Orientable Intracranial Occlusion Device and Method

Abstract

A method and device to correctly orient an intracranial occlusion device, such as a stent having differential porosity, with respect to desired areas of greater or lesser blood flow (e.g., branch vessels and aneurysms, respectively), said device being particularly adapted for use in treating aneurysms in intracranial or other tortuous vasculature. An intravascular device comprising a delivery catheter having a hub and angular lumen capable of constraining a pusher wire within a packaging catheter to deploy said stent in an orientation wherein the area of least porosity abuts the aneurysm, and area of maximal porosity permits blood flow to a branch or other vessel. A method of using same.

Claims

1. An intravascular device comprising: (a) a primary wire with fixed non-round shaped outer circumferential surface shape over the majority of its length, with a twelve o'clock marker on its proximal end and at or near the distal end of said shaped segment, (b) a delivery catheter having a proximal end, a distal end, an identical fixed angular primary inner lumen, (c) a corresponding twelve o'clock marker at its distal end, said delivery catheter of configured to (i) moving within a blood vessel to a target lesion, (ii) stopping proximal to said lesion, (iii) delivering a stent, and (iv) withdrawing from said blood vessel, (d) a primary stent loaded onto said catheter wherein said distal delivery catheter having an inner lumen that is configured to communicate with the outer surface of the proximal end of said primary wire, and can slide over the outside of the distal end of said primary wire in one of at least two different fixed orientations, said primary wire proximal end being adapted to deliver said distal end of said delivery catheter over said primary wire, wherein said primary wire containing an identical outer shape as the inner shape of the delivery catheter's primary lumen, with a slightly smaller diameter so that said delivery catheter is capable of slidable passage of said stent loaded on said catheter over said substantially non-round primary wire such that said primary wire substantially maintains said orientation relative to said delivery catheter during movement of said distal end of said delivery catheter through said blood vessel to target lesion, wherein said delivery catheter further being capable of configure to being capable of being rotated prior to marrying with the proximal end of said primary wire so that said primary stent thereon is rotated simultaneously by the same amount, whereupon said delivery catheter and primary stent can be advanced into said delivery catheter into a predicted orientation of said primary stent, and maintaining said orientation as it advanced over said primary wire through said vessel to said target lesion, and while said primary stent is deployed.

2. The device according to claim 1, wherein said catheter further has at least one balloon mounted thereon, and at least one secondary lumen dedicated solely for inflation and deflation of said at least one balloon, and said primary stent is loaded onto said at least one balloon.

3. The device according to claim 1, further comprising a 12 o'clock maker at said hub.

4. The device according to claim 1, wherein said delivery catheter includes radio-opaque markers at said distal end of said delivery catheter.

5. The device according to claim 1, wherein said packaging catheter has radio-opaque markers at said distal end of said pusher wire.

6. The device according to claim 1, wherein said pusher wire comprises an angular shape congruent with said angular lumen of said delivery catheter,

7. The device according to claim 1, wherein said pusher wire comprises an angular shape congruent with said angular lumen of said delivery catheter,

8. The device according to claim 1, comprising the form of a branching stent,

9. A method of using the device of claim 1, comprising the steps of (a) inserting said delivery catheter into a body, (b) pushing said proximal end of said delivery catheter until said distal end of said delivery catheter is proximal to a target aneurysm, (c) orienting said packaging catheter relative to said port of said hub so as to optimize orientation of said stent relative to said target aneurysm, (d) inserting said packaging catheter into said port of said hub, (e) attaching said hub to said proximal end of said delivery catheter, (f) pushing said pusher wire until said stent is proximal to said target aneurysm, (g) withdrawing said delivery catheter, (h) deploying said differentially porous occlusion device, (i) withdrawing said pusher wire.

10. An intravascular device comprising: (a) a delivery catheter having a proximal end, a distal end, an angular lumen, said delivery catheter capable of (i) moving within a blood vessel to a target aneurysm, (ii) stopping proximal to said target aneurysm, and (iii) withdrawing from said blood vessel, (b) a packaging catheter, a pusher hypotube having a proximal end, a distal end, and a differentially porous occlusion device releasably disposed on said distal end of said pusher hypotube, (c) said hub having delivery-catheter port and a packaging-catheter port, said packaging-catheter port being adapted to receive said distal end of said pusher hypotube, of slidable passage of said occlusion device through said angular lumen, such that said pusher hypotube substantially maintains said orientation relative to said delivery catheter during movement of said distal end of said pusher hypotube through said blood vessel to said target aneurysm, (d) said packaging catheter further being capable of rotating said distal end of said pusher hypotube within said delivery catheter to a predicted orientation of said occlusion device, and maintaining said orientation while said delivery catheter is withdrawn.

