Insitu formable and self-forming intravascular flow modifier (IFM) and IFM assembly for deployment of same

• US 6,190,402 B1
• Filed: 06/21/1996
• Issued: 02/20/2001
• Est. Priority Date: 06/21/1996
• Status: Expired due to Term

• Current Assignee: Micrus Corporation (Johnson & Johnson), MUSC Foundation For Research Development (State of South Carolina)
• Original Assignee: MUSC Foundation For Research Development (State of South Carolina)
• Inventors: Horton, Joseph A., Vincent, Diana Joan
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/668,229
• Time in Patent Office: 1,705 Days
• Field of Search: 606/108, 606/198, 606/191, 606/195, 623/1, 623/12
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30199 Three-dimensional shapes
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

An intravascular flow modifier (IFM) for use in a vessel has an outer layer formed of a strand configured as a longitudinally oriented coil of adjacent helical loops extending between a first end and a second end of the outer layer. The outer layer is secured in the vessel by at least some of the helical loops pressing against a portion of the interior surface of the vessel. The IFM also has an inner layer formed of a strand configured as a longitudinally oriented coil of adjacent helical loops extending between a first end and a second end of the inner layer. At least a portion of the outer layer surrounds at least a portion of the inner layer so that at least some of the loops of the outer layer overlap and contact at least some of the loops of the inner layer An assembly and method for deploying are also disclosed.

Claims

1. An intravascular flow modifier (IFM) for use in a vessel, the vessel having an interior surface, the IFM comprising:

an outer layer formed of a strand, said strand being formed of a shape memory material, said strand having a pre-deployed configuration that is substantially linear, and said strand having a deployed configuration of a longitudinally oriented coil of adjacent substantially circular helical loops extending between a first end and a second end of said outer layer, said outer layer adapted to be secured in the vessel in said deployed configuration by at least some of said helical loops pressing against a portion of the interior surface of the vessel; and

an inner layer formed of a strand, said strand being formed of a shape memory material, said strand having a pre-deployed configuration that is substantially linear, and said strand having a deployed configuration of a longitudinally oriented coil of adjacent substantially circular helical loops extending between a first end and a second end of said inner layer, at least a portion of said outer layer surrounding at least a portion of said inner layer in said deployed configuration so that at least some of said loops of said outer layer overlap and contact at least some of said loops of said inner layer no more than twice for each of said loops, wherein said outer layer and said inner layer are connected to form a continuous strand, and wherein said first end of said outer layer is connected to said second end of said inner layer to form a loop.

2. The IFM of claim 1, wherein said continuous strand is made of a biocompatible material.

3. The IFM of claim 1, wherein said strands are made of a Nitinol alloy.

4. The IFM of claim 1, wherein said second end of said outer layer is adapted to be anchored to the vessel proximal to said first end of said inner layer.

5. The IFM of claim 1, wherein said second end of said outer layer is joined to said first end of said inner layer to form a loop.

6. The IFM of claim 1, wherein said first end of said outer layer includes means for inhibiting said strand from penetrating through the interior surface of the vessel.

7. The IFM of claim 6, wherein said inhibiting means includes a loop on said first end of said strand.

8. The IFM of claim 1, wherein said second end of said inner layer includes means for inhibiting said strand from penetrating through the interior surface of the vessel.

9. The IFM of claim 8, wherein said inhibiting means includes a loop on said second end of said strand.

10. The IFM of claim 1, wherein said first end of said outer layer and said second end of said inner layer are distal ends relative to an insertion point into the vessel.

11. The IFM of claim 1, wherein said second end of said outer layer and said first end of said inner layer are proximal ends relative to an insertion point into the vessel.

12. The IFM of claim 1, wherein both said helical loops of said outer and inner layers wind in a predetermined direction.

13. The IFM of claim 1, wherein the number of said helical loops of said outer layer is N, where N is at least two.

14. The IFM of claim 1, wherein the number of said helical loops of said inner layer is M, where M is at least two.

15. The IFM of claim 1, wherein said outer layer deployed configuration is divided into at least a first end portion, a middle portion, and a second end portion along said longitudinally oriented coil, said first end, middle, and second end portions each having a pitch, the pitch of said middle portion being smaller than the pitch of said first end and second end portions.

16. The IFM of claim 15, wherein the pitch of said first end portion provides a gap between said helical loops of between 3 an 7 mm, the pitch of said middle portion provides a gap between said helical loops of between 0.5 and 3 mm, and the pitch of said second end portion provides a gap between said helical loops of between 3 and 7 mm.

17. The IFM of claim 15, wherein said strand of said outer layer has a diameter, the diameter of said strand of said first end and second end portions is smaller than the diameter of said strand of said middle portion.

