US 12,472,053 B2
Multiple layer vascular graft
Mohammed El-Kurdi, Mansfield, MA (US); Ryan Ayotte, Waltham, MA (US); Anh Thi Dinh, Brighton, MA (US); Kevin Farrell, New Smyrna Beach, FL (US); and Jon McGrath, Duxbury, MA (US)
Assigned to Xeltis AG, Zurich (CH)
Appl. No. 17/058,776
Filed by NEOGRAFT TECHNOLOGIES, INC., Taunton, MA (US)
PCT Filed Jun. 7, 2019, PCT No. PCT/US2019/036076
§ 371(c)(1), (2) Date Nov. 25, 2020,
PCT Pub. No. WO2019/237014, PCT Pub. Date Dec. 12, 2019.
Claims priority of provisional application 62/745,862, filed on Oct. 15, 2018.
Claims priority of provisional application 62/682,766, filed on Jun. 8, 2018.
Prior Publication US 2021/0196445 A1, Jul. 1, 2021
Int. Cl. A61F 2/06 (2013.01)
CPC A61F 2/06 (2013.01) [A61F 2210/0076 (2013.01); A61F 2250/0019 (2013.01); A61F 2250/0071 (2013.01)] 8 Claims
OG exemplary drawing
 
1. A graft device for a patient, the graft device comprising:
an inner layer comprising a first porous arrangement of fibers defining a first tube comprising an inner wall and an outer wall;
a first spiral pattern for strain-relief or kink-resistance over a length of the inner layer;
an outer layer comprising a second porous arrangement of fibers defining a second tube comprising an inner wall and an outer wall, wherein the second tube surrounds the first tube, wherein the outer layer circumferentially surrounds the inner layer; and
a plurality of macropores extending through at least the inner and the outer wall of the first tube,
wherein at least one of the inner layer, the outer layer, or both are made of biofragmentable material configured to mechanically fracture into one or more fragments over time,
wherein the first porous arrangement and the second porous arrangement are configured to promote endothelization by cellular ingrowth and tissue integration upon implantation of the graft device and over time to replace the mechanically fractured biofragmentable material,
wherein the graft device comprises a 2% secant modulus between 2 MPa and 16 MPa, an inner diameter of the first tube ranging from 3 mm to 30 mm and a combined wall thickness between 0.3 mm and 2.5 mm,
wherein the graft device as a result of a time-matched biofragmentation of the biofragmentable material and the cellular ingrowth and tissue integration comprises an over-time changing compliance range having a first compliance during a first period of time, wherein the first time period is defined as an initial state, and a second compliance during a second period of time, wherein the second period of time is defined as an over-time changing period of at least days after the implantation, and wherein the second compliance is greater than the first compliance, and wherein the first compliance comprises is no more than 1%/100 mmHg and the second compliance comprises at least 4%/100 mmHg.