11. The intravascular device according to claim 10, wherein said hypotube is adapted to deliver fluids therethrough, thereby reducing sump effect on a brain from flow reversal while maintaining retrograde flow sufficient to overcome external carotid artery flow, and maintain retrograde flow across a lesion during at least one of angioplasty and stenting.

12. The device according to claim 2, wherein said stent is differentially porous.

13. The device according to claim 12, wherein said stent contains at least one fenestration.

14. The device according to claim 13, wherein said stent contains at least one region that is substantially impermeable to fluid.

15. The device according to claim 2, wherein said stent contains at least one region that is substantially impermeable to fluid.

16. The device according to claim 2, further containing at least one adhered compound.

17. The device of claim 2, further comprising at least one radiopaque marker on said primary wire.

18. The device of claim 2, further comprising at least one radiopaque marker on said delivery catheter.

19. The device of claim 2, further comprising at least one radiopaque marker on said stent.

20. The device of claim 2, further comprising at least one radiopaque marker on said balloon.

21. The device according to claim 1, wherein said stent is optimized to treat a narrowed lumen.

22. The device according to claim 2, further containing a lubricious surface coating.

23. The device according to claim 2, wherein said primary delivery catheter has a rapid-exchange design.

24. The device according to claim 2, wherein said primary delivery catheter has an over-the-wire design.

25. The device of claim 2, wherein said primary wire has at least one anchor at or near its distal end.

26. The device of claim 25, wherein said anchor comprises a wire rotated in a spring-like shape.

27. The device of claim 25, wherein said anchor is comprises wire segment that splits into at two least wires, with a preset radial force that directs said wires into the proximal vessel walls in different directions.

28. The device of claim 27, wherein said anchor is able to be activated to split via an external stimulus applied at said proximal end.

29. The device of claim 25, wherein said anchor comprises a balled wire.

30. The device of claim 25, wherein said anchor comprises a retrievable stent.

31. The device of claim 25, wherein said primary wire and said anchor can initially be delivered through a secondary catheter.

32. The device of claim 31, wherein said secondary catheter can be delivered initially over a secondary wire.

33. The device of claim 2, further comprising an I.V.U.S. catheter with a similarly shaped and dimensioned inner lumen as said delivery catheter, and at least one corresponding 12 o'clock marker, which can be advanced over said wire and subsequently removed before delivery of said delivery catheter, to optimize imaging and orientation of the target lesion and the orifice of any side branch.

34. The device of claim 2, further comprising a tertiary lumen in the delivery catheter.

35. The device of claim 34, wherein said tertiary lumen is capable of delivering a tertiary wire.

36. The device of claim 34, wherein said tertiary lumen terminates distally in a side hole proximal to the end hole of said delivery catheters primary lumen.

37. The device of claim 36, wherein said balloon has a fenestration which overlies said side hole, and said primary stent has a fenestration, and said primary stent is loaded onto said balloon on said delivery catheter with the fenestration of said primary stent overlying said fenestration of said balloon and said side hole.

38. The device of claim 37, capable of delivering a tertiary wire into a side branch, via said tertiary lumen and said side hole.

39. The device of claim 38, wherein said tertiary wire has a distal anchor.

40. The device of claim 39, wherein said tertiary wire has a fixed substantially non-round shaped outer circumferential surface shape over the majority of its length.

41. The device of claim 38, wherein said tertiary wire has a fixed substantially non-round shaped outer circumferential surface shape over the majority of its length.

42. The device of claim 41, further comprising a secondary delivery catheter.

43. The device of claim 42, further comprising a secondary stent mounted on a secondary balloon on said secondary delivery catheter.

44. The device of claim 43, wherein said secondary stent has at least one fenestration.

45. The device of claim 43, wherein said secondary stent has at least one secondary compound adhered thereon.

46. The device of claim 43, wherein (a) said distal secondary delivery catheter having an inner lumen that is shaped to marry with the outer surface of the proximal end of said tertiary wire, and can slide over the outside of the distal end of the tertiary wire in one of at least 2 different fixed orientations, said tertiary wire proximal end being adapted to deliver said distal end of said delivery catheter over said primary wire (d) said tertiary wire containing an identical outer shape as the inner shape of the secondary delivery catheter's primary lumen, with a slightly smaller diameter so that said secondary delivery catheter is capable of slidable passage of said stent loaded on said catheter over said substantially non-round tertiary wire, such that said tertiary wire substantially maintains said orientation relative to said secondary delivery catheter during movement of said distal end of said secondary delivery catheter through said blood vessel to a target lesion, (e) said secondary delivery catheter further being capable of being rotated prior to marrying with the proximal end of said tertiary wire so that said secondary stent thereon is rotated simultaneously by the same amount, whereupon said secondary delivery catheter and secondary stent can be advanced over said tertiary wire into a predicted orientation of said secondary stent, and maintaining said orientation as it advanced through said vessel to said target lesion, and while said secondary stent is deployed.

