CA2316237A1 - Implantable cerebral protection device and methods of use - Google Patents

Implantable cerebral protection device and methods of use Download PDF

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Publication number
CA2316237A1
CA2316237A1 CA002316237A CA2316237A CA2316237A1 CA 2316237 A1 CA2316237 A1 CA 2316237A1 CA 002316237 A CA002316237 A CA 002316237A CA 2316237 A CA2316237 A CA 2316237A CA 2316237 A1 CA2316237 A1 CA 2316237A1
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CA
Canada
Prior art keywords
aortic
diverter
aorta
lumen
aortic diverter
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Granted
Application number
CA002316237A
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French (fr)
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CA2316237C (en
Inventor
John R. Mckenzie
Sachiko Hattori
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Embol-X, Inc.
John R. Mckenzie
Sachiko Hattori
Edwards Lifesciences Corporation
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Application filed by Embol-X, Inc., John R. Mckenzie, Sachiko Hattori, Edwards Lifesciences Corporation filed Critical Embol-X, Inc.
Priority to CA002647854A priority Critical patent/CA2647854A1/en
Priority to CA002650874A priority patent/CA2650874A1/en
Publication of CA2316237A1 publication Critical patent/CA2316237A1/en
Application granted granted Critical
Publication of CA2316237C publication Critical patent/CA2316237C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
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    • 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
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    • A61F2/011—Instruments for their placement or removal
    • A—HUMAN NECESSITIES
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
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    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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    • 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
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    • 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
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    • 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
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    • A—HUMAN NECESSITIES
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    • 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
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/902—Method of implanting

Abstract

This invention is devices, and methods for diverting emboli away from the carotid arteries in the aorta. The devices are aortic diverters (10) that generally comprise a hollow tube (20) with a substantially cylindrical or conical wall (25), which is impermeable to emboli. The hollow tube has a proximal end (30), terminating in a substantially circular edge adapted to fill the lumen of the aorta, and a distal end (40). The proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through the hollow tube, and exit the distal end. The hollow tube also has an anchoring mechanism (50) for securing the hollow tube to the lumen of the aorta. Additionally, snowshoe aortic diverters which are planar rather than cylindrical are also disclosed.

Claims

1. An aortic diverter insertable into an aorta for diverting emboli away from the carotid arteries, comprising:
a hollow tube comprising a substantially cylindrical or conical wall impermeable to emboli and permeable to blood, the hollow tube having a proximal end terminating in a substantially circular edge adapted to fill the lumen of the aorta, and a distal end terminating in a substantially circular edge, wherein the proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through the hollow tube, and exit the distal end, and wherein the circumference of the proximal end is larger than the circumference of the distal end; and an anchoring mechanism for securing the hollow tube to the lumen of the aorta.
3. The aortic diverter of claim 1, wherein the wall includes an opening on its surface, and wherein the opening is covered with a material impermeable to emboli.
4. The aortic diverter of claim 1, wherein the wall includes a plurality of openings in a predetermined pattern, and wherein the openings are covered with a material impermeable to emboli.
5. The aortic diverter of claim 1, wherein the wall comprises a monolithic molded material.
6. The aortic diverter of claim 1, wherein the wall comprises Teflon.

7. The aortic diverter of claim 1, wherein the wall comprises nitinol.
8. The aortic diverter of claim 1, wherein the wall comprises urethane.
9. The aortic diverter of claim 1, wherein the wall comprises a mesh material.
10. The aortic diverter of claim 1, wherein the wall comprises a woven material.
11. The aortic diverter of claim 1, wherein the wall comprises a biodegradable material.
12. The aortic diverter of claim 1, wherein the wall comprises a thin polymer.
13. The aortic diverter of claim 1, wherein the anchoring mechanism comprises a sleeve secured to the proximal end of the hollow tube, the sleeve being adapted to frictionally engage the lumen of the aorta.
14. The aortic diverter of claim 1, wherein the anchoring mechanism comprises at least one suture.
15. The aortic diverter of claim 1, wherein the anchoring mechanism comprises at least one clip.
16. The aortic diverter of claim 1, wherein the anchoring mechanism comprises at least one hook.

