Narrowing implant

• US 20030097172A1
• Filed: 09/26/2002
• Published: 05/22/2003
• Est. Priority Date: 03/27/2000
• Status: Abandoned Application

• Current Assignee: Neovasc Incorporated
• Original Assignee: Neovasc Incorporated
• Inventors: Shalev, Ilan, Darvish, Nissim, Tsehori, Jonathan
• Application Number:
  US10/239,980
• Publication Number:
  US 20030097172A1
• Time in Patent Office: Days
• US Class Current: 623/1.31
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A reducer implant for insertion in a blood vessel, for reducing an inner diameter of said vessel and flow therethrough, having at least one narrowed section having a first diameter; and at least one flared section having a diameter substantially greater than said first diameter. Optionally, the reducer is formed of a material and has a geometry that does not cause coagulation of blood in its vicinity.

Claims

1. A reducer for insertion in a blood vessel, comprising:

at least one narrowed section having a first diameter; and

at least one flared section having a diameter at least 20% greater than said first diameter,

wherein said reducer is formed of a material and has a geometry that does not cause coagulation of blood in its vicinity.

2. A reducer according to claim 1, wherein said reducer is operative to increase a coronary artery blood pressure when inserted in a coronary vein.

3. A reducer according to claim 1, wherein said reducer is operative to modify a coronary artery blood flow distribution when inserted in a coronary vein.

4. A reducer according to claim 1, wherein said reducer is operative to increase a coronary sinus blood pressure when inserted in a coronary sinus.

5. A reducer according to claim 1, wherein said reducer is operative to increase an intra-myocardial perfusion when inserted in a coronary sinus.

6. A reducer according to any of claims 1-5, wherein said flared section includes at least one area adapted to contact a wall of a vein.

7. A reducer according to claim 6, wherein said area is made large enough to prevent damage to the wall.

8. A reducer according to claim 7, wherein said area has an axial extent of at least 2 mm.

9. A reducer according to claim 7, wherein said area has an axial extent of at least 4 mm.

10. A reducer according to any of claims 1-9, wherein said flared section has an outside edge.

11. A reducer according to claim 10, wherein said outside edge lies on a single plane.

12. A reducer according to claim 10 or claim 11, wherein said outside edge is defined by a plurality of elongate sections that cooperate to define a maximal rim for said reducer.

13. A reducer according to any of claims 10-12, wherein said outside edge is smooth.

14. A reducer according to any of claims 10-13, wherein said outside edge is curved inwards towards an axis of said reducer.

15. A reducer according to any of claims 10-14, wherein said outside edge is coated with a soft material.

16. A reducer according to any of claims 1-15, wherein said reducer doesn'"'"'t cause turbulence inside a lumen defined by said narrowed section and said flared section.

17. A reducer according to any of claims 1-16, wherein said narrowed section comprises a ring segment having a different surface design from flared section.

18. A reducer according to any of claims 1-17, wherein said narrowed section comprises a solid ring.

19. A reducer according to any of claims 1-17, wherein said narrowed section comprises an array of cell elements.

20. A reducer according to any of claims 1-19, wherein said reducer is expanded, after insertion, from an unexpanded configuration to an expanded configuration.

21. A reducer according to claim 20, wherein said flared section is plastically deformable to provide said configuration change.

22. A reducer according to claim 20, wherein said flared section is self-expanding to provide said configuration change.

23. A reducer according to any of claims 20-22, wherein said narrowed section self-expanding to provide said configuration change.

24. A reducer according to any of claims 20-22, wherein said narrowed section is plastically deformable to provide said configuration change.

25. A reducer according to claim 20, wherein said narrowed section does not expand.

26. A reducer according to claim 20, wherein said narrowed section is further expandable after said reducer is in said expanded configuration.

27. A reducer according to any of claims 1-26, comprising a ring mounted outside of said narrowed section, said ring defining a maximal diameter of said narrowed section.

28. A reducer according to any of claims 1-27, wherein said narrowed section is formed of a pliable material.

29. A reducer according to any of claims 1-27, wherein said reducer is formed of at least one of an elastic material, a shape-memory material and a super-elastic material.

30. A reducer according to any of claims 1-29, wherein different parts of said reducer have different degrees of resistance to deforming.

31. A reducer according to claim 30, wherein said narrowed section has a greater resistance to deformation than said flared section.

32. A reducer according to claim 30, wherein a rim area of said flared section has a greater resistance to deformation than an adjacent part of said flared section.

33. A reducer according to any of claims 1-32, wherein said narrowed section has an axial extent of between 1 mm and 5 mm.

34. A reducer according to any of claims 1-33, wherein said reducer has an axial extent of between 10 nm and 30 mm.

35. A reducer according to any of claims 1-34, wherein said narrowed section has a cross-sectional area of less than 70% of a maximum cross-sectional area of said flared section.

36. A reducer according to any of claims 1-34, wherein said narrowed section has a cross-sectional area of less than 50% of a maximum cross-sectional area of said flared section.

37. A reducer according to any of claims 1-34, wherein said narrowed section has a cross-sectional area of less than 40% of a maximum cross-sectional area of said flared section.