47. A wire for intraluminal use, wherein said wire has an anchor at its distal end, wherein said anchor comprises a wire segment that splits into at least 2 wires, with a preset radial force that directs said wires into the adjacent vessel walls in different directions.

48. The device of claim 47, wherein said anchor is able to be activated to split via an external stimulus applied at a proximal end.

49. The device of claim 47, further comprising a central wire that continues centrally distally without an outwardly angled radial force.

50. The device of claim 48, further comprising a central wire that continues centrally distally without an outwardly angled radial force.

51. The device of claim 28, further comprising an I.V.U.S. catheter with a similarly shaped and dimensioned inner lumen as said delivery catheter, and at least one corresponding 12 o'clock marker, which can be advanced over said wire and subsequently removed before delivery of said delivery catheter, to optimize imaging and confirm orientation of the target lesion and the orifice of any side branch.

52. The device of claim 51, further comprising a tertiary lumen in the delivery catheter.

53. the device of claim 52, wherein said tertiary lumen terminates distally in a side hole proximal to the end hole of said delivery catheters primary lumen.

54. The device of claim 53, wherein said balloon has a fenestration which overlies said side hole, and said primary stent has a fenestration, and said primary stent is loaded onto said balloon on said delivery catheter with the fenestration of said primary stent overlying said fenestration of said balloon and said side hole.

55. The device of claim 54, capable of delivering a tertiary wire into a side branch, via said tertiary lumen and said side hole.

56. The device of claim 55, wherein said tertiary wire has a distal anchor.

57. The device of claim 56, wherein said tertiary wire has a fixed substantially non-round shaped outer circumferential surface shape over the majority of its length.

58. The device of claim 57, further comprising a secondary delivery catheter.

59. The device of claim 58, further comprising a secondary stent mounted on a secondary balloon on said secondary delivery catheter.

60. The device of claim 59, wherein said secondary stent has at least one fenestration.

61. The device of claim 60, wherein (a) said distal secondary delivery catheter having an inner lumen that is shaped to marry with the outer surface of the proximal end of said tertiary wire, and can slide over the outside of the distal end of the tertiary wire in one of at least 2 different fixed orientations, said tertiary wire proximal end being adapted to deliver said distal end of said delivery catheter over said primary wire (d) said tertiary wire containing an identical outer shape as the inner shape of the secondary delivery catheter's primary lumen, with a slightly smaller diameter so that said secondary delivery catheter is capable of slidable passage of said stent loaded on said catheter over said substantially non-round tertiary wire, such that said tertiary wire substantially maintains said orientation relative to said secondary delivery catheter during movement of said distal end of said secondary delivery catheter through said blood vessel to a target lesion, (e) said secondary delivery catheter further being capable of being rotated prior to marrying with the proximal end of said tertiary wire so that said secondary stent thereon is rotated simultaneously by the same amount, whereupon said secondary delivery catheter and secondary stent can be advanced over said tertiary wire into a predicted orientation of said secondary stent, and maintaining said orientation as it advanced through said vessel to said target lesion, and while said secondary stent is deployed.

62. The device of claim 61, further comprising at least one adhered compound on at least one component.

63. The device of claim 62, further comprising at least one radiopaque marker on at least one component.

64. The device of claim 63, further comprising an I.V.U.S. catheter with a similarly shaped and dimensioned inner lumen as said delivery catheter, and at least one corresponding 12 o'clock marker, which can be advanced over said wire and subsequently removed before delivery of said delivery catheter, to optimize imaging and confirm orientation of the target lesion and the orifice of any branch.

65. The device of claim 64, wherein the tertiary lumen has a peel-away side slit up to a rapid exchange length lumen.

66. The device of claim 2 further comprising at least one energy transfer component.

67. The device of claim 2, further comprising at least one additional delivery catheter capable of energy transfer at a target location.

