Extra-vascular wrapping for treating aneurysmatic aorta in conjunction with endovascular stent-graft and methods thereof

• US 8,486,131 B2
• Filed: 12/15/2008
• Issued: 07/16/2013
• Est. Priority Date: 12/15/2007
• Status: Expired due to Fees

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): TANNER, JOCELIN C
• Application Number:
  US12/808,037
• Publication Number:
  US 20100292774A1
• Time in Patent Office: 1,674 Days
• Field of Search: 623/1.11, 623 113- 116, 623/1.21, 623/1.22, 623/1.27, 623/1.25, 623/1.3, 623 134- 136, 623 142- 144, 623/1.46, 606/194, 606/198, 606/108, 606/153, 606/191, 606/195, 606/151, 606/155, 606/158
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

A system for treating an aneurysmatic abdominal aorta, comprising (a) an extra-vascular wrapping (EVW) comprising (i) at least one medical textile member adapted to at least partially encircle a segment of aorta in proximity to the renal arteries, and (ii) a structural member, wherein EVW is adapted for laparoscopic delivery, and (b) an endovascular stent-graft (ESG) comprising (i) a compressible structural member, and (ii) a substantially fluid impervious fluid flow guide (FFG) attached thereto. Also described is an extra-vascular ring (EVR) adapted to encircle the neck of an aortic aneurysm. Further described are methods for treating an abdominal aortic aneurysm, comprising laparoscopically delivering the extra-vascular wrapping (EVW) and endovascularly placing an endovascular stent-graft (ESG). Also described are methods to treat a type I endoleak.

Claims

1. An implantable kit for treating an aneurysmatic abdominal aorta of a human subject, the kit comprising:

an endovascular stent-graft (ESG) comprising;

a structural member (ESG-SM) adjustable between a radially-expanded state and a radially-compressed state; and

a fluid flow guide (FFG), substantially impervious to fluids and adjustable between an expanded state and a radially-compressed state;

said FFG including a proximal region along which the fluid flow guide is tubular to provide a primary conduit; and

said FFG being disposed adjacent to said ESG-SM and being securely attached thereto; and

an extra-vascular wrapping (EVW) comprising;

at least one structural member (EVW-SM), capable of reversibly interchanging between (i) a generally cylindrical expanded state characterized by an inner diameter and a length in the direction of said aorta suitable for surrounding at least an effective portion of said ESG; and

(ii) a deformed state suitable for laparoscopic delivery of said EVW from a location outside of said subject'"'"'s body to a location around said aorta, and vice versa; and

at least one medical textile member adapted to at least partially encircle a segment of said aneurysmatic aorta in proximity to the renal arteries, said medical textile member (a) being disposed adjacent to said EVW-SM and being securely attached thereto, and (b) comprising at least one internal macroporous layer, which comprises a polymer mesh characterized by pores ranging in dimension from 100 μ

m to 2 mm, the macroporous layer being adapted by means of size and shape to be positioned directly over said aneurysmatic abdominal aorta, and shaped so as to define voids dimensioned to allow free tissue ingrowth therethrough,

wherein said EVW-SM and either said ESG-SM or said FFG are in reversible attachment therebetween by one or more physical members connecting directly between said ESG and said EVW, so that dislocation of the kit along the aorta is avoided.

2. The kit according to claim 1, wherein said medical textile member comprises at least one external microporous layer.

3. The kit according to claim 2, wherein said external microporous layer comprises a smoothly surfaced material, configured to prevent scar tissue formation and attachment thereto and thereby prevent internal organs from sticking thereto, and wherein said external microporous layer is adapted by means of size and shape to be sparsely attached to said internal macroporous layer, so as to allow said free tissue ingrowth while preventing scar tissue formation and attachment to said microporous layer.

4. The kit according to claim 2, wherein at least one of said internal macroporous layer and said external microporous layer comprises attaching elements selected from the group consisting of:

threads, holes, screws, hooks, zips, fasteners, clips, flaps, claspers, springs, grips, zippers, hooks-and-loops, sutures, straps, strings, wires, cables, tabs, poppers, nails, buttons, brackets, glue, adhesives, and any combination thereof.