38. A reducer according to any of claims 1-34, wherein said narrowed section has a cross-sectional area of less than 30% of a maximum cross-sectional area of said flared section.

39. A reducer according to any of claims 1-34, wherein said narrowed section has a cross-sectional area of less than 20% of a maximum cross-sectional area of said flared section.

40. A reducer according to any of claims 1-39, wherein said flared section has an axial extent of between 4 mm and 10 mm.

41. A reducer according to any of claims 1-40, wherein said reducer is adapted for insertion in a human coronary sinus.

42. A reducer according to any of claims 1-41, wherein said reducer is adapted for insertion in a human coronary vein.

43. A reducer according to claim 41 or claim 42, wherein said adaptation is by size.

44. A reducer according to any of claims 1-43, wherein said at least one flared section comprises at least two flared sections.

45. A reducer according to any of claims 1-44, wherein said reducer describes an hourglass figure.

46. A reducer according to any of claims 1-45, wherein said flared section is dense, to reduce blood flow therethrough.

47. A reducer according to any of claims 1-46, wherein said flared section is coated, to reduce blood flow therethrough.

48. A reducer according to any of claims 1-47, wherein said reducer is formed of a soft material, to reduce contact force against an enclosing vessel wall.

49. A reducer according to any of claims 1-48, wherein said reducer is operative to release a slow release molecule after it is deployed.

50. A reducer according to any of claims 1-49, wherein said reducer has an outside surface adapted to attach to a wall of a vein.

51. A reducer according to any of claims 1-50, wherein said narrowed section comprises a valve.

52. A reducer for insertion in a blood vessel having a diameter, comprising:

at least one narrowed section having a first diameter; and

at least one flared section having a diameter at least 20% greater than said first diameter,

wherein said reducer is adapted to be plastically deformed from a first configuration in which said reducer is unexpanded to a second configuration in which said reducer is expanded.

53. A reducer according to claim 52, wherein said narrowing section has a length of at least 10% of a total axial length of said reducer.

54. A reducer according to claim 52, wherein said narrowing section has a length of at least 20% of a total axial length of said reducer.

55. A reducer for insertion in a blood vessel having a diameter, comprising:

at least one narrowed section having a first diameter; and

at least one flared section having a diameter greater than said first diameter,

wherein said reducer is adapted to contact a vein at said flared section.

56. A reducer according to claim 55, wherein said adaptation comprises forming said flared section to reduce a probability of damage to said vein.

57. A reducer according to claim 55, wherein said adaptation comprises forming said reducer of a soft material to reduce a contact force between said reducer and said vein.

58. A reducer according to claim 55, wherein said reducer is adapted to cause coagulation in an area defined between said reducer and a wall of said vein.

59. A reducer for insertion in a blood vessel having a diameter, comprising:

at least one narrowed section having a first diameter; and

at least one flared section having a diameter at least 20% greater than said first diameter,

wherein said flared section is resistant to blood flow across a wall of said section, such that at least 50% of blood flow through the reducer passes through a lumen defined by said flared section and said narrowed section.

60. A reducer according to claim 59, wherein at least 80% of blood flow through the reducer passes through a lumen defined by said flared section and said narrowed section.

61. A reducer according to claim 59, wherein at least 90% of blood flow through the reducer passes through a lumen defined by said flared section and said narrowed section.

62. A reducer for insertion in a blood vessel having a diameter, comprising:

at least one narrowed section having a first diameter; and

at least one flared section having a diameter substantially greater than said first diameter,

wherein said flared section and said narrowed section cooperate to substantially reduce blood flow through a lumen defined by said sections, relative to flow through a cylinder having a maximal diameter of the flared section

63. A blood vessel reducer delivery kit, comprising:

a guide catheter;

a plastically deformable reducer having an hour-glass figure when deformed and adapted to ride on said catheter; and

a balloon having an inflation profile matching said hour-glass figure.

64. A method of reducer selection, comprising:

determining a desired hemodynamic effect in a coronary vascular system; and

selecting a reducer having a suitable geometry to achieve said desired hemodynamic effect, from a set of reducers of different geometries.

65. A method according to claim 64, wherein said desired effect is at least one of:

increase in myocardial perfusion pressure, increase in myocardial pressure, increase in myocardial perfusion duration, increase in coronary artery pressure, redistribution of blood flow in coronary arteries, increase in pressure in a coronary sinus and/or a restarting of a coronary artery autoregulation mechanism.

66. A method of affecting hemodynamic parameters of a coronary system, comprising:

selecting a reducer for reducing a diameter of a coronary vein; and

implanting said reducer in said coronary vein.

67. A method according to claim 66, wherein said coronary vein is a coronary sinus.

68. A kit for reducing blood flow in a venous system, comprising:

a plurality of vascular implants, each defining a narrowed section, said plurality of implants including at least two implants with different geometrical properties.

69. A kit according to claim 68, wherein said two implants have different degrees of narrowing.

70. A kit according to claim 68 or claim 69, wherein said two implants have different outer diameters, for matching different coronary veins.