68. The device of claim 2, wherein at least one radio-opaque marker is the 12 o'clock marker on the distal end of said non-round segment of said primary wire.

69. The device according to claim 1, wherein the majority of said primary wire comprises an angular shape congruent with an angular lumen of said delivery catheter.

70. The device according to claim 1, wherein said non-round shape of said inner lumens and majority of said primary wire is non-angular.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] FIG. 1A shows a perspective view of a cylindrical delivery catheter 330 having a triangularly shaped lumen 1.

[0041] FIG. 1B shows an embodiment of delivery catheter lumen 3 without its cylindrical sheathing (not shown), having a proximal end 1 and a distal end 2, and has been passed through vessel 1000 such that distal end hole 2 in proximal to target aneurysm 2000.

[0042] FIG. 1C is a cutaway view of delivery catheter lumen 3 having a triangular lumen with ABC angles, and pusher wire 300 passing therethrough at offset C-A-B angles, in order to deliver a differentially porous occlusion device (not shown) at a 120 angle to deploy at a desired orientation.

[0043] FIG. 2 shows proximal end 10 and distal end 20 of stent-packaging catheter 30 (outside patient's body), hub 700 attached to delivery catheter lumen 3, packaging-catheter hub port 701 displaying push-wire 300 running therethrough, further showing push-wire 300 (in dashed lines extending through delivery catheter lumen 3) continuing through delivery catheter lumen 3, said push-wire 300 having its distal end 303 releasably attached to stent 301 proximal to target aneurysm 2000. The distal end 20 of stent-packaging catheter 30 disposed inside hub port 701 delivery catheter lumen 3 (oriented with triangular proximal end hole 1, and triangular distal end hole 2 proximal to target aneurysm 2000); delivery catheter lumen 3 being deployed within vessel walls 1000.

[0044] FIG. 3 shows push-wire 300 and stent 301 disposed at push-wire distal end 303 within vessel walls 1000 following removal of delivery catheter lumen 3 (shown in FIG. 2).

[0045] FIG. 4 shows an interior view of delivery catheter lumen 3 having a triangular shape, composed of proximal sides 4, 5 and 6, corresponding with distal sides 44 (oblique distal sides 55 and 66 behind 44 are shown in FIG. 5); facing side 444 illustrates the full length of the catheter side beginning at proximal side 4 and ending in distal side 44. Alternative embodiments (not shown) may employ other regular shapes such as rectangles or stars.

[0046] FIG. 5 shows an adjacent face 555 of the interior of delivery catheter of FIG. 4 (or FIG. 4 rotated once 120.), face 555 beginning at proximal side 5 and ending in distal side 55 (oblique distal sides 44 and 66 behind 55 shown in dashed cutaway); facing side 555 further includes radio-opaque orientation-aid markers 5550.

[0047] FIG. 6 shows a stent 301 attached to push-wire 300 at distal end 303 of push-wire 300 and proximal end of stent 301. Said stent 301 is triangular in shape, with distal end 3010 and triangular edges on a plane with distal end 303, namely edges 334, 355 and 366. At the distal end 3010 of stent 301, triangular edge 3550 is shown in dotted lines disclose the other two triangular edges 3440 and 3660. Triangular edge 335 forms a planar length terminating in edge 3550. On said plane, resides radio-opaque markers 55500.

[0048] FIG. 7A and FIG. 7B show delivery catheter lumen 3 geometry with relative position of radio-opaque markers.

[0049] FIG. 8 shows one geometry of a pusher wire;

[0050] FIG. 9 shows packing catheter.

[0051] FIG. 10 shows options for packing catheter.

[0052] FIG. 11 and FIG. 12 shows positions of radio-opaque markers relative to each other.

[0053] FIG. 13 and FIG. 14 show optional embodiments of reverse unsheathing stents.

DETAILED DESCRIPTION OF THE INVENTION

[0054] The embodiments of the device and variants of the device of the present invention are set forth with reference to the above drawings.

[0055] Referring to FIG. 1A, a perspective view is shown of a cylindrical delivery catheter 330 having a triangularly shaped lumen 1. The present invention discloses a traditional cylindrical delivery catheter with a linear lumen such as a triangle, square, other rectangle, star, hexagon or so on. Said linear lumen is designed to allow the second of a push wire which has a similar shape, adapted to be inserted into said lumen 1 at differing, fixed relative positions.

