TISSUE IMPLANT HAVING A BIASED LAYER AND COMPLIANCE THAT SIMULATES TISSUE

• US 20090024228A1
• Filed: 09/30/2008
• Published: 01/22/2009
• Est. Priority Date: 09/16/2004
• Status: Active Grant

• Current Assignee: Evera Medical, Inc.
• Original Assignee: Evera Medical, Inc.
• Inventors: Lesh, Michael
• Granted Patent: US 7,998,202 B2
• 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 tissue implant, comprising:

an inner layer configured to have a compliance which simulates tissue; and

an outer layer which covers the inner layer and is 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 elastically compress the outer layer between the first point and the second point when the inner layer is attached to the outer layer, and the inner layer may be stretched up to a limit set by the outer layer.

2. The tissue implant of claim 1, wherein the implant comprises a filler for providing the compliance which simulates tissue.

3. The tissue implant of claim 2, wherein the inner layer encloses a cavity configured to be filled with the filler after the implant has been introduced into the patient.

4. The tissue implant of claim 2, wherein the inner layer encloses a cavity containing the filler at a pressure of 1 psi or less.

5. The tissue implant of claim 2, wherein the implant is flaccidly filled with the filler such that the volume of filler introduced within the implant is less than the maximum fill volume of the implant.

6. 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.

7. 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.

8. A tissue implant, the implant having a first dimension measured between a first reference point on the implant and a second reference point on the implant, the implant comprising a first layer configured to be manipulatable by an external force to enlarge the distance between the first reference point and the second reference point from the first dimension to a second larger dimension, wherein the first layer is biased such that upon removal of the external force, the first layer is configured to recoil such that the distance between the first reference point and the second reference point returns to about the first dimension.

9. The tissue implant of claim 8, further comprising a second layer configured to provide the bias for the first layer, wherein the first layer is an outer layer and the second layer is an inner layer.

10. The tissue implant of claim 8, wherein the first layer comprises ePTFE.

11. The tissue implant of claim 9, wherein the second, larger dimension is limited by the first layer.