Exclusion of ascending/descending aorta and/or aortic arch aneurysm

• US 20030135257A1
• Filed: 05/10/2002
• Published: 07/17/2003
• Est. Priority Date: 01/14/2002
• Status: Active Grant

• Current Assignee: Syde A. Taheri
• Original Assignee: Syde A. Taheri
• Inventors: Taheri, Syde A.
• Granted Patent: US 6,723,116 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 : the stent being loosely attached to the graft material, e.g. by stitching

Abstract

A system and method for exclusion of an aneurysm of an aortic arch region using a graft delivery system capable of maneuvering around an aortic arch, an aortic arch graft, and an occluder system for isolating an aneurysm while occluding one or more corresponding arteries, and with bypass of those arteries being performed using one or more selected bypass grafts. The graft may be branched or branchless. The graft delivery system has a flexible sheath that is manipulated manually with the aid of a guidance system. A hoist delivery system may also be provided. The occluder system may comprise independent occluders with one or more anchor members adjacent to one end. Alternatively, the occluders can be provided as part of the aortic arch graft, either as a built-in singular self-deploying occluder or as built-in multiple occluders. A kit is also provided containing a graft, stents, occluders, and optional delivery system.

Claims

1. A method for exclusion of an aneurysm of an aortic arch region, comprising:

introducing via a percutaneous approach an aortic arch graft into an aortic arch region such that a proximal end of said graft lies proximate an ascending aorta above an aortic cusp and a distal end lies below a left subclavian artery; and

retaining said aortic arch graft in position by way of stenting.

2. A method in accordance with claim 1 wherein said aortic arch graft comprises branches having open ends.

3. A method in accordance with claim 2 wherein said aortic arch graft comprises two branches respectively adapted for deployment in a right innominate artery and a left subclavian artery.

4. A method in accordance with claim 1 wherein said aortic arch graft is branchless.

5. A method in accordance with claim 1 wherein said aortic arch graft is introduced via a delivery system comprising a sheath introducer adapted for deployment around an aortic arch.

6. A method in accordance with claim 5 wherein said sheath introducer comprises an inflatable tubular wall.

7. A method in accordance with claim 5 wherein said sheath introducer comprises an internal guidance mechanism capable of multi-directional maneuvering.

8. A method in accordance with claim 7 wherein said sheath introducer comprises a compliant tip section.

9. A method in accordance with claim 8 wherein said compliant tip section comprises one or more flexible ribs.

10. A method in accordance with claim 5 wherein said delivery system comprises a catheter equipped with a hydraulic inflatable tip.

11. A method in accordance with claim 5 wherein said aortic arch graft has multiple loop members at one end, said delivery system includes a catheter having multiple expandable portions at its proximal end, and said loop members are adapted for receiving deployment members for deploying and temporary positioning of said graft prior to stenting.

12. A method in accordance with claim 1 wherein said aortic arch graft comprises multiple loop members at one end and said introducing step includes attaching said loop members via hoisting elements to a flexible guide wire having an eyelet, passing said hoisting elements and said guide wire internally into said graft, and hoisting said graft into position by pulling on said hoisting elements.

13. A method in accordance with claim 12 wherein said aortic arch graft comprises a stent at each end of said graft and wherein said introducing step includes inserting said graft into a sheath introducer that comprises a flexible thin-walled sheath, said sheath introducer being made of a material capable of resisting the expansive pressure of a compressed stent.

14. A method in accordance with claim 12 wherein said aortic arch graft comprises a stent at each end of said graft, and said introducing step includes compressing said stents with releasable retaining members that are releasable from a location outside of a patient'"'"'s body.

15. A method in accordance with claim 14 wherein said aortic arch graft comprises multiple loop members around an outside portion of said graft and positioned near said stents, said loop members being adapted to retain said retaining members in position.

16. A method in accordance with claim 14 wherein said retaining members comprise elements selected from the group consisting of filaments and strings.

17. A method in accordance with claim 12 wherein said hoisting elements comprise elements selected from the group consisting of filaments and strings.