17. The aortic diverter of claim 1, wherein the anchoring mechanism comprises adhesive glue.
18. The aortic diverter of claim 1, wherein the anchoring mechanism comprises the proximal end of the hollow tube, wherein the proximal end of the hollow tube is adapted to frictionally engage the lumen of the aorta.
20. The aortic diverter of claim 1, wherein said hollow tube has a substantially frustoconical shape.
21. The aortic diverter of claim 1, wherein the wall is expandable between a compressed state for percutaneous delivery of the diverter and a radially expanded state for frictional engagement with the lumen of the aorta.
23. The aortic diverter of claim 21, wherein said hollow tube is a flexible windsock.
24. The aortic diverter of claim 23, wherein the anchoring mechanism comprises a sleeve secured to the proximal end of the hollow tube, the sleeve being adapted to frictionally engage the lumen of the aorta.
25. The aortic diverter of claim 24, wherein said sleeve is radially expandable.

26. An aortic diverter insertable in an aorta for diverting emboli away from the carotid arteries comprising:
a hollow tube comprising a substantially cylindrical or conical wall impermeable to emboli and permeable to blood, the hollow tube having a proximal end terminating in a substantially circular edge adapted to fill the lumen of the aorta, and a distal end terminating in a substantially circular edge, wherein the proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through.the hollow tube, and exit the distal end, and wherein the circumference of the proximal end is larger than the circumference of the distal end; and a sleeve secured to the proximal end of the hollow tube, the sleeve being adapted to frictionally engage the lumen of the aorta.
27. The aortic diverter of claim 26, wherein the wall is impermeable to blood.
28. The aortic diverter of claim 26, wherein the wall includes an opening on its surface, and wherein the opening is covered with a material impermeable to emboli.
29. The aortic diverter of claim 26, wherein the wall includes a plurality of openings in a predetermined pattern, and wherein the openings are covered with a material impermeable to emboli.
30. The aortic diverter of claim 26, wherein the wall comprises a monolithic molded material.

31. The aortic diverter of claim 26, wherein the wall comprises Teflon.
32. The aortic diverter of claim 26, wherein the wall comprises nitinol.
33. The aortic diverter of claim 26, wherein the wall comprises urethane.
34. The aortic diverter of claim 26, wherein the wall comprises a mesh.
35. The aortic diverter of claim 26, wherein the wall comprises a woven material.
36. The aortic diverter of claim 26, wherein the wall comprises a biodegradable material.
37. The aortic diverter of claim 26, wherein the wall comprises a thin polymer.
38. The aortic diverter of claim 26, wherein the wall is expandable between a compressed state for percutaneous delivery of the diverter and a radially expanded state for frictional engagement with the lumen of the aorta.
39. The aortic diverter of claim 38, wherein said hollow tube is a flexible windsock.
40. The aortic diverter of claim 39, wherein said hollow tube has a substantially frustoconical shape.

41. A method for protecting a patient against cerebral embolization, said method comprising the steps of:
a hollow tube comprising a substantially cylindrical or conical wall impermeable to emboli, the hollow tube having a proximal end terminating in a substantially circular edge adapted to fill the lumen of the aorta, and a distal end terminating in a substantially circular edge, wherein the proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through the hollow tube, and exit the distal end, and wherein the circumference of the proximal end is larger than the circumference of the distal end; and inserting the aortic diverter into the aortic arch in the region of the carotid arteries;
securing the aortic diverter to the lumen of the aorta, the proximal end of the aortic diverter extending upstream of the brachiocephalic trunk and the distal end of the aortic diverter extending downstream of the left subclavian artery or the left brachiocephalic trunk;
and flowing blood through the hollow tube and into the carotid arteries.
42. The method of claim 41, wherein the aortic diverter is secured to the lumen of the aorta by suturing the aortic diverter to the lumen of the aorta.
43. The method of claim 41, wherein the aortic diverter is secured to the lumen of the aorta by clipping the aortic diverter to the lumen of the aorta.
44. The method of claim 41, wherein the aortic diverter is secured to the lumen of the aorta with a hook.

