Methods of forming a tissue implant having a tissue contacting layer held under compression
First Claim
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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 the inner layer and be exposed to native tissue when the tissue implant is introduced into a patient, the inner layer having a compliance which simulates tissue;
stretching the inner layer;
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 while the inner layer is in a stretched state; and
releasing the inner layer after the attaching step such that the inner layer compresses the outer layer between the first point and the second point and holds the outer layer in a compressed state, wherein the releasing step is carried out with the outer layer attached to the inner layer to create an accordion effect on the outer layer.
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Abstract
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.
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Citations
12 Claims
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1. A method of forming a tissue implant, comprising the steps of:
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providing an outer layer and an inner layer, the outer layer configured to cover the inner layer and be exposed to native tissue when the tissue implant is introduced into a patient, the inner layer having a compliance which simulates tissue; stretching the inner layer; 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 while the inner layer is in a stretched state; and releasing the inner layer after the attaching step such that the inner layer compresses the outer layer between the first point and the second point and holds the outer layer in a compressed state, wherein the releasing step is carried out with the outer layer attached to the inner layer to create an accordion effect on the outer layer. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method of enlarging an implant, comprising the steps of:
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providing an implant manufactured in accordance with the steps of;
providing an outer layer and an inner layer, the outer layer configured to cover the inner layer and be exposed to native tissue when the tissue implant is introduced into a patient, the inner layer having a compliance which simulates tissue;
stretching the inner layer;
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 while the inner layer is in a stretched state; and
releasing the inner layer after the attaching step such that the inner layer compresses the outer layer between the first point and the second point and holds the outer layer in a compressed state, wherein the implant includes a central cavity enclosed by the inner layer; andintroducing a filler into the cavity to enlarge the implant. - View Dependent Claims (8, 9, 10, 11, 12)
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Specification