[0056] Now referring to FIG. 1B, shown is an embodiment of delivery catheter lumen 3 without its cylindrical sheathing (not shown). Said delivery catheter lumen 3 having a proximal end 1 and a distal end 2, and has been passed through vessel 1000 such that distal end hole 2 in proximal to target aneurysm 2000. Delivery catheter lumen 3 is inserted into blood vessel 1000 until stopped such that distal end 2 is proximal to target aneurysm 2000. Due to the linear geometry of the lumen 1, the delivery catheter lumen 3 has a set orientation with respect to having one side closest to said target aneurysm 2000.

[0057] Now referring to FIG. 1C, shown is a cutaway view of delivery catheter lumen 3 having a triangular lumen with A-B-C angles, and pusher wire 300 passing therethrough at offset C-A-B angles, in order to deliver a differentially porous occlusion device (not shown) at a 120 angle to deploy at a desired orientation. The present invention teaches that the orientation of a push-wire may be fixed outside the patient's body by fixing its relative orientation with respect to the delivery catheter lumen 3. Said delivery catheter lumen 3's orientation with respect to target aneurysm 2000, having been established prior to insertion of push-wire 300, allows the user of the device of the present invention to properly insert said push-wire 300 to achieve proper orientation with respect to aneurysm 2000 without turning said push-wire 300 inside the patient. The present disclosure includes the basic concept of having a non-circular, geometrically shaped inner lumen and matched pusher wire or hypotube. This allows the user to avoid unwanted turns of devices inside the delivery catheter and inside of vessels. It also allows delivery in a predictable radial orientation, utilizing a marker at the hub and a corresponding radial marker at the delivery catheter tip, so that when the orientation of the delivery catheter tip is imaged after positioning intracranial, or in similar tortuous anatomy, the degree of torsion, if any, relative to the corresponding hub marker and relative to the target pathology can be measured. The stent device can then be inserted at an appropriate orientation relative to the hub marker, so that the desired orientation is delivered to the target vessel. For example, if the hub marker is at 12 o'clock, and the tip marker is at 4 o'clock, the device/stent can be inserted knowing that whatever porosity is inserted at the hub at 12 o'clock, will consistently be delivered through the catheter tip at 4 o'clock. Similarly, stent devices can be preloaded in packaging catheters of a similar geometric shape, and with a similar 12 o'clock marker (or similar), at various radial circumferential orientations relative to the 12 o'clock position. Then, depending on which orientation is desired, the appropriate preloaded device can be chosen and utilized. Alternatively, the devices can all be preloaded in the same orientation, and the packaging catheter can be rotated at various angles relative to the delivery catheter and its hub, in order to achieve the desired orientation of the stent device as it is transferred from the packaging catheter to the delivery catheter. As is well known in the prior art, the packaging catheter it typically shorter than the delivery wire or delivery hypotube. The stent is preloaded onto said delivery wire or hypotube within said packaging catheter. Transfer of said stent device is then achieved by mating the packaging catheter with the delivery catheter, within the hub of the delivery catheter, and then advancing/pushing the back of the wire/hypotube, which is extending out the back of the packaging catheter. Said wire/hypotube is advanced, together with the stent mounted thereon, at a minimum until the stent is completely within the delivery catheter, and most often until the majority of the pusher wire/hypotube is as well. The packaging catheter is the removed from the remainder of the hypotube/wire, and the operator continues to push said hypotube/wire until the stent reaches the end of the delivery catheter. The stent can then be deployed by pushing it out, retracting the delivery catheter to unsheathe it, and/or a combination of these. Additionally, in the preferred embodiments the pusher wire/hypotube, packaging catheter, and delivery catheter have a matching geometrical shape, with the packaging catheter and delivery catheters (excluding the hub) having similar inner dimensions; the wire/hypotube fits snugly, but slideably, into the packaging catheter and delivery catheter, fitting in a lock-in-key fashion, so it can advance within said catheters but cannot rotate in said catheters. For example, in one embodiment the pusher wire/hypotube has and outer triangular cross-sectional shape, which fits into an inner triangular shaped packaging catheter and delivery catheter.

[0058] Now referring to FIG. 2, shown is proximal end 10 and distal end 20 of stent-packaging catheter 30 (outside patient's body), hub 700 attached to delivery catheter lumen 3, packaging-catheter hub port 701 displaying push-wire 300 running therethrough, further showing push-wire 300 (in dashed lines extending through delivery catheter lumen 3 and continuing through delivery catheter lumen 3, said push-wire 300 having its distal end 303 releasably attached to stent 301 proximal to target aneurysm 2000; the distal end 20 of stent-packaging catheter 30 disposed inside hub port 701, delivery catheter lumen 3 (oriented with triangular proximal end hole 1, and triangular distal end hole 2 proximal to target aneurysm 2000); delivery catheter lumen 3 being deployed within vessel walls 1000.

