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WO2016011267A1 - Dispositif de protection contre une embolie - Google Patents

Dispositif de protection contre une embolie Download PDF

Info

Publication number
WO2016011267A1
WO2016011267A1 PCT/US2015/040773 US2015040773W WO2016011267A1 WO 2016011267 A1 WO2016011267 A1 WO 2016011267A1 US 2015040773 W US2015040773 W US 2015040773W WO 2016011267 A1 WO2016011267 A1 WO 2016011267A1
Authority
WO
WIPO (PCT)
Prior art keywords
cage
protection device
embolic protection
frame
aortic arch
Prior art date
Application number
PCT/US2015/040773
Other languages
English (en)
Inventor
John P. PIGOTT
Original Assignee
Pigott John P
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pigott John P filed Critical Pigott John P
Publication of WO2016011267A1 publication Critical patent/WO2016011267A1/fr

Links

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
    • A61F2/011—Instruments for their placement or removal
    • 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
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • 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
    • A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • 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
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • 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
    • A61F2230/0017—Angular shapes
    • A61F2230/0019—Angular shapes rectangular
    • 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
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • Exemplary embodiments of the present invention relate generally to embolic protection devices, such as can be used to prevent or reduce the risks associated with emboli in the bloodstream.
  • this invention relates to an embolic protection device that can be inserted into a blood vessel to prevent emboli from entering multiple vessels that branch outwardly therefrom, while still allowing blood flow to those vessels.
  • Transcatheter aortic valve implantation is a minimally invasive procedure used to treat subjects with severe aortic valve stenosis or an abnormally narrowing of the aortic valve opening.
  • a prosthetic aortic valve is delivered through a catheter tube and inserted into the existing aortic valve.
  • the prosthetic aortic valve is then expanded therein and implanted to replace the existing aortic valve.
  • a risk associated with the TAVI procedure is the embolization of debris, such as plaque and calcified particles, which can be released from the existing aortic valve. In severe cases, a piece of embolus can travel through the aortic arch and into a carotid artery causing stroke or even death.
  • an embolus protection device in the aortic arch to prevent emboli from entering arterial vessels that branch outwardly therefrom.
  • One known device is an embolic deflector.
  • the embolic deflector is percutaneously inserted into the aortic arch and then deployed to cover the openings that lead into the various arterial vessels.
  • the embolic deflector may also include a screen portion to allow blood flow through the deflector and into the arterial vessels.
  • it would be desirable to provide an embolic protection device that can be positioned in a blood vessel to effectively prevent emboli from entering multiple vessels that branch outwardly therefrom while still allowing blood flow to those vessels.
  • This invention relates to an embolic protection device that can be inserted into a blood vessel to prevent emboli from entering multiple vessels that branch outwardly therefrom, while still allowing blood flow to those vessels.
  • a collapsible catheter device is disclosed that can be navigated through the arcuate arch of the aorta. The catheter device may then be deployed such that it opens to an expanded position that substantially seals against the walls of the aorta.
  • the device may comprise a larger mesh over the majority of the surface configured to maintain the structure of the device but otherwise allow blood flow to pass therethrough.
  • a distal portion of said device may expand to a larger radius than a proximal portion to reflect the anatomy of the aortal arch.
  • Select portions of the device may be covered with a much finer mesh adapted to stop emboli from traveling therethrough while still allowing blood flow.
  • portions of the device facing the branching arteries of the aorta including, without limitation, the brachioephalic artery, the left common arotid artery, and the left subclavian artery may be covered with said mesh.
  • the mesh may be of any shape or size, and may be comprised of several smaller, individual sections of mesh.
  • Figure 1 is a sectional elevation view of an aortic arch having an embolic protection device in accordance with this invention disposed therein, which is illustrated in a contracted position.
  • Figure 2 is an enlarged sectional elevation view of the embolic protection device shown in Figure 1.
  • Figure 3 is a sectional elevation view of the aortic arch shown in Figure 1 wherein the embolic protection device is illustrated in an expanded position.
  • Figure 4 is a side elevation view of the embolic protection device shown in Figure 3.
  • Figure 5 is a sectional elevation view of the aortic arch shown in Figure 1 wherein the embolic protection device is disposed therein in an alternative manner.
