METHODS OF FORMING A 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 method of forming a tissue implant, comprising the steps of:
providing an outer layer and an inner layer, the outer layer configured to cover at least a portion of the inner layer and be exposed to native tissue when the implant is introduced into a patient, the inner layer having a compliance which simulates tissue; and
attaching the outer layer to the inner layer at least a first point on the inner layer and at least a second point on the inner layer, such that following attachment the inner layer compresses the outer layer between the first point and second point and holds the outer layer in a compressed state to permit elongation of the implant between the first point and the second point when the implant is stretched, up to a limit defined by the outer layer.
2 . The method of claim 1 , wherein the outer layer comprises ePTFE.
3 . The method of claim 1 , wherein the outer layer is configured to cover the entire inner layer.
4 . The method of claim 1 , wherein the attaching step is carried out with the outer layer being attached to the inner layer to create an accordion effect on the outer layer.
5 . The method of claim 1 , further comprising the step of stretching the inner layer prior to attaching the outer layer to the inner layer.
6 . The method of claim 5 , wherein the attaching step is carried out while the inner layer is in an elongated state, so that releasing the inner layer causes the inner layer to compress the outer layer between the first point and the second point and hold the outer layer in the compressed state.
7 . The method of claim 1 , further comprising the step of filling the implant with a filler to provide the implant with compliance which simulates tissue.
8 . The method of claim 7 , wherein the filling step is carried out after the implant has been introduced into a patient.
9 . The method of claim 8 , wherein the filling step comprises introducing a volume of filler into the implant which is less than a maximum fill volume of the implant, resulting in the implant being flaccidly filled.
10 . The method of claim 1 , wherein the attaching step is carried out using an adhesive.