45. The method of claim 41, wherein the aortic diverter is secured to the lumen of the aorta with adhesive material.
46. The method of claim 41, wherein the aortic diverter is secured to the lumen of the aorta by fractionally engaging the lumen of the aorta.
47. The method of claim 41, wherein the aortic diverter is fractionally engaged to the lumen of the aorta by radially expanding the aortic diverter into frictional engagement to the lumen of the aorta.
48. The method of claim 41, wherein the aortic diverter comprises a sleeve secured to the proximal end of the hollow tube, the sleeve being adapted to fractionally engage the lumen of the aorta, and wherein the aortic diverter is secured to the lumen of the aorta by fractionally engaging the sleeve to the lumen of the aorta.
49. The method of claim 41, wherein the sleeve is fractionally engaged by radially expanding the sleeve into frictional engagement to the lumen of the aorta.
50. The method of claim 41, wherein the aortic diverter is surgically inserted into the aortic arch.
51. The method of claim 41, wherein the aortic diverter is percutaneously inserted into the aortic arch with an intravascular catheter.

52. A method for protecting a patient against cerebral embolization, said method comprising the steps of:
providing an aortic diverter comprising a substantially planar filter material which is impermeable to emboli while permitting substantial lateral blood flow;
inserting the filter material into the aortic arch in the region of the carotid arteries; and securing said filter material to the aortic lumen so that it covers a region over the anatomical openings leading into the carotid arteries extending from upstream of the brachiocephalic trunk to downstream of the left subclavian artery or the left brachiocephalic trunk, and from the anterior side of the lumen of the aorta to the posterior side of the lumen of the aorta.
53. The method of claim 52, wherein the aortic diverter is secured to the lumen of the aorta by suturing the aortic diverter to the lumen of the aorta.
54. The method of claim 52, wherein the aortic diverter is secured to the lumen of the aorta by clipping the aortic diverter to the lumen of the aorta.
55. The method of claim 52, wherein the aortic diverter is secured to the lumen of the aorta with a hook.
56. The method of claim 52, wherein the aortic diverter is secured to the lumen of the aorta with adhesive material.