  • Figure 6 is a sectional elevation view of the embolic protection device shown in Figure 5 illustrated with a portion of the outer mesh removed or otherwise rendered transparent to highlight additional features of the present invention.
  • Figure 7 is a top plan view of the embolic protection device shown in Figure 4.
  • Figure 8 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention.
  • Figure 9 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention.
  • Figure 10 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention.
  • Figure 11 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention.
  • Figure 12 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENT(S)
  • FIG. 1 an aortic arch 10 having an embolic protection device 20 disposed therein in accordance with the present invention.
  • the embolic protection device 20 in shown in the contracted position.
  • the embolic protection device 20 can be placed in the contracted position and percutaneously inserted into a blood vessel and positioned at a location where multiple vessels branch outwardly therefrom.
  • the embolic protection device 20 can be deployed and expanded within the blood vessel.
  • the embolic protection device 20 diverts emboli through the blood vessel and prevents the emboli from entering the branching vessels while still allowing blood flow to those vessels.
  • the embolic protection device 20 can be disposed within the aortic arch 10 of a subject prior to performing a transcatheter aortic valve
  • the embolic protection device 20 is useful to prevent or reduce the risks typically associated with emboli that are released during the TAVI procedure, such as a stroke for example. Although the embolic protection device 20 will be described and illustrated in the context of a TAVI procedure, it should be appreciated that the embolic protection device 20 can be used in any desired environment and for any desired purpose.
  • an ascending aorta 11 leads from the heart (not shown) to the aortic arch 10.
  • An aortic valve (not shown) is located between the heart and the ascending aorta 11.
  • Multiple arterial vessels branch outwardly from the aortic arch 10, such as the brachiocephalic artery 12, the left common carotid artery 13, and the left subclavian artery 14.
  • a descending aorta 15 continues from the aortic arch 10 to lower extremities of the subject's body.
  • blood flow is then diverted to the numerous arterial vessels or continues down the descending aorta 15, as indicated by the broken arrows.
  • the illustrated embolic protection device 20 is a cylindrical, flexible member that is capable of expanding from a first or contracted position (shown in figure 1 and figure 2) to a second or expanded position (shown in figure 3 and figure 4) wherein the diameter of the embolic protection device 20 is larger when in the expanded position.
  • the illustrated embolic protection device 20 may be placed in the contracted position and percutaneously inserted into a blood vessel, such as a femoral artery (not shown) for example, and fed over a previously positioned guide wire 16 until it is positioned in the aortic arch 10.
  • the embolic protection device 20 can be delivered into the aortic arch 10 using an aortic valve replacement catheter 18 as will be explained below or fed through a delivery catheter (not shown).
  • the illustrated embolic protection device 20 is initially disposed within an outer sheath 30, although such is not required.
  • the outer sheath 30 may extend from an operating handle (not shown), which will be further explained below.
  • the outer sheath 30 is an elongated, cylindrical tube that can be made from any biocompatible material, such as polyvinyl or polyethylene and may include a braided wall reinforcement if so desired. It should also be appreciated that the outer sheath 30 can have any outer diameter, wall thickness, or length for a desired application.
  • a plurality of linkages 40 are configured to attach the embolic protection device 20 to an inner tube 50.
  • the illustrated linkages 40 are connected at their first ends to an end portion of the embolic protection device 20.
  • the linkages 40 can be connected to the embolic protection device 20 by fused connections, pivotal hinge connections, fasteners, or in any other manner.
  • the linkages 40 may radially extend beyond an outer surface of the embolic protection device 20 to facilitate retrieval of the embolic protection device 20 within the outer sheath 30 if so desired.
  • the linkages 40 may continue to axially extend along any length of the inner or outer surface of the embolic protection device 20.
  • the linkages 40 can be wire, tubing, or any other elongated members and can be made from any generally resilient material such as a metal wire or the like.
  • the linkages 40 can be secured to the inner tube 50 using any process, such as a soldering, brazing, or welding process.
  • the linkages 40 can be secured to the inner tube 50 using a fastener arrangement, such as an annular collar, pivotal hinges, or any other components.
  • the illustrated inner tube 50 is a cylindrical member that extends within the outer sheath 30.
