METHODS OF FORMING A MULTILAYER TISSUE IMPLANT TO CREATE AN ACCORDION EFFECT ON THE OUTER LAYER

• US 20090024227A1
• Filed: 09/30/2008
• Published: 01/22/2009
• Est. Priority Date: 09/16/2004
• Status: Abandoned Application

• Current Assignee: Evera Medical, Inc.
• Original Assignee: Evera Medical, Inc.
• Inventors: Lesh, Michael
• Application Number:
  US12/241,970
• Publication Number:
  US 20090024227A1
• Time in Patent Office: Days
• US Class Current: 623/23.720
• CPC Class Codes: A61B 2017/00792 Plastic surgery
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

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.

Claims

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 create an accordion effect on the outer layer between the first point and the second point.

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, further comprising the step of stretching the inner layer prior to attaching the outer layer to the inner layer.

5. The method of claim 4, wherein the attaching step is carried out while the inner layer is in a stretched state, the inner layer being released after the outer layer is attached to the inner layer so that the inner layer compresses the outer layer between the first point and the second point and holds the outer layer in the compressed state.

6. A method of filling an implant, comprising the steps of providing an implant manufactured in accordance with the method of claim 1, said implant having a cavity enclosed by the inner layer, and further comprising the step of filling the cavity with an amount of filler sufficient to provide the implant with compliance which simulates tissue.

7. The method of claim 6, wherein the filling step is carried out after the implant is introduced into a patient.

8. The method of claim 7, wherein the filling step comprises introducing a volume of filler into the cavity which is less than a maximum fill volume of the cavity, resulting in the implant being flaccidly filled.

9. The method of claim 1, wherein the attaching step is carried out with an adhesive.