ANEURYSM TREATMENT DEVICE AND METHOD

• US 20170265869A1
• Filed: 08/05/2015
• Published: 09/21/2017
• Est. Priority Date: 08/07/2014
• Status: Active Grant

• Current Assignee: Perflow Medical Ltd.
• Original Assignee: Perflow Medical Ltd.
• Inventors: CIBULSKI, Gilad, RAPAPORT, Avraham, FARIN, Danny, BONNEAU, Itamar
• Granted Patent: US 10,792,043 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An intravascular device for treating a cerebral aneurysm, the device comprising an externally controllable expandable member, the expandable member comprising a plurality of wires that define walls of the expandable member; wherein in a relaxed state of the expandable member the walls comprise at least a first wall portion in which openings defined between the wires are small enough to prevent coils positioned within the aneurysm from exiting the aneurysm, the first wall portion comprising an axial length at least as long as a neck of the aneurysm; and at least a second wall portion in which openings defined between the wires are large enough to allow blood flow through; the second wall portion axially aligned relative to the first wall portion. In some embodiments, openings of the first wall portion are small enough to reduce radial blood flow to and/or from the aneurysm.

Claims

1. An intravascular device for treating a cerebral aneurysm, said device comprising an externally controllable expandable member, said expandable member comprising a plurality of wires that define walls of said expandable member;

wherein in a relaxed state of said expandable member said walls comprise;

at least a first wall portion in which openings defined between said wires are small enough to prevent coils positioned within said aneurysm from exiting said aneurysm, said first wall portion comprising an axial length at least as long as a neck of said aneurysm; and

at least a second wall portion in which openings defined between said wires are large enough to allow blood flow through;

said second wall portion axially aligned relative to said first wall portion.

2. The device according to claim 1, wherein said openings of said first wall portion are small enough to reduce radial blood flow to and/or from said aneurysm.

4. The device according to claim 1, wherein said expandable member substantially does not interfere with non-radial blood flow in said vessel.

5. The device according to claim 1, wherein said expandable member comprises a tubular shape, wherein said first wall portion comprising said small openings defines a central segment of said tubular shape, and said second wall portion comprising large openings defines a proximal end segment and a distal end segment of said tubular shape.

6. The device according to claim 5, wherein an axial length of said central segment is at least as long as an axial length of said aneurysm neck.

7. The device according to claim 1, wherein wires forming said first wall portion are paired to each other to form said second wall portion.

8. The device according to claim 6, wherein a ratio between a cross sectional area of an opening at said first wall portion and a cross sectional area of an opening at said second wall portion is between 1:

1.5 and 1;

3.8.

9. The device according to claim 6, wherein said first wall portion comprises 42 wires, and said second wall portion comprises 21 double stranded wires.

10. The device according to claim 1, wherein some of the wires that form said first wall portion are cut-off or are looped around other wires, so that only some of the wires that form said first wall portion extend to form said second wall portion.

11. The device according to claim 1, wherein a cross sectional area of an opening at said first wall portion is smaller than a maximal cross sectional area of an intra-aneurismal coil in its non-linear, curled-up form.

12. The device according to claim 1, wherein a push/pull cable extends through a lumen of said expandable member, said cable operatively coupled to a first element, said first element movable relative to a second element, at least said second element coupled to said expandable member;

said cable axially pullable and pushable from outside the body to modify a diameter of said expandable member by moving said first element relative to said second element.

13. The device according to claim 12, wherein said second element is an outer tube, said outer tube coupled to a proximal end of said expandable member by a detachable interface providing for removal of said outer tube.

14. The device according to claim 1, wherein at least some of said wires comprise a flat cross section profile.

15. The device according to claim 13, wherein said device further comprises a securing tube, said securing tube surrounding said expandable member, said securing tube axially displaceable with respect to a lumen of said expandable member, said securing tube comprising one or more wedges rigidly attached to an internal wall of said securing tube, said wedges located between said outer tube and said expandable member to limit movement of said expandable member.

16. The device according to claim 12, wherein said first element is a cup coupled to a distal end of said push/pull cable;

said cup axially movable relative to said outer tube to axially compress said expandable member and increase its diameter when pulled in a proximal direction by said cable or extend said expandable member and decrease its diameter when advanced in a distal direction by said cable.

17. The device according to claim 1, wherein said device comprises one or more radiopaque wires or wire segments positioned for orienting said expandable member relative to a long axis of said member, said radiopaque wires positioned at one or both of a periphery and center of said first wall portion, thereby facilitating aligning said first wall portion with said aneurysm neck.

3. (canceled)

18-34. -34. (canceled)

35. A method of treating a cerebral aneurysm, comprising:

positioning an expandable member in a cerebral blood vessel at a location of an aneurysm, said expandable member comprising a plurality of wires arranged to define at least one dense wall portion having openings that are smaller than one or more other wall portions of said expandable member;

expanding said expandable member to engage the blood vessel walls; and

allowing said dense wall portion to interfere with inner content of said aneurysm exiting the aneurysm.

37. The method according to claim 35, wherein said inner content comprises intra-aneurismal coils that were previously introduced into said aneurysm.

38. The method according to claim 35, comprising reducing radial flow into and/or out said aneurysm enough to allow a thrombus to form.

39. The method according to claim 35, further comprising adjusting a diameter of said expandable member from outside the patient'"'"'s body;

and

retracting a delivery system used for said positioning to temporarily or permanently deploy said expandable member in said vessel.

40. The method according to claim 35, wherein said adjusting is performed based on a clotting rate of blood at a location of said aneurysm.

41. The method according to claim 35, wherein said method further comprises delivering one or more coils into said aneurysm to induce said clotting.

42. The method according to claim 35, wherein said coils are introduced into said aneurysm through a lumen of said expandable member.

43. The method according to claim 35, wherein said coils are introduced into said aneurysm via a microcatheter at least partially axially aligned with said expandable member, and wherein said method further comprises expanding a diameter of said expandable member to capture said microcatheter between said expandable member and a wall of said blood vessel to prevent movement of said microcatheter during coil deployment and removing said microcatheter after coils were deployed and further expanding a diameter of said expandable member.

48. The method according to claim 35, wherein said retracting comprises releasing a distal end of said expandable member from a cup element in which it is crimped, said distal end self expanding to match a diameter of a more proximal portion of said expandable member.

36. (canceled)

44-47. -47. (canceled)

49-52. -52. (canceled)