  • the inner tube 50 can be formed from a generally resilient material such as nitinol, for example, which provides rigidity yet maintains adequate flexibility to enable the embolic protection device 20 to be passed through the blood vessel and into the aortic arch 10. It should be appreciated, however, that the inner tube 50 can be formed from any suitable material for a desired application. Further, the inner tube 50 need not be a cylindrical structure, but may alternatively be a solid wire or the like.
  • the embolic protection device 20 may be provided with an operating handle (not shown), although such is not required.
  • the operation handle can be any device that is configured to selectively operate the embolic protection device 20 between the contracted position and the expanded position.
  • the operating handle may include a first handle portion and a second handle portion that is moveable relative to the first handle portion.
  • An opposite end of the inner tube 50 can be attached to the first handle portion and an opposite end of the outer sheath 30 can be attached to the second handle portion.
  • the outer sheath 30 can be selectively moved relative to the embolic protection device 20 and the inner tube 50 by operation of the second handle portion.
  • the operating handle can be a powered device or any other movable mechanism if so desired.
  • the embolic protection device 20 is illustrated in the expanded position.
  • the embolic protection device 20 can be operable between the contracted position and the expanded position in any manner.
  • the outer sheath 30 can be moved relative to the embolic protection device 20 by the operating handle (not shown) until the embolic protection device 20 becomes fully exposed from the outer sheath 30.
  • the illustrated embolic protection device 20 is then configured to automatically expand once removed from the outer sheath 30, although such is not required.
  • the embolic protection device 20 may include a frame 22 that is biased for expansion.
  • the illustrated frame 22 is a cage-like structure made from a plurality of resilient members that are interconnected together, such as wire members or the like.
  • the frame 22 may be shaped as pair of abutting hollow cylinders having different outer diameters and a sloping transition section between the sections.
  • the resilient members can be interconnected in any manner for contraction and expansion of the embolic protection device 20.
  • the resilient members may be connected to form diamond shaped sections or any other deformable shape structure.
  • the resilient members may be intermeshed with one another to form a plurality of linked components if so desired.
  • the frame 22 need not be biased for expansion but can be expanded in any other manner, such as with expansion members (see figure 6) or a balloon catheter (not shown).
  • the frame 22 can be made from stainless steel, nitinol, plastic, or any other biocompatible material.
  • the frame 22 can be any flexible structure that is capable of expanding and contracting. Further, it should be appreciated that the frame 22 is not required.
  • the illustrated embolic protection device 20 includes a first diameter D1 and a second diameter D2 that is larger than the first diameter D1 , although such is not required.
  • the second diameter D2 is sized to fully traverse the inner lumen of the ascending aorta 11 such that the embolic protection device 20 engages the inner walls of the ascending aorta 11 forming a seal therebetween.
  • the first diameter D1 can be any diameter sufficient to allow adequate blood flow through the aortic arch 10, but need not engage the inner walls thereof. It should be
  • the first diameter D1 may be sized such that the embolic protection device 20 engages the inner walls of the descending aorta 15 forming a seal therebetween if so desired.
  • the illustrated embolic protection device 20 also includes a sleeve 24, although such is not required.
  • the sleeve 24 can be a layer of generally impermeable material that fully or partially extends around the circumference of the frame 22. As shown, the sleeve 24 extends around an inner circumference or surface of the frame 22 but may alternatively extend around an outer surface of the frame 22 if so desired.
  • the sleeve 24 can be made from polytetrafluoroethylene (PTFE) or any other biocompatible material. It should be appreciated that the sleeve 24 may be any thickness or can be partially impermeable if so desired, as will be explained below in another embodiment.
  • the illustrated embolic protection device 20 further includes a screen portion 26.
  • the screen portion 26 is configured to provide fluid communication through a surface of the embolic protection device 20.
  • the screen portion 26 can be any fluid permeable barrier that is configured to filter or otherwise remove emboli from the blood stream that enters the various arterial vessels 12, 13, and 14 through the embolic protection device 20.
  • the screen portion 26 can be embodied as a semipermeable membrane that allows blood, but not embolic debris, to pass therethrough.
  • the illustrated screen portion 26 is a flexible netting that is formed from interlaced or woven fibers.
  • the screen portion 26 can be made from any biocompatible material that is flexible, including but not limited to PTFE fibers, one or more thin-gauge wires, or other types of filtering elements commonly employed within the body, in hemodynamic circuits, or in heart lung machines and dialysis machines. Further, the screen portion 26 can be made using any suitable process. The screen portion 26 can be secured to the frame 22 or the sleeve 24 in any manner, including but not limited to a fusion process, a woven process, an adhesive, or threading.