18. A method in accordance with claim 1 further including performing one or more of:

a left carotid-subclavian bypass by placing a bypass graft between a left common carotid artery and a left subclavian artery;

a bilateral femoral-axillary bypass by placing a first bypass graft between a left femoral artery and a left subclavian artery and a second bypass graft between a right femoral artery and a right subclavian artery; and

occluding one or more of said left subclavian artery, said left common carotid artery and a right innominate artery proximate to an aortic arch.

19. A method in accordance with claim 18 wherein said aortic arch graft is branchless and said bypass step includes:

performing a left carotid-subclavian bypass by placing a bypass graft between a left common carotid artery and a left subclavian artery;

performing a bilateral femoral-axillary bypass by placing a first bypass graft between a left femoral artery and a left subclavian artery and a second bypass graft between a right femoral artery and a right subclavian artery; and

occluding said left subclavian artery, said left common carotid artery and a right innominate artery proximate to an aortic arch.

20. A method in accordance with claim 19 wherein said aortic arch graft is branched and said bypass step includes:

performing a left carotid-subclavian bypass by placing a bypass graft between a left common carotid artery and a left subclavian artery; and

occluding said left common carotid artery proximate to an aortic arch.

21. A method in accordance with claim 19 wherein said introducing step includes introducing an aortic arch graft with a built-in single self-deploying occluder via a femoral approach into said aortic arch such that said occluder faces and fills with blood to occlude said left subclavian artery, said left common carotid artery and a right innominate artery.

22. A method in accordance with claim 19 wherein said introducing step includes introducing an aortic arch graft with built-in multiple self-deploying occluders via a femoral approach into said aortic arch such that said occluders face and fill with blood to respectively occlude said left subclavian artery, said left common carotid artery and a right innominate artery.

23. A method in accordance with claim 22 wherein said introducing step includes introducing occluder guide members via a left subclavian artery, a left common carotid artery and a right innominate artery, passing said guide members via a descending aorta to a femoral artery, attaching said guide members to corresponding ones of said occluders, introducing said aortic arch graft via a femoral approach into said aortic arch, and occluding said left subclavian artery, said left common carotid artery and a right innominate artery proximate to an aortic arch with deployment of said occluders by manipulation of said guide members.

24. A method in accordance with claim 23 wherein said occluder guide members are elements selected from the group consisting of filaments and strings.

25. An aortic arch graft comprising a thin walled tubular body having an outside diameter of at least about 28-32 millimeters for fitting inside an aortic arch.

26. An aortic arch graft in accordance with claim 25 wherein said graft comprises branches.

27. An aortic arch graft in accordance with claim 25 wherein said graft is branchless.

28. An aortic arch graft in accordance with claim 25 wherein said aortic arch graft further includes loop members for receiving members adapted for one or more functions of hoisting said graft, temporarily positioning said graft, and maintaining said graft in a compressed condition.

29. An aortic arch graft in accordance with claim 25 further including not more than two stents, each of said stents being placed at opposite ends of said tubular body.

30. An aortic arch graft in accordance with claim 25 further including a built-in single self-deploying occluder for occluding aortic branches.

31. An aortic arch graft in accordance with claim 30 further including a support ring disposed at a base of said occluder.

32. An aortic arch graft in accordance with claim 25 further including built-in multiple self-deploying occluders for occluding aortic branches.

33. An aortic arch graft in accordance with claim 25 further including built-in multiple manually deployable occluders for occluding aortic branches.

34. An occluder for occluding an aortic branch, comprising at least one stent, a closed end thin-walled tubular body covering said stent, and an anchor member.

35. An occluder in accordance with claim 34 wherein said occluder further includes a radio-opaque marker.

36. An occluder in accordance with claim 34 wherein said anchor member comprises spike members adapted to engage an arterial wall.

37. A delivery system for introducing an aortic arch graft into an aortic arch region via a femoral approach, comprising:

a sheath introducer having a substantially tubular body;

a proximal end on said tubular body;

a distal end on said tubular body;

a flexible section extending from said proximal end toward said distal end; and

said flexible section having sufficient bending capability to facilitate deployment around an aortic arch.

