Surgical implant devices and methods for their manufacture and use

• US 9,138,335 B2
• Filed: 07/09/2012
• Issued: 09/22/2015
• 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 P., Gaskins, Ralph Edward
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US13/544,379
• Publication Number:
  US 20130123909A1
• Time in Patent Office: 1,170 Days
• Field of Search: 623/1.11, 623/1.13, 623/1.35
• US Class Current: 1/1
• 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

A sealable vascular system includes an endovascular implant to be delivered in a compressed or folded state to an implantation site. The endovascular implant includes a tubular implant body and a sealable circumferential collar at said tubular implant body and including a variable sealing device and a control lead traversing from said variable sealing device to a user for controlling said variable sealing device by the user, said variable sealing device and said control lead being cooperatively operable to reversibly expand and contract said sealable circumferential collar such that said sealable circumferential collar is circumferentially adjustable during deployment thereof to achieve a repositionable fluid-tight seal between said sealable circumferential collar and the internal walls of the implantation site.

Claims

1. A sealable vascular system, comprising:

an endovascular implant to be delivered in a compressed or folded state to an implantation site, said endovascular implant including;

a tubular implant body; and

a sealable circumferential collar at said tubular implant body and including;

a variable sealing device; and

a control lead traversing from said variable sealing device to a user for controlling said variable sealing device by the user, said variable sealing device and said control lead being cooperatively operable to reversibly expand and contract said sealable circumferential collar such that said sealable circumferential collar is circumferentially adjustable during deployment thereof to achieve a repositionable fluid-tight seal between said sealable circumferential collar and the internal walls of the implantation site.

2. The sealable vascular system of claim 1, wherein the vascular defect is an aneurysm.

3. The sealable vascular system of claim 1, wherein said endovascular implant further comprises a retraction device operable to reposition said endovascular implant during deployment.

4. An endovascular implant for placement in a vascular defect, the implant comprising:

a tubular implant body;

a sealable circumferential collar at said tubular implant body, said sealable circumferential collar including a variable sealing device operable to reversibly expand and contract said sealable circumferential collar such that said sealable circumferential collar is circumferentially adjustable during deployment thereof to achieve a repositionable fluid-tight seal between said sealable circumferential collar and internal walls of a blood vessel adjacent the vascular defect; and

a control lead connected to said variable sealing device, said control lead traversing from said variable sealing device to a user for controlling said variable sealing device by the user.

5. The endovascular implant of claim 4, wherein said tubular implant body is non-elastic.

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

7. The endovascular implant of claim 4, wherein said sealable circumferential collar is a proximal sealable circumferential collar, and further comprising:

a distal sealable circumferential collar at said distal end of said tubular implant body, said distal sealable circumferential collar including a distal variable sealing device operable to reversibly expand and contract said distal sealable circumferential collar such that said distal sealable circumferential collar is circumferentially adjustable during deployment thereof to achieve a repositionable fluid-tight seal between said distal sealable circumferential collar and internal walls of the blood vessel distal to the vascular defect.

8. The endovascular implant of claim 4, wherein:

said tubular implant body is operable to be housed within a main implant delivery catheter having a catheter proximal end and a catheter distal end, the main implant delivery catheter being operable to be disposed within the blood vessel to deliver said tubular implant body at the vascular defect; and

said control lead is operable to traverse said main implant delivery catheter from said variable sealing device at least to said catheter proximal end when housed therein for interface by the user.

9. The endovascular implant of claim 4, wherein:

said tubular implant body is operable to be housed within a main implant delivery catheter having a catheter proximal end and a catheter distal end, the main implant delivery catheter being operable to be disposed within the blood vessel to deliver said tubular implant body at the vascular defect;

said distal end of said tubular implant body further includes a distal variable sealing device and a distal control lead connected to said distal variable sealing device; and

said distal control lead is operable to traverse said main implant delivery catheter from said distal variable sealing device at least to said catheter proximal end when housed therein for interface by the user.

