Transluminally deliverable vascular blockers and methods for facilitating retrograde flow of arterial blood through veins

• US 6,746,426 B1
• Filed: 07/11/2000
• Issued: 06/08/2004
• Est. Priority Date: 07/11/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Lamson, Theodore C., Flaherty, J. Christopher
• Primary Examiner(s): Denion, Thomas
• Assistant Examiner(s): Chang, Ching
• Application Number:
  US09/613,675
• Time in Patent Office: 1,428 Days
• Field of Search: 604/104, 604/96.01, 604/164.13, 604/264, 604/523, 604/528, 604/532
• US Class Current: 604/104
• 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 17/12109 in a blood vessel
• 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 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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

Abstract

Transluminal methods and apparatus for causing arterial blood to flow through a vein of a mammalian patient, in a direction opposite normal venous blood flow, after an arterial blood containing conduit has been purposely or inadvertently connected to the vein. The method includes the use of a transluminally inserted vessel lumen occluding apparatus to at least partially block (e.g., occlude, embolize or close) the lumen of the vein at a location that is proximal to the location at which the arterial blood containing conduit is connected to the vein. The apparatus comprises a radially expandable lumen blocking device that is implantable in the vein lumen and catheters and other apparatus for implanting the radially expandable lumen blocking device into the lumen of the vein.

Claims

1. A system for facilitating flow of blood through the lumen of a blood vessel, said system comprising:

a tubular graft that is attachable to the blood vessel at a first location; and

a lumen occluding device that is implantable in the lumen of the blood vessel so as to facilitate a flow of blood from the graft, into the blood vessel, and through the blood vessel in a desired direction, said lumen occluding device comprising;

a generally cylindrical frame that is disposable in a radially compact configuration of a first diameter and is transitionable to a radially expanded configuration of a second diameter; and

a lumen occluding barrier attached to the frame, said lumen occluding barrier being configured such that, when the device is implanted in the lumen of a blood vessel with the frame in its radially expanded configuration, the occluding barrier will substantially block blood flow through that blood vessel lumen.

2. A system according to claim 1 further comprising:

a delivery catheter that comprises an elongate tubular catheter body having a lumen extending longitudinally therethrough;

the lumen occluding device being a) positionable within the lumen of the delivery catheter when the lumen occluding device is in its radially collapsed configuration and b) expellable out of the catheter and into the lumen of a blood vessel in which the catheter is positioned, such that the lumen occluding device will assume its radially expanded configuration and become implanted within the lumen of the blood vessel.

3. A system according to claim 2 wherein the delivery catheter has a length of 40-125 cm.

4. A system according to claim 2 wherein the delivery catheter has a length of 5-20 cm.

5. A system according to claim 2 wherein the delivery catheter further comprises:

a location identifier which provides an indication of the catheter within the blood vessel.

6. A system according to claim 5 wherein the location identifier comprises a marker that can be imaged by a separate imaging apparatus.

7. A system according to claim 6 wherein the marker is radiopaque so as to be radiographically imageable.

8. A system according to claim 6 wherein the marker is reflective of ultrasound so as to be imageable by ultrasound.

9. A system according to claim 5 wherein the location identifier is an energy emitting element.

10. A system according to claim 9 wherein the energy emitting element emits ultrasound.

11. A system according to claim 2 further comprising a pusher that is advanceable through the lumen of the delivery catheter to push the lumen occluding device out of the delivery catheter.

12. A system according to claim 11 wherein the pusher comprises an elongate member having a lumen extending longitudinally therethrough such that the pusher may be advanced over a guidewire.

13. A system according to claim 11 wherein the pusher comprises an elongate member having a proximal end to which a proximal hub member is attached, and wherein the length of the elongate member is sized relative to the length of the delivery catheter such that when the pusher is advanced distally through the catheter lumen the distal end of the pusher will not protrude beyond the distal end of the catheter body.

14. A system according to claim 2 wherein the lumen occluding device was placed in its radially compact configuration within the lumen of the delivery catheter prior to insertion of the delivery catheter into the blood vessel.

15. A system according to claim 2 wherein the lumen occluding device was placed in its radially compact configuration within the lumen of the delivery catheter after insertion of the delivery catheter into the blood vessel.

16. A system according to claim 2 further comprising:

a lumen occluding device introduction apparatus that is useable to facilitate radial collapsing of the lumen occluding device and introduction of the radially collapsed lumen occluding device into the lumen of the delivery catheter.

17. A system according to claim 16 wherein the lumen occluding device introduction apparatus comprises:

a rigid body having a lumen extending longitudinally therethrough, the distal end of the rigid body being connectable to the proximal end of the delivery catheter and the lumen of the blocker introduction apparatus being tapered from a first diameter at its proximal end to a second diameter at its distal end, said first diameter being larger than the diameter of the catheter lumen and said second diameter being approximately the same as the diameter of the catheter lumen.

18. A system according to claim 11 wherein the delivery catheter is less than 20 cm in length and insertable into a substantially straight segment of vein and wherein the pusher, when inserted into the lumen of the delivery catheter, not protrude out of the distal end of the delivery catheter.