18. The IFM of claim 17, wherein the diameter of said strand of said outer layer is no greater than 0.020 inches.

19. The IFM of claim 18, wherein the diameter of said strand of said outer layer comprising said first end and second end portions is between 0.001 and 0.002 inches, and the diameter of said strand comprising said middle portion is between 0.003 and 0.004 inches.

20. The IFM of claim 1, wherein said outer layer deployed configuration is divided into a first end portion, a middle portion, and a second end portion along said longitudinally oriented coil, said first end, middle, and second end portions each having a pitch, the pitch of said middle portion being larger than the pitch of said first end and second end portions.

21. The IFM of claim 1, wherein said inner layer deployed configuration is divided into at least a first end portion, a middle portion, and a second end portion along said longitudinally oriented coil, said first end, middle, and second end portions each having a pitch, the pitch of said middle portion being smaller than the pitch of said first end and second end portions.

22. The IFM of claim 21, wherein the pitch of said first end portion provides a gap between said helical loops of between 3 and 7 mm, the pitch of said middle portion provides a gap between said helical loops of between 0.5 and 3 mm, and the pitch of said second end portion provides a gap between said helical loops of between 3 and 7 mm.

23. The IFM of claim 21, wherein said strand of said inner layer has a diameter, the diameter of said strand of said first end and second end portions is smaller than the diameter of said strand of said middle portion.

24. The IFM of claim 23, wherein the diameter of said strand of said inner layer is no greater than 0.020 inches.

25. The IFM of claim 24, wherein the diameter of said strand of said inner layer comprising said first end and second end portions is between 0.001 and 0.002 inches, and the diameter of said strand comprising said middle portion is between 0.003 and 0.004 inches.

26. The IFM of claim 21, wherein said helical loops of said inner layer have a substantially constant inner diameter.

27. The IFM of claim 1, wherein said inner layer is divided into a first end portion, a middle portion, and a second end portion along said longitudinally oriented coil, said first end, middle, and second end portions each having a pitch, said pitch of said middle portion being larger than the pitch of said first end and second end portions.

28. An intravascular flow modifier (IFM) for use in a vessel, the vessel having an interior surface, the IFM comprising:

a continuous length of strand having a pre-deployed substantially linear configuration and a deployed configuration formed as a longitudinally oriented coil surrounding another longitudinally oriented coil, said coils forming an outer layer of adjacent substantially circular helical loops, said outer layer adapted to urge against a portion of the interior surface of the vessel, said helical loops of said inner layer urging against said loops of said outer layer at crossing points, no more than twice for each of said loops, said continuous length of strand forming at least one end loop.

29. An intravascular flow modifier (IFM) for use in a vessel, the vessel having an interior surface, the IFM comprising:

an outer layer formed of a strand having a first end, a second end opposite said first end, and having a pre-deployed configuration that is substantially linear and a deployed configuration in the form of a longitudinally oriented coil of adjacent helical loops between said first and second ends, said outer layer adapted to be secured in the vessel in said deployed configuration by at least some of said helical loops pressing against a portion of the interior surface of the vessel;

an inner layer formed of a strand having a first end, a second end opposite said first end, and having a pre-deployed configuration that is substantially linear and a deployed configuration in the form of a longitudinally oriented coil of adjacent loops between said first and second ends, at least a portion of said outer layer in its deployed configuration surrounding at least a portion of said inner layer in its deployed configuration so that at least some of said loops of said outer layer overlap and contact at least some of said loops of said inner layer no more than twice for each of said loops,

said strand of said outer and inner layers being a continuous strand formed of a high shape memory alloy, said helical loops of said outer and inner layers being substantially circular in said respective deployed configurations, said second end of said outer layerjoining said first end of said inner layer to form a loop, said first end of said outer layer and said second end of said inner layer being distal ends relative to an insertion point into the vessel, said second end of said outer layer and said first end of said inner layer being proximal ends relative to an insertion point into the vessel, said helical loops of said outer and inner layers winding in a predetermined direction.

