Sealable endovascular implants and methods for their use

• US 20090005760A1
• Filed: 07/31/2007
• Published: 01/01/2009
• Est. Priority Date: 07/31/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Syntheon Cardiology, LLC
• Inventors: Cartledge, Richard George, Cartledge, John, Gaskins, Ralph Edward JR.
• Granted Patent: US 8,252,036 B2
• Time in Patent Office: Days
• US Class Current: 604/534
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0065 telescopic
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

The present invention is directed towards sealable and repositionable endovascular implant grafts, and methods for their use for the treatment of aortic aneurysms and other structural vascular defects. Sealable, repositionable endograft systems for placement in a blood vessel are disclosed, in which endograft implants with circumferential sealable collars and variable sealing devices upon deployment achieve a desired controllable seal between the collar and the vessel'"'"'s inner wall. Embodiments of endovascular implants according to the present invention may further be provided with retractable retention tines or other retention devices allowing an implant to be repositioned before final deployment. An endograft system according to the present invention further comprises a delivery catheter to allow placement through a peripheral arteriotomy site, and of sufficient length to allow advancement into the thoracic or abdominal aorta.

Claims

1. A sealable vascular endograft system for placement in a vascular defect, comprising:

an elongated main implant delivery catheter with an external end and an internal end for placement into a blood vessel with internal walls, said main implant delivery catheter further comprising;

a main implant delivery catheter sheath which may be openable or removable at said internal end;

a main implant delivery catheter lumen containing within a compressed or folded endovascular implant;

said endovascular implant further comprising;

a non-elastic tubular implant body with an elastic proximal end and an elastic distal end, said elastic proximal end terminating in a proximal sealable circumferential collar controlled by a proximal variable sealing device which is operated by a proximal control lead that traverses said main implant delivery catheter and exits at said external end for interface by an operator, such that said proximal sealable circumferential collar may be expanded or contracted by said operator to achieve a fluid-tight seal;

between said proximal sealable circumferential collar and the internal walls of said blood vessel proximal to said vascular defect;

said elastic distal end terminating in a distal sealable circumferential collar controlled by a distal variable sealing device which is operated by a distal control lead that exits said main implant delivery catheter at said external end for interface by said operator, such that said distal sealable circumferential collar may be expanded or contracted by said operator to achieve a fluid-tight seal between said distal sealable circumferential collar and the internal walls of said blood vessel distal to said vascular defect.

2. An endovascular implant comprising:

a tubular implant body with a proximal end and a distal end,

said proximal end terminating in a proximal sealable circumferential collar controlled by a proximal variable sealing device which is operated by an operator, such that said proximal and distal sealable circumferential collar may be expanded or contracted by said operator to achieve a fluid-tight seal between said proximal sealable circumferential collar and the internal walls of said blood vessel proximal to said vascular defect;

and said elastic distal end terminating in a distal sealable circumferential collar controlled by a distal variable sealing device which is operated by said operator, such that said distal sealable circumferential collar may be expanded or contracted by said operator to achieve a fluid-tight seal between said distal sealable circumferential collar and the internal walls of said blood vessel distal to said vascular defect.

3. The endovascular implant of claim 2, wherein said tubular body is non-elastic.

4. The endovascular implant of claim 2, wherein said proximal sealable circumferential collar is elastic.

5. The endovascular implant of claim 2, wherein said distal sealable circumferential collar is elastic.

6. The endovascular implant of claim 2, wherein said proximal variable sealing device which is operated by a proximal control lead that traverses said main implant delivery catheter and exits at said external end for interface by said operator.

7. The endovascular implant of claim 2, wherein said distal variable sealing device which is operated by a distal control lead that traverses said main implant delivery catheter and exits at said external end for interface by said operator.

8. The endovascular implant of claim 2, wherein said tubular body may be straight.

9. The endovascular implant of claim 2, wherein said tubular body may branch into two or more branches.

10. The endovascular implant of claim 2, wherein said endovascular implant may be connected to one or more other endovascular implants in a variably sealable manner by operation of said proximal and distal sealable circumferential collars as controlled by said proximal and distal variable sealing devices, respectively, to achieve a fluid-tight seal between the proximal-most proximal sealable circumferential collar, the distal-most distal sealable circumferential collar and the internal walls of said blood vessel distal to said vascular defect.

11. The endovascular implant of claim 2 wherein said endovascular implant may be of solid construction of a biocompatible material.

12. The endovascular implant of claim 2 wherein said endovascular implant may be of woven construction of a biocompatible material.

13. The endovascular implant of claim 2 wherein said endovascular implant may be coated with a biocompatible material.

14. A method of treating a vascular defect such as an aneurysm in a blood vessel within a patient by an operator, comprising:

placing an elongated main implant delivery catheter with an external end and an internal end through a peripheral vascular entry into a blood vessel with internal walls;

opening or removing a main implant delivery catheter sheath at said internal end;

decompressing or unfolding a compressed or folded endovascular implant within said sheath;

employing radiographic or other real-time visualization means to monitor implant placement;

operating a proximal control lead that traverses said main implant delivery catheter and exits at said external end for interface by said operator, such that a proximal sealable circumferential collar may be expanded or contracted by said operator to achieve a fluid-tight seal;

between said proximal sealable circumferential collar and the internal walls of said blood vessel proximal to said vascular defect;

operating a distal control lead that exits said main implant delivery catheter at said external end for interface by said operator, such that a distal sealable circumferential collar may be expanded or contracted by said operator to achieve a fluid-tight seal between said distal sealable circumferential collar and the internal walls of said blood vessel distal to said vascular defect;

removing said proximal and distal control leads and said main implant delivery catheter through said peripheral vascular entry.

15. The method of claim 14, further comprising, connecting one or more endovascular implants in a variably sealable manner by operation of said proximal and distal sealable circumferential collars as controlled by said proximal and distal variable sealing devices, respectively, to achieve a fluid-tight seal between the proximal-most proximal sealable circumferential collar, the distal-most distal sealable circumferential collar and the internal walls of said blood vessel distal to said vascular defect.