57. The method of claim 52, wherein the aortic diverter is surgically inserted into the aortic arch.
58. The method of claim 52, wherein the aortic diverter is percutaneously inserted into the aortic arch with an intravascular catheter.
59. A method for protecting a patient against cerebral embolization, said method comprising the steps of:
a hollow tube comprising a substantially cylindrical or conical wall impermeable to emboli and permeable to blood, the hollow tube having a proximal end terminating in a substantially circular edge adapted to fill the lumen of the aorta, and a distal end terminating in a substantially circular edge, wherein the proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through the hollow tube, and exit the distal end, and wherein the circumference of the proximal end is larger than the circumference of the distal end, said hollow tube being substantially flexible, wherein said hollow tube is releasably carried by an intravascular catheter, wherein said hollow tube is in a compressed state for percutaneous delivery into the aorta;
introducing the intravascular catheter containing the compressed aortic diverter into the vascular system;
advancing the intravascular catheter into the aortic arch to the region of the carotid arteries;
deploying the aortic diverter, wherein the aortic diverter is radially expanded to contact the lumen of the aorta, the proximal end of the aortic diverter extending upstream of the brachiocephalic trunk and the distal end of the aortic diverter extending downstream of the left subclavian artery or the left brachiocephalic trunk; and securing the aortic diverter to the lumen of the aorta.
60. The method of claim 59, wherein the aortic diverter is secured to the lumen of the aorta by fractionally engaging the lumen of the aorta.
61. The method of claim 59, wherein the aortic diverter is secured to the lumen of the aorta with a hook.
62. The method of claim 59, wherein the aortic diverter is secured to the lumen of the aorta with adhesive material.
63. The method of claim 59, wherein the aortic diverter comprises a sleeve secured to the proximal end of the hollow tube, and wherein the aortic diverter is secured to the lumen of the aorta by radially expanding the sleeve to fractionally engage the lumen of the aorta.
64. The method of claim 59, wherein the sleeve includes a hook, and wherein the aortic diverter is secured to the lumen of the aorta by radially expanding the sleeve so that the hook engages the lumen of the aorta.
65. The method of claim 59, wherein the aortic diverter is circumferentially disposed over and closely associated with a distal end of the intravascular catheter, wherein a removable sleeve circumferentially and longitudinally surrounds the aortic diverter, and wherein the aortic diverter is deployed by removing the sleeve to allow the aortic diverter to radially self-expand.
66. The method of claim 59, wherein the aortic diverter is circumferentially disposed over an inflatable balloon which is mounted on the distal end of the intravascular catheter, and wherein the aortic diverter is deployed by inflating the balloon to radially expand the aortic diverter.
67. A method for protecting a patient against cerebral embolization, said method comprising the steps of:
providing a mechanical diverter for the purpose of diverting emboli within a blood stream;
inserting the mechanical diverter into a blood vessel; and deploying the mechanical diverter within a stream of blood, wherein emboli are diverted upon contact with the mechanical diverter.
68. The method of claim 67, wherein the mechanical diverter is deployed within a region of a blood vessel having a first branch and a second branch, and wherein the mechanical diverter diverts emboli selectively into the first branch.
69. The method of claim 67, wherein the mechanical diverter comprises a hollow tube comprising a substantially cylindrical or conical wall impermeable to emboli, the hollow tube having a proximal end terminating in a substantially circular edge adapted to fill the lumen of the aorta, and a distal end, wherein the proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through the hollow tube, and exit the distal end.
72. A snowshoe aortic diverter insertable into an aorta for temporary diverting of emboli away from the carotid arteries, comprising:
a substantially planar tongue with proximal and distal ends, the planar tongue being impermeable to emboli, said planar tongue having a length extending from upstream of the brachiocephalic trunk to downstream of the left subclavian artery or the left brachiocephalic trunk and a width extending from the anterior side of the lumen of the aorta to the posterior side of the lumen of the aorta; and a handle with proximal and distal ends attached to the proximal end of the planar tongue.
73. The snowshoe aortic diverter of claim 72, wherein the tongue is substantially flexible.
74. The snowshoe aortic diverter of claim 72, wherein the tongue is amoeba shaped.
75. The snowshoe aortic diverter of claim 72, wherein the tongue is curved.
76. The snowshoe aortic diverter of claim 72, wherein the tongue is tapered.
77. The snowshoe aortic diverter of claim 72, wherein the tongue comprises a thin, flexible membrane and a substantially flexible framework.

78. The snowshoe aortic diverter of claim 77, wherein the framework comprises rings.
79. The snowshoe aortic diverter of claim 77, wherein the framework comprises a figure eight suspension frame.
80. The snowshoe aortic diverter of claim 77, wherein the tongue is rolled up.
81. The snowshoe aortic diverter of claim 77, wherein the tongue is folded up.
82. The snowshoe aortic diverter of claim 77, wherein the membrane comprises mesh material.
83. The snowshoe aortic diverter of claim 77, wherein the membrane is cotton based.
84. The snowshoe aortic diverter of claim 77, wherein the membrane comprises Teflon.
85. The snowshoe aortic diverter of claim 77, wherein the membrane comprises nitinol.
86. The snowshoe aortic diverter of claim 77, wherein the membrane comprises urethane.
87. The snowshoe aortic diverter of claim 77, wherein the membrane comprises polyurethane.