30. An intracranial intravascular flow modifier (IFM) for use in a cranial vessel, the vessel having an interior surface, the IFM comprising:

an outer layer formed of a strand having a first end, a second end opposite said first end, and having a pre-deployed configuration that is substantially linear and a deployed configuration in the form of a longitudinally oriented coil of adjacent helical loops between said first and second ends, said outer layer adapted to be secured in the vessel in said deployed configuration by at least some of said helical loops pressing against a portion of the interior surface of the vessel;

an inner layer formed of a strand having a first end, a second end opposite said first end, and having a pre-deployed configuration that is substantially linear and a deployed configuration in the form of a longitudinally oriented coil of adjacent helical loops between said first and second ends, at least a portion of said outer layer in its deployed configuration surrounding at least a portion of said inner layer in its deployed configuration so that at least some of said loops of said outer layer overlap and contact at least some of said loops of said inner layer no more than twice for each of said loops,

said strand of said outer and inner layers being a continuous strand formed of a high shape memory alloy, said helical loops of said outer and inner layers being substantially circular in said respective deployed configurations, said second end of said outer layer joining said first end of said inner layer to form a loop, said first end of said outer layer and second end of said inner layer being distal ends relative to an insertion point into the vessel, said second end of said outer layer and first end of said inner layer being proximal ends relative to an insertion point into the vessel, said IFM having an outside diameter of between about 1.5 and 12 mm.

31. The IFM of claim 30, wherein in said deployed configuration said outer layer is divided into a first end portion, a middle portion, and a second end portion along said longitudinally oriented coil, said first end, middle, and second end portions each having a pitch, the pitch of said middle portion being smaller than the pitch of said first end and second end portions, and said inner layer is divided into a first end portion, a middle portion, and a second end portion along the longitudinally oriented coil, said first end, middle, and second end portions each having a pitch, the pitch of said middle portion being smaller than the pitch of said first end and second end portions.

32. An assembly for an intravascular repair of a defect of a body vessel, the vessel having an interior surface, the assembly comprising:

an elongated first catheter;

an intravascular flow modifier (IFM) having a deployed configuration when in the vessel at a site of the defect and a pre-deployed substantially linear configuration for movement through said first catheter;

said IFM in said deployed configuration including an outer layer formed of a strand, said strand being configured as a longitudinally oriented coil of adjacent substantially circular helical loops extending between a first end and a second end of said outer layer, once deployed said outer layer adapted to be secured in the vessel by at least some of said loops urging against a portion of the interior surface of the vessel, and an inner layer formed of a strand, said strand being configured as a longitudinally oriented coil of adjacent substantially circular helical loops extending between a first end and a second end of said inner layer, once deployed in the vessel at the site of the defect at least a portion of said outer layer surrounding at least a portion of said inner layer so that at least some of said loops of said outer layer overlap and contact at least some of said loops of said inner layer no more than twice for each of said loops, wherein said outer layer and said inner layer are connected to form a continuous strand, and wherein said first end of said outer layer is connected to said second end of said inner layer to form a loop; and

said first catheter having a proximal end, a distal end, and a central lumen extending axially therethrough, said lumen having a size and shape complementary to the pre-deployed configuration of said IFM such that said IFM is axially slidable therethrough.

33. The assembly of claim 32, further comprising a second catheter having a distal end, a proximal end, and a central lumen extending axially therethrough, said lumen of said second catheter having a size and shape complementary to said first catheter such that said first catheter is axially slidable therein, and such that at least a portion of said distal end of said first catheter can be inserted into said lumen of said second catheter at said proximal end and passes through said lumen of said second catheter and exits said second catheter at said distal end.

34. The assembly of claim 33, further comprising a third catheter having a distal end, a proximal end, and a central lumen extending axially therethrough, said lumen of said third catheter having a size and shape complementary to said second catheter such that said second catheter is axially slidable therein, and such that at least a portion of said distal end of said second catheter can be inserted into said lumen of said third catheter at said proximal end and passes through said lumen of said third catheter and exits said third catheter at said distal end.

35. The assembly of claim 33, wherein said second catheter has an inside diameter of at least approximately 0.022 inches.

36. The assembly of claim 32, wherein the vessel is a cranial vessel, and said IFM has a deployed diameter of between about 1.5 and 12 mm.

37. The assembly of claim 32, wherein said strand of said outer and inner layers has a diameter of no greater than about 0.020 inches.

38. The assembly of claim 32, wherein said first catheter has a outside diameter of between about 0.010 and about 0.014 inches.

39. The assembly of claim 32, wherein said first catheter has an inside diameter of between about 0.004 and about 0.006 inches.