[0059] Packaging catheter 30 is joined to hub 700 at port 701 such that stent 301 and push-wire 300 are oriented as desired so as to present the minimally porous surface of said stent 301 substantially toward the target aneurysm 2000.

[0060] Now referring to FIG. 3, shown is push-wire 300 and stent 301 disposed at push-wire distal end 303 within vessel walls 1000 following removal of delivery catheter lumen 3 (shown in FIG. 2). Once stent 301 is proximally paced next to aneurysm 2000, said stent 301 is activated and expands such that the substantially nonporous side of said stent 301 abuts said aneurysm 2000, while the other two sides of a triangularly elongated stent 301 are porous to promote blood flow. Additionally, the present invention discloses a single 12 o'clock marker on the hub, and a single radio-opaque 12 o'clock marker on the distal catheter tip.

[0061] Now referring to FIG. 4, shown is an interior view of delivery catheter lumen 3 having a triangular shape, composed of proximal sides 4, 5 and 6, corresponding with distal sides 44 (oblique distal sides 55 and 66 behind 44 are shown in FIG. 5); facing side 444 illustrates the full length of the catheter side beginning at proximal side 4 and ending in distal side 44.

[0062] The orientation of lumen of delivery catheter lumen 3 must be clearly identifiable. FIG. 4 shows a triangular shape having sides 4, 5 and 6 on the proximal end, 44 at the distal end of face 444. Alternative embodiments (not shown) may employ other regular shapes such as rectangles or stars.

[0063] Now referring to FIG. 5, shown is an adjacent face 555 of the interior of delivery catheter of FIG. 4 (or FIG. 4 rotated once 120.), face 555 beginning at proximal side 5 and ending in distal side 55 (oblique distal sides 44 and 66 behind 55 shown in dashed cutaway); facing side 555 further includes radio-opaque orientation-aid markers 5550. FIG. 5 is a rotated image of FIG. 4 displaying the opposing plane 555 which terminates at side end 5 on the proximal end, and 55 on the distal end. On said 555 surface, radio markers 5550 allow the user to ascertain the relative orientation of one side of the delivery catheter lumen 3. Using this information, the packaging catheter 30 may be properly oriented in hub port 701 such that when push-wire 300 and stent 301 are proximal to aneurysm 2000, they are properly aligned or oriented.

[0064] Now referring to FIG. 6, shown is a stent 301 attached to push-wire 300 at distal end 303 of push-wire 300 and proximal end of stent 301. Said stent 301 is triangular in shape, with distal end 3010 and triangular edges on a plane with distal end 303, namely edges 334, 355 and 366. At the distal end 3010 of stent 301, triangular edge 3550 is shown in dotted lines disclose the other two triangular edges 3440 and 3660. Triangular edge 335 forms a planar length terminating in edge 3550. On said plane, resides radio-opaque markers 55500.

First Method.

[0065] Use a delivery catheter with a 12 o'clock marker at the proximal hub of said catheter. The 12 o'clock marker may be disposed on the hub and on the delivery catheter tip (i.e., radio-opaque on the catheter tip). The user inserts the stent-packaging catheter having a differentially porous stent or occlusion device mounted on a push-wire therein. After testing, the user rotates the packaging catheter at the hub to the desired indicator.

[0066] The indicator may be disposed in any position on the hub to point to any direction on the hub, but terming this a 12 o'clock indicator or marker is convenient for describing positions relative to the marker for anyone familiar with an analog clock face. For example, instructing a user to rotate the hub to 3 o'clock, 6 o'clock, or 9 o'clock intuitively suggests a quarter turn, half turn, and three-quarter turn, respectively, with other times referring to approximate positions between these 90 references (e.g., 2 o'clock, 5 o'clock or 11 o'clock). The same effect could be achieved by reference to a North marker, utilizing terminology such as East, South, and West (or interstitial positions such as ESE or NW), but 12 o'clock is a preferred reference. The ability to rotate the relative orientation of the delivery catheter within a 360 range manually, not the terminology employed, is material.

