Inflatable prostheses and methods of making same

Abstract

An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

Description

RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 13 / 105,715, filed May 11, 2011, which is a continuation-in-part of U.S. patent application Ser. No. 13 / 021,523, filed on Feb. 4, 2011, which claims the benefit of U.S. Provisional Patent Application No. 61 / 301,910, filed on Feb. 5, 2010, and the benefit of U.S. Provisional Patent Application No. 61 / 409,440, filed on Nov. 2, 2010, the entire disclosure of each of these applications being incorporated herein in its entirely by this reference.BACKGROUND INFORMATION[0002]The present invention generally relates to medical implants and more specifically relates to inflatable prostheses, such as tissue expanders, suitable for implantation in a mammal.[0003]Prostheses or implants for reconstruction and / or augmentation of the human body are well known.[0004]Fluid filled prostheses, for example, mammary prostheses or breast implants, are widely used to replace excised tissue, for example after a r...

AI Technical Summary

Benefits of technology

[0042]Advantageously, the misaligned or overlapping members of the adjacent composite guards provide a puncture resistant, or puncture proof, area while not significantly sacrificing flexibility of the assembly as a whole. That is, the composite guards may be arranged such that there are no significant gaps between individual puncture resistant members. It can be appreciated that depending upon the use of the final assembly, there may be some gaps between members so long as the gaps are sufficiently narrow to resist or prevent penetration by the type of instrument that the assembly is intended to be protected against puncture from.

[0043]In any event, in some embodiments of the invention, the puncture resistant members of the composite guards may provide an area of protection that substantially entirely covers a first side of the needle guard assembly.

[0044]The assembly may further comprise a intermediate layer, for example, an elastomer, securing together the first and second composite guards such that the members maintain their offset relationship. The intermediate layer may be located between adjacent composite guards and may be bonded thereto. In one embodiment, the intermediate layer seals the flexible composite members together and encapsulates the composite guards. For example, the intermediate layer may be an fluid tight barrier containing the two or more layered composite guards. In some embodiments, the intermediate layer exhibits a springiness and resiliency or provides a shape memory characteristic to the assembly.

Problems solved by technology

Unfortunately, the valve or fill port is sometimes noticeable to the touch.

One problem with many conventional adjustable implants is that they require a valve to be part of the implant.

It has also proven difficult to develop a flexible protective material that is effective as a puncture resistant material while also being safe for implantation in the body.

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