh 702 coupled to the structural frame 710.
  • the structural frame 710 includes a proximal base 712, a distal base 714, and a longitudinal section 716 connecting the proximal base 712 and the distal base 714.
  • the proximal base 712 and the distal base 714 are annular
  • the longitudinal section 716 is split
  • the porous mesh 702 is cylindrical (hence why this example is called a cylindrical mesh, split-sectioned annular base cerebral embolic protection device).
  • the longitudinal section 716 is split into two sections, a proximal portion 718 and a distal portion 720.
  • Figure 7B illustrates a cylindrical mesh, split-sectioned annular base cerebral embolic protection device within an aortic arch of a patient.
  • the proximal portion 718 of the longitudinal section 716 and the distal portion 720 of the longitudinal section 716 extend into the catheter 730.
  • each of the proximal portion 718 of the longitudinal section 716 and the distal portion 720 of the longitudinal section 716 can extend from two inches to five feet (e.g., to the end) of the catheter 730.
  • the split longitudinal section 716 provides the ability for a physician to pull the proximal portion 718 of the longitudinal section 716 and the proximal base 712 (e.g., the proximal side) separately from the distal portion 720 of the longitudinal section 716 and the distal base 714 (e.g., the distal side) during the retraction of the cerebral embolic protection device 700 back into the delivery sheath 732 of the catheter 730.
  • the proximal side separately from the distal side, there is a lower chance of damage to the aortic arch 740 and the surrounding tissue when the cerebral embolic protection device 700 is removed (e.g., via the catheter 730).
  • each of the proximal portion 718 of the longitudinal section 716 and the distal portion 720 of the longitudinal section 716 can act as a tether (e.g., similar to the function of tethering wire 416, 516 described in Figures 4D, 4E, and 5D).
  • the proximal portion 718 of the longitudinal section 716 is shorter than the distal portion 720 of the longitudinal section 716 so that the split between the two portions 718, 720 is closer to the entry artery (e.g., in this case, the left subclavian artery 704).
  • FIG. 8A illustrates a semi-cylindrical mesh, split-sectioned annular base cerebral embolic protection device.
  • a cerebral embolic protection device 800 includes a structural frame 810 and a porous mesh 802 coupled to the structural frame 810.
  • the structural frame 810 includes a proximal base 812, a distal base 814, and a longitudinal section 816 connecting the proximal base 812 and the distal base 814.
  • the proximal base 812 and the distal base 814 are annular, the longitudinal section 816 is split, and the porous mesh 802 is semi-cylindrical (hence why this example is called a semi-cylindrical mesh, split-sectioned annular base cerebral embolic protection device).
  • the longitudinal section 816 is split into two sections, a proximal portion 818 and a distal portion 820.
  • Figure 8B illustrates a semi-cylindrical mesh, split-sectioned annular base cerebral embolic protection device within an aortic arch of a patient.
  • the proximal portion 818 of the longitudinal section 816 and the distal portion 820 of the longitudinal section 816 extend into the catheter 830.
  • each of the proximal portion 818 of the longitudinal section 816 and the distal portion 820 of the longitudinal section 816 can extend from two inches to five feet (e.g., to the end) of the catheter 830.
  • the split longitudinal section 816 provides the ability for a physician to pull the proximal portion 818 of the longitudinal section 816 and the proximal base 812 (e.g., the proximal side) separately from the distal portion 820 of the longitudinal section 816 and the distal base 814 (e.g., the distal side) during the retraction of the cerebral embolic protection device 800 back into the delivery sheath 832 of the catheter 830.
  • the proximal side separately from the distal side, there is a lower chance of damage to the aortic arch 840 and the surrounding tissue when the cerebral embolic protection device 800 is removed (e.g., via the catheter 830).
  • each of the proximal portion 818 of the longitudinal section 816 and the distal portion 820 of the longitudinal section 816 can act as a tether (e.g., similar to the function of tethering wire 416, 516 described in Figures 4D, 4E, and 5D).
  • the proximal portion 818 of the longitudinal section 816 is shorter than the distal portion 820 of the longitudinal section 816 so that the split between the two portions 818, 820 is closer to the entry artery (e.g., in this case, the left subclavian artery 804).
  • ranges are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated, and each separate value is incorporated into the specification as if it were individually recited. For example, if a range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expressly enumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest and highest value enumerated are to be considered to be expressly stated in this disclosure.

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Abstract

Dispositif de protection embolique cérébrale comprenant un cadre de structure et un treillis poreux accouplé au cadre de structure. Le cadre de structure comprend une base proximale et une base distale et une section longitudinale reliant la base proximale à la base distale. Dans certains cas, le cadre de structure est un matériau à mémoire de forme. Dans certains cas, la base proximale et la base distale sont conçues pour s'étendre radialement pour un ajustement sécurisé à l'intérieur d'un arc aortique d'un patient. Un procédé d'utilisation d'un dispositif de protection embolique cérébrale comprend les étapes consistant à : insérer un cathéter dans un arc aortique d'un patient ; déployer, par l'intermédiaire du cathéter, le dispositif de protection embolique cérébrale dans l'arc aortique du patient ; et positionner le dispositif de protection embolique cérébrale sur chaque entrée de trois grand vaisseaux menant au cerveau, à l'intérieur de l'arc aortique du patient.
PCT/US2021/026851 2020-04-10 2021-04-12 Dispositif de protection embolique cérébrale Ceased WO2021207728A1 (fr)

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US63/008,019 2020-04-10

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060195178A1 (en) * 2005-02-28 2006-08-31 Stephen West Aneurismal sack deflator
US20100305604A1 (en) * 2007-11-27 2010-12-02 Gunnar Pah Device for Filtering Blood
US20140100597A1 (en) * 2012-10-09 2014-04-10 Boston Scientific Scimed, Inc. Special opening aortic embolic protection device for structural heart procedures
US20140249566A1 (en) * 2013-03-01 2014-09-04 Aga Medical Corporation Embolic protection shield
US8852225B2 (en) * 2008-09-25 2014-10-07 Medtronic, Inc. Emboli guarding device
US20180064525A1 (en) * 2015-04-09 2018-03-08 Frid Mind Technologies 3d filter for prevention of stroke
US20180103958A1 (en) * 2004-05-25 2018-04-19 Covidien Lp Flexible vascular occluding device
US20200054432A1 (en) * 2018-03-27 2020-02-20 Maduro Discovery, Llc Accessory device to provide neuroprotection during interventional procedures

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180103958A1 (en) * 2004-05-25 2018-04-19 Covidien Lp Flexible vascular occluding device
US20060195178A1 (en) * 2005-02-28 2006-08-31 Stephen West Aneurismal sack deflator
US20100305604A1 (en) * 2007-11-27 2010-12-02 Gunnar Pah Device for Filtering Blood
US8852225B2 (en) * 2008-09-25 2014-10-07 Medtronic, Inc. Emboli guarding device
US20140100597A1 (en) * 2012-10-09 2014-04-10 Boston Scientific Scimed, Inc. Special opening aortic embolic protection device for structural heart procedures
US20140249566A1 (en) * 2013-03-01 2014-09-04 Aga Medical Corporation Embolic protection shield
US20180064525A1 (en) * 2015-04-09 2018-03-08 Frid Mind Technologies 3d filter for prevention of stroke
US20200054432A1 (en) * 2018-03-27 2020-02-20 Maduro Discovery, Llc Accessory device to provide neuroprotection during interventional procedures

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