MULTILAYER TISSUE IMPLANT HAVING A COMPLIANCE THAT SIMULATES TISSUE
Disclosed are implantable tissue augmentation devices, methods, and associated tools. The devices include an inflatable body, having an inner layer and an outer layer. A valve is provided for permitting the introduction of and retaining inflation media. At least one pull tab is provided on an end of the implant, to assist in positioning the implant. Kits and systems are also disclosed.
1 . A tissue implant, comprising:
A relatively stretchable inner layer configured to have a compliance which simulates tissue; and
An outer layer comprising a relatively non stretchable material, the outer layer covering the inner layer and exposed to native tissue when the implant is implanted into a patient, the outer layer being attached to the inner layer at least a first point on the inner layer and at least a second point on the inner layer, the inner layer configured to compress the outer layer between the first point and the second point and configured to hold the outer layer in a compressed state such that the distance between the first point and the second point increases when the inner layer and outer layer are stretched, up to a limit permitted by the outer layer.
2 . The tissue implant of claim 1 , wherein the implant is configured such that the inner layer has a stretched, elongated state prior to being attached to the outer layer; wherein the implant is also configured such that upon attaching the outer layer to the inner layer, the inner layer contracts such that a distance between the first point and the second point is decreased thereby reducing the length of the outer layer.
3 . The tissue implant of claim 1 , wherein the implant comprises a filler for providing the compliance which simulates tissue.
4 . The tissue implant of claim 3 , wherein the inner layer is configured to be filled with the filler after the implant has been introduced into the patient.
5 . The tissue implant of claim 3 , wherein the inner layer encloses a cavity which is filled with the filler to a pressure of 1 psi or less.
6 . The tissue implant of claim 3 , wherein the volume of filler introduced within the implant is less than the maximum fill volume of the implant so that the implant remains flaccid following introduction of the filler.
7 . The tissue implant of claim 1 , wherein the outer layer comprises a porous material.
8 . The tissue implant of claim 7 , wherein the outer layer comprises ePTFE.
9 . The tissue implant of claim 1 , wherein the inner layer is configured to axially elongate by at least about 10% between the first point and the second point upon application of tension to the implant.
10 . The tissue implant of claim 1 , wherein the inner layer is configured to axially elongate by at least about 25% between the first point and the second point upon application of tension to the implant.