Stent for endoluminal delivery of active principles or agents
The present invention provides a stent for implantation at a site within a human or animal body comprising: an expandable body having an inner surface and an outer surface; and treatment agents applied to the outer surface of the expandable body, the treatment agents comprising a combination of Paclitaxel and FK506 or their derivatives or analogues.
1 . A stent for implantation at a site within a human or animal body comprising:
an expandable body having an inner surface and an outer surface; and
treatment agents applied to the outer surface of the expandable body, the treatment agents comprising a combination of Paclitaxel and FK506 or their derivatives or analogues.
2 . The stent according to claim 1 , wherein the outer surface of the expandable body includes formations for receiving the treatment agents.
3 . The stent according to claim 2 , wherein the formations comprise cavities having an opening towards the outer surface of the expandable body.
4 . The stent according to claim 1 , wherein the expandable body is formed by elements defining a reticular structure.
5 . The stent according to claim 4 , wherein the formations are present on the elements.
6 . The stent according to claim 1 , wherein the treatment agents are present in a Paclitaxel:FK506 weight ratio with respect to the total quantity of said agents applied on the expandable body comprised in the range from 1:72 to 1:0.2.
7 . The stent according to claim 6 , wherein the weight ratio is comprised in the range from 1:18 to 1:0.2.
8 . The stent according to claim 6 , wherein the weight ratio is comprised in the range from 1:8 to 1:0.5.
9 . The stent according to claim 6 , wherein the weight ratio is comprised in the range from 1:2 to 1:0.7.
10 . The stent according to claim 6 , wherein the weight ratio is comprised in the range from 1:3 to 1:1.
11 . The stent according to claim 1 , wherein the treatment agents are present in a total quantity comprised in the range between 50 and 1000 micrograms.
12 . The stent according to claim 11 , wherein the total quantity is comprised in the range between 70 and 700 micrograms.
13 . The stent according to claim 11 , wherein the total quantity is comprised in the range between 140 and 500 micrograms.
14 . The stent according to claim 11 , wherein the total quantity is comprised in the range between 200 and 400 micrograms.
15 . The stent according to claim 1 , wherein Paclitaxel is present in a quantity by weight of at least 25 micrograms.
16 . The stent according to claim 15 , wherein Paclitaxel is present in a quantity by weight of at least 80 micrograms.
17 . The stent according to claim 1 , wherein FK506 is present in a quantity by weight of at least 60 micrograms.
18 . The stent according to claim 17 , wherein FK506 is present in a quantity by weight of at least 135 micrograms.
19 . The stent according to claim 2 , wherein the formations for receiving comprise cavities and wherein the cavities contain a homogeneous mixture of the treatment agents.
20 . The stent according to claim 2 , wherein the treatment agents are arranged in a layered structure in the formations comprising at least two layers.
21 . The stent according to claim 20 , wherein the layers are homogeneously constituted by one of the treatment agents or by a mixture of the treatment agents.
22 . The stent according to claim 20 , wherein the layered structure includes an associated layer comprising at least one of a polymeric material and an excipient substance.
23 . The stent according to claim 22 , wherein the associated layer is situated in an internal position of the layered structure.
24 . The stent according to claim 22 , wherein the associated layer is situated in a position external to the layered structure.
25 . The stent according to claim 1 , further comprising a top coat applied to the outer surface comprising one of the treatment agents or a mixture of the treatment agents.
26 . The stent according to claim 2 , wherein the formations for receiving comprise cavities having a substantially step-like profile.
27 . The stent according to claim 1 , wherein the treatment agents are applied in the form of powders or pastes obtained from the powders.
28 . The stent according to claim 1 , further comprising pharmacologically acceptable excipients/additives which are added to the treatment agents.
29 . The stent according to claim 1 , wherein the treatment agents comprise a combination of Paclitaxel and FK506.
30 . The stent according to claim 29 , wherein the combination of Paclitaxel and FK506 is present in a total quantity comprised in the range between 50 and 1000 micrograms.
31 . The stent according to claim 30 , wherein the total quantity is comprised in the range between 70 and 700 micrograms.
32 . The stent according to claim 30 , wherein the total quantity is comprised in the range between 140 and 500 micrograms.
33 . The stent according to claim 30 , wherein the total quantity is comprised in the range between 200 and 400 micrograms.
34 . The stent according to claim 29 , wherein Paclitaxel is present in a quantity by weight of at least 25 micrograms.
35 . The stent according to claim 34 , wherein Paclitaxel is present in a quantity by weight of at least 80 micrograms.
36 . The stent according to claim 29 , wherein FK506 is present in a quantity by weight of at least 60 micrograms.
37 . The stent according to claim 36 , wherein FK506 is present in a quantity by weight of at least 135 micrograms.