88. The snowshoe aortic diverter of claim 77, wherein the membrane comprises any combination of mesh material, cotton, Teflon, nitinol, urethane, or polyurethane.
89. The snowshoe aortic diverter of claim 72, wherein the tongue of the snowshoe diverter comprises a one-way valve for blood flow to the peripheral vasculature.
90. A method for temporarily protecting a patient against cerebral embolization, said method comprising the steps of:
inserting an aortic cannula through the wall of the aorta;
providing an aortic diverter, which is impermeable to emboli, wherein the diverter comprises a handle and a planar tongue;
inserting the diverter through the aortic cannula and into the aortic arch in the region of the carotid arteries; and introducing blood into the aorta through the cannula.
91. The method of claim 90, wherein supports are mounted on the planar tongue.
92. The method of claim 90, wherein the handle is cannulated.
93. The method of claim 92, wherein the blood-return cannula is in fluid communication with the handle of the snowshoe diverter.
94. The method of claim 90, wherein the blood-return cannula is in fluid communication with the aortic cannula.

95. The method of claim 90, wherein the blood-return cannula is inserted through the wall of the aorta upstream of the point of insertion of the aortic cannula.
96. The method of claim 90, wherein the blood-return cannula is inserted through the wall of the aorta downstream of the point of insertion of the aortic cannula.
97. The method of claim 95, wherein the tongue of the diverter comprises a one-way valve for blood flow to the peripheral vasculature.
98. The method of claim 90, wherein the aortic cannula comprises an inflatable balloon occluder concentrically mounted around its distal end.
99. The method of claim 98, wherein the balloon occluder is inflated to prevent back-flow of blood towards the region of the heart.
100. The method of claim 90, wherein the tongue comprises a thin, flexible membrane and a substantially flexible framework.
101. The method of claim 100, wherein the membrane is cotton based.
102. The method of claim 100, wherein the membrane comprises Teflon.
103. The method of claim 100, wherein the membrane comprises nitinol.

104. The method of claim 100, wherein the membrane comprises urethane.

105. The method of claim 100, wherein the membrane comprises polyurethane.

106. The method of claim 100, wherein the membrane comprises mesh material.

107. The method of claim 100, wherein the membrane comprises any combination of mesh material, cotton, Teflon, nitinol, urethane, and polyurethane.

108. The method of claim 100, wherein the framework comprises rings.

109. The method of claim 100, wherein the framework comprises a figure eight suspension frame.

110. The method of claim 100, wherein the planar tongue is rolled up during insertion into the aortic cannula.

111. The method of claim 100, wherein the planar tongue is folded up during insertion into the aortic cannula.

112. A method for temporarily protecting a patient against cerebral embolization, said method comprising the steps of:

introducing an aortic cannula with proximal and distal ends, wherein the aortic cannula comprises a planar aortic diverter, which is impermeable to emboli, wherein the diverter comprises a planar tongue with proximal and distal ends;
inserting the aortic cannula through the wall of the aorta;
positioning the aortic diverter in the region of the carotid arteries;
sealing the aortic wall against the outer wall of the aortic cannula; and introducing blood into the aorta through the cannula.

113. The method of claim 112, wherein supports are mounted on the planar tongue.

114. The method of claim 112, wherein the blood-return cannula is in fluid communication with the aortic cannula.

115. The method of claim 112, wherein the blood-return cannula is inserted through the wall of the aorta upstream of the point of insertion of the aortic cannula.

116. The method of claim 112, wherein the blood-return cannula is inserted through the wall of the aorta downstream of the point of insertion of the aortic cannula.

117. The method of claim 115, wherein the tongue of the diverter comprises a one-way valve for blood flow to the peripheral vasculature.

118. The method of claim 112, wherein the aortic cannula comprises an inflatable balloon occluder concentrically mounted around its distal end.

