Prosthesis and method for lowering abdominal pressure

Abstract

A two-sheet fascial expander prosthesis for temporary use and method of using it to treat abdominal hypertension and associated organ system function impairment, in which each flat sheet is attached to the fascia only at opposite sides of an incision. One side of each sheet is armed with mating fastening elements that bond when united to bring about high tensile shear strength and low tensile peeling-off resistance permitting easy separation for diagnostic and therapeutic abdominal entry. The invention is useful because it expands the fascia and adds compliance to the envelope of the abdominal cavity by bridging the gap between free borders of the incised fascia containing intra-abdominal organs without strangulating their blood supply and retaining some tension on the fascia to prevent retraction and bringing the edges closer together as healing progresses, and permitting final removal of the patch and fascia-to-fascia closure. The method of producing and testing biocompatibility of the two-sheet fascia prosthesis also is disclosed.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority based on Provisional Patent Application No. 0 / 230,202 filed Sep. 5, 2000. U.S. Pat. No. 5,893,368 Apr. 13, 1999 Sugerman (128 / 898; 601 / 11); U.S. Pat. No. 6,039,741 Mar. 21, 2000 Meislin (606 / 72); U.S. Pat. No. 4,452,245 Jun. 5, 1984 Usher (128 / 334 R) Continuation-in-part Application 37 CFR 1.53(b) (and Amendment 2).[0002]Sir, in response to Office Action of May 8, 2003, please file a continuation-in-part application. A hard copy of this Continuation-in-Part Application has been submitted Aug. 6, 2003 by snail mall. That copy was resubmitted Mar. 20, 2004. This is a technically slightly enhanced version of said Continuation-in-Part application using PTO electronic filing system PASSAT and ePAVE. Remarks / Arguments: Reconsideration of the application is respectfully requested. The application has been amended to more clearly define my invention considering the examiners objection regarding introduction of new...

AI Technical Summary

Benefits of technology

The device effectively decompresses the abdomen, reduces mortality and morbidity by adding compliance to the abdominal fascia, prevents hernia formation, and allows for atraumatic closure with minimal scarring, maintaining a sterile environment and reducing organ dysfunction.

Problems solved by technology

Increased intra-abdominal pressure or abdominal hypertension from any cause occurring acutely may lead to abdominal compartment syndrome because the abdominal cavity with its content is contained within an envelope of limited compliance.

Diminished blood flow to vital organs invariably leads to tissue hypoxia and sequential organ system dysfunction and, if not treated, to death.

Leaving the abdomen open, however, is invariably associated with high mortality rates, fistula formation, and large incisional hernias.

Plastic meshes, however, need to be reopened and often replaced for abdominal re-entry.

Re-uniting the fascias is rarely possible using prior art devices and high rates of abdominal hernias develop in most cases even when meshes are used to cover the open abdomen.

The use of available meshes (U.S. Pat. No. 4,452,245) to bridge the gap between fascias is also associated with high complications and mortality rates similar to the “leaving the abdomen open” technique.

Closing the abdomen forcefully in such situations over increased intra-abdominal volumes will increase intra-abdominal pressure, and lead to multi-system organ failure and death.

As treatment progresses and edema lessens most of the prior art devices cannot accommodate decreases in abdominal distention and have to be replaced by a similar member and resutured.

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