Methods and apparatus for flow restoration

• US 10,456,151 B2
• Filed: 10/16/2015
• Issued: 10/29/2019
• Est. Priority Date: 02/22/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Slee, Earl Howard, Wilder, Thomas, McCarthy, Thomas, Ashby, Mark Philip, Shrivastava, Sanjay
• Primary Examiner(s): McEvoy, Thomas M
• Application Number:
  US14/885,826
• Publication Number:
  US 20160100849A1
• Time in Patent Office: 1,474 Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section

Abstract

Methods for restoring blood flow in occluded blood vessels using an apparatus having a self-expandable distal segment that is pre-formed to assume a superimposed structure in an unconstrained condition but can be made to take on a volume-reduced form making it possible to introduce it with a microcatheter and a push wire arranged at the proximal end, with the distal segment in its superimposed structure assuming the form of a longitudinally open tube and having a mesh structure of interconnected strings or filaments or struts. In a preferred embodiment, the distal segment has a tapering structure at its proximal end where the strings or filaments or struts converge at a connection point.

Claims

1. A removable, integrated apparatus-thrombus mass, comprising a thrombus at least partially engaged with an apparatus, wherein the apparatus comprises:

a self-expandable structure comprising a first plurality of cells, the structure having a proximal end and a distal end, the proximal end and the distal end being open, and the first plurality of cells being expanded into at least a portion of the thrombus;

a tapering portion comprising a second plurality of cells, the tapering portion disposed toward the proximal end of the structure;

a connection portion, at which the tapering portion converges, located at a proximal end of the tapering portion; and

a push or guide wire, wherein a distal end of the push or guide wire is non-releasably attached at or adjacent to the connection portion,

wherein the apparatus is self-expandable and pre-formed to assume a volume-enlarged form and, in the volume-enlarged form, takes the form of a longitudinally open tube tapering toward the connection portion.

2. The removable, integrated apparatus-thrombus mass of claim 1, wherein a mesh size of the second plurality of cells is larger than a mesh size of the first plurality of cells.

3. The removable, integrated apparatus-thrombus mass of claim 2, wherein the structure has a distal portion comprising a third plurality of cells distal to the first plurality of cells, the third plurality of cells having a mesh size smaller than the mesh size of the first plurality of cells.

4. The removable, integrated apparatus-thrombus mass of claim 1, wherein the distal end of the structure is heated for a sufficient time to provide increased radial strength.

5. The removable, integrated apparatus-thrombus mass of claim 1, wherein the distal end of the structure comprises fibers.

6. The removable, integrated apparatus-thrombus mass of claim 1, wherein the distal end of the structure comprises one or more pegs and/or hooks.

7. The removable, integrated apparatus-thrombus mass of claim 1, wherein the structure is coated with an anticoagulant or antiplatelet drug.

8. The removable, integrated apparatus-thrombus mass of claim 7, wherein the structure is further coated with a biodegradable, biocompatible polymer to provide for sustained release of the anticoagulant or antiplatelet drug.

9. The removable, integrated apparatus-thrombus mass of claim 1, wherein the structure comprises reservoirs to hold an anticoagulant or antiplatelet drug.

10. The removable, integrated apparatus-thrombus mass of claim 1, wherein the apparatus can take a volume-reduced form, and the structure forms edges and is curled up such that the edges overlap in the volume-reduced form, and wherein in the volume-enlarged form the edges overlap less than in the volume-reduced form.

11. The removable, integrated apparatus-thrombus mass of claim 1, further comprising radiopaque markers on the distal end of the structure.

12. The removable, integrated apparatus-thrombus mass of claim 11, wherein the radiopaque markers are attached to distal tails at the distal end of the structure.

13. The removable, integrated apparatus-thrombus mass of claim 1, further comprising a radiopaque marker at a proximal end of the tapering portion.

14. The removable, integrated apparatus-thrombus mass of claim 1, further comprising fibers wrapped or wound around the structure.

15. The removable, integrated apparatus-thrombus mass of claim 1, wherein the integrated apparatus-thrombus mass is removable by retracting the push or guidewire through a blood vessel.

16. The removable, integrated apparatus-thrombus mass of claim 1, wherein the first plurality of cells are embedded within the thrombus.

17. The removable, integrated apparatus-thrombus mass of claim 1, wherein the first plurality of cells are implanted into the thrombus.

18. A removable, integrated apparatus-thrombus mass, comprising a thrombus at least partially engaged with a self-expandable apparatus, wherein the apparatus comprises:

a self-expandable structure comprising a first plurality of cells, the structure having a proximal end and a distal end, the proximal end and the distal end being open, and the first plurality of cells being expanded into and interlocked with at least a portion of the thrombus;

a tapering portion comprising a second plurality of cells, the tapering portion disposed toward the proximal end of the structure; and

a connection member, toward which the tapering portion converges, located at a proximal end of the tapering portion; and

a push or guide wire, and wherein a distal end of the push or guide wire is non-releasably attached to the tapering portion at or adjacent to the connection member,

wherein the self-expandable apparatus is configured to assume a volume-enlarged form and, in the volume-enlarged form, to take the form of a longitudinally open tube; and

wherein the thrombus extends outside of the structure.

19. The removable, integrated apparatus-thrombus mass of claim 18, wherein a mesh size of the second plurality of cells is larger than a mesh size of the first plurality of cells.

20. The removable, integrated apparatus-thrombus mass of claim 19, wherein the structure has a distal portion comprising a third plurality of cells distal to the first plurality of cells, the third plurality of cells having a mesh size smaller than the mesh size of the first plurality of cells.

21. The removable, integrated apparatus-thrombus mass of claim 18, wherein the distal end of the structure is heated for a sufficient time to provide increased radial strength.

22. The removable, integrated apparatus-thrombus mass of claim 18, wherein the distal end of the structure comprises fibers.

23. The removable, integrated apparatus-thrombus mass of claim 18, wherein the distal end of the structure comprises one or more pegs and/or hooks.

24. The removable, integrated apparatus-thrombus mass of claim 18, wherein the structure is coated with an anticoagulant or antiplatelet drug.

25. The removable, integrated apparatus-thrombus mass of claim 24, wherein the structure is further coated with a biodegradable, biocompatible polymer to provide for sustained release of the anticoagulant or antiplatelet drug.

26. The removable, integrated apparatus-thrombus mass of claim 18, wherein the structure comprises reservoirs to hold an anticoagulant or antiplatelet drug.

27. The removable, integrated apparatus-thrombus mass of claim 18, wherein the apparatus can take a volume-reduced form, and the structure forms edges and is curled up such that the edges overlap in the volume-reduced form, and wherein in the volume-enlarged form the edges overlap less than in the volume-reduced form.

28. The removable, integrated apparatus-thrombus mass of claim 18, further comprising radiopaque markers on the distal end of the structure.

29. The removable, integrated apparatus-thrombus mass of claim 28, wherein the radiopaque markers are attached to distal tails at the distal end of the structure.

30. The removable, integrated apparatus-thrombus mass of claim 18, further comprising a radiopaque marker at a proximal end of tapering portion.

31. The removable, integrated apparatus-thrombus mass of claim 18, further comprising fibers wrapped or wound around the structure.

32. The removable, integrated apparatus-thrombus mass of claim 18, wherein the integrated apparatus-thrombus mass is removable by retracting the push or guidewire through a blood vessel.

33. The removable, integrated apparatus-thrombus mass of claim 18, wherein the first plurality of cells are embedded within the thrombus.

34. The removable, integrated apparatus-thrombus mass of claim 18, wherein the first plurality of cells are implanted into the thrombus.