40. The assembly of claim 33, wherein said second catheter has an outside diameter of approximately 1 mm.

41. An assembly for an intravascular repair of a defect of a body vessel, the vessel having an interior surface, the assembly comprising:

an intravascular flow modifier (IFM) having a deployed configuration when in the vessel at a site of the defect and a pre-deployed substantially linear configuration for movement through the vessel towards the site of the defect;

said IFM in said deployed configuration including an outer layer formed of a strand, said strand being configured as alongitudinally oriented coil of adjacent substantially circular helical loops extending between a first end and a second end of said outer layer, once deployed said outer layer adapted to be secured in the vessel by at least some of said loops urging against a portion of the interior surface of the vessel, and an inner layer formed of a strand, said strand being configured as a longitudinally oriented coil of adjacent substantially circular helical loops extending between a first end and a second end of said inner layer, once deployed in the vessel at the site of the defect at least a portion of said outer layer surrounding at least a portion of said inner layer so that at least some of said loops of said outer layer overlap and contact at least some of said loops of said inner layer no more than twice for each of said loops, wherein said outer layer and said inner layer are connected to form a continuous strand, and wherein said first end of said outer layer is connected to said second end of said inner layer to form a loop; and

a means for moving and maintaining said IFM when in the pre-deployed configuration, the outer and inner layers of said IFM taking the deployed configuration when the moving and maintaining means is no longer applied thereto.

42. The IFM of claim 41, wherein the moving and maintaining means comprises an elongated first catheter having a proximal end, a distal end, and a central lumen extending axially therethrough, said lumen having a size and shape complementary to the respective size and shape of said IFM when in the pre-deployed configuration such that said outer and inner layers are axially slidable therein.

43. The IFM of claim 41, further comprising means for disposing said IFM within the vessel.

44. The IFM of claim 43, wherein the disposing means comprises:

an elongated first catheter having a proximal end, a distal end, and a central lumen extending axially therethrough, said lumen having a size and shape complementary to the respective size and shape of said IFM when in the pre-deployed configuration such that said IFM is axially slidable therein; and

an elongated second catheter having a proximal end, a distal end, and a central lumen extending axially therethrough, said lumen having a size and shape complementary to said first catheter such that said first catheter is axially slidable therein, and such that at least a portion of said distal end of said first catheter can be inserted into said lumen of said second catheter at said proximal end and passes through said lumen of said second catheter and exits said second catheter at said distal end.

45. The IFM of claim 41, and further comprising means for selectively varying the gap between said adjacent helical loops of said outer and inner layers.

46. The IFM of claim 45, wherein said selectively varying means comprises:

an elongated first catheter having a proximal end, a distal end, and a central lumen extending axially therethrough, said lumen having a size and shape complementary to the respective size and shape of said IFM when in the pre-deployed configuration such that said IFM is axially slidable therein;

an elongated second catheter having a proximal end, a distal end, and a central lumen extending axially therethrough, said lumen having a size and shape complementary to said first catheter such that said first catheter is axially slidable therein, and such that at least a portion of said distal end of said first catheter can be inserted into said lumen of said second catheter at said proximal end and passes through said lumen of said second catheter and exits said second catheter at said distal end; and

means for controlling axial movement of said IFM when in the pre-deployed configuration through said first catheter and out of said distal end of said first catheter.

47. The IFM of claim 46, wherein said controlling means includes means for controlling the axial movement of said IFM and said first catheter.

48. An assembly for an intravascular repair of a defect of a cranial vessel, the vessel having an interior surface, the assembly comprising:

an elongated first catheter;

an intravascular flow modifier (IFM) having a deployed configuration when in the vessel at a site of the defect and a pre-deployed substantially linear configuration for movement through said first catheter;

said IFM in said deployed configuration including an outer layer formed of a strand, said strand being configured as a longitudinally oriented coil of adjacent substantially circular helical loops extending between a first end and a second end of said outer layer, once deployed said outer layer adapted to be secured in the vessel by at least some of said loops urging against a portion of the interior surface of the vessel, and an inner layer formed of a strand, said strand being configured as a longitudinally oriented coil of adjacent substantially circular helical loops extending between a first end and a second end of said inner layer, once deployed in the vessel at the site of the defect at least a portion of said outer layer surrounding at least a portion of said inner layer so that at least some of said loops of said outer layer overlap and contact at least some of said loops of said inner layer no more than twice for each of said loops, said IFM having a deployed diameter of between about 1.5 and about 12 mm, wherein said outer layer and said inner layer are connected to form a continuous strand, and wherein said first end of said outer layer is connected to said second end of said inner layer to form a loop;

said first catheter having a proximal end, a distal end, and a central lumen extending axially therethrough, said lumen having an inside diameter of between about 0.004 and about .006 inches to receive the pre-deployed configuration of said IFM such that said IFM is axially slidable therethrough; and

a second catheter having a distal end, a proximal end, and a central lumen extending axially therethrough, said lumen of said second catheter having an inside diameter of at least about 0.022 inches to receive said first catheter such that said first catheter is axially slidable therein, and such that at least a portion of said distal end of said first catheter can be inserted into said lumen of said second catheter at said proximal end and passes through said lumen of said second catheter and exits said second catheter at said distal end.