119. The method of claim 118, wherein the balloon occluder is inflated to prevent back-flow of blood towards the region of the heart.

120. The method of claim 112, wherein the tongue comprises a thin, flexible membrane and a substantially flexible framework.

121. The method of claim 120, wherein the membrane is cotton based.

122. The method of claim 120, wherein the membrane comprises Teflon.

123. The method of claim 120, wherein the membrane comprises nitinol.

124. The method of claim 120, wherein the membrane comprises urethane.

125. The method of claim 120, wherein the membrane comprises polyurethane.

126. The method of claim 120, wherein the membrane comprises a mesh material.

127. The method of claim 120, wherein the membrane comprises any combination of mesh material, cotton, Teflon, nitinol, urethane, or polyurethane.

128. The method of claim 120, wherein the framework comprises rings.

129. The method of claim 120, wherein the framework comprises a figure eight suspension ring.

130. The method of claim 112, wherein the proximal end of the tongue is connected to the distal end of the aortic cannula.

131. The method of claim 112, wherein the tongue is inside the lumen of the cannula, and wherein the tongue is deployed after the cannula has been inserted through the wall of the aorta.

132. A method for temporarily protecting a patient against cerebral embolization, said method comprising the steps of:
introducing an aortic cannula with proximal and distal ends, wherein the aortic cannula comprises a planar aortic diverter, which is impermeable to emboli, wherein the diverter comprises a planar tongue with proximal and distal ends;
inserting the aortic cannula through the wall of the aorta;
positioning the aortic diverter in the region of the carotid arteries;
introducing a cardioplegia cannula comprising an opening in its distal end and an inflatable balloon occluder concentrically mounted around its distal end;
inserting the cardioplegia cannula through the wall of the aorta;
inflating the balloon occluder;
delivering cardioplegia solution to the heart; and introducing blood into the aorta through the aortic cannula.

133. The method of claim 132, wherein the tongue comprises a thin, flexible membrane and a substantially flexible framework.

134. The method of claim 133, wherein the membrane is cotton based.

135. The method of claim 133, wherein the membrane comprises Teflon.

136. The method of claim 133, wherein the membrane comprises nitinol.

137. The method of claim 133, wherein the membrane comprises urethane.

138. The method of claim 133, wherein the membrane comprises polyurethane.

139. The method of claim 133, wherein the membrane comprises a mesh material.

140. The method of claim 133, wherein the membrane comprises any combination of mesh material, cotton, Teflon, nitinol, urethane, or polyurethane.

141. The method of claim 133, wherein the framework comprises rings.

142. The method of claim 133, wherein the framework comprises a figure eight suspension ring.

143. The method of claim 132, wherein the proximal end of the tongue is connected to the distal end of the aortic cannula.

144. The method of claim 132, wherein the tongue is inside the lumen of the cannula, and wherein.the tongue is deployed after the cannula has been inserted through the wall of the aorta.

145. The method of claim 132, wherein the cardioplegia cannula is inserted through the wall of the aorta upstream to the point of insertion of the aortic cannula.

146. The method of claim 132, wherein the cardioplegia solution is delivered to the heart through the opening in the distal end of the cardioplegia cannula.

147. The method of claim 41, wherein the wall of the hollow tube is permeable to blood.
CA2316237A 1997-12-23 1998-12-21 Implantable cerebral protection device and methods of use Expired - Fee Related CA2316237C (en)

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US08/996,532 1997-12-23
PCT/US1998/027215 WO1999032050A1 (en) 1997-12-23 1998-12-21 Implantable cerebral protection device and methods of use

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US6258120B1 (en) 2001-07-10
EP1041940A4 (en) 2001-08-22
US6499487B1 (en) 2002-12-31
CA2650874A1 (en) 1999-07-01
DE69839193D1 (en) 2008-04-10
US20020077596A1 (en) 2002-06-20
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CA2316237C (en) 2010-03-30
AU745809B2 (en) 2002-04-11

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