19. A system according to claim 11 wherein the deliver catheter is greater than 20 cm in length and insertable into substantially tortuous vasculature wherein the pusher is longer than the catheter in length such that even when the catheter is positioned in tortuous vasculature the pusher may be advanced through the catheter lumen to a position where the distal end of the pusher is substantially coterminus with the distal end of the catheter.

20. A system according to claim 11 wherein the distal end of the pusher is imageable to facilitate monitoring of the position of the distal end of the pusher relative to the distal end of the catheter.

21. A system according to claim 1 wherein a guidewire passage aperture is formed in said occluding barrier so that a guidewire may pass therethrough, the device being thereby advanceable over a guidewire that has previously been inserted into the blood vessel.

22. A system for blocking blood flow through the lumen of a blood vessel, said system comprising:

a) a delivery catheter that comprises an elongate tubular catheter body having a lumen extending longitudinally therethrough;

b) a lumen occluding device that is positionable within the lumen of the catheter while in a radially collapsed configuration and thereafter expellable out of the catheter and into the lumen of a blood vessel in which the catheter is positioned, such that the lumen occluding device will assume its radially expanded configuration and become implanted within the lumen of the blood vessel, said lumen occluding device comprising

i) a generally cylindrical frame that is disposable in a radially compact configuration of a first diameter and is transitionable to a radially expanded configuration of a second diameter; and

ii) a lumen occluding barrier attached to the frame, said lumen occluding barrier being configured such that, when the device is implanted in the lumen of a blood vessel with the frame in its radially expanded configuration, the occluding barrier will substantially block blood flow through that blood vessel lumen, a guidewire passage aperture being formed in said occluding barrier so that a guidewire may pass therethrough, the device being thereby advanceable over a guidewire that has previously been inserted into the blood vessel; and

a lumen occluding device introduction apparatus comprising a substantially rigid body having a tapered lumen, said tapered lumen having a first end and a second end, the first end of said tapered lumen being larger in diameter than the second end, said introduction device being connectable to the delivery catheter;

said lumen occluding device being insertable, while in its radially expanded configuration, into the first end of the tapered lumen of the introduction apparatus and, thereafter, advanceable from the first end of the tapered lumen to the second end of the tapered lumen such that the decrease in diameter of the tapered lumen will compress the lumen occluding device to its radially collapsed configuration, said lumen occluding device being thereafter advanceable, while in its radially collapsed configuration, into the lumen of the delivery catheter.

23. A system according to claim 22 wherein the delivery catheter has a length of 40-125 cm.

24. A system according to claim 22 wherein the delivery catheter has a length of 5-20 cm.

25. A system according to claim 22 wherein the delivery catheter further comprises:

a location identifier which provides an indication of the catheter within the blood vessel.

26. A system according to claim 25 wherein the location identifier comprises a marker that can be imaged by a separate imaging apparatus.

27. A system according to claim 26 wherein the marker is radiopaque so as to be radiographically imageable.

28. A system according to claim 26 wherein the marker is reflective of ultrasound so as to be imageable by ultrasound.

29. A system according to claim 25 wherein the location identifier is an energy emitting element.

30. A system according to claim 29 wherein the energy emitting element emits ultrasound.

31. A system according to claim 22 further comprising a pusher that is advanceable through the lumen of the delivery catheter to push the lumen occluding device out of the delivery catheter.

32. A system according to claim 31 wherein the pusher comprises an elongate member having a lumen extending longitudinally therethrough such that the pusher may be advanced over a guidewire.

33. A system according to claim 31 wherein the pusher comprises an elongate member having a proximal end to which a proximal hub member is attached, and wherein the length of the elongate member is sized relative to the length of the delivery catheter such that when the pusher is advanced distally through the catheter lumen until the proximal hub of the pusher abuts against the delivery catheter, the distal end of the pusher will not protrude beyond the distal end of the catheter body.

34. A system according to claim 22 wherein the lumen occluding device is placed in its radially compact configuration within the lumen of the delivery catheter prior to insertion of the delivery catheter into the blood vessel.

35. A system according to claim 32 wherein the lumen occluding device is placed in its radially compact configuration within the lumen of the delivery catheter after insertion of the delivery catheter into the blood vessel.

36. A system according to claim 22 wherein the lumen occluding device introduction apparatus comprises:

a rigid body having a lumen extending longitudinally therethrough, the distal end of the rigid body being connectable to the proximal end of the delivery catheter and the lumen of the blocker introduction apparatus being tapered from a first diameter at its proximal end to a second diameter at its distal end, said first diameter being larger than the diameter of the catheter lumen and said second diameter being approximately the same as the diameter of the catheter lumen.

37. A system according to claim 31 wherein the delivery catheter is less than 20 cm in length and is insertable into a substantially straight segment of vein and wherein the pusher, when fully inserted into the lumen of the delivery catheter, does not protrude out of the distal end of the delivery catheter.