  • the embolic protection device 20 may be inserted and positioned in the blood vessel using an aortic valve replacement (AVR) catheter 18.
  • AVR aortic valve replacement
  • the AVR catheter 18 can be used to implant the prosthetic heart valve during a TAVI procedure.
  • the step of initially inserting the embolic protection device 20 into the aortic arch 10 using a separate catheter can be eliminated by using the AVR catheter 18 to position the embolic protection device 20 in the aortic arch 10.
  • the outer sheath 30 may initially extend over the AVR catheter 18 and the embolic protection device 20 to retain the embolic protection device 20 in the contracted position.
  • the embolic protection device 20 can be deployed and expanded by pulling the outer sheath 30 away from the embolic protection device 20.
  • the embolic protection device 20 may be attached to the AVR catheter 18 using any number of linkages 40 extending from a first end portion and/or a second end portion of the embolic protection device 20, although such is not required. It should be appreciated that the embolic protection device 20 may include any additional components to accomplish the functions described herein and below.
  • the illustrated embolic protection device 20 and any of the other embodiments described herein may include a plurality of extension members 28, although such is not required.
  • the illustrated extension members 28 are attached at their first ends to an outer surface of the AVR catheter 18 and at their second ends to the frame 22 of the embolic protection device 20.
  • the extension members 28 lie in a generally flat position parallel with the AVR catheter 18.
  • the embolic protection device 30 is deployed from the outer sheath 30, the extension members 28 pivot outwardly in a radial direction from the AVR catheter 18 so as to expand the embolic protection device 20.
  • extension members 28 may be biased to extend outwardly from the AVR catheter 18, such as with resilient connections or spring elements for example.
  • the extension members 28 may also be made from a generally resilient material, such as nitinol, or from any other suitable material, such as stainless steel or plastic.
  • the illustrated screen portion 26 has an elliptical shape that axially extends along the first diameter D1 of the embolic protection device 20.
  • the screen portion 26 has a sufficient length so that it can traverse each of the openings leading to the arterial vessels 12, 13, and 14.
  • the embolic protection device may be utilized in other areas of the body. In such
  • the screen portion 26 may have a sufficient length so that it can traverse the opening of whatever area is intended to be blocked.
  • the screen portion 26 also circumferentially extends along an upper surface of the embolic protection device 20 and is oriented towards the openings leading to the arterial vessels 12, 13, and 14. Numerous embodiments of the screen portion 26 will be further described and illustrated below.
  • embolic protection device 120 in accordance with another exemplary embodiment of this invention.
  • the embolic protection device 120 may include any structural features as described and illustrated above in the first embodiment, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 100 (i.e. 120, 122, 124, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.
  • the embolic protection device 120 may be fed over a guide wire 116 and include a frame 122 and a sleeve 124.
  • a plurality of linkages 140 are configured to attach the embolic protection device 120 to an inner tube 150, and the illustrated embolic protection device 120 may be initially disposed within an outer sheath 130, although such is not required.
  • the illustrated embolic protection device 120 further includes a plurality of screen portions 126.
  • the illustrated screen portions 126 are elliptical in shape and each extends along a substantial length of the first diameter D1. As such, the screen portions 126 may be positioned laterally adjacent to one another in a parallel manner. It should be appreciated that the screen portions 126 can have any length or width for a desired application.
  • the embolic protection device 120 may include any number or configuration of screen portions described herein.
  • the embolic protection device 120 may include screen portions 126 that are located about the circumference thereof if so desired.
  • the embolic protection device 120 may be positioned within the aortic arch 10 in any orientation.
  • embolic protection device 220 in accordance with another exemplary embodiment of this invention.
  • the embolic protection device 220 may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 200 (i.e. 220, 222, 224, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.
  • the embolic protection device 220 may be fed over a guide wire 216 and include a frame 222 and a sleeve 224.
  • a plurality of linkages 240 are configured to attach the embolic protection device 220 to an inner tube 250, and the illustrated embolic protection device 220 may be initially disposed within an outer sheath 230, although such is not required.
  • the illustrated embolic protection device 220 further includes a plurality of screen portions 226.
