Migration-resistant gastrointestinal barrier
View Patent ↗A prosthesis and a method for securing a prosthesis at a treatment site are provided. The prosthesis includes a material portion. The material portion includes a liquid-impermeable material layer, a porous material layer having a pore size adapted for promoting tissue ingrowth, and an adhesive portion provided on the porous material layer adapted to secure the material portion to a site for at least 24 hours following implantation of the prosthesis at the site. In some embodiments, the prosthesis further includes a body.
1. A migration resistant prosthesis, the prosthesis comprising:
a material portion, the material portion comprising:
a liquid-impermeable material layer having a proximal opening, a distal opening and a wall extending between the proximal and distal openings, the wall being free from fluid flow through the wall between the proximal opening and the distal opening;
a porous material layer on an outer surface of the material portion, the porous material layer having a pore size adapted for promoting tissue ingrowth; and
an adhesive portion provided on the porous material layer adapted to secure the material portion to a site for at least 24 hours following implantation of the prosthesis at the site.
2. The migration resistant prosthesis according to claim 1 , further comprising a body having a proximal portion, a distal portion and a lumen extending therethrough, at least a portion of the body providing a force adapted to expand the body radially outward in a final position of the prosthesis, the body further comprising a porous portion adapted for tissue ingrowth, the material portion operably connected to the body and extending distally from the body.
3. The prosthesis according to claim 2 , wherein the body comprises a metal, a polymer or a composite.
4. The prosthesis according to claim 2 , wherein the porous portion covers a portion of the body.
5. The prosthesis according to claim 2 , wherein a proximal end of the material portion is connected to a distal end of the body.
6. The prosthesis according to claim 1 , wherein the material portion comprises a non-porous material.
7. The prosthesis according to claim 1 , wherein a distal portion of the material portion is free of the adhesive portion.
8. The prosthesis according to claim 1 , wherein a distal portion of the material portion comprises the adhesive portion.
9. The prosthesis according to claim 1 , wherein the adhesive portion is provided on an outer surface of the material portion in a pattern.
10. The prosthesis according to claim 1 , wherein the liquid impermeable layer comprises a material having a thickness in the range of about 0.01 mm to about 0.5 mm.
11. The prosthesis according to claim 1 , wherein the material portion comprises a material selected from the group consisting of elastomers, thermoplastics, fluoropolymers, polymer weaves, non-woven polymers, biodegradable polymers and biological material.
12. The prosthesis according to claim 11 , wherein the material portion comprises a non-woven polymer.
13. The prosthesis according to claim 1 , wherein the adhesive portion comprises an adhesive selected from the group consisting of carbomers, polycarbophil, cyanoacrylates, mussel adhesive protein derivatives, polyacrylic acid, polyethylene glycol, polyvinylpyrrolidone, epoxies, thermoset adhesives, UV adhesives, redux adhesives and natural adhesives.
14. The prosthesis according to claim 1 , wherein the material portion is free from connection to a support structure.
15. The prosthesis according to claim 1 , wherein the adhesive portion comprises an adhesive selected from the group consisting of carbomers, polycarbophil, mussel adhesive protein derivatives, polyacrylic acid, polyethylene glycol, polyvinylpyrrolidone, and natural adhesives.
16. A method of securing a prosthesis at a treatment site in a bodily lumen to inhibit migration of the prosthesis, the method comprising:
positioning a material portion of a prosthesis within the bodily lumen, the material portion including a liquid-impermeable material layer having a proximal opening, a distal opening and a wall extending between the proximal and distal openings, the wall being free from fluid flow through the wall between the proximal opening and the distal opening, a porous material layer having a pore size adapted for promoting tissue ingrowth; and
contacting the porous material layer with the bodily lumen and adhering the portion of the material portion to the bodily lumen with an adhesive portion on the porous material layer so that the adhesive portion secures the porous material layer to the bodily lumen for at least 24 hours following implantation of the prosthesis at the site and the porous material layer is between the bodily lumen and the liquid-impermeable layer.
17. The method according to claim 16 , further comprising expanding a body operably connected to the material portion so that the body provides a radial force against the bodily lumen.
18. The method according to claim 16 , comprising positioning the prosthesis in the lower esophageal sphincter.
19. The method according to claim 16 , comprising positioning the prosthesis in the duodenum.