5. The kit according to claim 1, wherein said EVW is adapted by means of size and shape to wrap said aorta in a non-continuous manner.

6. The kit according to claim 1, wherein said deformed state of said EVW-SM comprises at least one of the following characteristics:

a. longitudinal deformability, adapted to reduce said length in the direction of said aorta and hence allow insertion of said EVW into a laparoscopic channel; and

b, circular-to-linear deformability, adapted to convert said generally cylindrical to a generally linear configuration, so as to provide the EVW to be pushed through a generally straight laparoscopic channel.

7. The kit according to claim 1, wherein said EVW additionally comprises a plurality of fastening elements, adapted to secure said EVW over said aneurysmatic aorta, which fastening elements are selected from the group consisting of:

threads, screws, hooks, zips, fasteners, clips, flaps, claspers, springs, staplers, grips, zippers, hooks and corresponding eyes, hook and loop reclosable fastener squares, hook and loop reclosable fastener strips, hook and loop reclosable fastener dots, hooks-and-loops, straps, holes and string, sutures, wires, cables, tabs, poppers, nails, buttons and corresponding button holes, press buttons brackets, glues, adhesives, and any combination thereof.

8. The kit according to claim 1, wherein said EVW-SM and ESG-SM are adapted by means of size and shape to be interlocked therebetween.

9. The kit according to claim 1, wherein said EVW when in said expanded state is in the form of a cylinder, wherein said cylinder is adapted for placement adjacently below renal arteries of said aorta, wherein said EVW when in said expanded state comprises one or more complete or partial interruptions, and wherein said cylinder is adapted for placement adjacently above and below said renal arteries of said aorta.

10. The kit according to claim 9, wherein said cylinder comprises interruptions adapted to allow passage of at least one artery selected from the group consisting of:

(a) said renal arteries;

(b) an inferior mesenteric artery exiting from said aorta;

(c) a celiac artery exiting from said aorta; and

(d) any combination thereof.

11. The kit according to claim 1, wherein said EVW-SM comprises a super-elastic metal selected from Nitinol or any alloy thereof.

12. The kit according to claim 1, wherein said length of said EVW-SM when in said expanded state is in the range between 1 to 3 centimeters, and wherein said inner diameter of said EVW-SM in its said expanded state is in the range between 2 to 4 centimeters.

13. A method for treating an aneurysmatic aorta, comprising:

identifying a subject suffering from an aneurysm of the abdominal aorta;

providing a fastenable implantable kit for treating said aneurysmatic abdominal aorta, comprising at least (i) an endovascular stent-graft (ESG) comprising;

(a) a structural member (ESG-SM) adjustable between an expanded state and a radially-compressed state; and

(b) a fluid flow guide (FFG), substantially impervious to fluids and adjustable between an expanded state and a radially-compressed state;

said FFG including a proximal region along which the fluid flow guide is tubular to provide a primary conduit; and

(ii) an extra-vascular wrapping (EVW), said EVW having at least one structural member (EVW-SM), capable of reversibly interchanging between (x) a generally cylindrical expanded state characterized by an inner diameter and a length in the direction of said aorta suitable for surrounding at least an effective portion of said implanted ESG; and

(y) a deformed state suitable for laparoscopic delivery of said EVW from a location outside of said subject'"'"'s body to a location around said aorta, and vice versa; and

introducing said EVW in said deformed state through a laparoscopic working channel to an abdominal location adjacent to renal arteries of said abdominal aorta of said subject;

laparoscopically positioning said EVW around said aorta, in a vicinity of said renal arteries;

endovascularly placing the ESG into said aneurysmatic aorta; and

connecting directly between said ESG in said aneurysmatic aorta and said EVW around said aorta, using one or more physical members.

14. The method according to claim 13, wherein identifying such subject as suffering from such aneurysm of the abdominal aorta comprises identifying a subject suffering from an aneurysm of the abdominal aorta, which aneurysm reaches about 2 centimeters or less to a closest renal artery of said subject.