  • the illustrated screen portions 226 are oval in shape and each circumferentially extends about a portion of the first diameter D1. As such, the screen portions 226 may be positioned along any axial length of the first diameter D1.
  • the screen portions 226 can have any length or width for a desired application.
  • the embolic protection device 220 may include any number or configuration of screen portions described herein.
  • the embolic protection device 220 may include screen portions 226 that extend along a top surface and a bottom surface thereof if so desired.
  • embolic protection device 320 in accordance with another exemplary embodiment of this invention.
  • the embolic protection device 320 may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 300 (i.e. 320, 322, 324, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.
  • the embolic protection device 320 may be fed over a guide wire 316 and include a frame 322 and a sleeve 324.
  • a plurality of linkages 340 are configured to attach the embolic protection device 320 to an inner tube 350, and the illustrated embolic protection device 320 may be initially disposed within an outer sheath 330, although such is not required.
  • the illustrated embolic protection device 320 further includes a plurality of screen portions 326A and screen portion 326B.
  • the illustrated screen portions 326A are generally oval in shape and are positioned laterally adjacent to one another.
  • the screen portion 326B is a square and may be positioned in any location relative to the screen portions 326A as desired.
  • the screen portions 326A can have any length or width, and the screen portion 326B can have any length sides for a desired application.
  • the embolic protection device 320 may include any number or configuration of screen portions 326A and 326B described herein.
  • FIG 11 there is illustrated an embolic protection device 420 in accordance with another exemplary embodiment of this invention.
  • the embolic protection device 420 may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 400 (i.e. 420, 422,424, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.
  • the embolic protection device 420 may be fed over a guide wire 416 and include a frame 422, a sleeve 424, and a screen portion 426.
  • a plurality of linkages 440 are configured to attach the embolic protection device 420 to an inner tube 450, and the illustrated embolic protection device 420 may be initially disposed within an outer sheath 430, although such is not required.
  • the illustrated screen portion 426 is spiral in shape, thereby extending around the circumference of the embolic protection device 420.
  • the screen portion 426 can axially extend along any length of the first diameter D1 or the second diameter D2 if so desired. It should be appreciated that the screen portion 426 can have any width for a desired application.
  • the embolic protection device 420 may be positioned within the aortic arch 10 in any desired orientation.
  • embolic protection device 520 in accordance with a sixth embodiment of this invention.
  • the embolic protection device 520 may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 500 (i.e. 520, 522, 524, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.
  • a plurality of linkages 540 are configured to attach the embolic protection device 520 to an inner tube 550.
  • the illustrated embolic protection device 520 may be fed over a guide wire 516 and include a first frame portion 522A and a second frame portion 522B that are located at opposite ends of an intermediate frame portion 522C, although such a configuration is not required.
  • the first frame portion 522A is located near an end portion of the first diameter D1 and the second frame portion 522B is located near an end portion of the second diameter D2.
  • the first and second frame portions 522A, 522B can provide rigidity to the ends of the embolic protection device 520.
  • first and second frame portions 522A, 522B may also be configured to automatically expand once deployed from an outer sheath 530, as the frame described above in the previous embodiments.
  • the first and second frame portions 522A, 522B may also engage the inner walls of the aortic arch (not shown) to provide a seal therewith, although such is not required.
  • the illustrated intermediate frame portion 522C includes a plurality of axially extending wire members that are laterally spaced apart from one another. Although not shown, the wire members may be intermeshed with one another if so desired.
  • the illustrated intermediate frame portion 522C allows the embolic protection device 520 to contract and expand with relative ease and provides increased flexibility for bending around the aortic arch (not shown) for example.
  • the embolic protection device 520 may also include any number of extension members (not shown) if so desired, as described above with reference to figure 5 and figure 6. It should be appreciated, however, that the frame of the embolic protection device 520 may be configured in any manner.
  • the illustrated embolic protection device 520 also includes a screen portion 526 that circumferentially extends along an entire length of the embolic protection device 520. However, the screen portion 526 may circumferentially extend about any portion of the embolic protection device 520 or along any length thereof.
  • the screen portion 526 can allow for increased blood flow through the embolic protection device 520 to the arterial vessels (not shown).
  • the screen portion 526 may also allow the embolic protection device 520 to be positioned within the aortic arch (not shown) in any orientation.
