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

• US 6,723,116 B2
• Filed: 05/10/2002
• Issued: 04/20/2004
• Est. Priority Date: 01/14/2002
• Status: Expired due to Fees

• Current Assignee: Syde A. Taheri
• Original Assignee: Syde A. Taheri
• Inventors: Taheri, Syde A.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Landrem, Kamrin R.
• Application Number:
  US10/143,532
• Publication Number:
  US 20030135257A1
• Time in Patent Office: 711 Days
• Field of Search: 623/1.11, 623/1.23, 623/1.13
• 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;

said aortic arch graft being introduced via a delivery system comprising a sheath introducer adapted for deployment around an aortic arch;

said sheath introducer comprising an internal guidance mechanism capable of multi-directional maneuvering; and

said sheath introducer further comprising a compliant tip section comprising one or more flexible ribs.

2. 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;

said aortic arch graft comprising 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;

said aortic arch graft comprising 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; and

said retaining members comprising elements selected from the group consisting of filaments and strings.

3. 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;

said aortic arch graft comprising 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; and

said hoisting elements comprising elements selected from the group consisting of filaments and strings.

4. 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;

retaining said aortic arch graft in position by way of stenting; and

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.

5. A method in accordance with claim 4 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 5 wherein said delivery system comprises a catheter equipped with a hydraulic inflatable tip.

10. 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.

11. A method in accordance with claim 5 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.

12. A method in accordance with claim 11 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.

13. A method in accordance with claim 11 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.

14. A method in accordance with claim 13 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.

15. A method in accordance with claim 4 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.

16. A method in accordance with claim 15 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.

17. A method in accordance with claim 15 wherein said introducing step includes introducing an aortic arch graft with a built-in single self-deploying occiuder 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.

18. A method in accordance with claim 15 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.

19. A method in accordance with claim 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.

20. A method in accordance with claim 19 wherein said occluder guide members are elements selected from the group consisting of filaments and strings.