[0067] Use a packaging catheter having a distal marker, advance a test stent or final stent at a particular orientation relative to the 12 o'clock marker on said delivery catheter. The stent (or other marked endovascular device) will generally end in a substantially similar, but unpredictable, orientation. The process may be repeated to verify that the markers on the delivery catheter and the packaging catheter are consistently aligned. Then image the markers on the test stent/device relative to the marker on the tip of the delivery catheter to determine what orientation (i.e., at what hour on the clock) the stent needs to be loaded into the delivery catheter in order to achieve the desired orientation. Or use a stent preloaded in a delivery catheter in a desired orientation relative to the 12 o'clock marker.

[0068] Optionally, the orientation can be confirmed with an additional test stent/device which is temporarily advanced in the predicted orientation, and then imaging can confirm, before the test device is removed and a permanent device is advanced and deployed.

[0069] By way of example, a test result shows a fenestration deploys at 7 o'clock, which is 90 clockwise relative to the target branch vessel. The treatment would then reorient the stent-packaging catheter at 4 o'clock, to have it appear correctly oriented proximal to the target branch.

[0070] When a catheter tip orientation is imaged, the stent loaded in the appropriate orientation relative to the similarly disposed hub marker can be deployed. Once again, if desired, test device/stents with additional radio-opaque markers can be retrievably deployed to confirm the orientation.

Second Method

[0071] Disclosed is a second method, using the steps and markers of the above-described First Method, and in addition using a delivery catheter having throughout its cross section a unique geometrically shaped inner lumen. In a typical embodiment, the surface of the delivery catheter will be conventionally cylindrical, substantially rounded, to facilitate advancement through circulatory vessels. An unrounded lumen minimizes the rotational tendency of a deploying stent-packaging catheter, or a wire, enhancing the predictability of orientation.

[0072] The accompanying figures show, by way of example, a triangularly shaped lumen. Alternatively, a square, hexagon, octagon, pentagon, a house silhouette or star shape. Any style of star may be used, such as 6-pointed, Star of David or others, or other geometric shapes, provided a single one is used throughout the lumen.

[0073] In a further embodiment, a packaging catheter may be shaped correspondingly to the shape of the lumen of the delivery catheter. This correspondence is shown in the accompanying FIGS. 1A and 1B, for example. This embodiment is configured such that the correspondingly shaped packaging catheter and delivery wire/hypotube are snug enough so as to not allow rotation, but loose enough to allow movement back and forth relative to one another. This embodiment will maintain a similar orientation through the advancement of the stent/device through the delivery catheter, allowing accurate and predicable deployment in appropriate and desired orientations.

[0074] Again here, a 12 O'clock marker that is at the same orientation can be on the hub and on the catheter tip (radio-opaque on the catheter tip). So, when/if the catheter tip orientation is imaged, the stent loaded in the appropriate orientation relative to the similarly disposed hub marker can be used. Once again, if desired, test device/stents with additional radio-opaque markers can be retrievably deployed to confirm the orientation. When the tip marker orientation can be well imaged after delivery intracranially, or into similar tortuous vasculature, the tip marker orientation, and its relative deflection on a rotary basis from the hub marker, can most often be used to determine rotational orientation, without the need for optional retrievable test-stent devices.

Common Method

[0075] Using any of the devices and methods above, a fenestration can be accurately deployed at the origin of a branch vessel. Then a wire can be advanced through that fenestration and into the branch, and either: (a) a balloon expandable device/stent can be delivered over the wire and deployed so that the proximal end minimally overlaps with the fenestration of the first stent/device; moreover, the branch may also optionally have a taper so it is somewhat larger at the fenestration side versus the portion that extends into the branch vessel; (b) a second delivery catheter (or the first can be re-used) can be delivered into the branch (the wire can optionally be removed) and an additional branch stent, most often self-expanding, can be delivered through the delivery catheter. Again, the branch stent may also optionally have a taper so it is somewhat larger at the fenestration side versus the portion that extends into the branch vessel.

[0076] Delivery method (b), however, has difficulty accurately landing the proximal stent, especially with woven or braided stents which can significantly, and unpredictably, foreshorten during deployment (compared to their length crimped in the delivery catheter).

[0077] Another option therefore is a novel delivery device for such stents. In this embodiment, it can be loaded in a device/catheter similar to the inner catheter with wings of a filter-tip TAVR (transcatheter aortic valve replacement) catheter, or said another way a central tube and retaining structure connected to the distal end of said central tube and extending in a direction from the distal end to the proximal end of said central tube also described and patented by Walzman (US1030724262). The wings provide the proper fixing of the orientation while being guided through the angular lumen 1 of the delivery catheter. Having a single or multiple external wires attached to a stent, in a preferred embodiment ideally attached to the proximal and distal ends of the stent (which can be over the wire or most ideally rapid exchange) once a first stent is deployed with the fenestration overlying a branch vessel origin, a second wire is advanced through the fenestration into the branch, and a second stent/device, delivered constrained within said retaining structure and having at least one second wire attached to said stent outside the central tube and/or an outer tube attached to said stent, is advanced over the wire to the desired position. The stent attached wire(s) (or, alternatively, the outer catheter) is held in place while the inner catheter with wings is advanced, exposing/unsheathing the stent from the proximal end first.