  • the screen portion 526 can be any permeable structure, such as described above for example.
  • any embodiment of the present invention may include any of the optional or preferred features of the other embodiments of the present invention.
  • the exemplary embodiments herein disclosed are not intended to be exhaustive or to unnecessarily limit the scope of the invention.
  • the exemplary embodiments were chosen and described in order to explain the principles of the present invention so that others skilled in the art may practice the invention. Having shown and described exemplary embodiments of the present invention, those skilled in the art will realize that many variations and modifications may be made to the described invention. Many of those variations and modifications will provide the same result and fall within the spirit of the claimed invention. It is the intention, therefore, to limit the invention only as indicated by the scope of the claims.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de protection contre une embolie (20), qui comprend un cadre en forme de cage (22) constitué d'éléments reliés entre eux. Un maillage (26) dimensionné pour filtrer des emboles recouvre une partie du cadre. Une pluralité d'éléments de raccordement s'étendent d'une première extrémité du cadre à un tube (50), et peuvent en outre s'étendre d'une seconde extrémité du cadre au tube. De préférence, le dispositif est dimensionné pour être fixé temporairement à l'intérieur de la crosse aortique (15) et empêcher des emboles de circuler à travers les artères (12, 13 et 14) partant de la crosse aortique.
PCT/US2015/040773 2014-07-18 2015-07-16 Dispositif de protection contre une embolie WO2016011267A1 (fr)

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US201462026179P 2014-07-18 2014-07-18
US62/026,179 2014-07-18

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CN107126298A (zh) * 2017-05-10 2017-09-05 上海长海医院 可回收式主动脉临时栓塞保护装置
WO2019210118A1 (fr) * 2018-04-26 2019-10-31 Boston Scientific Scimed, Inc. Systèmes pour protéger le système vasculaire cérébral
US10595994B1 (en) 2018-09-20 2020-03-24 Vdyne, Llc Side-delivered transcatheter heart valve replacement
US20210052375A1 (en) * 2019-08-19 2021-02-25 Encompass Technologies, Inc. Embolic protection access system
WO2021062288A1 (fr) * 2019-09-25 2021-04-01 Renalpro Medical, Inc. Dispositifs et procédés pour occlure au moins partiellement un vaisseau sanguin tout en maintenant une perfusion distale
US11071627B2 (en) 2018-10-18 2021-07-27 Vdyne, Inc. Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis
US11076956B2 (en) 2019-03-14 2021-08-03 Vdyne, Inc. Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis
US11109969B2 (en) 2018-10-22 2021-09-07 Vdyne, Inc. Guidewire delivery of transcatheter heart valve
US11166814B2 (en) 2019-08-20 2021-11-09 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11173027B2 (en) 2019-03-14 2021-11-16 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11185409B2 (en) 2019-01-26 2021-11-30 Vdyne, Inc. Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis
US11202706B2 (en) 2019-05-04 2021-12-21 Vdyne, Inc. Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus
US11234813B2 (en) 2020-01-17 2022-02-01 Vdyne, Inc. Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery
US11253359B2 (en) 2018-12-20 2022-02-22 Vdyne, Inc. Proximal tab for side-delivered transcatheter heart valves and methods of delivery
US11273033B2 (en) 2018-09-20 2022-03-15 Vdyne, Inc. Side-delivered transcatheter heart valve replacement
US11273032B2 (en) 2019-01-26 2022-03-15 Vdyne, Inc. Collapsible inner flow control component for side-deliverable transcatheter heart valve prosthesis
US11278437B2 (en) 2018-12-08 2022-03-22 Vdyne, Inc. Compression capable annular frames for side delivery of transcatheter heart valve replacement
US11298227B2 (en) 2019-03-05 2022-04-12 Vdyne, Inc. Tricuspid regurgitation control devices for orthogonal transcatheter heart valve prosthesis
US11331186B2 (en) 2019-08-26 2022-05-17 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11344413B2 (en) 2018-09-20 2022-05-31 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery
WO2023125743A1 (fr) * 2021-12-29 2023-07-06 上海微盾医疗科技有限公司 Filtre et dispositif de protection anti-embolie
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US11786366B2 (en) 2018-04-04 2023-10-17 Vdyne, Inc. Devices and methods for anchoring transcatheter heart valve
US12186187B2 (en) 2018-09-20 2025-01-07 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery

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CN107126298B (zh) * 2017-05-10 2023-11-10 上海长海医院 可回收式主动脉临时栓塞保护装置
CN107126298A (zh) * 2017-05-10 2017-09-05 上海长海医院 可回收式主动脉临时栓塞保护装置
US11786366B2 (en) 2018-04-04 2023-10-17 Vdyne, Inc. Devices and methods for anchoring transcatheter heart valve
JP7093849B2 (ja) 2018-04-26 2022-06-30 ボストン サイエンティフィック サイムド，インコーポレイテッド 脳血管系を保護するためのシステムと方法
EP4400086A3 (fr) * 2018-04-26 2024-09-25 Boston Scientific Scimed, Inc. Systèmes et procédés de protection du système vasculaire cérébral
CN112334093A (zh) * 2018-04-26 2021-02-05 波士顿科学国际有限公司 用于保护脑血管的系统
JP2021521972A (ja) * 2018-04-26 2021-08-30 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． 脳血管系を保護するためのシステムと方法
US11439491B2 (en) 2018-04-26 2022-09-13 Claret Medical, Inc. Systems and methods for protecting the cerebral vasculature
WO2019210118A1 (fr) * 2018-04-26 2019-10-31 Boston Scientific Scimed, Inc. Systèmes pour protéger le système vasculaire cérébral
US12186187B2 (en) 2018-09-20 2025-01-07 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery
US10595994B1 (en) 2018-09-20 2020-03-24 Vdyne, Llc Side-delivered transcatheter heart valve replacement
US11344413B2 (en) 2018-09-20 2022-05-31 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery
US11273033B2 (en) 2018-09-20 2022-03-15 Vdyne, Inc. Side-delivered transcatheter heart valve replacement
US11071627B2 (en) 2018-10-18 2021-07-27 Vdyne, Inc. Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis
US11109969B2 (en) 2018-10-22 2021-09-07 Vdyne, Inc. Guidewire delivery of transcatheter heart valve
US11278437B2 (en) 2018-12-08 2022-03-22 Vdyne, Inc. Compression capable annular frames for side delivery of transcatheter heart valve replacement
US11253359B2 (en) 2018-12-20 2022-02-22 Vdyne, Inc. Proximal tab for side-delivered transcatheter heart valves and methods of delivery
US11273032B2 (en) 2019-01-26 2022-03-15 Vdyne, Inc. Collapsible inner flow control component for side-deliverable transcatheter heart valve prosthesis
US11185409B2 (en) 2019-01-26 2021-11-30 Vdyne, Inc. Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis
US11298227B2 (en) 2019-03-05 2022-04-12 Vdyne, Inc. Tricuspid regurgitation control devices for orthogonal transcatheter heart valve prosthesis
US11076956B2 (en) 2019-03-14 2021-08-03 Vdyne, Inc. Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis
US11173027B2 (en) 2019-03-14 2021-11-16 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11202706B2 (en) 2019-05-04 2021-12-21 Vdyne, Inc. Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus
US11707351B2 (en) 2019-08-19 2023-07-25 Encompass Technologies, Inc. Embolic protection and access system
US20210052375A1 (en) * 2019-08-19 2021-02-25 Encompass Technologies, Inc. Embolic protection access system
US20220226107A1 (en) * 2019-08-19 2022-07-21 Encompass Technologies, Inc. Embolic protection access system
US11166814B2 (en) 2019-08-20 2021-11-09 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11179239B2 (en) 2019-08-20 2021-11-23 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11331186B2 (en) 2019-08-26 2022-05-17 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
CN115135256A (zh) * 2019-09-25 2022-09-30 睿诺帛医学科技股份有限公司 用于在保持远端灌注时至少局部闭塞血管的装置和方法
WO2021062288A1 (fr) * 2019-09-25 2021-04-01 Renalpro Medical, Inc. Dispositifs et procédés pour occlure au moins partiellement un vaisseau sanguin tout en maintenant une perfusion distale
US11234813B2 (en) 2020-01-17 2022-02-01 Vdyne, Inc. Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery
WO2023125743A1 (fr) * 2021-12-29 2023-07-06 上海微盾医疗科技有限公司 Filtre et dispositif de protection anti-embolie

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