38. A delivery system in accordance with claim 37 wherein said flexible section comprises multiple rib members.

39. A delivery system in accordance with claim 37 wherein said sheath introducer comprises an inflatable wall.

40. A delivery system in accordance with claim 39 further including an internal guidance mechanism capable of maneuvering said proximal end of said sheath introducer multi-directionally around an aortic arch.

41. A delivery system in accordance with claim 40 wherein said guidance mechanism comprises a wire or filament disposed within said sheath introducer and extending from said proximal end to said distal end, said wire or filament being attached to said proximal end and being adapted for controllable manipulation at said distal end.

42. A delivery system in accordance with claim 37 further including a catheter disposed within said sheath introducer, said catheter comprising a hydraulic inflatable tip at a proximal end thereof.

43. A delivery system in accordance with claim 42 wherein said catheter further comprises a first expandable portion at its proximal end adapted to interact with a proximal portion of a graft by way of said graft being secured to said first expandable portion using deployment members temporarily for positioning said graft prior to stenting, and wherein said catheter further includes a second expandable portion at its proximal end adapted to carry a stent for deployment.

44. A delivery system for introducing an aortic arch graft into an aortic arch region via a femoral approach, comprising:

a guide wire having a distal end and a proximal end, said proximal end being adapted to carry a hoisting assembly;

an aortic arch graft having a proximal end adapted to temporarily connect to a hoisting assembly; and

a hoisting assembly having a proximal end adapted to be temporarily connected to said graft and a distal end adapted to be manipulated for hoisting said graft.

45. A delivery system in accordance with claim 44 wherein said graft further includes loop members around a proximal end of said graft for temporary attachment to a hoisting system.

46. A delivery system in accordance with claim 44 wherein said aortic arch graft comprises a stent at each end of said graft, and wherein said delivery system further includes a sheath introducer having a soft bending compliant thin-wall sheath adapted to receive said graft and compress said stents for delivery into a patient'"'"'s body.

47. A delivery system in accordance with claim 44 wherein said aortic arch graft comprises:

a stent at each end of said graft;

loop members around an outside portion of said graft and positioned near said stents, said loop members being adapted to position retaining members around said stents; and

wherein said delivery system further includes;

retaining members adapted to compress said stents during delivery of said graft into a patient'"'"'s body, said retaining members being remotely releasable from said graft to deploy said stent.

48. A delivery system in accordance with claim 47 wherein said retaining members comprise strings.

49. A delivery system in accordance with claim 48 wherein said strings are wrapped around said stent in a releasable slipknot, with said releasable slipknot being released from a distal end of said string outside a patient'"'"'s body.

50. A kit for performing exclusion of an aneurysm of an aortic arch region, comprising:

an aortic arch graft;

stents for securing said graft in position; and

occluders for occluding one or more aortic branches.

51. A kit in accordance with claim 50 wherein said graft comprises branches.

52. A kit in accordance with claim 50 wherein said graft further includes loop members around a proximal end of said graft for temporary attachment to a hoisting system or for temporary attachment to deployment members adapted for positioning said graft prior to stenting.

53. A kit in accordance with claim 51 wherein said stents are mounted on said graft.

54. A kit in accordance with claim 53 wherein there are not more than two of said stents mounted on said graft, one at each end of said graft.

55. A kit in accordance with claim 52 wherein said graft comprises loop members around an outside portion of said graft and positioned near said stents, said loop members being adapted to retain a releasable retaining member.

56. A kit in accordance with claim 55 further including releasable retaining members to compress said stents during deployment in a patient'"'"'s body.

57. A kit in accordance with claim 50 wherein said occluders comprise anchor members.

58. A kit in accordance with claim 57 wherein said anchor members comprise spike members.

59. A kit in accordance with claim 50 further including a delivery system comprising a sheath introducer with an internal guidance mechanism capable of multi-directional maneuvering around an aortic arch.

60. A kit in accordance with claim 50 further including a delivery system comprising a sheath introducer with a soft, bending compliant thin-walled body adapted to bend around an aortic arch.