Graft with expandable region and methods of making and using the same

Patent metadata

Field	Value
Publication number	US-2016184079-A1
Application number	US-201414906853-A
Country	US
Kind code	A1
Filing date	Jul 22, 2014
Priority date	Jul 22, 2013
Publication date	Jun 30, 2016
Grant date	—

Abstract

A vascular graft suitable for implantation, and more particular to a vascular graft having an expandable outflow region for restoring patency of the graft after implantation into a body lumen.

First claim

1 . A graft, comprising:
a conduit having a wall, the conduit comprising:
a first vessel insertion region, a second vessel insertion region, and a coupling region providing fluid communication therebetween, the first and second vessel insertion regions each comprising:
a first fluid flow region and a second fluid flow region merging together at a junction, which is in fluid communication with an expandable third fluid flow region opposite the first fluid flow region;
a first aperture disposed at an outermost end of the first fluid flow region, a second aperture disposed at an outermost end of the second fluid flow region, and a third aperture disposed at an outermost end of the third fluid flow region, the second aperture of each of the first and second vessel insertion regions coupled to each other via the coupling region in a manner enabling fluid communication therebetween;

wherein the wall comprises a support structure and a biocompatible layer; and wherein the support structure along at least a portion of the third fluid flow region of at least the first vessel insertion region is under continuous compressive stress resulting from a continuous applied load caused by the biocompatible layer against the support structure.

2 . The graft of claim 1 , wherein the support structure along at least a portion of the third fluid flow region of the second vessel insertion region is under continuous compressive stress resulting from a continuous applied load caused by the biocompatible layer against the support structure.

3 . The graft of claim 1 , wherein the compressive stress resulting from the continuous applied load in the third fluid flow region is greater than a compressive stress resulting from a continuous applied load in either the first fluid flow region or the second fluid flow region.

4 . The graft of claim 1 , wherein the compressive stress experienced by the support structure resulting from the continuous applied load in the third fluid flow region incrementally decreases at each segment along the support structure until remaining substantially constant approaching the junction.

5 . The graft of claim 1 , wherein the compressive stress experienced by the support structure resulting from the continuous applied load in the third fluid flow region causes an elastic deformation of the support structure in the third fluid flow region that is substantially constant and then incrementally greater at each segment along the support structure that is incrementally more distal from the first aperture.

6 . The graft of claim 5 , wherein the elastic deformation of the support structure in the third fluid flow region is reversible such that reversing the elastic deformation of the support structure in the third fluid flow region expands the diameter of the support structure in the third fluid flow region to a diameter that is less than the uncompressed diameter of the support structure not under compressive stress resulting from the continuous applied load in the third fluid flow region.

7 . The graft of claim 1 , wherein elastic deformation of the support structure in the first fluid flow region due to a compressive stress resulting from the continuous applied load in the first fluid flow region is at most negligible.

8 . The graft of claim 1 , wherein elastic deformation of the support structure in the second fluid flow region due to a compressive stress resulting from the continuous applied load in the second fluid flow region is at most negligible.

9 . The graft of claim 1 , wherein prior to combination with the biocompatible layer to form the wall, the support structure along the first fluid flow region has a constant effective inner diameter measurement, and the support structure along the third fluid flow region comprises an effective inner diameter measurement that is substantially constant before becoming incrementally greater at each segment along the support structure that is incrementally more distal from the first aperture.

10 . The graft of claim 9 , wherein after combination with the biocompatible layer to form the wall, the support structure has a generally uniform effective er diameter measurement comprising the constant effective inner diameter measurement along the first fluid flow region, and a constrained effective inner diameter measurement along the third fluid flow region.

11 . The graft of claim 10 , wherein the constrained effective inner diameter measurement is approximately equal to the constant effective inner diameter measurement.

12 . The graft of claim 11 , wherein the compressive stress resulting from the continuous applied load maintains the support structure along the third fluid flow region at the constrained effective inner diameter measurement.

13 . The graft of claim 12 , wherein a counter force comprising a radial expansion force applied to the support structure along the third fluid flow region causes permanent deformation of the biocompatible layer.

14 . The graft of claim 13 , wherein a counter force comprising a radial expansion force applied to the support structure in the third fluid flow region causes a reduction of the compressive stress experienced by the support structure.

15 . The graft of claim 14 , wherein following application of a counter force comprising a radial expansion force applied to the support structure in the third fluid flow region, the graft reconfigures in such a way as to result in a permanently deformed biocompatible layer and a compressive stress experienced by the support structure that is less than the compressive stress experienced by the support structure prior to application of the counter force.

16 . The graft of claim 15 , wherein following application of a counter force comprising a radial expansion force applied to the support structure in the third fluid flow region, the graft reconfigures in such a way as to result in the support structure experiencing reduced compressive stress where there was previously greater compressive stress experienced by the support structure prior to application of the counter force.

17 . The graft of claim 16 , wherein a counter force comprising a radial expansion force applied to the support structure in the third fluid flow region reconfigures the support structure along the third fluid flow region from the constrained effective inner diameter measurement to an expanded effective inner diameter measurement that is greater than the constrained effective inner diameter measurement along at least a portion of the support structure in the third fluid flow region.

18 . The graft of claim 17 , wherein the expanded effective inner diameter measurement is at least 1 mm greater than the constrained effective inner diameter measurement long at least a portion of the support structure in the third fluid flow region.

19 . The graft of claim 18 , wherein the effective inner diameter measurement of the support structure along the third fluid flow region is larger than the constrained effective inner diameter measurement along an adjoining portion of the support structure in the third fluid flow region.

20 . The graft of claim 1 , wherein the expandable third fluid flow region in at least the first vessel insertion region comprises an elongate, expandable third fluid flow region.

21 - 225 . (canceled)

226 . The graft of claim 2 , wherein the compressive stress resulting from the continuous applied load in the third fluid flow region is greater than a compressive stress re

Assignees

• Atrium Medical Corp

Inventors

• Scutti James J
• Culp David G
• Dagher Ibrahim E
• Penn Kevin W

Classifications

• A61F2/07 Primary

  Stent-grafts · CPC title

• A61B2017/1139

  Side-to-side connections, e.g. shunt or X-connections · CPC title

• A61F2250/0071

  breakable or frangible · CPC title

• A61F2250/0048

  differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability · CPC title

• A61F2002/061

  provided with means for allowing access to secondary lumens · CPC title