Method and apparatus for allowing blood flow through an occluded vessel

• US 9,278,201 B2
• Filed: 06/15/2010
• Issued: 03/08/2016
• Est. Priority Date: 06/15/2009
• Status: Active Grant

• Current Assignee: Perflow Medical Ltd.
• Original Assignee: Perflow Medical Ltd.
• Inventors: Rapaport, Avraham, Cibulski, Gilad
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US12/815,428
• Publication Number:
  US 20100318178A1
• Time in Patent Office: 2,093 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.14, 623/1.15, 623/1.17, 606/198, 606/194, 606/127, 606/159, 606/200, 606/110, 606/113, 606/114
• US Class Current: 1/1
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device arranged to sustain and/or provide at least partial patency of a small blood vessel exhibiting an occlusion, the device constituted of a tubular body expandable from a first small diameter state for manipulation to, and through, the occlusion of the small blood vessel and a second large diameter state, the inner dimensions of the second large diameter state being no more than 50% of the diameter of the small blood vessel at the occlusion location, the device presenting a conduit for blood flow through the occlusion when in the large diameter state. In one embodiment the small blood vessel is an intracranial blood vessel.

Claims

1. A method of withdrawing at least a portion of an occlusion away from a target small blood vessel exhibiting an occlusion, the method comprising:

selecting an expandable tubular body having a proximal end and a distal end with a length therebetween;

constraining the tubular body in a first small diameter state within a recess of a delivery catheter so that a first member extends along the delivery catheter and is coupled with the proximal end of the tubular body and so that a second member extends along the delivery catheter and is coupled with the distal end of the tubular body;

advancing said selected expandable tubular body while constrained by the delivery catheter in said first small diameter state to the occlusion;

releasing the tubular body from the delivery catheter within the blood vessel and across the occlusion so that the selected and advanced expandable tubular body expands from the first small diameter to a second large diameter state;

at least one of reducing an open cross sectional area of the tubular body within the blood vessel by relative movement of the first and second members which expands the length between said proximal end and said distal end, and enlarging the open cross-sectional area of the tubular body within the blood vessel by relative movement of the first and second members which decreases the length between said proximal end and said distal end;

said enlarging comprising contacting the inner walls of a lumen of said blood vessel while exerting a radial force which is small enough so as not to traumatize said walls; and

withdrawing, during applying of a non-traumatizing radial force to said inner walls of said lumen, said tubular body from the target small blood vessel to withdraw at least a portion of said occlusion between said walls of said blood vessel and said tubular body without traumatizing said walls.

2. The method according to claim 1, further comprising:

further selecting the expandable tubular body such that said further selected expandable tubular body in the second large diameter state exhibits a length at least 14 times the inner diameter of the expandable tubular body in the second large diameter state.

3. The method according to claim 1, wherein the selected expandable tubular body in the second large diameter state exhibits an inner diameter no more than twice the inner diameter of the tubular body in the first small diameter state.

4. The method according to claim 1, wherein the selected expandable tubular body further comprises a distal filtering extension coupled to a distal end of said selected expandable tubular body.

5. The method according to claim 4, further comprising expanding the distal filtering extension to meet the inner wall of the target blood vessel distal of the occlusion.

6. The method according to claim 4, wherein the selected expandable tubular body further comprises a proximal securing member coupled to a proximal end of said selected expandable tubular body, the method further comprising expanding the proximal securing member to meet the inner wall of the target small blood vessel proximal of the occlusion.

7. The method according to claim 1, further comprising:

delivering a medicament to the occlusion through said selected expanded tubular body.

8. The method according to claim 1, wherein the small blood vessel has a luminal wall with a lumen diameter of less than 5 mm adjacent the occlusion;

wherein the second large diameter state does not urge to expand beyond 50% of the diameter of the target small blood vessel at the occlusion and further wherein the tubular body, when unstressed, has a maximum resting state diameter of no more than 50% of the diameter of the lumen diameter of the target small blood vessel so as to inhibit self-expansion trauma to the luminal wall when deployed across the occlusion;

and wherein said tubular body creates a conduit having an open cross-sectional area along the length of said tubular body for blood flow across the occlusion, the length of said tubular body at least 5 times the diameter of the tubular body in the second large diameter state, said conduit constituted of said provided expanded tubular body.

9. The method according to claim 1, wherein the small blood vessel is an intracranial blood vessel and the delivery catheter is an intracranial microcatheter, the microcather having an internal diameter between about 0.5 mm and 1.5 mm.

10. The method according to claim 1, wherein said tubular body self-expands from said first small diameter state to said second large diameter state.

11. The method according to claim 1, wherein in said second large diameter state said radial force applied by said tubular body is sufficient to prevent movement of said tubular body inside said occlusion.

