BYPASS GRAFT DEVICE AND DELIVERY SYSTEM AND METHOD

• US 20080294235A1
• Filed: 02/13/2008
• Published: 11/27/2008
• Est. Priority Date: 05/24/2007
• Status: Abandoned Application

• Current Assignee: Inverthis, Ltd.
• Original Assignee: Inverthis, Ltd.
• Inventors: Kilemnik, Ido, Bendory, Ehud, Bendory, Eran
• Application Number:
  US12/030,327
• Publication Number:
  US 20080294235A1
• Time in Patent Office: Days
• US Class Current: 623/1.13
• 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 2/90 characterised by a net-like or mesh-like structure
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Abstract

A device, system and methods for a minimally invasive bypass procedure, includes a graft having a supporting segment, an extending segment and a bypass segment. The supporting segment includes a flexible portion and a supporting member, and the extending segment includes a flexible portion and a supporting member. The extending segment has an initial configuration wherein it is unextended and a final configuration wherein it is extended proximally into the vessel. The bypass segment is positioned outside of the vessel to be treated, and the supporting segment is positioned within the vessel and distal to the incision. Once the supporting segment and the supporting member are anchored in place, the extending segment is extended proximally past the incision site. Thus, the supporting segment and the extending segment are substantially aligned, and allow for blood flow through the vessel while also providing blood flow around an obstruction via the bypass segment.

Claims

1. A device for positioning in a vessel, the device comprising:

a supporting segment comprised of a flexible material having a substantially tubular configuration and a supporting member comprised of a substantially rigid material, said supporting segment comprising a supporting segment proximal end and a supporting segment distal end;

an extending segment having a substantially tubular configuration comprising a flexible inverting portion comprised of a flexible material, said flexible inverting portion having a flexible inverting portion proximal end and a flexible inverting portion distal end; and

an internal supporting member comprised of a rigid material, said internal supporting member having an internal supporting member proximal end and an internal supporting member distal end, said internal supporting member proximal end attached to said flexible inverting portion proximal end at an attachment area, wherein in an initial configuration, said flexible inverting portion is inverted such that said flexible inverting portion proximal end is distal to said flexible inverting portion distal end and said internal supporting member is distal to said flexible inverting portion, and wherein in a deployed configuration, said flexible inverting portion is un-inverted such that said flexible inverting portion proximal end is proximal to said flexible inverting portion distal end and said internal supporting member is positioned within said flexible inverting portion; and

a bypass segment comprised of a flexible material having a substantially tubular configuration comprising a bypass segment proximal end and a bypass segment distal end, wherein said supporting segment, said extending segment and said bypass segment are in fluid communication with one another, and wherein said supporting segment proximal end, said extending segment distal end and said bypass segment proximal end are connected at a connecting area.

2. The device of claim 1, wherein said supporting segment, said extending segment and said bypass segment are comprised of the same material.

3. The device of claim 1, wherein said supporting member is comprised of a metal.

4. The device of claim 1, wherein said supporting member is an external supporting member and is positioned external to said flexible material of said supporting segment.

5. The device of claim 1, wherein said supporting member is sandwiched between two layers of said flexible material of said supporting segment.

6. The device of claim 1, wherein said internal supporting member is comprised of a metal.

7. The device of claim 1, wherein said internal supporting member further comprises an additional layer of flexible material therein, wherein said internal supporting member surrounds said additional layer of flexible material.

8. The device of claim 1, wherein said supporting member extends over said connecting area.

9. The device of claim 1, wherein said supporting member extends over a portion of said bypass segment.

10. A method for performing a minimally invasive bypass procedure, the method comprising:

providing a device having a supporting segment, an extending segment, and a bypass segment, wherein each of said supporting, extending and bypass segments is in fluid communication with the others of said supporting, extending and bypass segments, said extending segment initially in an unextended configuration;

making an incision in a vessel to be treated;

inserting the supporting segment directly into the vessel through the incision and positioning the supporting segment in the vessel distal to the incision with the bypass segment positioned through the incision and out of the vessel;

anchoring the supporting segment into the vessel; and

extending said extending segment in a proximal direction such that the extending segment is positioned in the vessel proximal to the incision.

11. The method of claim 10, wherein the vessel to be treated is a portion of a vessel which is upstream of a bifurcation.

12. The method of claim 10, wherein a flexible inverting portion of said extending segment is initially in an inverted configuration and wherein said extending comprises uninverting said flexible inverting portion.

13. The method of claim 12, wherein said uninverting comprises providing a delivery system having a guidewire with a bent distal end and a proximal extension portion extending from said bent distal end, and wherein said proximal extension portion is attached to said extending segment;

and pulling the guidewire in a proximal direction so as to push said extending segment in a proximal direction, thereby uninverting said extending segment.

14. The method of claim 10, wherein said extending segment comprises a flexible inverting portion having an initial inverted configuration and an internal supporting member having an uninverted configuration, and wherein said extending comprises uninverting the flexible inverting portion while the internal supporting member retains its uninverted configuration, such that following said uninverting, said internal supporting member is positioned inside said flexible inverting portion.

15. A delivery system for delivery of a graft to a vessel, the delivery system comprising:

a guidewire having a guidewire proximal end and a guidewire distal end, wherein said guidewire proximal end is positionable outside of a body and wherein said guidewire distal end is configured to enter the body at an incision site, said guidewire distal end having a bent configuration, said guidewire further comprising a proximal extension portion extending proximally from said guidewire distal end;

an internal sheath having a first portion for enclosing a first segment of the graft and a second portion for enclosing at least a portion of said guidewire and extending proximally to a point outside of the body, wherein said proximal extension portion of said guidewire is partially enclosed by said first portion of said internal sheath and is removably attached to the first segment of the graft located within said internal sheath, said internal sheath movable with respect to said guidewire;

a stopper attached to said proximal extension portion of said guidewire for holding the graft in place while said internal sheath is removed; and

an external sheath for enclosing a second member of the graft and extending proximally to a point outside of the body, said external sheath movable with respect to said internal sheath and said guidewire.

16. The delivery system of claim 15, wherein said first segment of the graft enclosed within said internal sheath is an extending segment, wherein in an initial configuration, a proximal end of said extending segment is distal to a distal end of said extending segment, and wherein in a final configuration, said proximal end of said extending segment is proximal to said distal end of said extending segment.

17. The delivery system of claim 15, further comprising a linking member for separatably placing said first portion and said second portion of said internal sheath together.

18. A device for positioning in a vessel, the device comprising:

a supporting segment configured to be placed directly through an incision in a vessel and to be anchored into the vessel in an area distal to the incision;

an extending segment, wherein in a first configuration said extending segment is positioned within said supporting segment and in a second configuration said extending segment is extended proximally so as to be anchored into the vessel in an area proximal to the incision; and

a bypass segment in fluid communication with said supporting segment and said extending segment, said bypass segment positioned through the incision and outside of the vessel.

19. The device of claim 18, wherein said first configuration is an inverted configuration and said second configuration is an un-inverted configuration.

20. The device of claim 18, wherein said supporting segment comprises a flexible material and a substantially rigid material.

21. The device of claim 18, wherein said extending segment comprises a flexible material and a substantially rigid material.