Hernia patch

Abstract

A hernia patch supporting tissue in-growth conforms to a tissue wall upon surgical installation and fixation within a patient. The hernia patch can include a base and positioning straps. The base is formed of two layers that are affixed to each other around the perimeter of the patch, for example by stitching. A stabilizing washer is provided between the two layers, and the stitch is provided peripherally around the stabilizing washer, keeping the washer free-floating between the layers. The base, positioning straps, and stabilizing washer are formed of a structure that does not separate the layers of the implant or form a space in the form of a pocket, and promotes more uniform and confluent tissue incorporation or in-growth after implantation. The hernia patch may further include a hydrolysable bioabsorbable cross-linked coating of a fatty acid based material, such as an omega-3 fatty acid based material.

Description

RELATED APPLICATION[0001]This application claims priority to, and the benefit of, co-pending U.S. Provisional Application No. 61 / 240,563, filed Sep. 8, 2009, for all subject matter common to both applications. The disclosure of said provisional application is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to a device suitable for use in various forms of hernia repair, and more particularly to an implantable hernia patch with improved handling, placement, and implant performance, having a structure that promotes tissue in-growth following implantation into a patient.BACKGROUND OF THE INVENTION[0003]A hernia is a protrusion of a tissue, structure, or part of an organ through the muscle tissue or the membrane by which it is normally contained. Abdominal hernias are one common type of hernia. In an abdominal hernia, a weakness in the abdominal wall grows into a hole, or defect. Tissue may protrude from the defect. Example herni...

AI Technical Summary

Benefits of technology

[0017]There is a need for a hernia patch constructed of a structural material that mechanically contours uniformly along the plane of the tissue involved in surgical repair of a hernia (e.g., abdominal wall) during installation and strap fixation, a

Problems solved by technology

One shortcoming of the polymeric-only materials used in some conventional hernia patches is that they may fracture, crack, break, and / or separate when subjected to bending, either during surgical installation, handling, insertion, and fixation, or experience the same mechanical failure after a period of time following insertion due to abdominal wall tension, flexion, compression, and / or stretching.

When such common polymer hernia repair materials begin to experience material failure due to mechanical manipulation and disruption, material separation of these components can lead to the formation of sharp edges, which can abrade, irritate, and / or perforate adjacent organ tissue in and around the vicinity of the hernia repair.

This relative stiffness of the conventional hernia patch 100 means that the conventional hernia patch 100 takes its own shape and does not conform itself well to the contours of tissue, such as a patient's abdominal wall.

While it does have some flexibility, such that it can be folded in half during implantation and then it will return to its original shape once the force is removed, it does not have a sufficiently high relative amount of flexibility or elasticity to respond well to the much smaller forces applied to the patch 100 as it is pressed up against a tissue wall.

Further, because the densified perimeter 122 polymer structure does not possess or exhibit a sufficient macro porosity for tissue in-growth, thereby permanently limiting the material from becoming incorporated by remodeling tissue involved in healing at the implant site, these non-conforming structures often become at risk for mechanical disruption, material contraction, and / or device protrusion into other surrounding tissues following implantation.

Such undesirable non-healing effects have further been implicated in published reports of higher reoccurrence rates of the primary hernia repair, chronic pain, and subsequent re-intervention requirements to surgically repair the post operative complication.

This creates a non-uniform and / or irregular shaped surface profile that is often a substantially conical shape in appearance, leaving an undesirable gap or open space between the perimeter body of the conventional hernia patch 100 and the abdominal wall.

This space becomes difficult for tissue to heal across, thereby requiring greater lengths of time for connective tissue to fill in between the perimeter rim of the patch.

Such spaces can further lead to complications of visceral organ entrapment involved with adhesion formation.

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