12. The method according to claim 1, wherein said relative movement between the first and second members comprises relatively pulling and pushing the members.

13. The method according to claim 1, further comprising controlling localization of said tubular body in said blood vessel using said first and second members.

14. The method according to claim 1, wherein said withdrawing comprises retracting said at least a portion of said occlusion away from the patient'"'"'s body.

15. The method according to claim 1, wherein said second member is a filament or a bundle of filaments which does not constitute the tubular body.

16. The method according to claim 1, wherein at least said second member extends in a proximal direction to outside the patient'"'"'s body, and said at least one of reducing and enlarging the cross sectional area of said tubular body comprises actuating said relative movement of said first and second members from outside the body.

17. The method according to claim 1, wherein during said withdrawing at least a part of said tubular body contacts said vessel wall.

18. The method according to claim 1, wherein said occlusion at least partially surrounds said tubular body.

19. The method according to claim 1, wherein at least a portion of an external surface of said tubular structure contacts said occlusion.

20. The method according to claim 1, comprising said reducing an open cross sectional area of the tubular body within the blood vessel by relative movement of the first and second members which expands the length between said proximal end and said distal end.

21. The method according to claim 1, comprising enlarging the open cross-sectional area of the tubular body within the blood vessel by relative movement of the first and second members which decreases the length between said proximal end and said distal end;

said enlarging comprising contacting the inner walls of a lumen of said blood vessel while exerting a radial force which is small enough so as not to traumatize said walls.

22. The method according to claim 21, wherein said tubular body has a resting state,

wherein said radial forces are exerted by said tubular body restrained by one or more of said lumen inner walls and said occlusion;

wherein a diameter of said tubular body in said resting state is larger than a diameter of the inner walls of said blood vessel in an area of the blood vessel distal of said occlusion.

23. The method according to claim 22, wherein said tubular body resting state diameter is 0.5-1.5 mm larger than a diameter of said inner walls of said blood vessel in an area of the blood vessel distal of said occlusion.

24. A method of treating an impaired region of a target small blood vessel, the method comprising:

a. selecting an expandable tubular body having a proximal end and a distal end with a length therebetween;

b. constraining the tubular body in a first small diameter state within a recess of a delivery catheter so that a first member extends along the delivery catheter and is coupled with the proximal end of the tubular body and so that a second member extends along the delivery catheter and is coupled with the distal end of the tubular body;

c. advancing said selected expandable tubular body while constrained by the delivery catheter in said first small diameter state to an impaired region in said small blood vessel;

d. releasing the tubular body from the delivery catheter within the blood vessel and across the impaired region so that the selected and advanced expandable tubular body expands from the first small diameter to a second large diameter state;

said releasing comprising contacting least a portion of the inner walls of a lumen of said blood vessel le exerting a radial force small enough so as not to traumatize said walls;

e. at least one of reducing an open cross sectional area of the tubular body within the blood vessel by relative movement of the first and second members which expands the length between said proximal end and said distal end, and enlarging the open cross-sectional area of the tubular body by relative movement of the first and second members which decreases the length between said proximal end and said distal end;

f. said enlarging comprising contacting the inner walls of a lumen of said blood vessel while exerting a radial force small enough so as not to traumatize said walls; and

g. withdrawing said tubular body from the target small blood vessel during exerting of a non-traumatizing radial force on said at least a portion of said inner lumen walls;

wherein said (a-g) do not traumatize said walls of said blood vessel.

25. The method according to claim 24, wherein said impaired region exhibits an occlusion, and wherein said withdrawing comprises withdrawing at least a portion of said occlusion between a wall of said blood vessel and said tubular body.

26. The method according to claim 25, wherein said occlusion at least partially surrounds said tubular body.

27. The method according to claim 25, wherein at least a portion of an external surface of said tubular structure contacts said occlusion.

28. The method according to claim 24, wherein step d comprises reducing an open cross sectional area of the tubular body within the blood vessel by relative movement of the first and second members which expands the length between said proximal end and said distal end.

29. The method according to claim 24, wherein step d comprises enlarging the open cross-sectional area of the tubular body by relative movement of the first and second members which decreases the length between said proximal end and said distal end

said enlarging comprising contacting the inner walls of a lumen of said blood vessel while exerting a radial force which is small enough so as not to traumatize said walls.

30. The method according to claim 29, wherein said tubular body has a resting state,

wherein said radial forces are exerted by said tubular body restrained by one or more of said lumen inner walls and said occlusion;

wherein a diameter of said tubular body in said resting state is larger than a diameter of the inner walls of said blood vessel in an area of the blood vessel distal of said occlusion.

31. The method according to claim 30, wherein said tubular body resting state diameter is 0.5-1.5 mm larger than a diameter of said inner walls of said blood vessel in an area of the blood vessel distal of said occlusion.