[0078] The present invention also discloses an unsheathing device for the branch stent. More specifically the present invention teaches a device which un-sheaths the proximal part first. In the foregoing, if the stent is attached by wires, the wires can expand with the stent. If the stent is attached to an outer catheter (which is outside the inner catheter, but still inside the stent; the wings are outside the stent), it would need to wait until entire stent is unsheathed before detaching the proximal end. Or if stent is attached circumferentially proximally to an outer catheter and also has at least one additional wire attached to the stents distal segmentor additional attachment(s) to the outer catheter at the distal stent segment, then the proximal attachments can be detached upon unsheathing the proximal segment of the stentto ensure appropriate orientation and position overlapping minimally the fenestration but not significantly overlapping/covering the primary vessel, and then the distal stent can be detached once the entire stent is deployed.

[0079] The stent can optimally be attached only distally to the outer catheter, in order to advance the system, the outer catheter is pushed, which pulls the attached stent and pushes the winged portion of the inner catheter (and subsequently the entire inner catheter in unison). Then, when the stent is properly positioned, the second stent can be unsheathed by holding the outer catheter (with attached stent) in position and then advancing the inner catheter, which will unsheath the proximal stent first. Using self-expanding stents, the proximal stent will automatically expand as it is unsheathed. If position is off, the inner catheter can be pulled back again and the proximal stent can be re-sheathed, and the stent can be repositioned before unsheathing again.

[0080] Additionally, when using braided or woven stents, full expansion can be slow and unpredictable, the proximal end of stent (and optionally other parts as well) can have a nitinol wire ring to encourage more immediate opening/self-expansion to its maximal diameter. There may optionally be similar attached longitudinal wires as well to help allow smooth re-sheathing when desired. Such rings may optionally be repeated at additional intervals along the stent device.

[0081] More particularly, a preferred method may be described by the following steps, using the embodiment of the device in which the pusher wire comprises an angular shape congruent with the angular lumen of the delivery catheter (e.g., a triangularly shaped pusher wire and triangular lumen): [0082] (a) inserting said delivery catheter into a body, [0083] (b) pushing said proximal end of said delivery catheter over a delivery wire until said distal end of said delivery catheter is proximal to a target aneurysm, [0084] (c) removing said delivery wire [0085] (d) imaging the orientation of said distal end radial marker relative to said target aneurysm [0086] (e) orienting said packaging catheter relative to a 12 o'clock hub marker so as to optimize orientation of said stent relative to said target aneurysm, [0087] (f) inserting said packaging catheter into said hub, [0088] (g) pushing said pusher wire until said stent is fully within said delivery catheter [0089] (h) removing said packaging catheter [0090] (i) pushing said pusher wire until said stent is proximal to said target aneurysm, [0091] (j) deploying the majority of said differentially porous occlusion device, [0092] (k) repeating imaging to confirm expected device orientation [0093] (l) deploying fully the remainder of said differentially porous occlusion device, and [0094] (m) withdrawing said pusher wire and said delivery catheter.

Bifurcated or V-Shaped Stents

[0095] Using the foregoing procedure, a Y shaped stent may be assembled from two stents in vivo by reference to markers.

[0096] The present invention may employ self-expanding components.

[0097] The present invention may employ balloon-expanding components.

[0098] The present invention may optionally contain radiopaque components and/or radiopaque markers. These can be especially valuable at ends of stent and at the ends and edges of covered zone. Radio-opaque materials and markers can also be optionally present in more places, and sometimes throughout.

[0099] The present invention may have branched stent elements.

[0100] The present invention's stent elements may optionally be fully re-sheathable.

[0101] The present invention's stent elements may optionally be partly re-sheathable.

[0102] All stent elements of the present invention may be optionally be detachable.

[0103] It will be understood by those skilled in the art that the above particular embodiments are shown and described by way of illustration only. The principles and the features of the present disclosure may be employed in various and numerous embodiments thereof without departing from the scope and spirit of the disclosure as claimed. The above-described embodiments illustrate the scope of the disclosure but do not restrict the scope of the disclosure.