10. The endovascular implant of claim 4, wherein said tubular implant body is straight.

11. The endovascular implant of claim 4, wherein said tubular implant body branches into two or more branches.

12. The endovascular implant of claim 4, wherein said tubular implant body is a plurality of tubular implant bodies each operable to be connected to another of said tubular implant bodies in a variably sealable manner by operation of said sealable circumferential collars as controlled by said variable sealing devices, respectively, to achieve a repositionable fluid-tight seal between:

a proximal-most one of said sealable circumferential collars and the internal walls of the blood vessel proximal to the vascular defect; and

a distal-most one of said sealable circumferential collars and the internal walls of the blood vessel distal to the vascular defect.

13. The endovascular implant of claim 4, wherein said tubular implant body is of:

solid construction; and

a biocompatible material.

14. The endovascular implant of claim 4, wherein said tubular implant body is of:

woven construction; and

a biocompatible material.

15. The endovascular implant of claim 4, wherein said endovascular implant is coated with a biocompatible material.

16. The endovascular implant of claim 4, further comprising a retraction device operable to reposition said tubular implant body during deployment.

17. A method of treating a vascular defect in a blood vessel within a patient, the method comprising:

placing an elongated main implant delivery catheter through a peripheral vascular entry into the blood vessel having internal walls, said implant delivery catheter having;

a catheter proximal end and a catheter distal end;

an implant delivery catheter sheath defining an implant delivery catheter lumen; and

an endovascular implant disposed within said implant delivery catheter lumen in a compressed or folded state, the endovascular implant having;

a tubular implant body having a proximal end and a distal end; and

a sealable circumferential collar at said tubular implant body including a variable sealing device having a control lead operatively connected thereto, said control lead being operable to traverse said implant delivery catheter from said variable sealing device at least to said catheter proximal end when housed therein for interface by a user;

employing real-time visualization to monitor implant placement in the blood vessel;

distally retracting said implant delivery catheter sheath to expose said proximal end of said endovascular implant;

cooperatively manipulating said control lead and said variable sealing device to circumferentially adjust said sealable circumferential collar to achieve a fluid-tight seal between said sealable circumferential collar and the internal walls of the blood vessel adjacent the vascular defect, said control lead and said variable sealing device being cooperatively operable to reversibly expand and contract said sealable circumferential collar such that the fluid-tight seal is repositionable;

distally retracting said implant delivery catheter sheath to expose said distal end of said endovascular implant; and

removing said control lead and said implant delivery catheter through said peripheral vascular entry.

18. The method of claim 17, further comprising the step of connecting one or more additional endovascular implants in a variably sealable manner by operation of said sealable circumferential collars as controlled by said variable sealing devices and control leads, respectively, to achieve a repositionable fluid-tight seal between:

a proximal-most one of said sealable circumferential collars and the internal walls of the blood vessel proximal to the vascular defect; and

a distal-most one of said sealable circumferential collars and the internal walls of the blood vessel distal to the vascular defect.

19. The method of claim 17, wherein the vascular defect is an aneurysm.

20. The method of claim 17, wherein said endovascular implant further comprises a retraction device operable to reposition said endovascular implant during deployment.

21. A system for circumferentially sealing within a lumen, comprising:

an implant to be delivered in a compressed or folded state to an implantation site, the implant comprising;

a tubular body having a variable circumferential-sealing collar; and

a control lead traversing from said collar to a user for controlling said collar by the user, said collar and said control lead being cooperatively operable to reversibly expand and contract said collar such that said collar is circumferentially adjustable during deployment thereof to achieve a repositionable fluid-tight seal between said collar and the implantation site.

22. A method of treating a vascular defect in a blood vessel within a patient, the method comprising:

employing real-time visualization to monitor placement of an endovascular implant in a compressed or folded state in the blood vessel, the endovascular implant having;

a tubular implant body;

a proximal end and a distal end;

a sealable circumferential collar at said tubular implant body including a variable sealing device; and

a control lead operatively connected to the variable sealing device and traversing therefrom to a user for interface by the user; and

cooperatively manipulating said control lead and said variable sealing device to circumferentially adjust said collar to achieve a fluid-tight seal between said collar and the internal walls of the blood vessel, said control lead and said variable sealing device being cooperatively operable to reversibly expand and contract said collar such that the fluid-tight seal is repositionable.