Multilayer vascular graft
Devices used to provide vascular access, methods of manufacture, and methods of use are disclosed. The devices may be a vascular graft having a wall configured to seal following repeated punctures with a needle. The wall may include a plurality of layers of differing materials. The wall may also include a bead configured to prevent kinking of the vascular graft. The bead may be spirally wrapped around the vascular graft or be discrete C-shaped beads that provide a gap for needle access.
1 . A vascular graft, comprising:
an inner sleeve comprising a first polymer;
an intermediate layer comprising a second polymer;
a tie layer comprising a third polymer; and
a porous outer sleeve;
wherein the intermediate layer is disposed between the inner sleeve and the tie layer and the tie layer is disposed between the intermediate layer and the porous outer sleeve;
wherein the first polymer is different than the second polymer;
wherein a hardness of the first polymer is harder than a hardness of the second polymer;
wherein a hardness of the third polymer is harder less than that the hardness of the second polymer;
wherein the tie layer forms a mechanical bond with the porous outer sleeve;
wherein the mechanical bond between the tie layer and the porous outer layer form a boundary in which the tie layer permeates into pores of the outer layer; and
wherein a material of the tie layer permeates into a material of the outer sleeve, such that a coupling zone of the mechanical bond comprises a depth between 1 μm to 20 μm.
2 . The vascular graft of claim 1 , wherein the first polymer comprises any one of a silicone, a polyurethane, and a fluoroelastomer with a hardness from SA to 80 A on the Shore A hardness scale.
3 . The vascular graft of claim 1 , wherein the inner sleeve comprises any one of expanded polytetrafluoroethylene (PTFE), rotational spun PTFE, and electrospun PTFE.
4 . The vascular graft of claim 1 , wherein the second polymer comprises any one of a silicone, a polyurethane, and a fluoroelastomer with a hardness from SA to 80 A on the Shore A hardness scale.
5 . The vascular graft of claim 1 , wherein the intermediate layer is a sprayed layer.
6 . The vascular graft of claim 1 , wherein the third polymer comprises any one of a silicone, a polyurethane, and a fluoroelastomer with a hardness from SA to 80 A on the Shore A hardness scale.
7 . The vascular graft of claim 1 , wherein the porous outer sleeve comprises any one of expanded PTFE, rotational spun PTFE, electrospun PTFE, polyethylene terephthalate, polyurethane, polyurethane, and polyamide.
8 . The vascular graft of claim 1 , wherein a first bond is disposed between the inner sleeve and the intermediate layer and a second bond is disposed between the intermediate layer and the tie layer.
9 . The vascular graft claim 1 , further comprising a bead disposed within the tie layer.
10 . The vascular graft of claim 9 , wherein the bead comprises any one of stainless steel, titanium, nickel-titanium alloy, fluorinated ethylene propylene, densified expanded polytetrafluoroethylene, high durometer silicone, polypropylene, polyether block amide, and polyurethane.
11 . The vascular graft of claim 10 , wherein the bead helically extends along at least a portion of the vascular graft.
12 . The vascular graft of claim 10 , wherein the bead comprises a plurality of C-shaped members,
wherein a first end of each C-shaped member is directed toward a first end of the vascular graft,
wherein a second end of each C-shaped member is directed toward a second end of the vascular graft, and
wherein the first end and the second end of the vascular graft arc disposed on opposite longitudinal ends of the vascular graft.
13 . The vascular graft of claim 12 , further comprising a gap disposed between opposing ends of each of the plurality of C-shaped members, wherein a thickness of a graft wall adjacent the gap is less than a thickness of a graft wall at a position opposite of the gap.
14 . The vascular graft of claim 1 , wherein the first polymer comprises a hardness from 40 A to 60 A on the Shore A hardness scale,
wherein the second polymer comprises a hardness from 15 A to 40 A on the Shore A hardness scale, and
wherein the third polymer comprises a hardness from 10 A to 25 A on the Shore A hardness scale.
15 . The vascular graft of claim 1 , wherein the first polymer comprises a hardness of about 50 A on the Shore A hardness scale, the second polymer comprises a hardness of about 25 A on the Shore A hardness scale, and the third polymer comprises a hardness of about 15 A on the Shore A hardness scale.
16 . The vascular graft of claim 1 , wherein the first polymer is silicone with a first hardness, the second polymer is silicone with a second hardness, and the third polymer is silicone with a third hardness,
wherein the first hardness is greater than the hardness of the second hardness and the third hardness,
wherein the second hardness is greater than the hardness of the third hardness but less than the hardness of the first hardness, and
wherein the third hardness is less than the hardness of the first hardness and the second hardness.
17 . The vascular graft of claim 16 , wherein the first hardness is between 40 A to 60 A on the Shore A hardness scale,
wherein the second hardness is between 15 A to 40 A on the Shore A hardness scale, and wherein the third hardness is between 10 A to 25 A on the Shore A hardness scale.
18 . The vascular graft of claim 16 , wherein the first hardness is about 50 A on the Shore A hardness scale, the second hardness is about 25 A on the Shore A hardness scale, and the third hardness is about 15 A on the Shore A hardness scale.